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T1562: Self-Expandable Partially Covered Metallic Stents to Palliate Malignant Biliary Strictures: Evaluation of the ComVi Stent
Abstracts with a mean of 125.5 days respectively (p⫽0.04). Subset analysis limited to malignant biliary obstruction gave overall patency rates in FC-SEMS and SEMS of 167.5 (range 6-446) days and 125.5 (range 12-515) days respectively (p⫽0.23). Complications with placement of SEMS occurred in 13.3% (4/30) with 2 episodes of pancreatitis and 2 minor bleeds, compared to 13.7% (4/29) with FC-SEMS (1 pancreatitis, 1 intra-tumor contained perforation upon removal, 1 outward stent migration, and 1 liver abscess) (p⫽1.0). Prior cholecystectomy had not been performed in 10 of the FC-SEMS patients compared to 9 of the SEMS patients. No episodes of acute cholecystitis were documented in either group despite no placement of gallbladder stents.CONCLUSION: In this retrospective case series, FC-SEMS were effective for palliation of biliary obstruction, had comparable patency to SEMS, and were easily removable, offering an advantage in benign biliary diseases. Rates of complications were similar between both types of stents. Acute cholecystitis did not occur in patients with intact gallbladders who underwent stenting with FC-SEMS. Randomized clinical trials evaluating the efficacy, safety, and removability of FC-SEMS in benign and malignant biliary tract disease are needed.
T1561 Endoscopic Palliation of Malignant Hilar Biliary Strictures by Self-Expandable Metal Stents: Clinical Results and Patency Evaluation Andrea Tringali, Ivo Bosˇkoski, Massimiliano Mutignani, Pietro Familiari, Vincenzo Perri, Guido Costamagna BACKGROUND AND OBJECTIVE Endoscopic biliary drainage of malignant hilar strictures (MHS) by self-expandable metal stents (SEMS) is technically difficult and expensive. Furthermore, little is known about the clinical impact on survival and the patency of multiple SEMS in MHS.METHODS We performed a retrospective review of all the patients that underwent SEMS insertion for MHS at our endoscopy unit between January 1998 and August 2009. MHS were classified according to Bismuth and Corlette. We included only patients with complex types of strictures that received two or more SEMS. The aim was to obtain a complete drainage of biliary ducts by endoscopic SEMS placement. A total of 101 patients were identified (56 F and 45 M, mean age 66.7 years, range 40-89). MHS were due to cholangiocarcinoma (CCA) (n⫽61), gallbladder cancer (GC) (n⫽24), lymphnode metastases (LMN) (n⫽12) and hepatocellular carcinoma (HCC) (n⫽4). Twenty-seven patients had type II MHS, 52 type IIIa, 1 type IIIb and 21 type IV.RESULTS Eighty-nine patients died and their mean survival was 335 days (range 12-1224). On follow-up (ongoing) 12 patients are still alive. According to the Kaplan-Mayer survival analysis, a shorter life expectancy was found for patients with type IV MHS when compared with type II and III (p⫽0.05). This was confirmed by the Cox multivariate analysis (type IV: RR 1; type II: RR 0.64, CI 0.33-0.95; type III: RR 0.52, CI 0.29-0.95). There was no relationship between patients age (RR 0.99, CI 0.98-1.02), gender (RR 0.99, CI 0.62-1.58) and presence of metastases (RR 0.83, CI 0.39-1.78), No relation was found in terms of survival between the type of stricture and type of neoplasia (CCA: RR 1; GC: RR 1.19, CI 0.69-2.05; LNM and HCC: RR 0.79, CI 0.36-1.39). A total of 63 re-interventions for SEMS malfunction were performed (range 0-6; 0.62 per patient). SEMS malfunction was due to sludge formation (24%), ingrowth (23%), overgrowth (13%) and stent migration/impaction (3%). Survival rate resulted higher in patients with more re-interventions for SEMS malfunction (RR 0.39, CI 0.24-0.64). This could be due probably to the slow tumor evolution in some cases, so patients that lived longer had more re-interventions or maybe because SEMS can improve patients survival rate.CONCLUSIONS Endoscopic SEMS insertion is an expensive and challenging way for the palliation of MHS. Endoscopic biliary drainage with SEMS can give a satisfactory (1 year) mean survival, independently of the type of malignancy, presence of metastases, age and gender. Probably SEMS in MHS can improve patients survival, this however has to be confirmed in future prospective, comparative trials.
haemobilia d) cholangitis at the time of stenting; e) previous percutaneous, endoscopic or surgical biliary drainage; f) age ⬍ 18; g) refusal to sign the informed consent.Primary end-point: to evaluate the stent patency. Secondary end-points: evaluation of causes for stent dysfunction, occurrence of cholecystitis and survival. Patients underwent a bi-monthly follow-up until death. The protocol was approved by the local ethical committee.Aim of the study was to enroll 70 patients.Results.Between November 2006 and May 2009, 70 patients were enrolled (mean age 69 years, 36 F). Reasons for malignant stricture were pancreatic cancer (n⫽50), cholangiocarcinoma (n⫽13), lymphnode metastases (n⫽5) and gallbladder cancer (n⫽2). Fifty-nine patients had the gallbladder in situ (51 alithiasic, 8 lithiasic), 11 were cholecystectomized.Thirty-nine patients (56%) died after a mean of 5.6 months with a patent stent; 10 (14%) are alive after a mean of 6.1 months without signs of stent malfunction (follow-up is ongoing); 21 (30%) had cholangitis due to stent clogging after a mean of 5.4 months (9 overgrowth, 5 sludge formation, 3 ingrowth, 3 stent migration due to tumor necrosis, 1 food reflux due to duodenal stricture) and were successfully retreated endoscopically (17 died after a mean of 5 months from retreatment, 4 are alive after a mean of 3 months from retreatment). One patient of 59 (1.7%) with gallbladder in situ experienced cholecystitis and was successfully treated by percutaneous cholecystostomy.Conclusions.The partially covered nitinol ComVi SEMS provides a satisfactory palliation of jaundice with a low risk of tumor ingrowth. The risk of cholecystitis using covered SEMS is low.
T1563 Predictors of the Need for Emergency ERCP for Acute Cholangitis in Japan Takayoshi Nishino, Izumi Shirato, Atsushi Mitsunaga, Miho Shirato Background and Aim: Cases of acute cholangitis (AC) vary in severity from mild to severe, and it is not always easy to predict whether a patient will respond to medical treatment or will require urgent biliary decompression. This study was undertaken to identify predictors and develop a prognostic scoring system that could be used to predict the requirement for urgent biliary decompression.Patients and Methods: We prospectively reviewed 38 consecutive cases of AC between July 2008 and October 2009. We divided the cases into an emergency-ERCP group (Group A, n⫽15) and an elective-ERCP group (Group B, n⫽23). The diagnosis and evaluation of the severity of AC were made based on the Tokyo Guideline published in 2007. Emergency ERCP was performed within 24 hours after admission, in the cases diagnosed as severe AC and in the cases in which SIRS developed despite initial treatment. Results: 1. AC was severe in 9 cases and moderate in 6 cases in Group A, and moderate in 7 cases and mild in 16 cases in Group B. 2. One patient with severe AC in Group A died of uncontrolled septicemia despite successful decompression of biliary obstruction.3. Univariate analysis identified five factors on admission as being associated with subsequent failure of medical treatment and need for emergency ERCP: maximum heart rate (MHR) greater than 100/min, body temperature above 38.5 degrees Celsius centigrade, serum albumin level below 3.0 mg/dl, BUN above 20 mg/dl, and platelet count below 100,000/l (p⫽0.0003, 0.001, 0.02, 0.01, and 0.01, respectively.)4. Multivariate analysis identified two of the above factors associated with subsequent need for emergency ERCP: MHR greater than 100/min and platelet count below 100,000/l .5. A blood culture positive for the presence of bacteria was strongly associated with aspiration of purulent bile during ERCP.6. When the five predictors were used to devise a scoring system in which 1 point was assigned for each factor (maximum score possible: 5 points), the receiver-operator characteristic curve of the scores showed good test performance for predicting emergency ERCP and a positive blood culture with an area under the curve of 0.95 (95%CI; 0.88-0.99) and 0.93 (95% CI; 0.79-0.99), respectively. The optimal cut-off value was 2 points, with a sensitivity of 73.3% and specificity of 95.9% for emergency ERCP and sensitivity of 81.8% and specificity of 88.5% for a positive blood culture.Conclusions: We recommend that emergency ERCP be performed in patients who are positive for two or more the predictors identified in this study.
T1562 Self-Expandable Partially Covered Metallic Stents to Palliate Malignant Biliary Strictures: Evaluation of the ComVi Stent Andrea Tringali, Michele Marchese, Pietro Familiari, Jang Sungil, Ho Gak Kim, Massimiliano Mutignani, Vincenzo Perri, Dongki Lee, Guido Costamagna
T1564 Outcomes of Sphincter of Oddi Manometry in a Low Volume Center John P. Rice, Bret J. Spier, Deepak V. Gopal, Mark Reichelderfer, Anurag Soni, Patrick Pfau
Background and aim.Endoscopic palliation of jaundice secondary to malignant biliary strictures by stent insertion is currently considered the treatment of choice. Self-Expandable Metal Stents (SEMS) have a longer patency than plastic. Membrane-coated SEMS can prevent tumor ingrowth leading to a longer patency than uncovered SEMS. Aim of this multi-centre, single-arm study is to prospectively evaluate a new nitinol partially covered SEMS (ComVi, TaewoongMedical, Korea)Materials and methods.Inclusion criteria: a) unresectable or unoperable malignancy leading to stenoses at the middle/distal common bile duct; b) absence of liver metastases; c) first attempt at endoscopic biliary drainage; d) at least 6 months life expectancy (Karnofsky score ⬎ 60).Exclusion criteria: a) ampullary cancer; b) hilar and/or intra-hepatic ducts malignancy; c)
Background: Sphincter of oddi manometry (SOM) is a highly specialized procedure associated with an increased risk of procedural complications. Studies published on SOM have been performed in large volume manometry centers with suggestions that SOM be limited to such centers. The outcomes and safety of SOM performed in smaller numbers have not been established.Aim: To examine the outcomes and complication rate of SOM when performed in small volumes.Methods: From January 1, 2003 until July 1, 2009 all ERCPs were reviewed and filtered for inclusion of manometry. Once the population was determined, patient records were reviewed to determine procedure success, SOM findings, performance of sphincterotomy, complications, and symptom improvement. Patients were only included in the outcome portion of the study if
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Volume 71, No. 5 : 2010 GASTROINTESTINAL ENDOSCOPY AB309
T1561 Endoscopic Palliation of Malignant Hilar Biliary Strictures by Self-Expandable Metal Stents: Clinical Results and Patency Evaluation Andrea Tringali, Ivo Bosˇkoski, Massimiliano Mutignani, Pietro Familiari, Vincenzo Perri, Guido Costamagna BACKGROUND AND OBJECTIVE Endoscopic biliary drainage of malignant hilar strictures (MHS) by self-expandable metal stents (SEMS) is technically difficult and expensive. Furthermore, little is known about the clinical impact on survival and the patency of multiple SEMS in MHS.METHODS We performed a retrospective review of all the patients that underwent SEMS insertion for MHS at our endoscopy unit between January 1998 and August 2009. MHS were classified according to Bismuth and Corlette. We included only patients with complex types of strictures that received two or more SEMS. The aim was to obtain a complete drainage of biliary ducts by endoscopic SEMS placement. A total of 101 patients were identified (56 F and 45 M, mean age 66.7 years, range 40-89). MHS were due to cholangiocarcinoma (CCA) (n⫽61), gallbladder cancer (GC) (n⫽24), lymphnode metastases (LMN) (n⫽12) and hepatocellular carcinoma (HCC) (n⫽4). Twenty-seven patients had type II MHS, 52 type IIIa, 1 type IIIb and 21 type IV.RESULTS Eighty-nine patients died and their mean survival was 335 days (range 12-1224). On follow-up (ongoing) 12 patients are still alive. According to the Kaplan-Mayer survival analysis, a shorter life expectancy was found for patients with type IV MHS when compared with type II and III (p⫽0.05). This was confirmed by the Cox multivariate analysis (type IV: RR 1; type II: RR 0.64, CI 0.33-0.95; type III: RR 0.52, CI 0.29-0.95). There was no relationship between patients age (RR 0.99, CI 0.98-1.02), gender (RR 0.99, CI 0.62-1.58) and presence of metastases (RR 0.83, CI 0.39-1.78), No relation was found in terms of survival between the type of stricture and type of neoplasia (CCA: RR 1; GC: RR 1.19, CI 0.69-2.05; LNM and HCC: RR 0.79, CI 0.36-1.39). A total of 63 re-interventions for SEMS malfunction were performed (range 0-6; 0.62 per patient). SEMS malfunction was due to sludge formation (24%), ingrowth (23%), overgrowth (13%) and stent migration/impaction (3%). Survival rate resulted higher in patients with more re-interventions for SEMS malfunction (RR 0.39, CI 0.24-0.64). This could be due probably to the slow tumor evolution in some cases, so patients that lived longer had more re-interventions or maybe because SEMS can improve patients survival rate.CONCLUSIONS Endoscopic SEMS insertion is an expensive and challenging way for the palliation of MHS. Endoscopic biliary drainage with SEMS can give a satisfactory (1 year) mean survival, independently of the type of malignancy, presence of metastases, age and gender. Probably SEMS in MHS can improve patients survival, this however has to be confirmed in future prospective, comparative trials.
haemobilia d) cholangitis at the time of stenting; e) previous percutaneous, endoscopic or surgical biliary drainage; f) age ⬍ 18; g) refusal to sign the informed consent.Primary end-point: to evaluate the stent patency. Secondary end-points: evaluation of causes for stent dysfunction, occurrence of cholecystitis and survival. Patients underwent a bi-monthly follow-up until death. The protocol was approved by the local ethical committee.Aim of the study was to enroll 70 patients.Results.Between November 2006 and May 2009, 70 patients were enrolled (mean age 69 years, 36 F). Reasons for malignant stricture were pancreatic cancer (n⫽50), cholangiocarcinoma (n⫽13), lymphnode metastases (n⫽5) and gallbladder cancer (n⫽2). Fifty-nine patients had the gallbladder in situ (51 alithiasic, 8 lithiasic), 11 were cholecystectomized.Thirty-nine patients (56%) died after a mean of 5.6 months with a patent stent; 10 (14%) are alive after a mean of 6.1 months without signs of stent malfunction (follow-up is ongoing); 21 (30%) had cholangitis due to stent clogging after a mean of 5.4 months (9 overgrowth, 5 sludge formation, 3 ingrowth, 3 stent migration due to tumor necrosis, 1 food reflux due to duodenal stricture) and were successfully retreated endoscopically (17 died after a mean of 5 months from retreatment, 4 are alive after a mean of 3 months from retreatment). One patient of 59 (1.7%) with gallbladder in situ experienced cholecystitis and was successfully treated by percutaneous cholecystostomy.Conclusions.The partially covered nitinol ComVi SEMS provides a satisfactory palliation of jaundice with a low risk of tumor ingrowth. The risk of cholecystitis using covered SEMS is low.
T1563 Predictors of the Need for Emergency ERCP for Acute Cholangitis in Japan Takayoshi Nishino, Izumi Shirato, Atsushi Mitsunaga, Miho Shirato Background and Aim: Cases of acute cholangitis (AC) vary in severity from mild to severe, and it is not always easy to predict whether a patient will respond to medical treatment or will require urgent biliary decompression. This study was undertaken to identify predictors and develop a prognostic scoring system that could be used to predict the requirement for urgent biliary decompression.Patients and Methods: We prospectively reviewed 38 consecutive cases of AC between July 2008 and October 2009. We divided the cases into an emergency-ERCP group (Group A, n⫽15) and an elective-ERCP group (Group B, n⫽23). The diagnosis and evaluation of the severity of AC were made based on the Tokyo Guideline published in 2007. Emergency ERCP was performed within 24 hours after admission, in the cases diagnosed as severe AC and in the cases in which SIRS developed despite initial treatment. Results: 1. AC was severe in 9 cases and moderate in 6 cases in Group A, and moderate in 7 cases and mild in 16 cases in Group B. 2. One patient with severe AC in Group A died of uncontrolled septicemia despite successful decompression of biliary obstruction.3. Univariate analysis identified five factors on admission as being associated with subsequent failure of medical treatment and need for emergency ERCP: maximum heart rate (MHR) greater than 100/min, body temperature above 38.5 degrees Celsius centigrade, serum albumin level below 3.0 mg/dl, BUN above 20 mg/dl, and platelet count below 100,000/l (p⫽0.0003, 0.001, 0.02, 0.01, and 0.01, respectively.)4. Multivariate analysis identified two of the above factors associated with subsequent need for emergency ERCP: MHR greater than 100/min and platelet count below 100,000/l .5. A blood culture positive for the presence of bacteria was strongly associated with aspiration of purulent bile during ERCP.6. When the five predictors were used to devise a scoring system in which 1 point was assigned for each factor (maximum score possible: 5 points), the receiver-operator characteristic curve of the scores showed good test performance for predicting emergency ERCP and a positive blood culture with an area under the curve of 0.95 (95%CI; 0.88-0.99) and 0.93 (95% CI; 0.79-0.99), respectively. The optimal cut-off value was 2 points, with a sensitivity of 73.3% and specificity of 95.9% for emergency ERCP and sensitivity of 81.8% and specificity of 88.5% for a positive blood culture.Conclusions: We recommend that emergency ERCP be performed in patients who are positive for two or more the predictors identified in this study.
T1562 Self-Expandable Partially Covered Metallic Stents to Palliate Malignant Biliary Strictures: Evaluation of the ComVi Stent Andrea Tringali, Michele Marchese, Pietro Familiari, Jang Sungil, Ho Gak Kim, Massimiliano Mutignani, Vincenzo Perri, Dongki Lee, Guido Costamagna
T1564 Outcomes of Sphincter of Oddi Manometry in a Low Volume Center John P. Rice, Bret J. Spier, Deepak V. Gopal, Mark Reichelderfer, Anurag Soni, Patrick Pfau
Background and aim.Endoscopic palliation of jaundice secondary to malignant biliary strictures by stent insertion is currently considered the treatment of choice. Self-Expandable Metal Stents (SEMS) have a longer patency than plastic. Membrane-coated SEMS can prevent tumor ingrowth leading to a longer patency than uncovered SEMS. Aim of this multi-centre, single-arm study is to prospectively evaluate a new nitinol partially covered SEMS (ComVi, TaewoongMedical, Korea)Materials and methods.Inclusion criteria: a) unresectable or unoperable malignancy leading to stenoses at the middle/distal common bile duct; b) absence of liver metastases; c) first attempt at endoscopic biliary drainage; d) at least 6 months life expectancy (Karnofsky score ⬎ 60).Exclusion criteria: a) ampullary cancer; b) hilar and/or intra-hepatic ducts malignancy; c)
Background: Sphincter of oddi manometry (SOM) is a highly specialized procedure associated with an increased risk of procedural complications. Studies published on SOM have been performed in large volume manometry centers with suggestions that SOM be limited to such centers. The outcomes and safety of SOM performed in smaller numbers have not been established.Aim: To examine the outcomes and complication rate of SOM when performed in small volumes.Methods: From January 1, 2003 until July 1, 2009 all ERCPs were reviewed and filtered for inclusion of manometry. Once the population was determined, patient records were reviewed to determine procedure success, SOM findings, performance of sphincterotomy, complications, and symptom improvement. Patients were only included in the outcome portion of the study if
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Volume 71, No. 5 : 2010 GASTROINTESTINAL ENDOSCOPY AB309