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Self Expandable Metal Stents in Liver Transplanted Patients with Biliary Stricture: Fully Covered Versus Partially Covered Metal Stents?
Abstracts
a safer alternative to standard cannulation (SC) techniques and BS in patients with coagulopathy. Aims: To compare the safety, effectiveness and cost-effectiveness (CE) of SPP and SC in patients with cirrhosis. Methods: A prospective study comparing the procedural outcomes of decompensated cirrhotic patients undergoing ERCP for management of choledocolithiasis was carried out. Results: One-hundred and five patients (56 [53.3%] men, mean [SD] age 56 [15.8]) with coagulopathy due to chronic liver disease underwent ERCP for treatment of common bile duct (CBD) stones. SPP and standard cannulation (SC) were performed in 42 and 63 patients respectively. Successful access of the CBD was achieved in 56/63 (89%) and 40/42 (95%) of patients undergoing SC and SPP respectively [pZ0.13; 95% CI (-0.16; 0.03)]. Complications occurred in 15/63 (24%) of patients undergoing SC and 6/42 (14%) SPP [pZ0.20; 95% CI (-0.24, 0.04)]. Eight (12.6%) and 3 (7.1%) episodes of post-sphincterotomy bleeding was seen in the SC and SPP group respectively (pZ0.36, 95% CI [-0.167, 0.05]). In contrast, 4 (6.3%) episodes of pancreatitis were seen in the SC group while patients in the SPP did not experience this complication (p!0.05; 95% CI [0.003; 0.12]). The CE analysis demonstrated that SC is less expensive and effective than SPP. SPP is an acceptable alternative at an incremental CE ratio of US$ 2740.77 per additional procedure success. Conclusion: SPP is a safe effective and cost-effective technique to access the biliary system and remove common bile duct stones in patients with cirrhosis and coagulopathy. SPP is associated with a significant lower rate of post-ERCP pancreatitis. Although a trend toward less bleeding also existed in the SPP group, larger studies to validate this finding are necessary.
S1330 Self Expandable Metal Stents in Liver Transplanted Patients with Biliary Stricture: Fully Covered Versus Partially Covered Metal Stents? Melissa S. Phillips, Bryan Sauer, Lavone A. Smith, Michele E. Rehan, Kara A. Regan, Kristi Ellen, Timothy M. Schmitt, Michel Kahaleh Background: Liver transplant (LT) related strictures are typically managed with ERCP and plastic stents placement and often require multiple session to achieve complete resolution. Temporary placement of partially covered (PCMS) or fully covered (CSEMS) metal stents has been described by our group for benign biliary strictures. This report analyzes a series of anastamotic and nonanastamotic strictures following LT that were treated with a CSEMS or PCMS and compares their long term efficacy and safety. Methods: Between 2003 and 2008, 39 patients who had undergone LT presented with biliary stricture. Patients were captured prospectively and followed until resolution. Safety, efficacy of PCMS and CSEMS, and eventual complications were compared. Results: 37 patients (26 male) median age 56 years (range: 33-75) underwent temporary placement of a metal stent following LT. A CSEMS (Viabil, Conmed, Utica, NY) was placed in 18 patient while a PCMS (Wallstent, Boston Scientific, Natick, MA) was placed in the remaining 19 patient. Metal stents were left in place for a median of 112 days (range: 24-329) with median follow up after CSEMS removal of 374 days (range: 26-1752). Following treatment with metal stenting, 29/34 patients (85%) had resolution of their biliary stricture, 5 patients had continued stricture with two undergoing hepaticojejunostomy, one patient has stent in place with outcome pending, and three patients required retransplantation. Four patients had stent migration and two had superficial ulceration of the bile duct post metal stent removal. One developed cholangitis while the CSEMS was in place and patent. When CSEMS were compared to PCMS no statistical difference was noticed in term of efficacy or complication (Table 1). Conclusions: This study didn’t demonstrate a difference between CSEMS and PCMS for the treatment of biliary strictures following LT. This data should be confirmed in a randomized trial. Table 1. Stent Comparison N Male (%) Age (mean yrs) Stent Time (days) Follow-up after stent (days) Success Complications
Viabil
Wallstent
P value
18 12/18 (67%) 56.5 138 206 15/17 (88%) 5/18 (28%)
19 14/19 (74%) 55.7 198 761 14/17 (82%) 2/19 (11%)
0.73 0.96 0.90 0.003 1.00 0.23
Values listed as number (%) P values based on Fisher’s exact (categorical variables) and Wilcoxon Rank Sum test (continuous variables) ) Excludes those that underwent retransplantation (nZ3)
S1331 Three- or Four-Branched Endoscopic Deployment of Multiple Metallic Stents in the Patients with High Grade Hilar Biliary Strictures Due to Biliary Tract Carcinoma-Its Feasibility and Limitation Hirofumi Kawamoto, Hironari Kato, Naoko Kurihara, Ken Hirao, Osamu Mizuno, Etsuji Ishida, Tsuneyoshi Ogawa, Kazuhide Yamamoto
www.giejournal.org
Background: It is technically demanding to deploy multiple metallic stents (MMS) via transpapillary route in the patients with malignant hilar biliary strictures. This study evaluates technical feasibility and limitations of endoscopic three- or fourbranched MMS deployment using partial stent-in-stent (PSIS) procedure. Patients and Methods: Between April 2005 and December 2007, 21 patients with Bismuth type 3a or 4 due to biliary tract carcinoma enrolled in this study (M: F 15: 6; Mean age: 64 y.o.; Cholangiocarcimoma nZ17, Gallbladder carcinoma nZ4; Mean observation period 251 days). The patients with huge tumor involving whole right or left lobe were excluded. Twenty patients with jaundice were subject to two or more plastic stents deployment before that of metallic stents, simply because their definitive diagnosis and resectability of tumor were not confirmed on admission. One patient without jaundice was initially subjected to MMS deployment. In case jaundice or cholangitis was not improved with first biliary decompression, percutaneous transhepatic biliary drainage (PTBD) was performed on undrained biliary branches. After confirmative diagnosis of unresectable biliary tract carcinoma, multiple JOSTENT SelfX (Abbott Vascular Devices, Redwood City, California, USA) were deployed in left hepatic duct and right anterior and posterior branches of right hepatic duct via transpapillary route, using PSIS procedure. Success rate and time of the procedure, stent patency, and procedure-related complications were evaluated. Results: MMS deployment was successfully achieved in 19 patients (90%) only via transpapillary route. Rendezvous technique was employed in remaining 2 patients to achieve MMS deployment. Three-branched MMS deployment was achieved in 17 patients and four-branched was in 4. Mean procedure time was 66 minutes (range: 33-127). Mean patency time was 139 days (range: 21-827). Chemotherapy using gemcitabine or S-1 was performed on 15 patients (71%). Partial response or stationary disease was attained in 8 patients. In these patients, mean patency time of the stents was 470 days, which was significantly longer (p!0.001) than that of remaining patients (90 days). Cholecystitis (nZ4), liver abscess (nZ1), and hemobilia (nZ1) were major complications. All patients recovered from these morbidities. After stent obstruction, multiple plastic stents were successfully deployed through the metallic stents via transpapillary route. Conclusion: Endoscopic MMS deployment is an acceptable approach to the patients with high-grade malignant hilar biliary strictures.
S1332 A Comparative Evaluation of Stent Malfunction Rates Among Biliary Conventional vs. Wing (ViaductÒ) Stents Devi Mukkai Krishnamurty, Vikesh Singh, Anne Marie Lennon, Patrick Okolo, Marcia I. Canto, Sanjay B. Jagannath Conventional plastic biliary stents (CS) used in ERCP are thin, hollow tubes that are electively exchanged every 3 months because of the high rate of stent occlusion. The biliary Wing stent (WS) (ViaductÒ) is a novel plastic biliary stent that lacks a lumen, and is designed for bile to flow on the outside of the stent. The occlusion rate in WS may be lower since there is no lumen. No studies exist to date comparing the stent malfunction rate among these two different stent designs (CS vs. WS). Aim: To compare stent malfunction rates among CS vs. WS in patients who underwent ERCP with biliary stent placement. Methods: IRB-approved, retrospective analysis of all outpatients who underwent an ERCP with biliary stent placement from 2003 to 2008. Patients were identified using the our institutional billing database and electronic medical records. Patient demographics and clinical presentation, procedural factors, and laboratory results were recorded for the index ERCP as well as all successive ERCP procedures. The primary outcome was stent malfunction (CS vs. WS) stratified by ERCP indication. Stent malfunction was defined as an unscheduled or emergent stent removal or exchange accompanied by the presence of any of the following: abdominal pain, fever, leukocytosis (O12,000/ mm3), enlarged bile duct on radiographic imaging, or an increase in liver biochemical tests in the absence of an alternative diagnosis. Data was analyzed using STATA and a p-value !0.05 was considered statistically significant. Results: A total of 274 stents were inserted, 240 (88%) were CS and 34 (12%) were WS. An equal percentage of CS and WS were placed for benign [147 (61.5%) vs. 22 (64.7%), pZNS] and malignant [62 (25.9%) vs. 8 (23.5%), pZNS] indications. Stent malfunction was seen in 30 patients with CS (12.5%) vs. 5 patients with WS (14.7%), pZNS. There is no significant difference among stent malfunction rates between CS and WS. However, there is a trend towards improved patency of the WS for cholangiocarcinoma, PSC, and chronic pancreatitis. This study is limited by the small sample size of WS. Conclusion: Stent malfunction rates are similar for the WS and CS across several indications. The trend towards improved patency rates for the wing stent among patients with cholangiocarcinoma, PSC, and chronic pancreatitis warrants further prospective investigation. Stent Malfunction Rates CS Cholangiocarcinoma PSC Chronic Pancreatitis CBD Stones Miscellaneous
2/9 5/17 5/35 4/13 14/166
(22%) (29%) (14%) (31%) (8.4%)
WS 0/4 0/4 0/4 3/10 2/12
(0) (0) (0) (30%) (16.7%)
Volume 69, No. 5 : 2009 GASTROINTESTINAL ENDOSCOPY AB145
a safer alternative to standard cannulation (SC) techniques and BS in patients with coagulopathy. Aims: To compare the safety, effectiveness and cost-effectiveness (CE) of SPP and SC in patients with cirrhosis. Methods: A prospective study comparing the procedural outcomes of decompensated cirrhotic patients undergoing ERCP for management of choledocolithiasis was carried out. Results: One-hundred and five patients (56 [53.3%] men, mean [SD] age 56 [15.8]) with coagulopathy due to chronic liver disease underwent ERCP for treatment of common bile duct (CBD) stones. SPP and standard cannulation (SC) were performed in 42 and 63 patients respectively. Successful access of the CBD was achieved in 56/63 (89%) and 40/42 (95%) of patients undergoing SC and SPP respectively [pZ0.13; 95% CI (-0.16; 0.03)]. Complications occurred in 15/63 (24%) of patients undergoing SC and 6/42 (14%) SPP [pZ0.20; 95% CI (-0.24, 0.04)]. Eight (12.6%) and 3 (7.1%) episodes of post-sphincterotomy bleeding was seen in the SC and SPP group respectively (pZ0.36, 95% CI [-0.167, 0.05]). In contrast, 4 (6.3%) episodes of pancreatitis were seen in the SC group while patients in the SPP did not experience this complication (p!0.05; 95% CI [0.003; 0.12]). The CE analysis demonstrated that SC is less expensive and effective than SPP. SPP is an acceptable alternative at an incremental CE ratio of US$ 2740.77 per additional procedure success. Conclusion: SPP is a safe effective and cost-effective technique to access the biliary system and remove common bile duct stones in patients with cirrhosis and coagulopathy. SPP is associated with a significant lower rate of post-ERCP pancreatitis. Although a trend toward less bleeding also existed in the SPP group, larger studies to validate this finding are necessary.
S1330 Self Expandable Metal Stents in Liver Transplanted Patients with Biliary Stricture: Fully Covered Versus Partially Covered Metal Stents? Melissa S. Phillips, Bryan Sauer, Lavone A. Smith, Michele E. Rehan, Kara A. Regan, Kristi Ellen, Timothy M. Schmitt, Michel Kahaleh Background: Liver transplant (LT) related strictures are typically managed with ERCP and plastic stents placement and often require multiple session to achieve complete resolution. Temporary placement of partially covered (PCMS) or fully covered (CSEMS) metal stents has been described by our group for benign biliary strictures. This report analyzes a series of anastamotic and nonanastamotic strictures following LT that were treated with a CSEMS or PCMS and compares their long term efficacy and safety. Methods: Between 2003 and 2008, 39 patients who had undergone LT presented with biliary stricture. Patients were captured prospectively and followed until resolution. Safety, efficacy of PCMS and CSEMS, and eventual complications were compared. Results: 37 patients (26 male) median age 56 years (range: 33-75) underwent temporary placement of a metal stent following LT. A CSEMS (Viabil, Conmed, Utica, NY) was placed in 18 patient while a PCMS (Wallstent, Boston Scientific, Natick, MA) was placed in the remaining 19 patient. Metal stents were left in place for a median of 112 days (range: 24-329) with median follow up after CSEMS removal of 374 days (range: 26-1752). Following treatment with metal stenting, 29/34 patients (85%) had resolution of their biliary stricture, 5 patients had continued stricture with two undergoing hepaticojejunostomy, one patient has stent in place with outcome pending, and three patients required retransplantation. Four patients had stent migration and two had superficial ulceration of the bile duct post metal stent removal. One developed cholangitis while the CSEMS was in place and patent. When CSEMS were compared to PCMS no statistical difference was noticed in term of efficacy or complication (Table 1). Conclusions: This study didn’t demonstrate a difference between CSEMS and PCMS for the treatment of biliary strictures following LT. This data should be confirmed in a randomized trial. Table 1. Stent Comparison N Male (%) Age (mean yrs) Stent Time (days) Follow-up after stent (days) Success Complications
Viabil
Wallstent
P value
18 12/18 (67%) 56.5 138 206 15/17 (88%) 5/18 (28%)
19 14/19 (74%) 55.7 198 761 14/17 (82%) 2/19 (11%)
0.73 0.96 0.90 0.003 1.00 0.23
Values listed as number (%) P values based on Fisher’s exact (categorical variables) and Wilcoxon Rank Sum test (continuous variables) ) Excludes those that underwent retransplantation (nZ3)
S1331 Three- or Four-Branched Endoscopic Deployment of Multiple Metallic Stents in the Patients with High Grade Hilar Biliary Strictures Due to Biliary Tract Carcinoma-Its Feasibility and Limitation Hirofumi Kawamoto, Hironari Kato, Naoko Kurihara, Ken Hirao, Osamu Mizuno, Etsuji Ishida, Tsuneyoshi Ogawa, Kazuhide Yamamoto
www.giejournal.org
Background: It is technically demanding to deploy multiple metallic stents (MMS) via transpapillary route in the patients with malignant hilar biliary strictures. This study evaluates technical feasibility and limitations of endoscopic three- or fourbranched MMS deployment using partial stent-in-stent (PSIS) procedure. Patients and Methods: Between April 2005 and December 2007, 21 patients with Bismuth type 3a or 4 due to biliary tract carcinoma enrolled in this study (M: F 15: 6; Mean age: 64 y.o.; Cholangiocarcimoma nZ17, Gallbladder carcinoma nZ4; Mean observation period 251 days). The patients with huge tumor involving whole right or left lobe were excluded. Twenty patients with jaundice were subject to two or more plastic stents deployment before that of metallic stents, simply because their definitive diagnosis and resectability of tumor were not confirmed on admission. One patient without jaundice was initially subjected to MMS deployment. In case jaundice or cholangitis was not improved with first biliary decompression, percutaneous transhepatic biliary drainage (PTBD) was performed on undrained biliary branches. After confirmative diagnosis of unresectable biliary tract carcinoma, multiple JOSTENT SelfX (Abbott Vascular Devices, Redwood City, California, USA) were deployed in left hepatic duct and right anterior and posterior branches of right hepatic duct via transpapillary route, using PSIS procedure. Success rate and time of the procedure, stent patency, and procedure-related complications were evaluated. Results: MMS deployment was successfully achieved in 19 patients (90%) only via transpapillary route. Rendezvous technique was employed in remaining 2 patients to achieve MMS deployment. Three-branched MMS deployment was achieved in 17 patients and four-branched was in 4. Mean procedure time was 66 minutes (range: 33-127). Mean patency time was 139 days (range: 21-827). Chemotherapy using gemcitabine or S-1 was performed on 15 patients (71%). Partial response or stationary disease was attained in 8 patients. In these patients, mean patency time of the stents was 470 days, which was significantly longer (p!0.001) than that of remaining patients (90 days). Cholecystitis (nZ4), liver abscess (nZ1), and hemobilia (nZ1) were major complications. All patients recovered from these morbidities. After stent obstruction, multiple plastic stents were successfully deployed through the metallic stents via transpapillary route. Conclusion: Endoscopic MMS deployment is an acceptable approach to the patients with high-grade malignant hilar biliary strictures.
S1332 A Comparative Evaluation of Stent Malfunction Rates Among Biliary Conventional vs. Wing (ViaductÒ) Stents Devi Mukkai Krishnamurty, Vikesh Singh, Anne Marie Lennon, Patrick Okolo, Marcia I. Canto, Sanjay B. Jagannath Conventional plastic biliary stents (CS) used in ERCP are thin, hollow tubes that are electively exchanged every 3 months because of the high rate of stent occlusion. The biliary Wing stent (WS) (ViaductÒ) is a novel plastic biliary stent that lacks a lumen, and is designed for bile to flow on the outside of the stent. The occlusion rate in WS may be lower since there is no lumen. No studies exist to date comparing the stent malfunction rate among these two different stent designs (CS vs. WS). Aim: To compare stent malfunction rates among CS vs. WS in patients who underwent ERCP with biliary stent placement. Methods: IRB-approved, retrospective analysis of all outpatients who underwent an ERCP with biliary stent placement from 2003 to 2008. Patients were identified using the our institutional billing database and electronic medical records. Patient demographics and clinical presentation, procedural factors, and laboratory results were recorded for the index ERCP as well as all successive ERCP procedures. The primary outcome was stent malfunction (CS vs. WS) stratified by ERCP indication. Stent malfunction was defined as an unscheduled or emergent stent removal or exchange accompanied by the presence of any of the following: abdominal pain, fever, leukocytosis (O12,000/ mm3), enlarged bile duct on radiographic imaging, or an increase in liver biochemical tests in the absence of an alternative diagnosis. Data was analyzed using STATA and a p-value !0.05 was considered statistically significant. Results: A total of 274 stents were inserted, 240 (88%) were CS and 34 (12%) were WS. An equal percentage of CS and WS were placed for benign [147 (61.5%) vs. 22 (64.7%), pZNS] and malignant [62 (25.9%) vs. 8 (23.5%), pZNS] indications. Stent malfunction was seen in 30 patients with CS (12.5%) vs. 5 patients with WS (14.7%), pZNS. There is no significant difference among stent malfunction rates between CS and WS. However, there is a trend towards improved patency of the WS for cholangiocarcinoma, PSC, and chronic pancreatitis. This study is limited by the small sample size of WS. Conclusion: Stent malfunction rates are similar for the WS and CS across several indications. The trend towards improved patency rates for the wing stent among patients with cholangiocarcinoma, PSC, and chronic pancreatitis warrants further prospective investigation. Stent Malfunction Rates CS Cholangiocarcinoma PSC Chronic Pancreatitis CBD Stones Miscellaneous
2/9 5/17 5/35 4/13 14/166
(22%) (29%) (14%) (31%) (8.4%)
WS 0/4 0/4 0/4 3/10 2/12
(0) (0) (0) (30%) (16.7%)
Volume 69, No. 5 : 2009 GASTROINTESTINAL ENDOSCOPY AB145