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Surgery for Obesity and Related Diseases ] (2014) 00–00

Original article

A novel dedicated endoscopic stent for staple-line leaks after laparoscopic sleeve gastrectomy: a case series Giuseppe Galloroa,*, Luca Magnoa, Mario Musellab, Raffaele Mantad, Angelo Zulloe, Pietro Forestieric a

Department of Clinical Medicine and Surgery, Surgical Digestive Endoscopy Unit, Federico II University, Naples, Italy b Department of Innovative Bio-Medical Sciences, General Surgery Unit, Federico II University, Naples, Italy c Department of Clinical Medicine and Surgery, General and Bariatric Surgery Unit; Federico II University, Naples, Italy d Gastroenterology and Digestive Endoscopy Unit, Nuovo S. Agostino Estense Hospital, Modena, Italy e Gastroenterology and Digestive Endoscopy, Nuovo Regina Margherita Hospital, Rome, Italy Received October 24, 2013; accepted February 20, 2014

Abstract

Background: Staple-line leak is the most serious complication of laparoscopic sleeve gastrectomy (LSG) occurring in .57% of cases. Patients with this complication are often managed with an esophageal covered, self-expandable metal stent positioned at endoscopy. Unfortunately, migration of these stents has been reported in 30–50% of cases. A novel fully-covered, self-expanding metal stent (Megastent), specifically designed for post-LSG leaks is now available. The objective of this study was to describe the first case series of patients with a staple-line leak after LSG who were endoscopically managed with such a novel stent. Methods: Four patients who developed a staple-line leak after LSG were treated by positioning a Megastent at endoscopy. The stents were removed after 8 weeks. Results: A complete leak repair was achieved in all patients. No stent migration occurred. Prokinetic therapy was needed to treat vomiting episodes during stent presence. At endoscopic evaluation after stent removal, a decubitus lesion at the distal part of the duodenal bulb was observed. Conclusion: These preliminary results would suggest the use of the Megastent as an option for stenting of a staple-line leak after LSG. Further studies are still necessary. (Surg Obes Relat Dis 2014;]:00–00.) r 2014 American Society for Metabolic and Bariatric Surgery. All rights reserved.

Keywords:

Endoscopic therapy; Postsurgical leak; Obesity; Sleeve gastrectomy

Laparoscopic sleeve gastrectomy (LSG), pioneered in 2003, has become a well-standardized therapeutic option for surgical treatment of different degrees of obesity and obesity-related diseases [1]. Although generally effective and safe, some complications may occur after LSG such as bleeding (02%), strictures (02%), and staple-line leaks (0.57%) [1–4]. The latter complication is the most serious *

Correspondence: Prof. Giuseppe Galloro, University of Naples Federico II - School of Medicine, Via S. Pansini, 5 80131 Napoli, Italy. E-mail: [email protected]

and it has been associated with a significant morbidity [2]. The use of esophageal covered, self-expandable metal stents has effective in managing this problem. This approach allows a temporary bypass of the leak, favoring its healing and enabling oral nutrition, without requiring a further intervention. Unfortunately, migration of these esophageal stents occurs in 30–50% of cases [3]. A novel fullycovered, self-expanding metal stent (Megastent, Taewoong Medical Industries, Kangseo-Gu Songjung-Dong, South Korea), specifically designed for post-LSG leak treatment, has been recently introduced. This is the first case series of

http://dx.doi.org/10.1016/j.soard.2014.02.027 1550-7289/r 2014 American Society for Metabolic and Bariatric Surgery. All rights reserved.

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patients with a staple-line leak after LSG who were endoscopically treated with this new stent. Endoscopic procedures All endoscopic procedures were performed with patient in lateral-left decubitus, under deep sedation (propofol, fentanyl, and midazolam) and anesthesiologist assistance. An upper gastrointestinal endoscopy was performed with a single-channel endoscope (EG 490 ZW; Fujinon, Omiya, Japan). Two radiopaque endoclips, the first in distal esophagus some centimeters above the leak, and the second in duodenal bulb were placed to mark the point of maximum insertion of the stent. A stiff guide wire (X Wire 035450 SS, ConMed Endoscopic Technologies Inc., Chelmsford, MA, USA) was placed into the duodenal bulb, and its correct placement was confirmed under fluoroscopy. The endoscope was removed, leaving the remaining guide wire in place, and the stent (23-cm long and a 24-mm diameter Megastent) was deployed over the guide wire and positioned, under fluoroscopic control, between the 2 radiopaque markers. The endoscope was then reinserted beside the guide wire until the distal esophagus to ensure that the proximal end of the delivery system of the stent was positioned at the optimal position. Then the stent was opened, by its distal delivery system, under fluoroscopic control and under direct endoscopic visualization at the proximal end. The day after the stent deployment, a radiologic control was performed to ensure its correct positioning with the 2 flares placed between the proximal and distal radiopaque marks. During stent permanence, clinical controls were performed monthly, while radiologic controls were performed weekly during the first month, and then 1 month to monitor the stent position and to anticipate leak recurrence. After 60 days, the patient was readmitted for stent removal.

Fig. 1. Gastrographin swallow showing a gastric staple-line leak with extravasation of contrast medium and a substenosis in the middle part of the sleeve.

biliary vomiting, so prokinetic therapy with domperidone, 10 mg t.i.d., was administered, which relieved her symptoms. After 8 weeks, she underwent stent removal. Upper endoscopy showed that the leak had healed, with a whitish granulation tissue filling the hole, and a decubitus lesion at the distal part of the duodenal bulb.

Case series Patient 1 A 27-year-old woman underwent LSG for morbid obesity (Body mass index [BMI] 51 kg/m2) in November 2011. One month after discharge, the patient complained of nausea and vomiting. The Gastrographin swallow was negative, and upper endoscopy showed only a mild substenosis in the middle of the sleeve. Due to the persistence of her symptoms, the patient was readmitted 14 days later. A new Gastrographin swallow showed a gastric leak, with peritoneal extravasation of contrast medium, as well as the previously described substenosis (Fig. 1). A computerized tomographic (CT) scan excluded the presence of abscess, fluid collections adjacent to the sleeve, and free intraabdominal liquid. Consequently, we decided to treat the leak by placing a Megastent. The Gastrographin swallow showed the correct position of the stent (Fig. 2), and 6 days later the patient was discharged. The patient complained of

Fig. 2. A Gastrographin swallow control performed the day after Megastent placement shows the correct positioning of the stent, from the distal esophagus to the first part of the duodenum.

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Patient 2

Patient 4

A 47-year-old man underwent LSG for obesity (BMI 58 kg/m2) in January 2012. Six days after discharge, the patient was admitted due to nausea, vomiting, epigastric pain, fever (38.81C), and leukocytosis. A Gastrographin swallow showed a gastric leak, with peritoneal extravasation of contrast medium, without stenosis of the sleeve lumen. A CT scan with oral contrast confirmed the leak with a small fluid collection adjacent to the sleeve, which was removed by a percutaneous CT-guided drainage. Clinical improvement occurred in few days, and Megastent was placed in the gastric sleeve. After 1 week, a liquid high protein diet was initiated followed by a soft diet, and he was discharged 3 days later. At follow-up, prokinetic therapy was needed to treat biliary vomiting. After 8 weeks, the stent was endoscopically removed, and a healed leak was documented, with evidence of a decubitus lesion in the distal part of the duodenal bulb.

A 52-year-old woman underwent LSG for morbid obesity (BMI 46 kg/m2) in August 2012. Six days after surgery, the patient complained of vomiting, fever, leukocytosis, and clinical signs of peritonitis. A CT scan with oral contrast documented the presence of a proximal leak with a large fluid collection adjacent to the sleeve. A minimally invasive laparoscopic drainage of the collection was performed coupled with placement of the Megastent. Ten days after the patient was discharged, prokinetic therapy was prophylactically started. The stent was removed after 60 days, and endoscopic examination documented healing of the leak and a small decubitus lesion at the distal part of the duodenal bulb.

Patient 3 A 61-year-old man underwent LSG for morbid obesity (BMI 51 kg/m2) in February 2012. Two weeks after discharge he developed a staple-line leak that was treated with placement of a 15-cm covered self-expanding metal esophageal stent (Ultraflex NG Stent System, Boston Scientific, Natick, MA, USA) in another hospital. However, 8 days after the stent placement, the patient was referred to our endoscopy unit due to the onset of dysphagia. Gastrographin swallow showed distal migration of the stent and persistence of the leak localized at the first third of the staple-line. A CT scan excluded the presence of abscess, fluid collections adjacent to the sleeve, and free intraabdominal fluid. We decided to remove the stent and replace it with a Megastents. Seven days after stent placement, he started a liquid high protein diet followed by a soft diet, and 3 days later, he was discharged in good clinical conditions. Due to biliary vomiting episodes, prokinetic therapy was started. The stent was therefore removed 8 weeks later, and upper endoscopy documented complete healing of the leak and a decubitus lesion at the distal part of the duodenal bulb.

Discussion Staple-line leak is a potential complication of LSG, with an incidence widely ranging from .57–24% [4]. Different therapeutic approaches have been proposed to manage these patients, including operative (jejunostomy; surgical revision with exploration, cleaning, drain, and sometime resuture; Roux limb; total gastrectomy in selected cases) [5] and nonoperative options (drainage placed under CT scan guidance; percutaneous microcoil embolization, endoscopic clipping or sealing using cyanoacrylate or biological glues) [6]. A more conservative endoscopic treatment has been proposed, with placement of esophageal covered selfexpandable metal stents placement, particularly for those leaks located either in the proximal or mid-part of the sleeve, with a o2-cm diameter [7,8]. The stent is generally removed after 6–9 weeks. A highly variable success rate has been reported after this procedure [7–9]. Table 1 summarizes the leading data of the latest studies concerning the treatment of staple-line leaks after sleeve gastrectomy by using esophageal covered self-expandable metal stents. As shown, a wide variability of results in healing the leaks is reported. Moreover, the failure of treating those leaks presenting 446 weeks as well as chronic (412 wk) leaks with stents is a limitation. In addition, the cost of stent

Table 1 Staple-line leaks after sleeve gastrectomy treated with esophageal stent reported in literature Author

Leaks treated*

Jurowich et al. [2] 1 early; 2 intermediate Blackmon et al. [3] 3 early; 1 late Baltasar et al. [5] 1 early Tan et al. [6] 5 early; 3 late Nguyen et al. [8] 1 intermediate; 2 late de Aretxabala et al. [10] 2 early; 2 late Casella et al. [12] 3 early Csendes et al. [13] 1 late Lacy et al. [14] 3 NA

Site of leaks Type of stent

Main outcome

Proximal Proximal Proximal Proximal NA NA Proximal NA NA

3 1 1 4 3 1 2 1 3

Niti-S, Tae Wong Ultraflex, Boston Hanaro, MI TECH NA 2 Alimaxx-E; 1 Alveolus NA 1 Ultraflex, Boston NA NA

Further therapies

healing None healing; 3 migration 3 reintervention leak persistence 1 reintervention healing; 3 migration; 1 kinking 3 reintervention healing None healing; 3 migration 1 reintervention; 2 restenting healing; 1 migration 1 restenting failure 1 reintervention failure 3 reintervention

NA ¼ not available. Early ¼ leak appearing 1 to 3 days after surgery; Intermediate ¼ leak appearing 4–7 days after surgery; Late ¼ leak appearing Z8 days after surgery

*

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and the possible onset of dysphagia and pain during stent permanence should be considered. Furthermore, stent migration occurs in a significant number of cases, with rates as high as 42–50% in some series [1,10]. This dismal event most likely depends on the use of covered esophageal stents, which are unsuitably placed along the last portion of the esophagus and the gastric sleeve where a proper containment of the stent is lacking. Moreover, the coating of the stent prevents its integration into the stomach, and consequently reduces the grip with the gastric wall, predisposing migration during peristalsis. Recently a novel, fully covered, self-expanding stent, specifically designed for post-LSG leak treatment, has been introduced (Megastent). In detail, both proximal and distal ends of this device are slightly flared with a high edge profile, allowing a more firm anchorage. In addition, the body of the stent is longer than that of the currently available esophageal stents (18 and 23 cm) with placement of the distal end of the stent into the duodenal bulb. Different from esophageal stents, such a length also ensures the treatment of leaks localized in the distal portion of the gastric sleeve. Furthermore, the large diameter (22, 24, and 28 mm) provides an optimal adherence between the stent and the sleeve wall, even in the antral portion, conferring an adequate radial strength to dilate a possible stenosis. Finally, although entirely coated, the stent nets are sufficiently flexible allowing a correct adaptation of the stent into the postoperative anatomy of the gastric sleeve. We chose a 23-cm long and a 24-mm diameter Megastent, positioned from distal esophagus to the duodenal bulb and, consequently, bypassing the entire gastric sleeve. This allowed resolution of the high-pressure condition that develops in the gastric sleeve after the resection of fundus and corpus, thus promoting healing of the leak [10,11]. In our series, the staple-line leak resolved in all cases, and no stent migration occurred. At endoscopic evaluation after stent removal a decubitus lesion in the duodenal bulb, due to the free edge of the distal end of the stent, was seen in all cases. However, this condition remained asymptomatic. Although nausea and vomiting may occur after any type of esophageal stent and tend to disappear within few days [8], biliary vomiting episodes occurred in all of our patients during the 8-week permanence of the Megastent. Such a high incidence could depend on the stent conformation. In detail, Megastent configures a complete bypass of the gastric sleeve, and this could favor a biliary reflux directly from the duodenum to the esophagus. In addition, distention of duodenal bulb by the enlarged distal part of the stent—mimicking a continuous gastric outlet—may stimulate biliary secretion. However, vomiting was successfully managed with an oral prokinetic therapy. Similarly, the decubitus lesion observed at duodenal bulb after the stent removal could depend on the pression on duodenal wall exerted by the high edge profile, characteristic of the Megastent. Although

asymptomatic, the actual significance of such mucosal injury needs to be assessed in a larger series. A possible limitation was that our small and retrospective case series included only those patients with an early (o4 wk) leak, so that the potential role of Megastent in treating other leaks remains unclear. In conclusion, this case series found that patients with post-LSG staple-line leaks may be safely and effectively managed with the endoscopic placement of a Megastent. This novel device seems to cause little discomfort and has prevented the need for other interventions. Further prospective studies are needed to confirm the favorable risk-tobenefit ratio of these stents. Disclosures ■■■ References [1] Baltasar A, Serra C, Perez N, Bou R, Bengochea M, Ferri L. Laparoscopic sleeve gastrectomy: a multi-purpose bariatric operation. Obes Surg 2005;15:1124–8. [2] Jurowich C, Thalheimer A, Seyfried F, et al. Gastric leakage after sleeve gastrectomy: clinical presentation and therapeutic options. Langenbecks Arch Surg 2011;396:981–7. [3] Blackmon SH, Santora R, Schwarz P, Barroso A, Dunkin BJ. Utility of removable esophageal covered self-expanding metal stents for leak and fistula management. Ann Thorac Surg 2010;89:931–7. [4] Clinical Issues: Committee of American Society for Metabolic and Bariatric Surgery Updated position statement on sleeve gastrectomy as a bariatric procedure. Surg Obes Relat Dis 2010;6:1–5. [5] Baltasar A, Bou R, Bengochea M, Serra C, Cipaguata L. Use of a Roux limb to correct esophagogastric junction fistulas after sleeve gastrectomy. Obes Surg 2007;17:1408–10. [6] Tan JT, Kariyawasam S, Wijeratne T, Chandraratna HS. Diagnosis and management of gastric leaks after laparoscopic sleeve gastrectomy for morbid obesity. Obes Surg 2010;20:403–9. [7] Manta R, Magno L, Conigliaro R, et al. Endoscopic repair of postsurgical gastrointestinal complications. Dig Liver Dis. Epub 2013 Apr 23. [8] Nguyen NT, Nguyen X-MT, Dholakia C. The use of endoscopic stent in management of leaks after sleeve gastrectomy. Obes Surg 2010;20: 1289–92. [9] Ferrer Márquez M, Ferrer Ayza M, Belda Lozano R, et al. Gastric leak after laparoscopic sleeve gastrectomy. Obes Surg 2010;20: 1306–11. [10] de Aretxabala X, Leon J, Wiedmaier G, et al. Gastric leak after sleeve gastrectomy: analysis of its management. Obes Surg 2011;21:1232–7. [11] Yehoshua RT, Eidelman LA, Stein M, et al. Laparoscopic sleeve gastrectomy volume and pressure assessment. Obes Surg 2008;18: 1083–8. [12] Casella G, Soricelli E, Rizzello M, et al. Nonsurgical treatment of staple line leaks after laparoscopic sleeve gastrectomy. Obes Surg 2009;19:821–6. [13] Csendes A, Braghetto I, León P, Burgos AM. Management of leaks after laparoscopic sleeve gastrectomy in patients with obesity. J. Gastrointest Surg 2010;14:1343–8. [14] Lacy A, Obarzabal A, Pando E, et al. Revisional surgery after sleeve gastrectomy. Surg Laparosc Endosc Percutan Tech 2010;20:351–6.

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A novel dedicated endoscopic stent for staple-line leaks after laparoscopic sleeve gastrectomy: a case series.

Staple-line leak is the most serious complication of laparoscopic sleeve gastrectomy (LSG) occurring in .5-7% of cases. Patients with this complicatio...
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