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Single Balloon Enteroscopy (SBE) Versus Double Balloon (DBE) ERCP in Patients with Roux-en-Y Anastomosis
Abstracts
S1307 Single Balloon Enteroscopy (SBE) Versus Double Balloon (DBE) ERCP in Patients with Roux-en-Y Anastomosis Klaus Mo ¨nkemu ¨ller, Lucia C. Fry, Helmut Neumann, Peter Malfertheiner Background: ERCP in patients with Roux-en-Y anastomosis remains a challenging procedure. However, DBE-ERCP has become another option to perform ERCP in these patients. The use of the single-balloon enteroscope method to perform ERCP in patients has not been compared to DBE-ERCP. Aim: To assesses the technical success of performing ERCP with the DBE versus SBE in patients with Roux-en-Y anastomosis with or without hepaticojejunostomy. Methods: Prospective evaluation of patients with Roux-en-Y anastomosis undergoing ERCP with the DBE or SBE. Diagnostic success was defined as successful duct cannulation or securing the diagnosis and therapeutic success was defined as the ability to treat the underlying disorder. Complications of ERCP and DBE were defined according to standard criteria (Cotton et al, 1991, Mensink et al, 2007). Results: A total of 24 patients underwent 33 ERCPs using the DBE (17 ERCPs in 11 pts; 1 F, 10 M, mean age 59.7 years, range 25 to 77) or SBE (16 ERCPs in 13 patients (3 F, 10 M, mean age 64.4 years, range 36 to 77). There were no differences in the demographic and clinical data. The main indications for ERCP were biliary obstruction, cholelithiasis or cholestasis. The mean duration of the procedure did not differ among both groups (DBE-ERCP, 60 min (range 35-240), SBE-ERCP, 52 min, (range 25-90) (pZ0.1). The overall diagnostic success for DBE-ERCP was 82%, as compared to 77% for SBEERCP (pZ0.2). The overall therapeutic success was 58% for DBE-ERCP and 55% for SBE-ERCP (pZ0.2). One major complication occurred using DBE-ERCP: perforation of the hepaticojejunostomy in a patient with recurrent choledocolithiasis, which was successfully resolved surgically. The preparation time for ERCP using SBE (2.3 minutes) was significantly less than DBE (13.7 minutes) (p !0.02). The difference in time was solely due to the technical factor of applying the balloon to the tip of the enteroscope (DBE). Conclusions: ERCP using SBE is as efficient as using DBE in patients with Roux-en-Y anastomosis, permitting diagnostic and therapeutic interventions in an equal percentage of cases. The total time for performing SBE-ERCP was shorter than DBE-ERCP, probably because SBE does not require the use of a balloon on the scope the preparation time for ERCP is decreased.
S1308 Single Session Endoscopic Mucosal Resection (EMR) and Papillectomy for Giant Ampullary Adenomas with Significant Extra-Papilliary Extension (GAPE): Technique and Outcome Andrew D. Hopper, Michael J. Bourke, Michael P. Swan, Stephen J. Williams Introduction: Successful endoscopic treatment of conventional ampullary adenomas is well described. However many authors recommend surgical ampullectomy for larger lesions with significant extra-papillary extension. If a single session endoscopic technique was a viable option then in comparison to surgery, substantial cost savings and reduced morbidity and mortality might be anticipated. Methods: Over a 24-month period to November 2008 patients undergoing endoscopic treatment of ampullary adenomas were enrolled prospectively. GAPE lesions (O30mm and involving up to 2/3 of the duodenal circumference) underwent pre-resection staging which included computed tomography, multiple biopsies, endoscopic ultrasonography and ERCPþ/-MRCP to exclude intra-ductal extension. The technique of GAPE resection was standardized, the key aspect being en-bloc excision of the papilla. GAPE with predominant vertical extra papillary extension was treated by initial maximal papillectomy in the vertical plane and beyond the inferior aspect of the true papilla, followed by EMR of residual tissue. Submucosal injection was not performed prior to papillectomy. Adenomas with predominant lateral spreading morphology underwent EMR with a stiff spiral snare and submucosal injection at one edge working generally from left to right to isolate the papilla, which allowed en-bloc papillectomy. A 5Fr pancreatic stent was placed after papillectomy. Argon plasma coagulation (APC) was not used. All neoplastic tissue was removed with the snare including a 1-3mm margin of normal tissue. Results: Endoscopic papillectomy was performed in 22 patients of whom 8 (2 female; age 42-80) had GAPE lesions (size 30-80mm; mean 45). All 8 patients had complete adenoma removal performed in one session. 4 patients were discharged home the same or following day. 3 patients required admission (range 2-8 days) and repeat endoscopy for resection site bleeding, 1 required clip placement to a bleeding vessel. The final patient was admitted for a 35 day stay due to cholecystitis and known co-morbidities. There was no pancreatitis or perforation. 7 patients have completed 3 month surveillance and biopsy, with residual adenoma being found in only 1: this was treated with APC. Histology in all patients revealed tubulovillious adenoma (5 with focal high grade dysplasia) without carcinoma in situ. Conclusion: Single session combination EMR and papillectomy is a viable option for GAPE lesions after careful pre-staging. Initial experience would indicate that most patients are cured with a single intervention. This approach should be considered as an alternative to surgery especially in patients with significant co-morbidity.
www.giejournal.org
S1309 Interleukine-6 in the Differential Diagnosis of Extrahepatic Malignancy in Patients Presenting with Obstructive Jaundice Ivanhoe Larracilla-Salazar, Angelica Hernandez-Guerrero, Juan Octavio Alonso-Larraga, Sergio R. Sobrino-Cossio, Jose-Guillermo De La Mora-Levy, Beatriz F. Barranco, Marina Robles-Flores Background: Cancer that affects the extrahepatic biliary tract (cholangiocarcinomaCC, gallbladder cancer- GC, pancreatic- PC and ampullary cancer-AC), can sometimes be difficult to diagnose due to the size, location and surrounding desmoplastic reaction that often yield insufficient diagnostic material for cytology. Interleukine-6 (IL-6) is a powerful mitogen for biliary epithelial cells and can play a role in the regulation of growth in normal and neoplastic cholangiocytes. Increased levels have been noted in CC patients in comparison to healthy controls as well as in some patients with hepatocarcinoma and metastasic liver. Some other investigators have suggested that IL-6 could be used as a prognostic indicator (correlated to tumor burden) or as indication of response to photodynamic therapy. Our aim was to study the value of IL-6 to identify cancer in a group of patients presenting with obstructive jaundice, in which this test could be useful to differentiate benign vs. malignant causes. Material and Methods: A series of consecutive patients presenting with obstructive jaundice were included. Healthy volunteers were used as controls. Patients with other causes known to increase IL-6 were excluded. The final diagnosis was established by a combination of: cytology, histology, imaging studies and clinical follow-up. IL-6 was measured by ELISA in a sample of 10 ml of peripheral blood taken before the ERCP. Blood levels were compared between groups, the diagnostic values (Sn, Sp, PPV & NPV) were calculated and the ideal cut-off value established by ROC curve. Results: We included 124 patients, 82 female and 42 male. The patients were divided into three groups: Group A: 24 healthy controls. Group B: 52 patients with benign lesions (3 fistulas, 9 post-operative strictures and 40 bile duct stones). Group C: 48 patients with cancer (10 CC, 5 GB, 11 AC, 19 PC & 3 metastasic liver. Groups B & C were comparable for age. The values for IL-6 were: group A: 3.3 1.2 pg/ml, group B: 6.1 4.8 pg/ml and group C: 40.8 87.5 pg/ml (pZ0.002 for A,B vs C). A PPV of 100% for malignancy was obtained at a cut-off level of 20 pg/ml. The best sensitivity (79.1%) was obtained at a cut-off level of 5 pg/ml. Using a ROC Curve the best overall values were obtained at a cut-off of 10 pg/ml with a sensitivity, specificity, positive and negative predictive value of 64%, 81%, 76% and 71% respectively. Conclusions: IL-6 may be a helpful diagnostic tool for patients presenting with a suspected malignant obstructive jaundice.
S1310 A Sequential Cannulation Protocol Including Early Pancreatic Stent Placement and Needle Knife Sphincterotomy: Interim Analysis of a Randomised Trial Michael P. Swan, Michael J. Bourke, Sina Alexander, Stephen J. Williams, Adam A. Bailey, Rick Hope, David C. Ruppin Background: Competent biliary endoscopists fail selective biliary cannulation in 510% of cases. Needle knife sphincterotomy (NKS) can augment cannulation success, but is often used as a last resort and this may be responsible for the association with post ERCP pancreatitis (PEP). Prospective early NKS studies in difficult cannulation are few and inconclusive. Limited data exists on early pancreatic stent placement. Patients and Methods: Patients with a naı¨ve papilla were invited to participate; exclusion criteria included pancreatic or ampullary cancer and acute pancreatitis within 2 weeks. A strict wire guided cannulation protocol was followed in all patients with allowance of a maximum of 5 minutes, 4 attempts or 2 pancreatic duct (PD) cannulations. The Fellow commenced the majority of the procedures and if any cannulation parameter was exceeded the consultant then attempted with the same protocol. If the consultant exceeded any parameter, the patient was randomized to either early NKS or continued standard cannulation (SC) for a further 10 minutes at which time cross over to NKS was allowed. PD stent insertion was performed if PD instrumentation had occurred and NKS was required. Prospective data collection included patient factors, time and comprehensive cannulation parameters. 24 hour and 30 day complication rates were assessed by phone interview and 24 hr serum lipase and amylase level. Results:1299 ERCPs were performed over 18 months. 478 patients had an intact papilla of which 319 were enrolled. 268 had early biliary cannulation success, 51 were randomized. Cannulation success was 98.4% (314/319) in the entire group 24/26 (92%) in NKS arm and 12/25 (48%) in SC arm (p! 0.005); 13 of the SC group required salvage NKS of which 10 were successful, final success in the SC arm was 22/25 (88%). PD stent insertion was performed in 15 of NKS arm and 10 of SC arm. PEP was 5.6% overall (16 mild, 2 moderate, 0 severe), and 2.9% with early success (!10min). No difference in PEP was observed between the randomized groups (19% NKS, 20% SC). Increasing cannulation time was associated with increased risk of PEP (pZ0.005). Risk of PEP increased with number of attempts on papilla, rising to greater than 10% after six or more attempts. There were no perforations or deaths. Conclusions: NKS is not associated with an increased risk of PEP and is an important intervention in
Volume 69, No. 5 : 2009 GASTROINTESTINAL ENDOSCOPY AB139
S1307 Single Balloon Enteroscopy (SBE) Versus Double Balloon (DBE) ERCP in Patients with Roux-en-Y Anastomosis Klaus Mo ¨nkemu ¨ller, Lucia C. Fry, Helmut Neumann, Peter Malfertheiner Background: ERCP in patients with Roux-en-Y anastomosis remains a challenging procedure. However, DBE-ERCP has become another option to perform ERCP in these patients. The use of the single-balloon enteroscope method to perform ERCP in patients has not been compared to DBE-ERCP. Aim: To assesses the technical success of performing ERCP with the DBE versus SBE in patients with Roux-en-Y anastomosis with or without hepaticojejunostomy. Methods: Prospective evaluation of patients with Roux-en-Y anastomosis undergoing ERCP with the DBE or SBE. Diagnostic success was defined as successful duct cannulation or securing the diagnosis and therapeutic success was defined as the ability to treat the underlying disorder. Complications of ERCP and DBE were defined according to standard criteria (Cotton et al, 1991, Mensink et al, 2007). Results: A total of 24 patients underwent 33 ERCPs using the DBE (17 ERCPs in 11 pts; 1 F, 10 M, mean age 59.7 years, range 25 to 77) or SBE (16 ERCPs in 13 patients (3 F, 10 M, mean age 64.4 years, range 36 to 77). There were no differences in the demographic and clinical data. The main indications for ERCP were biliary obstruction, cholelithiasis or cholestasis. The mean duration of the procedure did not differ among both groups (DBE-ERCP, 60 min (range 35-240), SBE-ERCP, 52 min, (range 25-90) (pZ0.1). The overall diagnostic success for DBE-ERCP was 82%, as compared to 77% for SBEERCP (pZ0.2). The overall therapeutic success was 58% for DBE-ERCP and 55% for SBE-ERCP (pZ0.2). One major complication occurred using DBE-ERCP: perforation of the hepaticojejunostomy in a patient with recurrent choledocolithiasis, which was successfully resolved surgically. The preparation time for ERCP using SBE (2.3 minutes) was significantly less than DBE (13.7 minutes) (p !0.02). The difference in time was solely due to the technical factor of applying the balloon to the tip of the enteroscope (DBE). Conclusions: ERCP using SBE is as efficient as using DBE in patients with Roux-en-Y anastomosis, permitting diagnostic and therapeutic interventions in an equal percentage of cases. The total time for performing SBE-ERCP was shorter than DBE-ERCP, probably because SBE does not require the use of a balloon on the scope the preparation time for ERCP is decreased.
S1308 Single Session Endoscopic Mucosal Resection (EMR) and Papillectomy for Giant Ampullary Adenomas with Significant Extra-Papilliary Extension (GAPE): Technique and Outcome Andrew D. Hopper, Michael J. Bourke, Michael P. Swan, Stephen J. Williams Introduction: Successful endoscopic treatment of conventional ampullary adenomas is well described. However many authors recommend surgical ampullectomy for larger lesions with significant extra-papillary extension. If a single session endoscopic technique was a viable option then in comparison to surgery, substantial cost savings and reduced morbidity and mortality might be anticipated. Methods: Over a 24-month period to November 2008 patients undergoing endoscopic treatment of ampullary adenomas were enrolled prospectively. GAPE lesions (O30mm and involving up to 2/3 of the duodenal circumference) underwent pre-resection staging which included computed tomography, multiple biopsies, endoscopic ultrasonography and ERCPþ/-MRCP to exclude intra-ductal extension. The technique of GAPE resection was standardized, the key aspect being en-bloc excision of the papilla. GAPE with predominant vertical extra papillary extension was treated by initial maximal papillectomy in the vertical plane and beyond the inferior aspect of the true papilla, followed by EMR of residual tissue. Submucosal injection was not performed prior to papillectomy. Adenomas with predominant lateral spreading morphology underwent EMR with a stiff spiral snare and submucosal injection at one edge working generally from left to right to isolate the papilla, which allowed en-bloc papillectomy. A 5Fr pancreatic stent was placed after papillectomy. Argon plasma coagulation (APC) was not used. All neoplastic tissue was removed with the snare including a 1-3mm margin of normal tissue. Results: Endoscopic papillectomy was performed in 22 patients of whom 8 (2 female; age 42-80) had GAPE lesions (size 30-80mm; mean 45). All 8 patients had complete adenoma removal performed in one session. 4 patients were discharged home the same or following day. 3 patients required admission (range 2-8 days) and repeat endoscopy for resection site bleeding, 1 required clip placement to a bleeding vessel. The final patient was admitted for a 35 day stay due to cholecystitis and known co-morbidities. There was no pancreatitis or perforation. 7 patients have completed 3 month surveillance and biopsy, with residual adenoma being found in only 1: this was treated with APC. Histology in all patients revealed tubulovillious adenoma (5 with focal high grade dysplasia) without carcinoma in situ. Conclusion: Single session combination EMR and papillectomy is a viable option for GAPE lesions after careful pre-staging. Initial experience would indicate that most patients are cured with a single intervention. This approach should be considered as an alternative to surgery especially in patients with significant co-morbidity.
www.giejournal.org
S1309 Interleukine-6 in the Differential Diagnosis of Extrahepatic Malignancy in Patients Presenting with Obstructive Jaundice Ivanhoe Larracilla-Salazar, Angelica Hernandez-Guerrero, Juan Octavio Alonso-Larraga, Sergio R. Sobrino-Cossio, Jose-Guillermo De La Mora-Levy, Beatriz F. Barranco, Marina Robles-Flores Background: Cancer that affects the extrahepatic biliary tract (cholangiocarcinomaCC, gallbladder cancer- GC, pancreatic- PC and ampullary cancer-AC), can sometimes be difficult to diagnose due to the size, location and surrounding desmoplastic reaction that often yield insufficient diagnostic material for cytology. Interleukine-6 (IL-6) is a powerful mitogen for biliary epithelial cells and can play a role in the regulation of growth in normal and neoplastic cholangiocytes. Increased levels have been noted in CC patients in comparison to healthy controls as well as in some patients with hepatocarcinoma and metastasic liver. Some other investigators have suggested that IL-6 could be used as a prognostic indicator (correlated to tumor burden) or as indication of response to photodynamic therapy. Our aim was to study the value of IL-6 to identify cancer in a group of patients presenting with obstructive jaundice, in which this test could be useful to differentiate benign vs. malignant causes. Material and Methods: A series of consecutive patients presenting with obstructive jaundice were included. Healthy volunteers were used as controls. Patients with other causes known to increase IL-6 were excluded. The final diagnosis was established by a combination of: cytology, histology, imaging studies and clinical follow-up. IL-6 was measured by ELISA in a sample of 10 ml of peripheral blood taken before the ERCP. Blood levels were compared between groups, the diagnostic values (Sn, Sp, PPV & NPV) were calculated and the ideal cut-off value established by ROC curve. Results: We included 124 patients, 82 female and 42 male. The patients were divided into three groups: Group A: 24 healthy controls. Group B: 52 patients with benign lesions (3 fistulas, 9 post-operative strictures and 40 bile duct stones). Group C: 48 patients with cancer (10 CC, 5 GB, 11 AC, 19 PC & 3 metastasic liver. Groups B & C were comparable for age. The values for IL-6 were: group A: 3.3 1.2 pg/ml, group B: 6.1 4.8 pg/ml and group C: 40.8 87.5 pg/ml (pZ0.002 for A,B vs C). A PPV of 100% for malignancy was obtained at a cut-off level of 20 pg/ml. The best sensitivity (79.1%) was obtained at a cut-off level of 5 pg/ml. Using a ROC Curve the best overall values were obtained at a cut-off of 10 pg/ml with a sensitivity, specificity, positive and negative predictive value of 64%, 81%, 76% and 71% respectively. Conclusions: IL-6 may be a helpful diagnostic tool for patients presenting with a suspected malignant obstructive jaundice.
S1310 A Sequential Cannulation Protocol Including Early Pancreatic Stent Placement and Needle Knife Sphincterotomy: Interim Analysis of a Randomised Trial Michael P. Swan, Michael J. Bourke, Sina Alexander, Stephen J. Williams, Adam A. Bailey, Rick Hope, David C. Ruppin Background: Competent biliary endoscopists fail selective biliary cannulation in 510% of cases. Needle knife sphincterotomy (NKS) can augment cannulation success, but is often used as a last resort and this may be responsible for the association with post ERCP pancreatitis (PEP). Prospective early NKS studies in difficult cannulation are few and inconclusive. Limited data exists on early pancreatic stent placement. Patients and Methods: Patients with a naı¨ve papilla were invited to participate; exclusion criteria included pancreatic or ampullary cancer and acute pancreatitis within 2 weeks. A strict wire guided cannulation protocol was followed in all patients with allowance of a maximum of 5 minutes, 4 attempts or 2 pancreatic duct (PD) cannulations. The Fellow commenced the majority of the procedures and if any cannulation parameter was exceeded the consultant then attempted with the same protocol. If the consultant exceeded any parameter, the patient was randomized to either early NKS or continued standard cannulation (SC) for a further 10 minutes at which time cross over to NKS was allowed. PD stent insertion was performed if PD instrumentation had occurred and NKS was required. Prospective data collection included patient factors, time and comprehensive cannulation parameters. 24 hour and 30 day complication rates were assessed by phone interview and 24 hr serum lipase and amylase level. Results:1299 ERCPs were performed over 18 months. 478 patients had an intact papilla of which 319 were enrolled. 268 had early biliary cannulation success, 51 were randomized. Cannulation success was 98.4% (314/319) in the entire group 24/26 (92%) in NKS arm and 12/25 (48%) in SC arm (p! 0.005); 13 of the SC group required salvage NKS of which 10 were successful, final success in the SC arm was 22/25 (88%). PD stent insertion was performed in 15 of NKS arm and 10 of SC arm. PEP was 5.6% overall (16 mild, 2 moderate, 0 severe), and 2.9% with early success (!10min). No difference in PEP was observed between the randomized groups (19% NKS, 20% SC). Increasing cannulation time was associated with increased risk of PEP (pZ0.005). Risk of PEP increased with number of attempts on papilla, rising to greater than 10% after six or more attempts. There were no perforations or deaths. Conclusions: NKS is not associated with an increased risk of PEP and is an important intervention in
Volume 69, No. 5 : 2009 GASTROINTESTINAL ENDOSCOPY AB139