Ileoscopic stricture dilation
fact that feeding into the stomach by PEG tube and dislocation or clogging of a PEG-J tube into the stomach led to exacerbation of symptoms in all cases. PEG-J tubes can bypass the stomach and deliver nutrition effectively into the jejunum. PEG-J tube placement also leads to decreased gastric residual volume, which can decrease vomiting frequency. So far, there have been 3 previous reports (n Z 5) of hyperemesis gravidarum managed with PEGJ tubes.10-12 However, HEG was not classified as severe versus not severe, and details of the procedures involving PEG-J tube placement in pregnant patients were not described in these reports. In conclusion, endoscopically inserted feeding tubes at an experienced facility may be a safer method of providing enteral nutrition in patients with severe HEG to prevent adverse maternal and fetal outcomes.
REFERENCES 1. Fairweather DV. Nausea and vomiting in pregnancy. Am J Obstet Gynecol 1968;102:135-75. 2. Vlachodimitropoulou-Koumoutsea E, Gosh S, Manmatharajah B, et al. Pregnancy outcomes in severe hyperemesis gravidarum in a multiethnic population. J Obstet Gynecol 2013;33:455-8.
Chen & Shen 3. Gross S, Librach C, Cecutti A. Maternal weight loss associated with hyperemesis gravidarum: a predictor of fetal outcome. Am J Obstet Gynecol 1989;160:906-9. 4. Russo-Stieglitz KE, Levine AB, Wagner BA, et al. Pregnancy outcome in patients requiring parenteral nutrition. J Maternal-Fetal Med 1999;8: 164-7. 5. Barclay BA. Experience with enteral nutrition in the treatment of hyperemesis gravidarum. Nutrit Clin Pract 1990;5:153-5. 6. Guidelines for endoscopy in pregnant and lactating women. Gastrointest Endosc 2012;76:18-24. 7. Senadhi V, Chaudhary J, Dutta S. Percutaneous endoscopic gastrostomy placement during pregnancy in the critical care setting. Endoscopy 2010;42(suppl 2):E358-9. 8. Cappell MS, Colon VJ, Sidhom OA. A study of eight medical centers of the safety and clinical efficacy of esophagogastroduodenoscopy in 83 pregnant females with follow-up of fetal outcome with comparison control groups. Am J Gastroenterol 1996;91:348-54. 9. Lee NM, Saha S. Nausea and vomiting of pregnancy. Gastroenterol Clin N Am 2011;40:309-34, vii. 10. Serrano P, Velloso A, Garcia-Luna PP, et al. Enteral nutrition by percutaneous endoscopic gastrojejunostomy in severe hyperemesis gravidarum: a report of two cases. Clin Nutrit (Edinburgh, Scotland) 1998;17: 135-9. 11. Godil A, Chen YK. Percutaneous endoscopic gastrostomy for nutrition support in pregnancy associated with hyperemesis gravidarum and anorexia nervosa. JPEN 1998;22:238-41. 12. Irving PM, Howell RJ, Shidrawi RG. Percutaneous endoscopic gastrostomy with a jejunal port for severe hyperemesis gravidarum. Eur J Gastroenterol Hepatol 2004;16:937-9.
Ileoscopic balloon dilation of Crohn’s disease strictures via stoma Min Chen, MD, PhD,1,2 Bo Shen, MD1 Cleveland, Ohio, USA
Permanent ileostomy with or without a partial or complete colectomy is a surgical modality in treating patients with severe distal or perianal Crohn’s disease (CD). Approximately 10% of patients with CD will eventually have a permanent stoma.1 Adverse events after stoma surgery are common, such as retraction, prolapse, and peristomal pyo-
Reprint requests: Bo Shen, MD, Digestive Disease Institute/A31, The Cleveland Clinic Foundation, 9500 Euclid Ave, Cleveland, Ohio 44195.
derma gangrenosum. One of the most significant adverse sequelae in CD patients with stomas is the development of strictures at the distal small bowel. In addition to recurrent CD, other factors may contribute to the development of strictures, including nonsteroidal anti-inflammatory drug (NSAID) use, surgery-related ischemia, or the healing process after medical therapy for bowel inflammation, particularly after anti-tumor necrosis factor-a (anti-TNF-a) therapy.2 The management of CD strictures, especially fibrostenotic ones, can be challenging, because their mechanical nature often makes them refractory to medical therapy. Therefore, those fibrostenotic strictures usually have been managed with surgical intervention, including bowel resection or stricturoplasty. However, patients treated with the surgery carry the risk of developing operative morbidity and mortality. In addition, strictures often recur after surgery, with a reported frequency ranging from 19% to 34%.3,4 For the past decade, endoscopic therapy has emerged as a valid alternative to surgical treatment. The endoscopic approach is less invasive than surgery. Endoscopic
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Abbreviations: CD, Crohn’s disease; IBD, inflammatory bowel disease; IC, indeterminate colitis; IQR, interquartile range; IRB, Institutional Review Board; NSAID, non-steroidal anti-inflammatory drugs; SD, standard deviation; TNF-a, tumor necrosis factor-a; UC, ulcerative colitis. DISCLOSURE: All authors disclosed no financial relationships relevant to this publication. Copyright ª 2014 by the American Society for Gastrointestinal Endoscopy 0016-5107/$36.00 http://dx.doi.org/10.1016/j.gie.2013.11.005 Received September 26, 2013. Accepted November 2, 2013. Current affiliations: Department of Gastroenterology/Hepatology, Cleveland Clinic Foundation, Cleveland, Ohio, USA (1); Department of Gastroenterology, Zhongnan Hospital of Wuhan University, Wuhan, Hubei Province, China (2).
Chen & Shen
Ileoscopic stricture dilation
Figure 1. Ileoscopic balloon dilation via stoma in a patient with a small-bowel Crohn’s disease stricture. A, Direct visualization of the neo-distal smallbowel CD stricture. B, Inflation of ileoscopic balloon.
balloon dilation has been shown to be an effective and safe option for the treatment of strictures at the colon,5-7 small bowel,8,9 and ileal pouch10 in CD patients without ileostomy. However, there were no published studies in the current literature in the management of small-bowel strictures in patients with ileostomies. The aim of this study was to assess the feasibility, efficacy, and safety of ileoscopic balloon dilation of small-bowel strictures in patients with CD with permanent end ileostomies.
METHODS Patients The Cleveland Clinic Institutional Review Board approved this study (IRB #13-660). Consecutive patients were identified from our Center for Inflammatory Bowel Disease (IBD) from January 2001 to July 2013. Inclusion criteria were: (1) CD patients with permanent end ileostomies; (2) patients having small-bowel strictures, with or without bowel obstruction symptoms; and (3) ileoscopic balloon dilation of strictures via a stoma. Excluded were those with (1) underlying ulcerative colitis (UC) or indeterminate colitis (IC) with temporary loop ileostomy for the ileal pouch construction; (2) conditions other than inflammatory bowel disease, such as motor vehicle accident; (3) temporary diverting ileostomy; (4) small-bowel strictures longer than 5 cm, which were not amenable to endoscopic dilation; (5) strictures complicated by fistula or abscess; (6) malignant strictures; or (7) ileal pouch strictures.
Endoscopic protocol Informed consent pertaining to endoscopic treatment of strictures was obtained from all patients undergoing ileoscopy via stoma. Routine diagnostic or surveillance (for monitoring of recurrent CD) ileoscopy was performed in an outpatient setting by the experienced endoscopist (B.S.). Before the initial procedure, patients typically had www.giejournal.org
CT enterography and/or retrograde water-soluble contrasted enema via the stoma to delineate the number, degree, length, and location of strictures and associated conditions (such as fistula or abscess). Once strictures were detected during endoscopy, balloon dilation therapy was routinely performed, regardless of the presence or absence of symptoms. The postoperative endoscopic recurrence of CD in patients with ileostomies was retrospectively graded, based on the Rutgeerts Score.11 The degree of strictures was quantified by the endoscopist, based on the degree of resistance to the passage of an upper endoscope10 (0 Z no resistance; 1 Z mild resistance; 2 Z moderate resistance; 3 Z severe resistance; and 4 Z pinhole and not traversable). Ileoscopic dilation not guided by fluoroscopy was performed via stoma with an 8.6-mm, flexible, single-channel, upper endoscope (GIF-160 or H-180 series; Olympus Optical, Tokyo, Japan), with a through-the-scope balloon system (CRE balloon, Boston Scientific Microvasive, Natick, Mass). The balloon size ranged from 16 to 20 mm. For high-grade or angulated strictures not traversable to the endoscope, antegrade, wire-exchange technique balloon dilation was used (Fig. 1). Intralesional corticosteroid injection was performed in selected patients at the discretion of the endoscopist. A long-acting, non-diluted corticosteroid (Kenalog 50 mg/ 5 mL) was injected. In selected patients with tight, fibrotic strictures that were refractory to endoscopic balloon dilation, endoscopic needle-knife stricturotomy was attempted. Patients were closely monitored for signs of excessive bleeding and bowel perforation after the procedure in the endoscopy recovery room for at least 30 minutes.
Definitions of variables Demographic and clinical variables were defined as follows: (1) active smokerdconsumption of more than 7 cigarettes per week for at least 6 months before the Volume 79, No. 4 : 2014 GASTROINTESTINAL ENDOSCOPY 689
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TABLE 1. Demographic and clinical characteristics Factor
All (N [ 25)
TABLE 1. Continued Factor
All (N [ 25)
Age at diagnosis of CD, mean SD, y
24.6 11.9
Age at ileostomy, mean SD, y
37.5 13.8
Cholecystectomy
5 (20.0%)
Age at the first dilation, mean SD, y
44.5 13.1
Hysterectomy
2 (8.0%)
Duration of CD, mean SD, y
19.4 13.4
Ventral hernia repair
4 (16.0%)
Duration of ileostomy, mean SD, y
7.3 6.0
Male sex, no. (%)
11 (44.0%)
Smoking habit, no. (%)
History of abdominal surgery not related to IBD, no. (%)
Concomitant therapies at the first dilation, no. (%) Mesalamine
5 (20.0%)
Corticosteroid
10 (40.0%)
Never
18 (72.0%)
Immunomodulators
8 (32.0%)
Former
4 (16.0%)
Anti-tumor necrosis factor-a
7 (28.0%)
Active
3 (12.0%)
Antibiotics
3 (12.0%)
Family history of IBD, no. (%) CD
5 (20.0%)
UC
1 (4.0%)
Chronic NSAID use, no. (%)
4 (16.0%)
Disease location before ileostomy, no. (%) Ileum
1 (4.0%)
Ileocolon
24 (96.0%)
Upper GI tract
5 (20.0%)
Disease phenotype before ileostomy, no. (%) Inflammatory
4 (16.0%)
Stricturing
3 (12.0%)
Penetrating
18 (72.0%)
Perianal
7 (28.0%)
Extraintestinal manifestations, no. (%)
CD, Crohn’s disease; SD, standard deviation; IBD, inflammatory bowel disease; UC, ulcerative colitis; NSAID, nonsteroidal antiinflammatory drug.
6 (24.0%)
Symptoms at the first dilation, no. (%) Asymptomatic
7 (28.0%)
Abdominal pain
14 (56.0%)
Nausea or vomiting
7 (28.0%)
Bloating
3 (12.0%)
IBD-related surgery before the first dilation, no. (%)
data entry; (2) former smokerdcessation of smoking at least 6 months before the data entry; and (3) concomitant therapy at first dilationdany use of mesalamine, corticosteroid, immunomodulators, anti-tumor necrosis factor-a agents, or antibiotics for more than 3 months before the data entry. The phenotype of CD in this cohort was retrospectively documented, based on a modification from the Montreal Classification.12
Outcome measurement The primary outcomes were immediate technical success and long-term success. The passage of the endoscope through the endoscopically treated strictures without resistance was defined as immediate technical success. Longterm success was defined as the avoidance of surgical intervention. A complete and partial technical failure was defined as the failure of passage of the endoscope through all and some of the strictures after dilation. The secondary outcome was the safety of the endoscopic therapy. The safety was defined as the occurrence of any major adverse event (excessive bleeding or bowel perforation) related to the procedure that required hospitalization and/or surgical intervention.
Bowel resection
24 (96.0%)
Stricturoplasty
4 (16.0%)
Stricture resection
1 (4.0%)
Statistical analysis
Stricturoplasty and stricture resection
2 (8.0%)
Kaplan-Meier analysis was performed to assess the surgery-free survival. SPSS version 13.0 (SPSS Institute Chicago, IL) was used to perform all analyses.
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TABLE 2. Characteristics of strictures and dilation procedures Factor
All cases (N [ 25)
Strictures at ileum within 20 cm of the stoma, no. (%)
20 (80.0%)
No. of strictures, mean SD
2.4 1.7
Cases with multiple strictures (R 2 strictures), no. (%)
14 (56.0%)
Stricture length, mean SD, cm
1.1 0.6
Degree of stricture, mean SD
2.5 1.0
Rutgeerts score, mean SD
1.3 0.9
No. of ileoscopies with dilations, median (IQR)
2.0 (1.0-4.5)
Cumulative no. of strictures dilated, median (IQR)
3.0 (1.5-9.5)
Balloon size, median (IQR), mm
19 (16-20)
Cases with corticosteroid injection ever, no. (%)
7 (28.0%)
Cases with use of needle-knife therapy ever, no. (%)
4 (16.0%)
SD, Standard deviation; IQR, interquartile range.
RESULTS Demographic and clinical features We identified 25 consecutive eligible outpatients with ileoscopic balloon dilations of CD strictures via stoma. Demographic and clinical characteristics of patients are shown in Table 1.
Characteristics of strictures A total of 179 strictures were detected in the 25 patients, with 178 strictures being endoscopically dilated. One stricture was not dilated, because of the presence of a concomitant fistula. Twenty patients (80.0%) had strictures at the neo-distal ileum within 20 cm of the stoma. Fourteen patients (56.0%) had more than one stricture. The mean ( standard deviation [SD]) number of strictures per patient was 2.4 1.7; the mean length of strictures was 1.1 0.6 cm, and the mean degree of stricture was 2.5 1.0. The mean Rutgeerts Score of the 24 patients with surgical history of bowel resection was 1.3 0.9.
patient. The median size of endoscopic balloon used was 19 mm (IQR: 16-20 mm) (Table 2). Seven patients (28.0%) had intralesional corticosteroid injection during the endoscopy dilation. Four patients (16.0%) were treated with needle-knife stricturotomy for strictures refractory to endoscopic dilation.
Immediate outcome of initial endoscopic therapy Of the 75 ileoscopic dilation procedures, a complete technical success was achieved in 70 (93.3%) sessions. Endoscopic dilation partially failed in 2 sessions. In 1 session for the treatment of 3 strictures, 1 stricture was tight and angulated, not allowing for the safe position of the balloon. In another session for treating 2 strictures of the same patients, the endoscope was traversed in only 1 stricture after dilation. Endoscopic dilation therapy completely failed in 3 sessions of 3 different patients. In 1 session for treating 1 stricture, the endoscope could not be passed through the stricture after balloon dilation. In another 2 sessions, endoscopic dilation failed because the 2 patients had procedurerelated bowel perforations.
Long-term outcome of endoscopic treatment Of the 25 patients undergoing the initial dilation, 7 (28.0%) did not require surgery or further endoscopic dilation during the follow-up period; 16 (64.0%) required further endoscopic dilations; and 2 (8.0%) had surgery for newly developed fistulas (n Z 1) or bowel perforation from the endoscopic procedure (n Z 1). Of the 16 patients undergoing the second dilation, 4 (25.0%) required no further dilation or surgery; 10 (62.5%) required further endoscopic dilation; and 2 (12.5%) required surgery for persistent obstructive bowel symptoms during the follow-up period. Of the 10 patients undergoing the third dilation, 2 (20.0%) did not need further endoscopic dilation or surgery; 7 (70.0%) required additional endoscopic dilations; and 1 (10.0%) had surgery for procedure-asscociated bowel perforation. The mean ( SD) follow-up period for the whole cohort was 21.6 26.1 months (range, 5 days-94 months). Of the 25 patients, a total of 20 (80.0%) remained surgery-free at the end of follow-up, and a total of 5 (20.0%) required surgical intervention for newly developed fistulas (n Z 1), persistent obstructive bowel symptoms (n Z 2), or bowel perforations (n Z 2) (Fig. 2). The cumulative frequency of surgery-free survival is shown in Figure 3.
Endoscopic treatment A total of 75 sessions of ileoscopic balloon dilation via stoma were performed in the 25 patients. There were a median of 2 ileoscopies (interquartile ratio [IQR]: 1.0-4.5) and 3 cumulative strictures dilated (IQR: 1.5-9.5) for each
Safety of endoscopic therapy
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The majority of patients tolerated the procedure well. Procedure-related bowel perforation occurred in 2 patients (2.7%), requiring hospitalization and urgent surgery.
Ileoscopic stricture dilation
Chen & Shen
Figure 2. Flowchart of outcome of 25 patients with ileoscopic balloon dilation via stoma after a median follow-up of 21.6 months.
Small-bowel stricture is a common adverse event in patients with CD with stomas. In 1 study of 99 patients with CD with permanent end ileostomy, the prevalence of strictures was as high as 16.2%.13 The management of CD strictures has been challenging. CD strictures, particularly fibrostenotic ones, typically did not respond to medical therapy. Although surgical bowel resection and reanastomosis or stricturoplasty is effective in treating
CD strictures, the risk of postoperative recurrence is high. In addition, the surgery is often associated with postoperative complications. Previous studies showed that 34% of patients with CD who underwent stricturoplasty3 and 19% who underwent stricture resection4 had recurrent strictures after a median follow-up of 7.5 and 4.2 years, respectively. Therefore, endoscopic balloon dilation appears to be a valid alternative to surgical intervention in the treatment of CD strictures. Endoscopic balloon dilation has been demonstrated to be a feasible and effective procedure in the treatment of CD strictures at the colon,5-7 small bowel,8,9 or ileal pouch10 in patients without ileostomies. A meta-analysis of 23 publications, with a total of 574 patients, reported a technical success rate of 90%, with a surgery-free rate ranging from 53% to 92%.14 In a separate meta-analysis involving 13 studies, with a total of 347 patients, the technical success rate was 86%, and long-term, surgery-free survival was achieved in 58% of patients.15 However, there were no published data on ileoscopic balloon dilation of small-bowel CD strictures via stoma. Our study showed that ileoscopic balloon dilation via stoma is feasible and efficacious in treating small-bowel CD strictures, with a high technical success rate of 93.3% (70/ 75) and a high surgery-free rate of 80.0% (20/25). Although only 6 patients (24.0%) did not require further dilation and surgery after the initial dilation, this procedure can be repeated safely. After 1 or more dilations, a total of 20 patients (80.0%) remained surgery-free at the end of the follow-up. In addition, endoscopic balloon dilation spaced out the need for surgery for a median
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Figure 3. Kaplan-Meier curve for surgery-free survival after the first balloon dilation.
DISCUSSION
Chen & Shen
Ileoscopic stricture dilation
follow-up of 11.6 months in the other 5 patients who required surgery. With an invasive procedure, safety is a major concern. The reported adverse event rate of balloon dilation in patients without stoma ranged from 0% to 18%, with the rate being lower than 5% in the majority of studies.15 In our study, the adverse event rate was similar to those of published studies in patient without stomas, with a low frequency of 2.7% (2/75). Bowel perforation occurred in treating 2 strictures, which were tight and refractory to balloon dilation and were treated with a needle-knife. However, for those patients with refractory strictures, surgical treatment would be inevitable if needle-knife therapy had not been attempted. The findings of our study have several clinical implications. Ileoscopic balloon dilation via stoma is technically feasible for small-bowel CD strictures in experienced hands. Given the good outcome of this technique in our cohort, ileoscopic balloon dilation via stoma may be attempted for strictures !5 cm in patients with CD with ileostomies. In addition, our study demonstrated that endoscopic balloon dilation appeared to be safe. Our study has several limitations. The study was not randomized or controlled. It has been difficult to conduct a randomized trial in this setting. Another limitation of our study is the small number of patients, although the largest in the literature, which precluded a meaningful multivariable analysis of risk factors associated with failure of endoscopy therapy. In addition, this study was performed in a tertiary referral center, which may have led to potential referral or selection bias. It is not clear whether we should treat the CD strictures of asymptomatic patients with ileoscopic balloon dilation. In conclusion, ileoscopic balloon dilation via stoma appeared to be feasible, effective, and safe in treating CD strictures in selected patients with ileostomies.
REFERENCES
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Volume 79, No. 4 : 2014 GASTROINTESTINAL ENDOSCOPY 693
1. Cosnes J, Gower-Rousseau C, Seksik P, et al. Epidemiology and natural history of inflammatory bowel diseases. Gastroenterology 2011;140: 1785-94. 2. Toy LS, Scherl J, Kornbluth A, et al. Complete bowel obstruction following initial response to infliximab therapy for Crohn’s disease: a series of newly described complications. Gastroenterology 2000;118:A569. 3. Dietz DW, Laureti S, Strong SA, et al. Safety and longterm efficacy of strictureplasty in 314 patients with obstructing small bowel Crohn’s disease. J Am Coll Surg 2001;192:330-7. 4. Scarpa M, Angriman I, Barollo M, et al. Risk factors for recurrence of stenosis in Crohn’s disease. Acta Biomed 2003;74(suppl 2):80-3. 5. Scimeca D, Mocciaro F, Cottone M, et al. Efficacy and safety of endoscopic balloon dilation of symptomatic intestinal Crohn’s disease strictures. Dig Liver Dis 2011;43:121-5. 6. Gustavsson A, Magnuson A, Blomberg B, et al. Endoscopic dilation is an efficacious and safe treatment of intestinal strictures in Crohn’s disease. Aliment Pharmacol Ther 2012;36:151-8. 7. Thienpont C, D'Hoore A, Vermeire S, et al. Long-term outcome of endoscopic dilatation in patients with Crohn’s disease is not affected by disease activity or medical therapy. Gut 2010;59:320-4. 8. Despott EJ, Gupta A, Burling D, et al. Effective dilation of small-bowel strictures by double-balloon enteroscopy in patients with symptomatic Crohn’s disease (with video). Gastrointest Endosc 2009;70:1030-6. 9. Pohl J, May A, Nachbar L, et al. Diagnostic and therapeutic yield of push-and-pull enteroscopy for symptomatic small bowel Crohn’s disease strictures. Eur J Gastroenterol Hepatol 2007;19:529-34. 10. Shen B, Lian L, Kiran RP, et al. Efficacy and safety of endoscopic treatment of ileal pouch strictures. Inflamm Bowel Dis 2011;17:2527-35. 11. Rutgeerts P, Geboes K, Vantrappen G, et al. Predictability of the postoperative course of Crohn’s disease. Gastroenterology 1990;99:956-63. 12. Satsangi J, Silverberg MS, Vermeire S, et al. The Montreal classification of inflammatory bowel disease: controversies, consensus, and implications. Gut 2006;55:749-53. 13. Vadlamudi N, Alkhouri N, Mahajan L, et al. Ileoscopy via stoma after diverting ileostomy: a safe and effective tool to evaluate for Crohn’s recurrence of neoterminal ileum. Dig Dis Sci 2011;56:866-70. 14. Wibmer AG, Kroesen AJ, Grone J, et al. Comparison of strictureplasty and endoscopic balloon dilatation for stricturing Crohn’s diseased review of the literature. Int J Colorectal Dis 2010;25:1149-57. 15. Hassan C, Zullo A, De Francesco V, et al. Systematic review: endoscopic dilatation in Crohn’s disease. Aliment Pharmacol Ther 2007;26:1457-64.
fact that feeding into the stomach by PEG tube and dislocation or clogging of a PEG-J tube into the stomach led to exacerbation of symptoms in all cases. PEG-J tubes can bypass the stomach and deliver nutrition effectively into the jejunum. PEG-J tube placement also leads to decreased gastric residual volume, which can decrease vomiting frequency. So far, there have been 3 previous reports (n Z 5) of hyperemesis gravidarum managed with PEGJ tubes.10-12 However, HEG was not classified as severe versus not severe, and details of the procedures involving PEG-J tube placement in pregnant patients were not described in these reports. In conclusion, endoscopically inserted feeding tubes at an experienced facility may be a safer method of providing enteral nutrition in patients with severe HEG to prevent adverse maternal and fetal outcomes.
REFERENCES 1. Fairweather DV. Nausea and vomiting in pregnancy. Am J Obstet Gynecol 1968;102:135-75. 2. Vlachodimitropoulou-Koumoutsea E, Gosh S, Manmatharajah B, et al. Pregnancy outcomes in severe hyperemesis gravidarum in a multiethnic population. J Obstet Gynecol 2013;33:455-8.
Chen & Shen 3. Gross S, Librach C, Cecutti A. Maternal weight loss associated with hyperemesis gravidarum: a predictor of fetal outcome. Am J Obstet Gynecol 1989;160:906-9. 4. Russo-Stieglitz KE, Levine AB, Wagner BA, et al. Pregnancy outcome in patients requiring parenteral nutrition. J Maternal-Fetal Med 1999;8: 164-7. 5. Barclay BA. Experience with enteral nutrition in the treatment of hyperemesis gravidarum. Nutrit Clin Pract 1990;5:153-5. 6. Guidelines for endoscopy in pregnant and lactating women. Gastrointest Endosc 2012;76:18-24. 7. Senadhi V, Chaudhary J, Dutta S. Percutaneous endoscopic gastrostomy placement during pregnancy in the critical care setting. Endoscopy 2010;42(suppl 2):E358-9. 8. Cappell MS, Colon VJ, Sidhom OA. A study of eight medical centers of the safety and clinical efficacy of esophagogastroduodenoscopy in 83 pregnant females with follow-up of fetal outcome with comparison control groups. Am J Gastroenterol 1996;91:348-54. 9. Lee NM, Saha S. Nausea and vomiting of pregnancy. Gastroenterol Clin N Am 2011;40:309-34, vii. 10. Serrano P, Velloso A, Garcia-Luna PP, et al. Enteral nutrition by percutaneous endoscopic gastrojejunostomy in severe hyperemesis gravidarum: a report of two cases. Clin Nutrit (Edinburgh, Scotland) 1998;17: 135-9. 11. Godil A, Chen YK. Percutaneous endoscopic gastrostomy for nutrition support in pregnancy associated with hyperemesis gravidarum and anorexia nervosa. JPEN 1998;22:238-41. 12. Irving PM, Howell RJ, Shidrawi RG. Percutaneous endoscopic gastrostomy with a jejunal port for severe hyperemesis gravidarum. Eur J Gastroenterol Hepatol 2004;16:937-9.
Ileoscopic balloon dilation of Crohn’s disease strictures via stoma Min Chen, MD, PhD,1,2 Bo Shen, MD1 Cleveland, Ohio, USA
Permanent ileostomy with or without a partial or complete colectomy is a surgical modality in treating patients with severe distal or perianal Crohn’s disease (CD). Approximately 10% of patients with CD will eventually have a permanent stoma.1 Adverse events after stoma surgery are common, such as retraction, prolapse, and peristomal pyo-
Reprint requests: Bo Shen, MD, Digestive Disease Institute/A31, The Cleveland Clinic Foundation, 9500 Euclid Ave, Cleveland, Ohio 44195.
derma gangrenosum. One of the most significant adverse sequelae in CD patients with stomas is the development of strictures at the distal small bowel. In addition to recurrent CD, other factors may contribute to the development of strictures, including nonsteroidal anti-inflammatory drug (NSAID) use, surgery-related ischemia, or the healing process after medical therapy for bowel inflammation, particularly after anti-tumor necrosis factor-a (anti-TNF-a) therapy.2 The management of CD strictures, especially fibrostenotic ones, can be challenging, because their mechanical nature often makes them refractory to medical therapy. Therefore, those fibrostenotic strictures usually have been managed with surgical intervention, including bowel resection or stricturoplasty. However, patients treated with the surgery carry the risk of developing operative morbidity and mortality. In addition, strictures often recur after surgery, with a reported frequency ranging from 19% to 34%.3,4 For the past decade, endoscopic therapy has emerged as a valid alternative to surgical treatment. The endoscopic approach is less invasive than surgery. Endoscopic
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Abbreviations: CD, Crohn’s disease; IBD, inflammatory bowel disease; IC, indeterminate colitis; IQR, interquartile range; IRB, Institutional Review Board; NSAID, non-steroidal anti-inflammatory drugs; SD, standard deviation; TNF-a, tumor necrosis factor-a; UC, ulcerative colitis. DISCLOSURE: All authors disclosed no financial relationships relevant to this publication. Copyright ª 2014 by the American Society for Gastrointestinal Endoscopy 0016-5107/$36.00 http://dx.doi.org/10.1016/j.gie.2013.11.005 Received September 26, 2013. Accepted November 2, 2013. Current affiliations: Department of Gastroenterology/Hepatology, Cleveland Clinic Foundation, Cleveland, Ohio, USA (1); Department of Gastroenterology, Zhongnan Hospital of Wuhan University, Wuhan, Hubei Province, China (2).
Chen & Shen
Ileoscopic stricture dilation
Figure 1. Ileoscopic balloon dilation via stoma in a patient with a small-bowel Crohn’s disease stricture. A, Direct visualization of the neo-distal smallbowel CD stricture. B, Inflation of ileoscopic balloon.
balloon dilation has been shown to be an effective and safe option for the treatment of strictures at the colon,5-7 small bowel,8,9 and ileal pouch10 in CD patients without ileostomy. However, there were no published studies in the current literature in the management of small-bowel strictures in patients with ileostomies. The aim of this study was to assess the feasibility, efficacy, and safety of ileoscopic balloon dilation of small-bowel strictures in patients with CD with permanent end ileostomies.
METHODS Patients The Cleveland Clinic Institutional Review Board approved this study (IRB #13-660). Consecutive patients were identified from our Center for Inflammatory Bowel Disease (IBD) from January 2001 to July 2013. Inclusion criteria were: (1) CD patients with permanent end ileostomies; (2) patients having small-bowel strictures, with or without bowel obstruction symptoms; and (3) ileoscopic balloon dilation of strictures via a stoma. Excluded were those with (1) underlying ulcerative colitis (UC) or indeterminate colitis (IC) with temporary loop ileostomy for the ileal pouch construction; (2) conditions other than inflammatory bowel disease, such as motor vehicle accident; (3) temporary diverting ileostomy; (4) small-bowel strictures longer than 5 cm, which were not amenable to endoscopic dilation; (5) strictures complicated by fistula or abscess; (6) malignant strictures; or (7) ileal pouch strictures.
Endoscopic protocol Informed consent pertaining to endoscopic treatment of strictures was obtained from all patients undergoing ileoscopy via stoma. Routine diagnostic or surveillance (for monitoring of recurrent CD) ileoscopy was performed in an outpatient setting by the experienced endoscopist (B.S.). Before the initial procedure, patients typically had www.giejournal.org
CT enterography and/or retrograde water-soluble contrasted enema via the stoma to delineate the number, degree, length, and location of strictures and associated conditions (such as fistula or abscess). Once strictures were detected during endoscopy, balloon dilation therapy was routinely performed, regardless of the presence or absence of symptoms. The postoperative endoscopic recurrence of CD in patients with ileostomies was retrospectively graded, based on the Rutgeerts Score.11 The degree of strictures was quantified by the endoscopist, based on the degree of resistance to the passage of an upper endoscope10 (0 Z no resistance; 1 Z mild resistance; 2 Z moderate resistance; 3 Z severe resistance; and 4 Z pinhole and not traversable). Ileoscopic dilation not guided by fluoroscopy was performed via stoma with an 8.6-mm, flexible, single-channel, upper endoscope (GIF-160 or H-180 series; Olympus Optical, Tokyo, Japan), with a through-the-scope balloon system (CRE balloon, Boston Scientific Microvasive, Natick, Mass). The balloon size ranged from 16 to 20 mm. For high-grade or angulated strictures not traversable to the endoscope, antegrade, wire-exchange technique balloon dilation was used (Fig. 1). Intralesional corticosteroid injection was performed in selected patients at the discretion of the endoscopist. A long-acting, non-diluted corticosteroid (Kenalog 50 mg/ 5 mL) was injected. In selected patients with tight, fibrotic strictures that were refractory to endoscopic balloon dilation, endoscopic needle-knife stricturotomy was attempted. Patients were closely monitored for signs of excessive bleeding and bowel perforation after the procedure in the endoscopy recovery room for at least 30 minutes.
Definitions of variables Demographic and clinical variables were defined as follows: (1) active smokerdconsumption of more than 7 cigarettes per week for at least 6 months before the Volume 79, No. 4 : 2014 GASTROINTESTINAL ENDOSCOPY 689
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TABLE 1. Demographic and clinical characteristics Factor
All (N [ 25)
TABLE 1. Continued Factor
All (N [ 25)
Age at diagnosis of CD, mean SD, y
24.6 11.9
Age at ileostomy, mean SD, y
37.5 13.8
Cholecystectomy
5 (20.0%)
Age at the first dilation, mean SD, y
44.5 13.1
Hysterectomy
2 (8.0%)
Duration of CD, mean SD, y
19.4 13.4
Ventral hernia repair
4 (16.0%)
Duration of ileostomy, mean SD, y
7.3 6.0
Male sex, no. (%)
11 (44.0%)
Smoking habit, no. (%)
History of abdominal surgery not related to IBD, no. (%)
Concomitant therapies at the first dilation, no. (%) Mesalamine
5 (20.0%)
Corticosteroid
10 (40.0%)
Never
18 (72.0%)
Immunomodulators
8 (32.0%)
Former
4 (16.0%)
Anti-tumor necrosis factor-a
7 (28.0%)
Active
3 (12.0%)
Antibiotics
3 (12.0%)
Family history of IBD, no. (%) CD
5 (20.0%)
UC
1 (4.0%)
Chronic NSAID use, no. (%)
4 (16.0%)
Disease location before ileostomy, no. (%) Ileum
1 (4.0%)
Ileocolon
24 (96.0%)
Upper GI tract
5 (20.0%)
Disease phenotype before ileostomy, no. (%) Inflammatory
4 (16.0%)
Stricturing
3 (12.0%)
Penetrating
18 (72.0%)
Perianal
7 (28.0%)
Extraintestinal manifestations, no. (%)
CD, Crohn’s disease; SD, standard deviation; IBD, inflammatory bowel disease; UC, ulcerative colitis; NSAID, nonsteroidal antiinflammatory drug.
6 (24.0%)
Symptoms at the first dilation, no. (%) Asymptomatic
7 (28.0%)
Abdominal pain
14 (56.0%)
Nausea or vomiting
7 (28.0%)
Bloating
3 (12.0%)
IBD-related surgery before the first dilation, no. (%)
data entry; (2) former smokerdcessation of smoking at least 6 months before the data entry; and (3) concomitant therapy at first dilationdany use of mesalamine, corticosteroid, immunomodulators, anti-tumor necrosis factor-a agents, or antibiotics for more than 3 months before the data entry. The phenotype of CD in this cohort was retrospectively documented, based on a modification from the Montreal Classification.12
Outcome measurement The primary outcomes were immediate technical success and long-term success. The passage of the endoscope through the endoscopically treated strictures without resistance was defined as immediate technical success. Longterm success was defined as the avoidance of surgical intervention. A complete and partial technical failure was defined as the failure of passage of the endoscope through all and some of the strictures after dilation. The secondary outcome was the safety of the endoscopic therapy. The safety was defined as the occurrence of any major adverse event (excessive bleeding or bowel perforation) related to the procedure that required hospitalization and/or surgical intervention.
Bowel resection
24 (96.0%)
Stricturoplasty
4 (16.0%)
Stricture resection
1 (4.0%)
Statistical analysis
Stricturoplasty and stricture resection
2 (8.0%)
Kaplan-Meier analysis was performed to assess the surgery-free survival. SPSS version 13.0 (SPSS Institute Chicago, IL) was used to perform all analyses.
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TABLE 2. Characteristics of strictures and dilation procedures Factor
All cases (N [ 25)
Strictures at ileum within 20 cm of the stoma, no. (%)
20 (80.0%)
No. of strictures, mean SD
2.4 1.7
Cases with multiple strictures (R 2 strictures), no. (%)
14 (56.0%)
Stricture length, mean SD, cm
1.1 0.6
Degree of stricture, mean SD
2.5 1.0
Rutgeerts score, mean SD
1.3 0.9
No. of ileoscopies with dilations, median (IQR)
2.0 (1.0-4.5)
Cumulative no. of strictures dilated, median (IQR)
3.0 (1.5-9.5)
Balloon size, median (IQR), mm
19 (16-20)
Cases with corticosteroid injection ever, no. (%)
7 (28.0%)
Cases with use of needle-knife therapy ever, no. (%)
4 (16.0%)
SD, Standard deviation; IQR, interquartile range.
RESULTS Demographic and clinical features We identified 25 consecutive eligible outpatients with ileoscopic balloon dilations of CD strictures via stoma. Demographic and clinical characteristics of patients are shown in Table 1.
Characteristics of strictures A total of 179 strictures were detected in the 25 patients, with 178 strictures being endoscopically dilated. One stricture was not dilated, because of the presence of a concomitant fistula. Twenty patients (80.0%) had strictures at the neo-distal ileum within 20 cm of the stoma. Fourteen patients (56.0%) had more than one stricture. The mean ( standard deviation [SD]) number of strictures per patient was 2.4 1.7; the mean length of strictures was 1.1 0.6 cm, and the mean degree of stricture was 2.5 1.0. The mean Rutgeerts Score of the 24 patients with surgical history of bowel resection was 1.3 0.9.
patient. The median size of endoscopic balloon used was 19 mm (IQR: 16-20 mm) (Table 2). Seven patients (28.0%) had intralesional corticosteroid injection during the endoscopy dilation. Four patients (16.0%) were treated with needle-knife stricturotomy for strictures refractory to endoscopic dilation.
Immediate outcome of initial endoscopic therapy Of the 75 ileoscopic dilation procedures, a complete technical success was achieved in 70 (93.3%) sessions. Endoscopic dilation partially failed in 2 sessions. In 1 session for the treatment of 3 strictures, 1 stricture was tight and angulated, not allowing for the safe position of the balloon. In another session for treating 2 strictures of the same patients, the endoscope was traversed in only 1 stricture after dilation. Endoscopic dilation therapy completely failed in 3 sessions of 3 different patients. In 1 session for treating 1 stricture, the endoscope could not be passed through the stricture after balloon dilation. In another 2 sessions, endoscopic dilation failed because the 2 patients had procedurerelated bowel perforations.
Long-term outcome of endoscopic treatment Of the 25 patients undergoing the initial dilation, 7 (28.0%) did not require surgery or further endoscopic dilation during the follow-up period; 16 (64.0%) required further endoscopic dilations; and 2 (8.0%) had surgery for newly developed fistulas (n Z 1) or bowel perforation from the endoscopic procedure (n Z 1). Of the 16 patients undergoing the second dilation, 4 (25.0%) required no further dilation or surgery; 10 (62.5%) required further endoscopic dilation; and 2 (12.5%) required surgery for persistent obstructive bowel symptoms during the follow-up period. Of the 10 patients undergoing the third dilation, 2 (20.0%) did not need further endoscopic dilation or surgery; 7 (70.0%) required additional endoscopic dilations; and 1 (10.0%) had surgery for procedure-asscociated bowel perforation. The mean ( SD) follow-up period for the whole cohort was 21.6 26.1 months (range, 5 days-94 months). Of the 25 patients, a total of 20 (80.0%) remained surgery-free at the end of follow-up, and a total of 5 (20.0%) required surgical intervention for newly developed fistulas (n Z 1), persistent obstructive bowel symptoms (n Z 2), or bowel perforations (n Z 2) (Fig. 2). The cumulative frequency of surgery-free survival is shown in Figure 3.
Endoscopic treatment A total of 75 sessions of ileoscopic balloon dilation via stoma were performed in the 25 patients. There were a median of 2 ileoscopies (interquartile ratio [IQR]: 1.0-4.5) and 3 cumulative strictures dilated (IQR: 1.5-9.5) for each
Safety of endoscopic therapy
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The majority of patients tolerated the procedure well. Procedure-related bowel perforation occurred in 2 patients (2.7%), requiring hospitalization and urgent surgery.
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Figure 2. Flowchart of outcome of 25 patients with ileoscopic balloon dilation via stoma after a median follow-up of 21.6 months.
Small-bowel stricture is a common adverse event in patients with CD with stomas. In 1 study of 99 patients with CD with permanent end ileostomy, the prevalence of strictures was as high as 16.2%.13 The management of CD strictures has been challenging. CD strictures, particularly fibrostenotic ones, typically did not respond to medical therapy. Although surgical bowel resection and reanastomosis or stricturoplasty is effective in treating
CD strictures, the risk of postoperative recurrence is high. In addition, the surgery is often associated with postoperative complications. Previous studies showed that 34% of patients with CD who underwent stricturoplasty3 and 19% who underwent stricture resection4 had recurrent strictures after a median follow-up of 7.5 and 4.2 years, respectively. Therefore, endoscopic balloon dilation appears to be a valid alternative to surgical intervention in the treatment of CD strictures. Endoscopic balloon dilation has been demonstrated to be a feasible and effective procedure in the treatment of CD strictures at the colon,5-7 small bowel,8,9 or ileal pouch10 in patients without ileostomies. A meta-analysis of 23 publications, with a total of 574 patients, reported a technical success rate of 90%, with a surgery-free rate ranging from 53% to 92%.14 In a separate meta-analysis involving 13 studies, with a total of 347 patients, the technical success rate was 86%, and long-term, surgery-free survival was achieved in 58% of patients.15 However, there were no published data on ileoscopic balloon dilation of small-bowel CD strictures via stoma. Our study showed that ileoscopic balloon dilation via stoma is feasible and efficacious in treating small-bowel CD strictures, with a high technical success rate of 93.3% (70/ 75) and a high surgery-free rate of 80.0% (20/25). Although only 6 patients (24.0%) did not require further dilation and surgery after the initial dilation, this procedure can be repeated safely. After 1 or more dilations, a total of 20 patients (80.0%) remained surgery-free at the end of the follow-up. In addition, endoscopic balloon dilation spaced out the need for surgery for a median
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Figure 3. Kaplan-Meier curve for surgery-free survival after the first balloon dilation.
DISCUSSION
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follow-up of 11.6 months in the other 5 patients who required surgery. With an invasive procedure, safety is a major concern. The reported adverse event rate of balloon dilation in patients without stoma ranged from 0% to 18%, with the rate being lower than 5% in the majority of studies.15 In our study, the adverse event rate was similar to those of published studies in patient without stomas, with a low frequency of 2.7% (2/75). Bowel perforation occurred in treating 2 strictures, which were tight and refractory to balloon dilation and were treated with a needle-knife. However, for those patients with refractory strictures, surgical treatment would be inevitable if needle-knife therapy had not been attempted. The findings of our study have several clinical implications. Ileoscopic balloon dilation via stoma is technically feasible for small-bowel CD strictures in experienced hands. Given the good outcome of this technique in our cohort, ileoscopic balloon dilation via stoma may be attempted for strictures !5 cm in patients with CD with ileostomies. In addition, our study demonstrated that endoscopic balloon dilation appeared to be safe. Our study has several limitations. The study was not randomized or controlled. It has been difficult to conduct a randomized trial in this setting. Another limitation of our study is the small number of patients, although the largest in the literature, which precluded a meaningful multivariable analysis of risk factors associated with failure of endoscopy therapy. In addition, this study was performed in a tertiary referral center, which may have led to potential referral or selection bias. It is not clear whether we should treat the CD strictures of asymptomatic patients with ileoscopic balloon dilation. In conclusion, ileoscopic balloon dilation via stoma appeared to be feasible, effective, and safe in treating CD strictures in selected patients with ileostomies.
REFERENCES
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1. Cosnes J, Gower-Rousseau C, Seksik P, et al. Epidemiology and natural history of inflammatory bowel diseases. Gastroenterology 2011;140: 1785-94. 2. Toy LS, Scherl J, Kornbluth A, et al. Complete bowel obstruction following initial response to infliximab therapy for Crohn’s disease: a series of newly described complications. Gastroenterology 2000;118:A569. 3. Dietz DW, Laureti S, Strong SA, et al. Safety and longterm efficacy of strictureplasty in 314 patients with obstructing small bowel Crohn’s disease. J Am Coll Surg 2001;192:330-7. 4. Scarpa M, Angriman I, Barollo M, et al. Risk factors for recurrence of stenosis in Crohn’s disease. Acta Biomed 2003;74(suppl 2):80-3. 5. Scimeca D, Mocciaro F, Cottone M, et al. Efficacy and safety of endoscopic balloon dilation of symptomatic intestinal Crohn’s disease strictures. Dig Liver Dis 2011;43:121-5. 6. Gustavsson A, Magnuson A, Blomberg B, et al. Endoscopic dilation is an efficacious and safe treatment of intestinal strictures in Crohn’s disease. Aliment Pharmacol Ther 2012;36:151-8. 7. Thienpont C, D'Hoore A, Vermeire S, et al. Long-term outcome of endoscopic dilatation in patients with Crohn’s disease is not affected by disease activity or medical therapy. Gut 2010;59:320-4. 8. Despott EJ, Gupta A, Burling D, et al. Effective dilation of small-bowel strictures by double-balloon enteroscopy in patients with symptomatic Crohn’s disease (with video). Gastrointest Endosc 2009;70:1030-6. 9. Pohl J, May A, Nachbar L, et al. Diagnostic and therapeutic yield of push-and-pull enteroscopy for symptomatic small bowel Crohn’s disease strictures. Eur J Gastroenterol Hepatol 2007;19:529-34. 10. Shen B, Lian L, Kiran RP, et al. Efficacy and safety of endoscopic treatment of ileal pouch strictures. Inflamm Bowel Dis 2011;17:2527-35. 11. Rutgeerts P, Geboes K, Vantrappen G, et al. Predictability of the postoperative course of Crohn’s disease. Gastroenterology 1990;99:956-63. 12. Satsangi J, Silverberg MS, Vermeire S, et al. The Montreal classification of inflammatory bowel disease: controversies, consensus, and implications. Gut 2006;55:749-53. 13. Vadlamudi N, Alkhouri N, Mahajan L, et al. Ileoscopy via stoma after diverting ileostomy: a safe and effective tool to evaluate for Crohn’s recurrence of neoterminal ileum. Dig Dis Sci 2011;56:866-70. 14. Wibmer AG, Kroesen AJ, Grone J, et al. Comparison of strictureplasty and endoscopic balloon dilatation for stricturing Crohn’s diseased review of the literature. Int J Colorectal Dis 2010;25:1149-57. 15. Hassan C, Zullo A, De Francesco V, et al. Systematic review: endoscopic dilatation in Crohn’s disease. Aliment Pharmacol Ther 2007;26:1457-64.
