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Temporary Placement of Fully Covered Self-Expandable Metal Stents (CSEMS) in Benign Biliary Strictures (BBS): Does Etiology of Stricture Matter?
Abstracts
salvaging cannulation success where standard attempts fail. Risk of PEP increases with greater time to cannulation and increasing cannulation attempts. Further data is required to establish whether early use of NKS (to reduce cannulation time and attempts) may reduce PEP occurrence.
S1311 Temporary Placement of Fully Covered Self-Expandable Metal Stents (CSEMS) in Benign Biliary Strictures (BBS): Does Etiology of Stricture Matter? Bryan Sauer, Kara A. Regan, Henry C. Ho, Anshu Mahajan, Melissa S. Phillips, Vanessa M. Shami, Kristi Ellen, Michele E. Rehan, Timothy M. Schmitt, Michel Kahaleh Introduction: Benign biliary strictures (BBS) have been endoscopically managed with placement of multiple plastic stents. Uncovered metal stents have been associated with mucosal hyperplasia and partially covered self-expandable metal stents with migration. We sought to analyze the efficacy and complication rates of CSEMS in the treatment of BBS. Methods: CSEMS (8 or 10 mm diameter, Viabil, Conmed) were placed in 59 patients with BBS from November 2006 - September 2008. CSEMS were left in place until adequate biliary drainage was achieved; confirmed by resolution of symptoms, normalization of LFTs, and imaging. Results: 59 patients with BBS (37 men, mean age 56.6 13.5) had CSEMS placed due to strictures related to chronic pancreatitis (CP) (nZ24), gallstone disease (nZ16), post liver transplant (nZ17), autoimmune pancreatitis (nZ1) and primary sclerosing cholangitis (nZ1). Twenty-two (36%) had plastic stents placed prior to CSEMS without resolution of stricture. CSEMS were removed in 53 (90%) patients after a mean stent time of 4.4 2.7 months. Six patients did not have CSEMS removed: three had recent placement and are awaiting follow-up for removal and three died of unrelated causes (pneumonia, cirrhosis, metastatic colon cancer). Resolution of the BBS was confirmed in 45/53 patients (85%). Patients with strictures related to chronic pancreatitis had resolution of stricture in 68% whereas all other causes had resolution of stricture in 94% (pZ0.02)(See Table 1). Complications during placement of CSEMS were observed in 10 patients (17%) including pain (nZ3), post-ERCP pancreatitis (nZ5), bleeding (nZ1), and wire perforation (nZ1). Complications during stent removal occurred in 5 patients (9%) including pain (nZ2) and post-ERCP pancreatitis (nZ3). Stent complications were observed in 9 patients (15%) including debris in stent (nZ4), stent migration (nZ3), stent occlusion (nZ1), and stent unravelling (nZ1). Conclusion: Temporary placement of CSEMS for BBS might offer an alternative to plastic stenting in cases not related to chronic pancreatitis. However further investigations are required in order to decrease complication rate and further evaluate long-term efficacy. Table 1. Resolution of Strictures Chronic Panc All Others P value Biliary Stricture Resolved) 45/53 (85%) 13/19 (68%) 32/34 (94%) 0.02 Biliary Stricture Resolved ITT)) 45/56 (80%) 13/21 (62%) 32/35 (91%) 0.01 ) Values listed as number (%) P value based on Fisher’s Exact Test Resolution based on individuals with stent removed )) Intention to treat analysis, includes three patient who died of unrelated causes.
S1312 Long Duration of Patency with Intrabiliary Plastic Stent Placement for Malignant Biliary Strictures: A Pilot Study Hidemichi Imamura, Atsushi Irisawa, Lyndon V. Hernandez, Takuto Hikichi, Goro Shibukawa, Tadayuki Takagi, Takeru Wakatsuki, Yuta Takahashi, Ai Sato, Masaki Sato, Tsunehiko Ikeda, Rei Suzuki, Katsutoshi Obara, Hiromasa Ohira Background/Aim: Stent clogging is a major hindrance to palliative treatment for malignant biliary obstruction. When used for malignant common bile duct strictures, wide-bore, self-expanding metal stents (SEMS) typically remain patent longer than plastic stents. Previous reports have described partial or total occlusion of plastic stents, frequently accompanied by cholangitis, occurring 2-4 months after insertion of standard 10F plastic stents, necessitating their replacement. Because the distal tip of the stent (duodenal side) is located in the duodenal lumen, plastic stents involve sludge deposition from clogging by backward cholangio-infection and food impaction into the stent lumen. Considering these facts, we hypothesized that intrabiliary plastic stent placement (with the distal tip of stent, or the duodenal side, located completely within the bile duct) prolongs the patency of plastic stents, avoiding sludge deposition caused by backward cholangio-infection and food impaction. We performed a pilot study to evaluate the effectiveness of intrabiliary plastic stent placement for upper-middle bile ductal obstruction attributable to cholangiocarcinoma. Patients/Methods: In this study, 33 patients who had malignant proximal and middle biliary obstruction during Jul. 2006 - Aug. 2008 were enrolled: 7 patients for drainage for surgical operation and 26 patients for permanent drainage. Plastic stents (straight type with flaps on both ends) were selected based on the minimal length and degree of the stricture. The distal tip of the stent (duodenal side) was positioned within the bile duct over a guide-wire using
AB140 GASTROINTESTINAL ENDOSCOPY Volume 69, No. 5 : 2009
a pusher catheter. In cases where it was necessary to remove them, an extraction basket or balloon catheter was used. Diameters of the plastic stents used for this study were 8.5 French (Fr.) in 4 patients, 7 Fr. in 29 patients, and 5 Fr. in 4 patient. Results: In patients who underwent stent placement for drainage related to a surgical operation, all stents were patent until surgical operations. Among patients who underwent permanent drainage, long duration of non-clogged performance was achieved, with one-year patency rate of 49.6%. No directly procedure-related complications were identified. In all cases where it was necessary to remove the indwelled stents, they could be extracted. Conclusions: Our method constitutes another option for endoscopists who treat patients with malignant biliary strictures. Further prospective trials are necessary to assess the efficacy and safety of this method and to develop stents that are designed specifically for intrabiliary placement.
S1313 The Result of Japanese Multicenter, Randomized Trial of Endoscopic Stenting for the Nonresectable Pancreatic Head Cancer (JM-Test) Retrospective Investigation Hiroyuki Isayama, Ichiro Yasuda, Shomei Ryozawa, Hiroyuki Maguchi, Yoshinori Igarashi, Yutaka Matsuyama, Akio Katanuma, Osamu Hasebe, Atsushi Irisawa, Takao Itoi, Hidekazu Mukai, Yoshifumi Arisaka, Kazumu Okushima, Koji Uno, Mitsuhiro Kida, Kiichi Tamada Background and Aim: Both DoubleLayerÒ stent (DLS) and Covered WallstentÒ (CWS) are effective for management of malignant distal biliary obstructions, previously reported. DLS has tannenbaum type structure constructed 3 layers; perfluoro alkoxy (inner), polyamid elstmar (outer) sandwiched wire mesh layer. We estimated efficacy and safety of DLS compared with CWS in the patient with pancreas head cancer (PHC). Patients and Methods: Between May 2005 and April 2007, we enrolled 120 unresectable PHC with distal biliary obstructions. They were randomly assigned to DLS or CWS placement and observe at least 6 months. Results: we excluded 6 failed cases with digestive obstruction and 9 cases with imperfect data and follow up, finally we estimated 105 cases (53 DLS, 52 CWS). There are still alive cases; 10 in DLS (5 with patent stent) and 11 in CWS (8 with patent stent). There was no significantly difference in patient survival between 2 groups. The cumulative stent patency in CWS was significantly higher than that of DLS group (pZ0.026). Median survival and stent patency were 250 and 130 days in DLS, and 215 and 419 days in CWS. Stent occlusion occurred in 31 (58.5%) after a median of 110 days in DLS group, and in 18 patients (34.6%) after a median of 144 days in CWS group. The incidence of DLS occlusion was significantly higher than that of CWS (p Z 0.0190). The causes of occlusions were tumor overgrowth (0, 2), ingrowth (0, 2), sludge (24, 3), food impaction (1, 3) and kinking bile duct (2, 0). Other complications were pancreatitis (0, 1), cholecystitis (0, 4), migrations (0, 4), liver abscess (2, 0) and other (1, 2). There was no significantly difference in the incidence of complications between 2 groups. Conclusion: DLS did not show longer patency to CWS in the patients with pancreas cancer. Cholecystitis and migration were still unresolved complications in CWS, but the incidence did not significantly differed from DLS.
S1314 Antibiotics Alone or in Combination with Ursodeoxycholic Acid (UDCA) for the Prevention of Plastic Biliary Stent Occlusion in Malignant Biliary Obstruction. A Meta-Analysis and Systemic Review of Randomized Controlled Trials (RCTs) Mohamed O. Othman, Michael D. Gilles, Moustafa A. Youssef, Richard M. Hoffman, Praveen K. Roy, Gulshan Parasher Introduction: Endoscopic insertion of plastic polyethylene biliary stents is an effective treatment for relief of benign and malignant biliary obstruction. However, its use is limited by stent occlusion. Bacterial adherence within the stent and bile salt aggregation is a possible mechanism for stent occlusion. Many RCTs have investigated the long term use of antibiotics with or without UDCA for prevention of biliary stent occlusion. We conducted a meta-analysis regarding the efficacy of these agents in preventing stent occlusion. Methods: MEDLINE (1966-October 2008) and abstracts of Gastroenterology scientific meetings were searched. RCTs comparing antibiotics with or without UDCA vs conventional treatment in patients undergoing palliative plastic biliary stent insertion were included. Studies were assigned a quality score. Standard forms were used to extract data regarding study design, outcome measures, and adverse events by 2 reviewers. We performed a meta-analysis with a random effects model to compare stent occlusion and overall survival. Each main outcome was analyzed separately via Risk Ratio (RR). Survival data was expressed as Hazard Ratio (HR). Heterogeneity was assessed by I2 measure of inconsistency. Results: 8 RCTs were included with a total of 465 patients, median age 65 -74 yrs. In 6 trials, 59% of patients had pancreatic carcinoma and 34% had cholangiocarcinoma. 7 RCTs were in English and 1 was in Italian. Ciprofloxacin or Norfloxacin were used in 7 RCTs while combination antibiotics were used in 1 trial. 3 RCTs compared antibiotics alone vs conventional treatment and included 186 patients. Antibiotics administration did not decrease the rate of stent occlusion [RR 0.84 (95% CI: 0.59 to 1.2)]. Similarly, there was no difference in survival between both groups [(HR 1.19 (0.86 to 1.68)]. 3 RCTs compared antibiotic with UDCA vs
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salvaging cannulation success where standard attempts fail. Risk of PEP increases with greater time to cannulation and increasing cannulation attempts. Further data is required to establish whether early use of NKS (to reduce cannulation time and attempts) may reduce PEP occurrence.
S1311 Temporary Placement of Fully Covered Self-Expandable Metal Stents (CSEMS) in Benign Biliary Strictures (BBS): Does Etiology of Stricture Matter? Bryan Sauer, Kara A. Regan, Henry C. Ho, Anshu Mahajan, Melissa S. Phillips, Vanessa M. Shami, Kristi Ellen, Michele E. Rehan, Timothy M. Schmitt, Michel Kahaleh Introduction: Benign biliary strictures (BBS) have been endoscopically managed with placement of multiple plastic stents. Uncovered metal stents have been associated with mucosal hyperplasia and partially covered self-expandable metal stents with migration. We sought to analyze the efficacy and complication rates of CSEMS in the treatment of BBS. Methods: CSEMS (8 or 10 mm diameter, Viabil, Conmed) were placed in 59 patients with BBS from November 2006 - September 2008. CSEMS were left in place until adequate biliary drainage was achieved; confirmed by resolution of symptoms, normalization of LFTs, and imaging. Results: 59 patients with BBS (37 men, mean age 56.6 13.5) had CSEMS placed due to strictures related to chronic pancreatitis (CP) (nZ24), gallstone disease (nZ16), post liver transplant (nZ17), autoimmune pancreatitis (nZ1) and primary sclerosing cholangitis (nZ1). Twenty-two (36%) had plastic stents placed prior to CSEMS without resolution of stricture. CSEMS were removed in 53 (90%) patients after a mean stent time of 4.4 2.7 months. Six patients did not have CSEMS removed: three had recent placement and are awaiting follow-up for removal and three died of unrelated causes (pneumonia, cirrhosis, metastatic colon cancer). Resolution of the BBS was confirmed in 45/53 patients (85%). Patients with strictures related to chronic pancreatitis had resolution of stricture in 68% whereas all other causes had resolution of stricture in 94% (pZ0.02)(See Table 1). Complications during placement of CSEMS were observed in 10 patients (17%) including pain (nZ3), post-ERCP pancreatitis (nZ5), bleeding (nZ1), and wire perforation (nZ1). Complications during stent removal occurred in 5 patients (9%) including pain (nZ2) and post-ERCP pancreatitis (nZ3). Stent complications were observed in 9 patients (15%) including debris in stent (nZ4), stent migration (nZ3), stent occlusion (nZ1), and stent unravelling (nZ1). Conclusion: Temporary placement of CSEMS for BBS might offer an alternative to plastic stenting in cases not related to chronic pancreatitis. However further investigations are required in order to decrease complication rate and further evaluate long-term efficacy. Table 1. Resolution of Strictures Chronic Panc All Others P value Biliary Stricture Resolved) 45/53 (85%) 13/19 (68%) 32/34 (94%) 0.02 Biliary Stricture Resolved ITT)) 45/56 (80%) 13/21 (62%) 32/35 (91%) 0.01 ) Values listed as number (%) P value based on Fisher’s Exact Test Resolution based on individuals with stent removed )) Intention to treat analysis, includes three patient who died of unrelated causes.
S1312 Long Duration of Patency with Intrabiliary Plastic Stent Placement for Malignant Biliary Strictures: A Pilot Study Hidemichi Imamura, Atsushi Irisawa, Lyndon V. Hernandez, Takuto Hikichi, Goro Shibukawa, Tadayuki Takagi, Takeru Wakatsuki, Yuta Takahashi, Ai Sato, Masaki Sato, Tsunehiko Ikeda, Rei Suzuki, Katsutoshi Obara, Hiromasa Ohira Background/Aim: Stent clogging is a major hindrance to palliative treatment for malignant biliary obstruction. When used for malignant common bile duct strictures, wide-bore, self-expanding metal stents (SEMS) typically remain patent longer than plastic stents. Previous reports have described partial or total occlusion of plastic stents, frequently accompanied by cholangitis, occurring 2-4 months after insertion of standard 10F plastic stents, necessitating their replacement. Because the distal tip of the stent (duodenal side) is located in the duodenal lumen, plastic stents involve sludge deposition from clogging by backward cholangio-infection and food impaction into the stent lumen. Considering these facts, we hypothesized that intrabiliary plastic stent placement (with the distal tip of stent, or the duodenal side, located completely within the bile duct) prolongs the patency of plastic stents, avoiding sludge deposition caused by backward cholangio-infection and food impaction. We performed a pilot study to evaluate the effectiveness of intrabiliary plastic stent placement for upper-middle bile ductal obstruction attributable to cholangiocarcinoma. Patients/Methods: In this study, 33 patients who had malignant proximal and middle biliary obstruction during Jul. 2006 - Aug. 2008 were enrolled: 7 patients for drainage for surgical operation and 26 patients for permanent drainage. Plastic stents (straight type with flaps on both ends) were selected based on the minimal length and degree of the stricture. The distal tip of the stent (duodenal side) was positioned within the bile duct over a guide-wire using
AB140 GASTROINTESTINAL ENDOSCOPY Volume 69, No. 5 : 2009
a pusher catheter. In cases where it was necessary to remove them, an extraction basket or balloon catheter was used. Diameters of the plastic stents used for this study were 8.5 French (Fr.) in 4 patients, 7 Fr. in 29 patients, and 5 Fr. in 4 patient. Results: In patients who underwent stent placement for drainage related to a surgical operation, all stents were patent until surgical operations. Among patients who underwent permanent drainage, long duration of non-clogged performance was achieved, with one-year patency rate of 49.6%. No directly procedure-related complications were identified. In all cases where it was necessary to remove the indwelled stents, they could be extracted. Conclusions: Our method constitutes another option for endoscopists who treat patients with malignant biliary strictures. Further prospective trials are necessary to assess the efficacy and safety of this method and to develop stents that are designed specifically for intrabiliary placement.
S1313 The Result of Japanese Multicenter, Randomized Trial of Endoscopic Stenting for the Nonresectable Pancreatic Head Cancer (JM-Test) Retrospective Investigation Hiroyuki Isayama, Ichiro Yasuda, Shomei Ryozawa, Hiroyuki Maguchi, Yoshinori Igarashi, Yutaka Matsuyama, Akio Katanuma, Osamu Hasebe, Atsushi Irisawa, Takao Itoi, Hidekazu Mukai, Yoshifumi Arisaka, Kazumu Okushima, Koji Uno, Mitsuhiro Kida, Kiichi Tamada Background and Aim: Both DoubleLayerÒ stent (DLS) and Covered WallstentÒ (CWS) are effective for management of malignant distal biliary obstructions, previously reported. DLS has tannenbaum type structure constructed 3 layers; perfluoro alkoxy (inner), polyamid elstmar (outer) sandwiched wire mesh layer. We estimated efficacy and safety of DLS compared with CWS in the patient with pancreas head cancer (PHC). Patients and Methods: Between May 2005 and April 2007, we enrolled 120 unresectable PHC with distal biliary obstructions. They were randomly assigned to DLS or CWS placement and observe at least 6 months. Results: we excluded 6 failed cases with digestive obstruction and 9 cases with imperfect data and follow up, finally we estimated 105 cases (53 DLS, 52 CWS). There are still alive cases; 10 in DLS (5 with patent stent) and 11 in CWS (8 with patent stent). There was no significantly difference in patient survival between 2 groups. The cumulative stent patency in CWS was significantly higher than that of DLS group (pZ0.026). Median survival and stent patency were 250 and 130 days in DLS, and 215 and 419 days in CWS. Stent occlusion occurred in 31 (58.5%) after a median of 110 days in DLS group, and in 18 patients (34.6%) after a median of 144 days in CWS group. The incidence of DLS occlusion was significantly higher than that of CWS (p Z 0.0190). The causes of occlusions were tumor overgrowth (0, 2), ingrowth (0, 2), sludge (24, 3), food impaction (1, 3) and kinking bile duct (2, 0). Other complications were pancreatitis (0, 1), cholecystitis (0, 4), migrations (0, 4), liver abscess (2, 0) and other (1, 2). There was no significantly difference in the incidence of complications between 2 groups. Conclusion: DLS did not show longer patency to CWS in the patients with pancreas cancer. Cholecystitis and migration were still unresolved complications in CWS, but the incidence did not significantly differed from DLS.
S1314 Antibiotics Alone or in Combination with Ursodeoxycholic Acid (UDCA) for the Prevention of Plastic Biliary Stent Occlusion in Malignant Biliary Obstruction. A Meta-Analysis and Systemic Review of Randomized Controlled Trials (RCTs) Mohamed O. Othman, Michael D. Gilles, Moustafa A. Youssef, Richard M. Hoffman, Praveen K. Roy, Gulshan Parasher Introduction: Endoscopic insertion of plastic polyethylene biliary stents is an effective treatment for relief of benign and malignant biliary obstruction. However, its use is limited by stent occlusion. Bacterial adherence within the stent and bile salt aggregation is a possible mechanism for stent occlusion. Many RCTs have investigated the long term use of antibiotics with or without UDCA for prevention of biliary stent occlusion. We conducted a meta-analysis regarding the efficacy of these agents in preventing stent occlusion. Methods: MEDLINE (1966-October 2008) and abstracts of Gastroenterology scientific meetings were searched. RCTs comparing antibiotics with or without UDCA vs conventional treatment in patients undergoing palliative plastic biliary stent insertion were included. Studies were assigned a quality score. Standard forms were used to extract data regarding study design, outcome measures, and adverse events by 2 reviewers. We performed a meta-analysis with a random effects model to compare stent occlusion and overall survival. Each main outcome was analyzed separately via Risk Ratio (RR). Survival data was expressed as Hazard Ratio (HR). Heterogeneity was assessed by I2 measure of inconsistency. Results: 8 RCTs were included with a total of 465 patients, median age 65 -74 yrs. In 6 trials, 59% of patients had pancreatic carcinoma and 34% had cholangiocarcinoma. 7 RCTs were in English and 1 was in Italian. Ciprofloxacin or Norfloxacin were used in 7 RCTs while combination antibiotics were used in 1 trial. 3 RCTs compared antibiotics alone vs conventional treatment and included 186 patients. Antibiotics administration did not decrease the rate of stent occlusion [RR 0.84 (95% CI: 0.59 to 1.2)]. Similarly, there was no difference in survival between both groups [(HR 1.19 (0.86 to 1.68)]. 3 RCTs compared antibiotic with UDCA vs
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