Digestive Endoscopy 2015; 27: 37–43
doi: 10.1111/den.12321
Original Article
Clinical outcomes of secondary gastroduodenal self-expandable metallic stent placement by stent-in-stent technique for malignant gastric outlet obstruction Takashi Sasaki,1 Hiroyuki Isayama,1 Yousuke Nakai,1 Naminatsu Takahara,1 Tsuyoshi Hamada,1 Suguru Mizuno,1 Dai Mohri,1 Hiroshi Yagioka,2 Hirofumi Kogure,1 Toshihiko Arizumi,3 Osamu Togawa,4 Saburo Matsubara,5 Yukiko Ito,6 Natsuyo Yamamoto,1 Naoki Sasahira,7 Kenji Hirano,1 Nobuo Toda,3 Minoru Tada1 and Kazuhiko Koike1 1
Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 2Department of Gastroenterology, JR Tokyo General Hospital, 3Department of Gastroenterology, Mitsui Memorial Hospital, 4 Department of Gastroenterology, Kanto Central Hospital, 5Department of Gastroenterology, Tokyo Metropolitan Police Hospital, 6Department of Gastroenterology, Japanese Red Cross Medical Center and 7Department of Gastroenterology, Sempo Tokyo Takanawa Hospital, Tokyo, Japan Background and Aim: To evaluate the efficacy and safety of secondary gastroduodenal stent placement after first stent dysfunction for malignant gastric outlet obstruction. Methods: We conducted a retrospective analysis to investigate the efficacy and safety of secondary stent-in-stent gastroduodenal stent placement. Results: Among 260 patients who had been treated with first gastroduodenal stent placement for malignant gastric outlet obstruction, 29 patients (11.2%) were treated with secondary gastroduodenal stent placement because of first stent dysfunction. Pancreatic cancer was the major primary cancer (55.2%). A WallFlex duodenal stent was the most frequently inserted stent both as a first stent (75.9%) and as a secondary stent (62.1%). There were 22 patients (75.9%) that received gastroduodenal stents at the bending site (supraduodenal angle or infraduodenal
INTRODUCTION
M
ALIGNANT GASTRIC OUTLET obstruction (GOO) is a late complication of advanced gastric or pancreatobiliary cancer. Prognoses of these advanced cancers are poor, and the median overall survival is approximately 1 year.1–3 Malignant GOO dramatically diminishes the quality of life in these patients who have a limited life
bs_bs_banner
Corresponding: Hiroyuki Isayama, Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan, Email: isayama-2im @h.u-tokyo.ac.jp Received 23 April 2014; accepted 10 June 2014.
angle). Technical and clinical success rates were 100% and 86.2%, respectively. Median eating period was 3.0 months, and median survival time was 3.5 months. As for related complications, gastrointestinal perforation, insufficient stent expansion, tumor ingrowth, tumor overgrowth, and cholangitis were experienced in 13.8% (four cases), 6.9% (two cases), 6.9% (two cases), 3.4% (one case), and 3.4% (one case), respectively.
Conclusion: Secondary gastroduodenal stent placement might be effective for managing first stent dysfunction in malignant gastric outlet obstruction. However, gastrointestinal perforation was the major complication. Key words: axial force, gastric outlet obstruction, gastrointestinal perforation, re-intervention, stent-in-stent
expectancy. Patients suffer from persistent nausea and vomiting, intolerance to oral feeding, and have associated bodyweight loss. Therefore, it is very important to relieve these obstructive symptoms to maintain a better quality of life for patients in the terminal phase. Self-expandable metallic stent (SEMS) placement has been widely used for the palliation of malignant GOO because it is considered a less invasive procedure.4–6 The placement of a SEMS is considered an alternative treatment to surgical bypass, especially for patients with short prognoses and poor general condition.7 As a result of the recent improvement of anticancer treatments, patients who are treated with a SEMS for malignant GOO can survive longer than expected. In such cases, the SEMS is often occluded and requires secondary SEMS placement.
© 2014 The Authors Digestive Endoscopy © 2014 Japan Gastroenterological Endoscopy Society
37
38
T. Sasaki et al.
Secondary gastroduodenal SEMS placement is usually carried out using a stent-in-stent technique because an uncovered or partially covered SEMS is inserted as a first stent. A fully covered SEMS is not used as a gastroduodenal stent because of the high migration rate. Previous reports of secondary gastroduodenal SEMS placement after first stent dysfunction are limited. There are only three Korean reports available prior to 2013.8–10 Therefore, we conducted a retrospective analysis to evaluate the efficacy and safety of secondary gastroduodenal SEMS placement using a stent-instent technique for the management of first stent dysfunction in patients with malignant GOO.
METHODS Patient population
B
ETWEEN SEPTEMBER 2009 and January 2013, 29 patients (11.2%) were treated with secondary gastroduodenal SEMS placement using a stent-in-stent technique among 260 patients who had been treated with first gastroduodenal SEMS placement for malignant GOO. Procedures for the secondary gastroduodenal SEMS placement were carried out at seven hospitals in Tokyo, Japan. First stent dysfunction was confirmed endoscopically or fluoroscopically. Contraindications to secondary gastroduodenal SEMS placement were inability to tolerate the endoscopic procedure because of poor general condition and multiple stenoses in the gastrointestinal tract. Peritoneal carcinomatosis and massive ascites were not considered contraindications to secondary gastroduodenal SEMS placement.11 Written informed consent was obtained from each patient prior to the procedure.
Self-expandable metallic stent placement and follow up All SEMS placements were conducted under endoscopic and fluoroscopic guidance. The endoscope was carefully inserted near the obstruction site, and the causes of first stent dysfunction were evaluated endoscopically. A water-soluble radiographic contrast medium was injected under fluoroscopic guidance to identify the length of the obstruction. The obstruction was negotiated using a standard biliary guidewire and endoscopic retrograde cholangiopancreatography (ERCP) catheter. The ERCP catheter was passed through the obstruction site, and the position of the stent placement was determined using both endoscopic and fluoroscopic views. The stent delivery system was advanced over the guidewire through the working channel of the endoscope and deployed at the obstruction site under endoscopic and fluoroscopic guidance.
Digestive Endoscopy 2015; 27: 37–43
There were three types of SEMS used in the present analysis. The WallFlex duodenal stent (Boston Scientific Japan, Tokyo, Japan) is an uncovered SEMS composed of nitinol. It has a flare at the proximal end to minimize the risk of migration. The diameter is 22 mm at the body and 27 mm at the flared proximal end. This SEMS is available in lengths of 6, 9, and 12 cm. The Niti-S D pyloric/duodenal stent (Taewoong Medical, Seoul, Korea) is also an uncovered SEMS woven with a ‘D-Weave’ configuration. There is no flare in this SEMS. The diameter is 22 mm, and this SEMS is available in lengths of 6, 8, 10, and 12 cm. The modified ComVi stent (Taewoong Medical, Seoul, Korea) is a partially covered SEMS with a double-layered design that has a longer uncovered portion (5–15 mm) compared to the original Niti-S ComVi stent (Taewoong Medical, Seoul, Korea) at both ends.12 This modified ComVi stent was made to reduce stent migration, which was the major complication of the original Niti-S ComVi stent.13 There is no flare in this SEMS. The diameter is 20 mm, and this SEMS is available in lengths of 8, 10, and 12 cm. Choice of SEMS was made by each endoscopist. Abdominal X-rays were routinely obtained after SEMS placement to monitor SEMS expansion. Oral liquid intake was allowed after the procedure, followed by soft solids. Patients were permitted to eat a full diet if possible. Chemotherapy including oral anticancer drug regimens was also allowed after SEMS placement if the patient maintained good general condition.
Definitions and data analysis Data on age, gender, primary cancer site, Karnofsky performance status, gastric outlet obstruction scoring system (GOOSS), history of prior gastrectomy, and the presence of peritoneal dissemination and ascites were prospectively collected as baseline at the secondary gastroduodenal SEMS placement. GOOSS is a scoring system dependent on the patient’s level of oral intake: 0, no oral intake; 1, liquids only; 2, soft solids; and 3, low-residual or full diet.14 Presence of peritoneal dissemination and ascites was evaluated using computed tomography prior to the procedure. Clinical outcomes of secondary gastroduodenal SEMS placement were evaluated according to the following criteria: (i) technical success; (ii) clinical success; (iii) procedure time; (iv) status of oral intake evaluated with GOOSS; (v) eating period; (vi) survival time; (vii) re-intervention rate; and (viii) complications. Technical success was defined as satisfactory SEMS placement and precise positioning at the obstruction site. Clinical success was defined as an improvement of GOOSS after SEMS placement. Procedure time was calculated from the insertion to the removal of the
© 2014 The Authors Digestive Endoscopy © 2014 Japan Gastroenterological Endoscopy Society
Digestive Endoscopy 2015; 27: 37–43
Outcomes of secondary duodenal stent 39
Table 1 Characteristics of patients treated with secondary gastroduodenal stent placement
Table 2 Details of stent placement in patients treated with secondary gastroduodenal stent placement
Age (years) Median (range) Gender Male Female Primary cancer site Pancreatic cancer Gastric cancer Biliary tract cancer Other Karnofsky performance status 100-90 80-60 50-30 Gastric outlet obstruction scoring system 0 1 2 Prior gastrectomy Peritoneal dissemination Ascites
Primary obstruction site Pylorus First portion Second portion Third portion Anastomosis First stent WallFlex duodenal stent Niti-S D pyloric/duodenal stent Modified ComVi stent Stent placement at bending site Reason for secondary stent placement Tumor ingrowth/tumor overgrowth Insufficient length of primary stent Hemostasis for tumor bleeding Median time from first stent placement Median time from the diagnosis of primary cancer Secondary stent† (n = 31) WallFlex duodenal stent Niti-S D pyloric/duodenal stent Modified ComVi stent Length of stent† (cm) (n = 31) 6 8 9 10 12 Secondary stent position against the first stent (proximal end/distal end) Inside/inside Outside/inside Inside/outside Outside/outside
66 (48–91) 24 (82.8%) 5 (17.2%) 16 (55.2%) 7 (24.1%) 3 (10.3%) 3 (10.3%) 9 (31.0%) 17 (58.6%) 3 (10.3%) 14 (48.3%) 10 (34.5%) 5 (17.2%) 3 (10.3%) 13 (44.8%) 19 (65.5%)
endoscope. Eating period was defined as the time from first oral intake after SEMS placement until the patient was unable to ingest oral food. Survival time was defined as the time from the date of SEMS placement to the final follow up or to death from any cause. Complications were monitored after SEMS placement. The final analysis was conducted using the follow-up data through the end of March 2013. Categorical variables were compared by using the chi-squared test. An improvement of GOOSS prior to and after SEMS placement was compared using the Wilcoxon signed-rank test. A P-value
doi: 10.1111/den.12321
Original Article
Clinical outcomes of secondary gastroduodenal self-expandable metallic stent placement by stent-in-stent technique for malignant gastric outlet obstruction Takashi Sasaki,1 Hiroyuki Isayama,1 Yousuke Nakai,1 Naminatsu Takahara,1 Tsuyoshi Hamada,1 Suguru Mizuno,1 Dai Mohri,1 Hiroshi Yagioka,2 Hirofumi Kogure,1 Toshihiko Arizumi,3 Osamu Togawa,4 Saburo Matsubara,5 Yukiko Ito,6 Natsuyo Yamamoto,1 Naoki Sasahira,7 Kenji Hirano,1 Nobuo Toda,3 Minoru Tada1 and Kazuhiko Koike1 1
Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 2Department of Gastroenterology, JR Tokyo General Hospital, 3Department of Gastroenterology, Mitsui Memorial Hospital, 4 Department of Gastroenterology, Kanto Central Hospital, 5Department of Gastroenterology, Tokyo Metropolitan Police Hospital, 6Department of Gastroenterology, Japanese Red Cross Medical Center and 7Department of Gastroenterology, Sempo Tokyo Takanawa Hospital, Tokyo, Japan Background and Aim: To evaluate the efficacy and safety of secondary gastroduodenal stent placement after first stent dysfunction for malignant gastric outlet obstruction. Methods: We conducted a retrospective analysis to investigate the efficacy and safety of secondary stent-in-stent gastroduodenal stent placement. Results: Among 260 patients who had been treated with first gastroduodenal stent placement for malignant gastric outlet obstruction, 29 patients (11.2%) were treated with secondary gastroduodenal stent placement because of first stent dysfunction. Pancreatic cancer was the major primary cancer (55.2%). A WallFlex duodenal stent was the most frequently inserted stent both as a first stent (75.9%) and as a secondary stent (62.1%). There were 22 patients (75.9%) that received gastroduodenal stents at the bending site (supraduodenal angle or infraduodenal
INTRODUCTION
M
ALIGNANT GASTRIC OUTLET obstruction (GOO) is a late complication of advanced gastric or pancreatobiliary cancer. Prognoses of these advanced cancers are poor, and the median overall survival is approximately 1 year.1–3 Malignant GOO dramatically diminishes the quality of life in these patients who have a limited life
bs_bs_banner
Corresponding: Hiroyuki Isayama, Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan, Email: isayama-2im @h.u-tokyo.ac.jp Received 23 April 2014; accepted 10 June 2014.
angle). Technical and clinical success rates were 100% and 86.2%, respectively. Median eating period was 3.0 months, and median survival time was 3.5 months. As for related complications, gastrointestinal perforation, insufficient stent expansion, tumor ingrowth, tumor overgrowth, and cholangitis were experienced in 13.8% (four cases), 6.9% (two cases), 6.9% (two cases), 3.4% (one case), and 3.4% (one case), respectively.
Conclusion: Secondary gastroduodenal stent placement might be effective for managing first stent dysfunction in malignant gastric outlet obstruction. However, gastrointestinal perforation was the major complication. Key words: axial force, gastric outlet obstruction, gastrointestinal perforation, re-intervention, stent-in-stent
expectancy. Patients suffer from persistent nausea and vomiting, intolerance to oral feeding, and have associated bodyweight loss. Therefore, it is very important to relieve these obstructive symptoms to maintain a better quality of life for patients in the terminal phase. Self-expandable metallic stent (SEMS) placement has been widely used for the palliation of malignant GOO because it is considered a less invasive procedure.4–6 The placement of a SEMS is considered an alternative treatment to surgical bypass, especially for patients with short prognoses and poor general condition.7 As a result of the recent improvement of anticancer treatments, patients who are treated with a SEMS for malignant GOO can survive longer than expected. In such cases, the SEMS is often occluded and requires secondary SEMS placement.
© 2014 The Authors Digestive Endoscopy © 2014 Japan Gastroenterological Endoscopy Society
37
38
T. Sasaki et al.
Secondary gastroduodenal SEMS placement is usually carried out using a stent-in-stent technique because an uncovered or partially covered SEMS is inserted as a first stent. A fully covered SEMS is not used as a gastroduodenal stent because of the high migration rate. Previous reports of secondary gastroduodenal SEMS placement after first stent dysfunction are limited. There are only three Korean reports available prior to 2013.8–10 Therefore, we conducted a retrospective analysis to evaluate the efficacy and safety of secondary gastroduodenal SEMS placement using a stent-instent technique for the management of first stent dysfunction in patients with malignant GOO.
METHODS Patient population
B
ETWEEN SEPTEMBER 2009 and January 2013, 29 patients (11.2%) were treated with secondary gastroduodenal SEMS placement using a stent-in-stent technique among 260 patients who had been treated with first gastroduodenal SEMS placement for malignant GOO. Procedures for the secondary gastroduodenal SEMS placement were carried out at seven hospitals in Tokyo, Japan. First stent dysfunction was confirmed endoscopically or fluoroscopically. Contraindications to secondary gastroduodenal SEMS placement were inability to tolerate the endoscopic procedure because of poor general condition and multiple stenoses in the gastrointestinal tract. Peritoneal carcinomatosis and massive ascites were not considered contraindications to secondary gastroduodenal SEMS placement.11 Written informed consent was obtained from each patient prior to the procedure.
Self-expandable metallic stent placement and follow up All SEMS placements were conducted under endoscopic and fluoroscopic guidance. The endoscope was carefully inserted near the obstruction site, and the causes of first stent dysfunction were evaluated endoscopically. A water-soluble radiographic contrast medium was injected under fluoroscopic guidance to identify the length of the obstruction. The obstruction was negotiated using a standard biliary guidewire and endoscopic retrograde cholangiopancreatography (ERCP) catheter. The ERCP catheter was passed through the obstruction site, and the position of the stent placement was determined using both endoscopic and fluoroscopic views. The stent delivery system was advanced over the guidewire through the working channel of the endoscope and deployed at the obstruction site under endoscopic and fluoroscopic guidance.
Digestive Endoscopy 2015; 27: 37–43
There were three types of SEMS used in the present analysis. The WallFlex duodenal stent (Boston Scientific Japan, Tokyo, Japan) is an uncovered SEMS composed of nitinol. It has a flare at the proximal end to minimize the risk of migration. The diameter is 22 mm at the body and 27 mm at the flared proximal end. This SEMS is available in lengths of 6, 9, and 12 cm. The Niti-S D pyloric/duodenal stent (Taewoong Medical, Seoul, Korea) is also an uncovered SEMS woven with a ‘D-Weave’ configuration. There is no flare in this SEMS. The diameter is 22 mm, and this SEMS is available in lengths of 6, 8, 10, and 12 cm. The modified ComVi stent (Taewoong Medical, Seoul, Korea) is a partially covered SEMS with a double-layered design that has a longer uncovered portion (5–15 mm) compared to the original Niti-S ComVi stent (Taewoong Medical, Seoul, Korea) at both ends.12 This modified ComVi stent was made to reduce stent migration, which was the major complication of the original Niti-S ComVi stent.13 There is no flare in this SEMS. The diameter is 20 mm, and this SEMS is available in lengths of 8, 10, and 12 cm. Choice of SEMS was made by each endoscopist. Abdominal X-rays were routinely obtained after SEMS placement to monitor SEMS expansion. Oral liquid intake was allowed after the procedure, followed by soft solids. Patients were permitted to eat a full diet if possible. Chemotherapy including oral anticancer drug regimens was also allowed after SEMS placement if the patient maintained good general condition.
Definitions and data analysis Data on age, gender, primary cancer site, Karnofsky performance status, gastric outlet obstruction scoring system (GOOSS), history of prior gastrectomy, and the presence of peritoneal dissemination and ascites were prospectively collected as baseline at the secondary gastroduodenal SEMS placement. GOOSS is a scoring system dependent on the patient’s level of oral intake: 0, no oral intake; 1, liquids only; 2, soft solids; and 3, low-residual or full diet.14 Presence of peritoneal dissemination and ascites was evaluated using computed tomography prior to the procedure. Clinical outcomes of secondary gastroduodenal SEMS placement were evaluated according to the following criteria: (i) technical success; (ii) clinical success; (iii) procedure time; (iv) status of oral intake evaluated with GOOSS; (v) eating period; (vi) survival time; (vii) re-intervention rate; and (viii) complications. Technical success was defined as satisfactory SEMS placement and precise positioning at the obstruction site. Clinical success was defined as an improvement of GOOSS after SEMS placement. Procedure time was calculated from the insertion to the removal of the
© 2014 The Authors Digestive Endoscopy © 2014 Japan Gastroenterological Endoscopy Society
Digestive Endoscopy 2015; 27: 37–43
Outcomes of secondary duodenal stent 39
Table 1 Characteristics of patients treated with secondary gastroduodenal stent placement
Table 2 Details of stent placement in patients treated with secondary gastroduodenal stent placement
Age (years) Median (range) Gender Male Female Primary cancer site Pancreatic cancer Gastric cancer Biliary tract cancer Other Karnofsky performance status 100-90 80-60 50-30 Gastric outlet obstruction scoring system 0 1 2 Prior gastrectomy Peritoneal dissemination Ascites
Primary obstruction site Pylorus First portion Second portion Third portion Anastomosis First stent WallFlex duodenal stent Niti-S D pyloric/duodenal stent Modified ComVi stent Stent placement at bending site Reason for secondary stent placement Tumor ingrowth/tumor overgrowth Insufficient length of primary stent Hemostasis for tumor bleeding Median time from first stent placement Median time from the diagnosis of primary cancer Secondary stent† (n = 31) WallFlex duodenal stent Niti-S D pyloric/duodenal stent Modified ComVi stent Length of stent† (cm) (n = 31) 6 8 9 10 12 Secondary stent position against the first stent (proximal end/distal end) Inside/inside Outside/inside Inside/outside Outside/outside
66 (48–91) 24 (82.8%) 5 (17.2%) 16 (55.2%) 7 (24.1%) 3 (10.3%) 3 (10.3%) 9 (31.0%) 17 (58.6%) 3 (10.3%) 14 (48.3%) 10 (34.5%) 5 (17.2%) 3 (10.3%) 13 (44.8%) 19 (65.5%)
endoscope. Eating period was defined as the time from first oral intake after SEMS placement until the patient was unable to ingest oral food. Survival time was defined as the time from the date of SEMS placement to the final follow up or to death from any cause. Complications were monitored after SEMS placement. The final analysis was conducted using the follow-up data through the end of March 2013. Categorical variables were compared by using the chi-squared test. An improvement of GOOSS prior to and after SEMS placement was compared using the Wilcoxon signed-rank test. A P-value
