- Email: [email protected]
Mo1441 Is There a Role of FISH in the Diagnosis of Cholangiocarcinoma in Routine Clinical Practice?
Abstracts
Mo1438 Accessing the Papilla for ERCP in Bariatric Roux-en-Y Gastric Bypass (RNYGB): Can Clinical Features Predict Success of PerOral Endoscopy? David Y. Lo1, Douglas A. Howell1, Lee D. Hallagan2, Jennifer Lewis1, Eric Wright1, Gennadiy Bakis1, Andreas M. Stefan1, Roy A. Cobean2 1 Pancreaticobilary Center, Maine Medical Center, Portland, ME; 2 Surgery, Maine Medical Center, Portland, ME Background: RNYGB has been increasingly performed worldwide resulting in growing numbers of patients needing ERCP. Accessing the papilla for ERCP includes peroral enteroscopic techniques and laparoscopic access to the bypassed stomach to allow antegrade passage of a standard ERCP endoscope via a 15mm port. Study Aim: Attempt to define clinical features which might predict success or failure of peroral access to the papilla. Methods: All bariatric RNYGB patients undergoing peroral attempt at ERCP entered in a prospective ERCP database from a single center were identified after IRB approval. Pre-procedure clinical features suspected to have an impact on success were: 1. Recorded length of Roux limb. 2. Pre-op BMI. 3. Absolute weight loss. 4. Percent of weight loss. 5. BMI at the time of ERCP. 6. Open vs laparoscopic RNYGB. Patients: 43 pts identified underwent 55 peroral attempts at RNYGB ERCP (M:5; F:38), age 24 to 81) and had complete or partial data available for analysis of these defined variables. Patients were divided into 2 groups: Group A (n⫽23), cases done using single balloon enteroscopes (Olympus America) or rotational overtubes (Spirus Medical) and Group B (n⫽20), earlier cases using a variety of endoscopes. Results: Of 43 cases, the papilla could be reached in 30 cases (69.8%). Success in reaching the RUQ was more frequent when open surgery had been done (74.2% vs 50%) despite some failures due to obvious adhesions detected during the ERCP. Comparing Group A to Group B, there was a trend toward increased success of RUQ access, despite longer Roux limbs done more recently (A⫽ 18/23 (78.3%) vs B⫽ 12/20 (60%), p⫽ 0.074). Once the RUQ was reached, none of the pre-procedure clinical features impacted the success of the planned ERCP (25/30, (83.3%)). Among Group A pts, 3 features were strongly associated with success or failure to reach the RUQ on univariate analysis (see Table). The categorical variable which best predicted failure was the recorded length of the Roux limb ⬎ 150cm, as 60% failed. Conclusions: Clinical features which document or suggest long Roux limbs (⬎ 150 cm) (recorded length of the Roux, pre-op BMI ⬎55, and absolute weight loss) increased the likelihood of failure to access the right upper quadrant, even using the most recent enteroscopic devices. Avoiding failed peroral attempts at ERCP in RNYGB patients is highly desirable but cannot be absolutely predicted using these clinical features. Until technologies improve, the decision to attempt peroral ERCP initially or move directly to laparoscopic access should be based on a careful estimate of the likelihood of failure that is acceptable to the patient. Impact of Clinical Features on Group A Cases
Length of Roux (cm) Pre-op BMI Absolute wt loss (lb) Wt loss (%) BMI at ERCP
Failures (nⴝ5)
Successes (nⴝ18)
P-Value
150 62.3 187.9 49.2 35.2
100.9 50.2 102.2 34.5 32.5
0.0000058 0.03999 0.04965 0.14344 0.68655
All results are mean values
Mo1439 A Meta-Analysis Comparing the Patency of Covered and Uncovered Self-Expandable Metal Stents (SEMS) for Palliation of Distal Malignant Bile Duct Obstruction Atif Saleem, Todd H. Baron, Leggett Cadman, Mohammad H. Murad Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, Rochester, MN Background and Aim: Self expandable metal stents (SEMS) are used for palliation of malignant biliary obstruction. We performed a meta-analysis to compare stent patency and stent survival of covered SEMS (cSEMS) and uncovered SEMS (uSEMS) in patients with unresectable, malignant, distal biliary obstruction. Methods: A comprehensive search of several databases (from each database’s earliest inclusive dates to November 2010, any language, and any population) was conducted. Eligible studies for this meta-analysis were original longitudinal randomized controlled studies (RCT) that compared the clinical effectiveness of cSEMS vs. uSEMS for treatment of distal malignant biliary obstruction whether placed endoscopically or percutaneously. Outcomes of interest included stent patency, stent survival, patient survival and cause for stent dysfunction (ingrowth, overgrowth, migration and sludge formation).Working independently and in duplicate, two reviewers screened all abstracts and titles and subsequently the full text of selected references. Results: The search identified 337 potential abstracts and titles of which 16 were retrieved in full text. Review of references identified 17 additional studies. We found 5 multicenter randomized controlled
studies (RCT) containing 780 patients, which met our inclusion criteria. The median age was 66 (46% women). The median length of follow-up was 212 days. Compared to uncovered SEMS, covered SEMS were associated with significantly prolonged stent patency (WMD 60.5 days; 95% CI, 25.9, 95.2; p⫽0.001; I2⫽ 0%) and longer stent survival (WMD 68.8 days; 95% CI, 25.6, 112.1; p⫽0.002; I2⫽ 79%). SEMS dysfunction due to stent ingrowth was significantly lower with cSEMS (RR 0.23; 95% CI, 0.08, 0.67; p⬍0.01; I2 ⫽54%). Stent migration, tumor overgrowth and sludge formation were significantly higher with cSEMS (RR 8.1; 95% CI, 1.47, 44.75; p⫽0.01; I2 ⫽0%), (RR 2.02; 95% CI, 1.08, 3.78; p⫽0.02; I2 ⫽0%), (RR 2.89; 95% CI, 1.27, 6.55; p⫽0.01; I2 ⫽0%). Conclusions: 1) Despite two recent randomized trials, this meta-analysis show covered SEMS has a significantly prolonged patency than uncovered SEMS. 2) When re-obstruction (stent survival) occurs, there is a trend it is delayed when cSEMS are used. 3) Re-obstruction after cSEMS placement is more likely due to tumor overgrowth, sludge and stent migration while with uncovered SEMS is due to tumor ingrowth. Key Words:Self expandable metal stent (SEMS), Uncovered SEMS (uSEMS), Covered SEMS (cSEMS), and Randomized controlled trials (RCT).
Mo1440 The Biodurability of Covering Materials in Covered Metal Stents Under a Bile Flow Phantom Byoung Wook Bang1, Seok Jeong1, Yong Woon Shin1, Don Haeng Lee1, Se Chul Lee2, Sung-Gwon Kang3,2, Jung IL Lee1, Kye Sook Kwon1, Hyung Gil Kim1, Young Soo Kim1 1 Inha University School of Medicine, Incheon, Republic of Korea; 2SNG Biotech Inc, Seongnam, Republic of Korea; 3Department of Radiology, Seoul National University School of Medicine, Seongnam, Republic of Korea Background/Aim: Covered biliary metallic stents have been introduced to overcome tumor ingrowth and treat benign biliary stricture. Therefore, it is important to know biodurability of the covering materials against bile juice in clinical applications of covered biliary metal stents. However, few data are available about biodurability of the covering materials. We evaluate the biodurability of three types of commercially available membrane (e-PTFE, silicone, polyurethane) for the biliary metal stents in the phantom bile flow. Materials and methods: Experimental perfusion system which consists of bile reservoir, peristaltic pump and four branched silicon tubes was made. Each tube contained three pairs of different membrane-covered stents. The peristaltic pump was operated continuously for 6 months as human bile was replaced every 2 days. Each tube was removed respectively 1, 2, 4 and 6 months after the stents had begun to be exposed to bile juice. After removing the stents from the tubes, we grossly inspected the covered stents for bile staining, patency and structural deformities. We measured expansile force of the stents using a universal testing machine. After the membranes were stripped away from the stents, we observed the membrane surface by scanning electron microscopy. And we measured tensile strength and tear strength of the membrane using a universal testing machine. Results: Grossly, there were no holes or cracks in all membranes during the experiment. After bile exposure, bile staining of the membrane progressed gradually, but the progress was the fastest in e-PTFE. In electron microscopic exam, polyurethane surface was smooth, and silicon surface was relatively smooth. However e-PTFE had rough and uneven surface. After bile exposure, there were no significant changes in polyurethane and silicone, but biofilms and microcracks were observed in e-PTFE. Both tensile strength and tear strength of polyurethane and silicone decreased slowly, but those of e-PTFE reduced rapidly during the experiment. However, the values of e-PTFE which were measured 6 months after bile exposure were higher than that of silicone and polyurethane because the baseline values were the highest in case of e-PTFE. Conclusion: Silicone and polyurethane may be more biodurable than e-PTFE for up to 6 months after bile exposure. e-PTFE has a tendency to form more biofilms during bile exposure.
Mo1441 Is There a Role of FISH in the Diagnosis of Cholangiocarcinoma in Routine Clinical Practice? Michael M. Einstein1, Shawn M. Hancock2, Hershel Raff3, Patrick Pfau2, Nalini M. Guda4,5, Marc F. Catalano4,5, Joseph E. Geenen4,5 1 Gastroenterology and Hepatology, Aurora Health Care, Milwaukee, WI; 2Gastroenterology and Hepatology, University of Wisconsin Hospital and Clinics, Madison, WI; 3Endocrine Research Laboratory, Aurora St. Luke’s Medical Center, Milwaukee, WI; 4GI Associates, LLC, Milwaukee, WI; 5Pancreatobiliary Center, St. Luke’s Medical Center, Milwaukee, WI Background: Cholangiocarcinoma (CCA) is difficult to diagnose. Tumor markers are insensitive and the yield of cytology is low. Fluorescent in situ hybridization (FISH) examines for chromosomal abnormalities that may occur in CCA. Reported sensitivity and specificity is 34-46% and 88-99%, respectively. It is
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Abstracts
unclear if these data can be applied in routine clinical practice. Aims: 1. Determine if FISH can aid in the diagnosis of CCA in patients with nondiagnostic cytology. 2. Evaluate the accuracy of FISH in a routine clinical setting. Methods: This is a retrospective chart review of patients with biliary strictures including those with and without primary sclerosing cholangitis (PSC) who had an endoscopic retrograde cholangiopancreatography (ERCP) and brushings for both cytology and FISH analysis between2007-2010. A dominant stricture was found in 53% of those with PSC. ERCP was performed to evaluate obstructive signs/symptoms, or as part of surveillance for CCA in those with PSC. Patients with prior malignancy or positive cytology before or at the time of initial ERCP were excluded. Brushings for cytology were obtained within 1 year of FISH in 10 patients, and at the time of FISH in 46. Cytology reported as suspicious, atypical or negative was recorded as negative. FISH was positive if ⬎ 5 cells had gains of 2 or more probes. Patients were considered to have malignancy if there was radiographic progression, positive cytology, or conclusive pathology from surgery or autopsy. Results: Brushing for FISH was obtained in 56 patients in whom cytology was non-diagnostic for malignancy. 3 were excluded as they had an inadequate sample for FISH. There were a total of 81 FISH specimen on these 53 patients, as some had multiple ERCP. PSC was the primary diagnosis in 37, while 16 underwent ERCP for signs or symptoms of a biliary stricture. Overall, 5 out of 53 had positive FISH (9.4%) and 3 of these positive patients had CCA. In the other two, one had pancreatic cancer and the other underwent liver transplantation with neoadjuvant chemo- and radiation therapy; his explant was negative for CCA. All patients with an initial negative FISH remained negative on subsequent tests. There were 5 who had negative FISH but subsequently developed CCA. The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy of FISH for CCA were 37.5%, 95.6%, 60%, 89.6%, and 86.8% respectively. Conclusions: In cases of indeterminate biliary stricture and negative cytology, FISH may be performed to evaluate for CCA. FISH has an additive role in detecting CCA with modest PPV and high NPV. These findings are congruent with initial studies evaluating FISH and hence applicable to clinical practice. Those with negative FISH need intensive follow-up and there appears to be no added benefit of repeating FISH if initially negative.
Mo1442 Long-Term Follow-Up of a Randomized Trial of Laparascopic Cholecystectomy and Laparascopic Common Bile Duct Exploration vs. ERCP With Sphincterotomy and Laparascopic Cholecystectomy for Common Bile Duct Stone Disease Michael C. Larsen1, Stanley Rogers2, Alex Rodas1, John P. Cello1 1 Gastroenterology, University of California, San Francisco, San Francisco, CA; 2Surgery, University of California, San Francisco, San Francisco, CA
Background: Trainees with one session of supervised EMS practice had significantly higher success rate in cannulating the common bile duct (CBD) during early training (AJG 2010, in press). The impact of additional unsupervised practice is unknown. Aim: To evaluate the effects of multiple vs single-session practice on clinical outcomes. Methods: 8 ERCP-naive trainees per year were randomized to study (n⫽4) and control (n⫽4) groups in 2007 and 2009, respectively. All trainees received 4 hours of ERCP didactic discussions. The study groups underwent one session of supervised EMS practice. In 2009, the study group continued biweekly unsupervised EMS practice over 3 months. All trainees received routine clinical ERCP training; success of selective CBD cannulation and performance score (1⫽poor, 2⫽fair, 3⫽neutral, 4⫽good, 5⫽excellent, rated by trainers blinded to the randomization) were recorded. The group-averaged effects of single and multiple practices were estimated and compared by generalized estimation equation (GEE) with pooled data from 2007 and 2009, adjusting for number of ERCPs before each ERCP, difficulty of papilla (prior papillotomy and multiple stenting as easy) and year of study. Results: Baseline characteristics of the procedures were comparable between study and control groups in both years (not shown). Clinical performance was superior in study groups compared to control groups in all outcome measures (all p⬍0.05) (Table 1). The adjusted odds ratio (OR) by GEE analysis further confirmed both single and multiple sessions practice conferred significant benefits with no difference between the 2 study groups (Table 2). Conclusion: As an educational tool a single supervised practice session with the EMS appears to augment the novice trainees’ understanding sufficiently to significantly enhance clinical performance (success of CBD cannulation) in the first three months of training. The superior performance was unmistakable to blinded clinical trainers. Table 1. Factors associated with success of deep CBD cannulation by trainees Year 2007
BACKGROUND: Common bile duct stone disease can be treated endoscopically with ERCP sphincterotomy (ERCP/S) or surgically via laparascopic common bile duct exploration (LCBDE). Published data on the long-term follow-up of patients undergoing these two techniques in a controlled clinical trial is limited. AIMS: To determine differences in rates of recurrent common bile duct stone disease or biliary complications between randomized prospectively studied patients who underwent either ERCP/S or LCBDE. METHODS: We randomized 122 patients (ASA grade 1 or 2) with classic signs and symptoms of cholelithiasis and likely common bile duct stones to either ERCP/S or LCBDE with laparascopic cholecystectomy between 1998 and 2003 (Arch Surg. 2010 Jan;145(1):28-33). Currently, we retrospectively reviewed the medical record of all patients enrolled in the initial trial to evaluate for recurrent biliary disease. Our hospital Institutional Review Board approved this study. RESULTS: Short-term follow-up data from our published randomized trial reported significantly more common bile duct stones detected by ECRP/S than by LCBDE (56% vs 30%; P ⫽ .007), however total stone clearance rates were not significantly different (98% for ECRP/S vs 88% for LCBDE; P ⫽ .28). The mean and median follow-up times for the overall group in the current study were 5.4 and 5 years (range: 1-12 years). The mean follow-up times for the ERCP/S patients (5.56 years) and LCBDE patients (5.14 years) were not different. Overall, there was no significant difference in rates of recurrent stone disease between the two groups. One patient in the ERCP/S group was hospitalized six years following his original study procedures with choledocholithiasis and required ERCP with stone extraction. No patients in the LCBDE group developed recurrent common bile duct stone disease. No patients in either group subsequently required additional biliary surgery. Two patients in the ERCP/S group and one patient in the LCBDE group required repeat ERCP with stent placement after laparascopic cholecystectomy because of a bile leak. No other biliary complications were reported. CONCLUSIONS: Long-term follow-up does not demonstrate any significant difference in long-term outcome between ERCP/S and LCBDE with respect to clearance of common bile duct stones.
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Mo1443 A Single Session of Supervised ERCP Mechanical Simulator (EMS) Practice Prepares Novice Trainees for Superior Clinical Performance Wei-Chih Liao1, Joseph W. Leung2,3, Hsiu-Po Wang1, Wen-Hsiung Chang4, Cheng-Hsin Chu4, Jaw-Town Lin1,5, Catherine Ngo3, Brian S. Lim6, Felix W. Leung7,8 1 Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan; 2Section of Gastroenterology, Sacramento VA Medical Center, Mather, CA; 3Gastroenterology, University of California Davis Medical Center, Sacramento, CA; 4Gastroenterology, Mackay Memorial Hospital, Taipei, Taiwan; 5Internal Medicine, E-DA Hospital and IShou University, Kaohsiung, Taiwan; 6Gastroenterology, Riverside Kaiser Permanente Medical Center, Riverside, CA; 7Gastroenterology, Sepulveda Ambulatory Care Center, VAGLAHS, North Hills, CA; 8 Gastroenterology, David Geffen School of Medicine at UCLA, Los Angeles, CA
Single EMS
Clinical performance
Year 2009 Multiple EMS
Control
Control
CBD cannulation success, n(%) 31/40 (77.5) 20/39 (51.3) 40/58 (69.0) 23/53 (43.4) Steps* accomplished (%), 75 (35) 53 (45) 80 (32) 53 (41) mean (SD) Performance score, mean (SD) 3.8 (0.9) 3.2 (0.7) 4.0 (0.7) 3.2 (0.7) *Steps: selective CBD cannulation, ampullary/biliary dilation, biliary stenting. Table 2. Effects of single/multiple EMS practices on clinical performance: pooled analysis Cannulation success GEE analysis Single EMS Multiple EMS Per 1 ERCP Easy papilla 2009 vs 2007 *P⫽.83; **P⫽.74.
Performance score
OR
95% CI
P
OR
95% CI
P
3.80* 3.33* 1.01 4.01 0.58
2.07-6.96 1.27-8.76 0.99-1.03 2.66-6.05 0.27-1.24
⬍.001 .015 .245 ⬍.001 .160
3.82** 6.19** 1.03 1.16 0.73
1.60-9.10 2.98-12.86 1.00-1.06 0.85-1.58 0.31-1.74
.003 ⬍.001 .022 .341 .483
Mo1444 Air Cholangiogram Is Not Inferior to Dye Cholangiogram: A Randomized Study Randhir Sud1, Rajesh Puri1, Parvesh Kumar Jain2, Smruti R. Mishra1 1 Department of Digestive and Hepatobiliary Sciences, Medanta, The Medicity, Gurgaon, India; 2Victoria Hospital, Bangalore, India Background and Aims: Endoscopic biliary drainage is the palliative treatment of choice in patients with malignant hilar biliary obstruction, but contrast injection
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Mo1438 Accessing the Papilla for ERCP in Bariatric Roux-en-Y Gastric Bypass (RNYGB): Can Clinical Features Predict Success of PerOral Endoscopy? David Y. Lo1, Douglas A. Howell1, Lee D. Hallagan2, Jennifer Lewis1, Eric Wright1, Gennadiy Bakis1, Andreas M. Stefan1, Roy A. Cobean2 1 Pancreaticobilary Center, Maine Medical Center, Portland, ME; 2 Surgery, Maine Medical Center, Portland, ME Background: RNYGB has been increasingly performed worldwide resulting in growing numbers of patients needing ERCP. Accessing the papilla for ERCP includes peroral enteroscopic techniques and laparoscopic access to the bypassed stomach to allow antegrade passage of a standard ERCP endoscope via a 15mm port. Study Aim: Attempt to define clinical features which might predict success or failure of peroral access to the papilla. Methods: All bariatric RNYGB patients undergoing peroral attempt at ERCP entered in a prospective ERCP database from a single center were identified after IRB approval. Pre-procedure clinical features suspected to have an impact on success were: 1. Recorded length of Roux limb. 2. Pre-op BMI. 3. Absolute weight loss. 4. Percent of weight loss. 5. BMI at the time of ERCP. 6. Open vs laparoscopic RNYGB. Patients: 43 pts identified underwent 55 peroral attempts at RNYGB ERCP (M:5; F:38), age 24 to 81) and had complete or partial data available for analysis of these defined variables. Patients were divided into 2 groups: Group A (n⫽23), cases done using single balloon enteroscopes (Olympus America) or rotational overtubes (Spirus Medical) and Group B (n⫽20), earlier cases using a variety of endoscopes. Results: Of 43 cases, the papilla could be reached in 30 cases (69.8%). Success in reaching the RUQ was more frequent when open surgery had been done (74.2% vs 50%) despite some failures due to obvious adhesions detected during the ERCP. Comparing Group A to Group B, there was a trend toward increased success of RUQ access, despite longer Roux limbs done more recently (A⫽ 18/23 (78.3%) vs B⫽ 12/20 (60%), p⫽ 0.074). Once the RUQ was reached, none of the pre-procedure clinical features impacted the success of the planned ERCP (25/30, (83.3%)). Among Group A pts, 3 features were strongly associated with success or failure to reach the RUQ on univariate analysis (see Table). The categorical variable which best predicted failure was the recorded length of the Roux limb ⬎ 150cm, as 60% failed. Conclusions: Clinical features which document or suggest long Roux limbs (⬎ 150 cm) (recorded length of the Roux, pre-op BMI ⬎55, and absolute weight loss) increased the likelihood of failure to access the right upper quadrant, even using the most recent enteroscopic devices. Avoiding failed peroral attempts at ERCP in RNYGB patients is highly desirable but cannot be absolutely predicted using these clinical features. Until technologies improve, the decision to attempt peroral ERCP initially or move directly to laparoscopic access should be based on a careful estimate of the likelihood of failure that is acceptable to the patient. Impact of Clinical Features on Group A Cases
Length of Roux (cm) Pre-op BMI Absolute wt loss (lb) Wt loss (%) BMI at ERCP
Failures (nⴝ5)
Successes (nⴝ18)
P-Value
150 62.3 187.9 49.2 35.2
100.9 50.2 102.2 34.5 32.5
0.0000058 0.03999 0.04965 0.14344 0.68655
All results are mean values
Mo1439 A Meta-Analysis Comparing the Patency of Covered and Uncovered Self-Expandable Metal Stents (SEMS) for Palliation of Distal Malignant Bile Duct Obstruction Atif Saleem, Todd H. Baron, Leggett Cadman, Mohammad H. Murad Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, Rochester, MN Background and Aim: Self expandable metal stents (SEMS) are used for palliation of malignant biliary obstruction. We performed a meta-analysis to compare stent patency and stent survival of covered SEMS (cSEMS) and uncovered SEMS (uSEMS) in patients with unresectable, malignant, distal biliary obstruction. Methods: A comprehensive search of several databases (from each database’s earliest inclusive dates to November 2010, any language, and any population) was conducted. Eligible studies for this meta-analysis were original longitudinal randomized controlled studies (RCT) that compared the clinical effectiveness of cSEMS vs. uSEMS for treatment of distal malignant biliary obstruction whether placed endoscopically or percutaneously. Outcomes of interest included stent patency, stent survival, patient survival and cause for stent dysfunction (ingrowth, overgrowth, migration and sludge formation).Working independently and in duplicate, two reviewers screened all abstracts and titles and subsequently the full text of selected references. Results: The search identified 337 potential abstracts and titles of which 16 were retrieved in full text. Review of references identified 17 additional studies. We found 5 multicenter randomized controlled
studies (RCT) containing 780 patients, which met our inclusion criteria. The median age was 66 (46% women). The median length of follow-up was 212 days. Compared to uncovered SEMS, covered SEMS were associated with significantly prolonged stent patency (WMD 60.5 days; 95% CI, 25.9, 95.2; p⫽0.001; I2⫽ 0%) and longer stent survival (WMD 68.8 days; 95% CI, 25.6, 112.1; p⫽0.002; I2⫽ 79%). SEMS dysfunction due to stent ingrowth was significantly lower with cSEMS (RR 0.23; 95% CI, 0.08, 0.67; p⬍0.01; I2 ⫽54%). Stent migration, tumor overgrowth and sludge formation were significantly higher with cSEMS (RR 8.1; 95% CI, 1.47, 44.75; p⫽0.01; I2 ⫽0%), (RR 2.02; 95% CI, 1.08, 3.78; p⫽0.02; I2 ⫽0%), (RR 2.89; 95% CI, 1.27, 6.55; p⫽0.01; I2 ⫽0%). Conclusions: 1) Despite two recent randomized trials, this meta-analysis show covered SEMS has a significantly prolonged patency than uncovered SEMS. 2) When re-obstruction (stent survival) occurs, there is a trend it is delayed when cSEMS are used. 3) Re-obstruction after cSEMS placement is more likely due to tumor overgrowth, sludge and stent migration while with uncovered SEMS is due to tumor ingrowth. Key Words:Self expandable metal stent (SEMS), Uncovered SEMS (uSEMS), Covered SEMS (cSEMS), and Randomized controlled trials (RCT).
Mo1440 The Biodurability of Covering Materials in Covered Metal Stents Under a Bile Flow Phantom Byoung Wook Bang1, Seok Jeong1, Yong Woon Shin1, Don Haeng Lee1, Se Chul Lee2, Sung-Gwon Kang3,2, Jung IL Lee1, Kye Sook Kwon1, Hyung Gil Kim1, Young Soo Kim1 1 Inha University School of Medicine, Incheon, Republic of Korea; 2SNG Biotech Inc, Seongnam, Republic of Korea; 3Department of Radiology, Seoul National University School of Medicine, Seongnam, Republic of Korea Background/Aim: Covered biliary metallic stents have been introduced to overcome tumor ingrowth and treat benign biliary stricture. Therefore, it is important to know biodurability of the covering materials against bile juice in clinical applications of covered biliary metal stents. However, few data are available about biodurability of the covering materials. We evaluate the biodurability of three types of commercially available membrane (e-PTFE, silicone, polyurethane) for the biliary metal stents in the phantom bile flow. Materials and methods: Experimental perfusion system which consists of bile reservoir, peristaltic pump and four branched silicon tubes was made. Each tube contained three pairs of different membrane-covered stents. The peristaltic pump was operated continuously for 6 months as human bile was replaced every 2 days. Each tube was removed respectively 1, 2, 4 and 6 months after the stents had begun to be exposed to bile juice. After removing the stents from the tubes, we grossly inspected the covered stents for bile staining, patency and structural deformities. We measured expansile force of the stents using a universal testing machine. After the membranes were stripped away from the stents, we observed the membrane surface by scanning electron microscopy. And we measured tensile strength and tear strength of the membrane using a universal testing machine. Results: Grossly, there were no holes or cracks in all membranes during the experiment. After bile exposure, bile staining of the membrane progressed gradually, but the progress was the fastest in e-PTFE. In electron microscopic exam, polyurethane surface was smooth, and silicon surface was relatively smooth. However e-PTFE had rough and uneven surface. After bile exposure, there were no significant changes in polyurethane and silicone, but biofilms and microcracks were observed in e-PTFE. Both tensile strength and tear strength of polyurethane and silicone decreased slowly, but those of e-PTFE reduced rapidly during the experiment. However, the values of e-PTFE which were measured 6 months after bile exposure were higher than that of silicone and polyurethane because the baseline values were the highest in case of e-PTFE. Conclusion: Silicone and polyurethane may be more biodurable than e-PTFE for up to 6 months after bile exposure. e-PTFE has a tendency to form more biofilms during bile exposure.
Mo1441 Is There a Role of FISH in the Diagnosis of Cholangiocarcinoma in Routine Clinical Practice? Michael M. Einstein1, Shawn M. Hancock2, Hershel Raff3, Patrick Pfau2, Nalini M. Guda4,5, Marc F. Catalano4,5, Joseph E. Geenen4,5 1 Gastroenterology and Hepatology, Aurora Health Care, Milwaukee, WI; 2Gastroenterology and Hepatology, University of Wisconsin Hospital and Clinics, Madison, WI; 3Endocrine Research Laboratory, Aurora St. Luke’s Medical Center, Milwaukee, WI; 4GI Associates, LLC, Milwaukee, WI; 5Pancreatobiliary Center, St. Luke’s Medical Center, Milwaukee, WI Background: Cholangiocarcinoma (CCA) is difficult to diagnose. Tumor markers are insensitive and the yield of cytology is low. Fluorescent in situ hybridization (FISH) examines for chromosomal abnormalities that may occur in CCA. Reported sensitivity and specificity is 34-46% and 88-99%, respectively. It is
AB346 GASTROINTESTINAL ENDOSCOPY Volume 73, No. 4S : 2011
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Abstracts
unclear if these data can be applied in routine clinical practice. Aims: 1. Determine if FISH can aid in the diagnosis of CCA in patients with nondiagnostic cytology. 2. Evaluate the accuracy of FISH in a routine clinical setting. Methods: This is a retrospective chart review of patients with biliary strictures including those with and without primary sclerosing cholangitis (PSC) who had an endoscopic retrograde cholangiopancreatography (ERCP) and brushings for both cytology and FISH analysis between2007-2010. A dominant stricture was found in 53% of those with PSC. ERCP was performed to evaluate obstructive signs/symptoms, or as part of surveillance for CCA in those with PSC. Patients with prior malignancy or positive cytology before or at the time of initial ERCP were excluded. Brushings for cytology were obtained within 1 year of FISH in 10 patients, and at the time of FISH in 46. Cytology reported as suspicious, atypical or negative was recorded as negative. FISH was positive if ⬎ 5 cells had gains of 2 or more probes. Patients were considered to have malignancy if there was radiographic progression, positive cytology, or conclusive pathology from surgery or autopsy. Results: Brushing for FISH was obtained in 56 patients in whom cytology was non-diagnostic for malignancy. 3 were excluded as they had an inadequate sample for FISH. There were a total of 81 FISH specimen on these 53 patients, as some had multiple ERCP. PSC was the primary diagnosis in 37, while 16 underwent ERCP for signs or symptoms of a biliary stricture. Overall, 5 out of 53 had positive FISH (9.4%) and 3 of these positive patients had CCA. In the other two, one had pancreatic cancer and the other underwent liver transplantation with neoadjuvant chemo- and radiation therapy; his explant was negative for CCA. All patients with an initial negative FISH remained negative on subsequent tests. There were 5 who had negative FISH but subsequently developed CCA. The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy of FISH for CCA were 37.5%, 95.6%, 60%, 89.6%, and 86.8% respectively. Conclusions: In cases of indeterminate biliary stricture and negative cytology, FISH may be performed to evaluate for CCA. FISH has an additive role in detecting CCA with modest PPV and high NPV. These findings are congruent with initial studies evaluating FISH and hence applicable to clinical practice. Those with negative FISH need intensive follow-up and there appears to be no added benefit of repeating FISH if initially negative.
Mo1442 Long-Term Follow-Up of a Randomized Trial of Laparascopic Cholecystectomy and Laparascopic Common Bile Duct Exploration vs. ERCP With Sphincterotomy and Laparascopic Cholecystectomy for Common Bile Duct Stone Disease Michael C. Larsen1, Stanley Rogers2, Alex Rodas1, John P. Cello1 1 Gastroenterology, University of California, San Francisco, San Francisco, CA; 2Surgery, University of California, San Francisco, San Francisco, CA
Background: Trainees with one session of supervised EMS practice had significantly higher success rate in cannulating the common bile duct (CBD) during early training (AJG 2010, in press). The impact of additional unsupervised practice is unknown. Aim: To evaluate the effects of multiple vs single-session practice on clinical outcomes. Methods: 8 ERCP-naive trainees per year were randomized to study (n⫽4) and control (n⫽4) groups in 2007 and 2009, respectively. All trainees received 4 hours of ERCP didactic discussions. The study groups underwent one session of supervised EMS practice. In 2009, the study group continued biweekly unsupervised EMS practice over 3 months. All trainees received routine clinical ERCP training; success of selective CBD cannulation and performance score (1⫽poor, 2⫽fair, 3⫽neutral, 4⫽good, 5⫽excellent, rated by trainers blinded to the randomization) were recorded. The group-averaged effects of single and multiple practices were estimated and compared by generalized estimation equation (GEE) with pooled data from 2007 and 2009, adjusting for number of ERCPs before each ERCP, difficulty of papilla (prior papillotomy and multiple stenting as easy) and year of study. Results: Baseline characteristics of the procedures were comparable between study and control groups in both years (not shown). Clinical performance was superior in study groups compared to control groups in all outcome measures (all p⬍0.05) (Table 1). The adjusted odds ratio (OR) by GEE analysis further confirmed both single and multiple sessions practice conferred significant benefits with no difference between the 2 study groups (Table 2). Conclusion: As an educational tool a single supervised practice session with the EMS appears to augment the novice trainees’ understanding sufficiently to significantly enhance clinical performance (success of CBD cannulation) in the first three months of training. The superior performance was unmistakable to blinded clinical trainers. Table 1. Factors associated with success of deep CBD cannulation by trainees Year 2007
BACKGROUND: Common bile duct stone disease can be treated endoscopically with ERCP sphincterotomy (ERCP/S) or surgically via laparascopic common bile duct exploration (LCBDE). Published data on the long-term follow-up of patients undergoing these two techniques in a controlled clinical trial is limited. AIMS: To determine differences in rates of recurrent common bile duct stone disease or biliary complications between randomized prospectively studied patients who underwent either ERCP/S or LCBDE. METHODS: We randomized 122 patients (ASA grade 1 or 2) with classic signs and symptoms of cholelithiasis and likely common bile duct stones to either ERCP/S or LCBDE with laparascopic cholecystectomy between 1998 and 2003 (Arch Surg. 2010 Jan;145(1):28-33). Currently, we retrospectively reviewed the medical record of all patients enrolled in the initial trial to evaluate for recurrent biliary disease. Our hospital Institutional Review Board approved this study. RESULTS: Short-term follow-up data from our published randomized trial reported significantly more common bile duct stones detected by ECRP/S than by LCBDE (56% vs 30%; P ⫽ .007), however total stone clearance rates were not significantly different (98% for ECRP/S vs 88% for LCBDE; P ⫽ .28). The mean and median follow-up times for the overall group in the current study were 5.4 and 5 years (range: 1-12 years). The mean follow-up times for the ERCP/S patients (5.56 years) and LCBDE patients (5.14 years) were not different. Overall, there was no significant difference in rates of recurrent stone disease between the two groups. One patient in the ERCP/S group was hospitalized six years following his original study procedures with choledocholithiasis and required ERCP with stone extraction. No patients in the LCBDE group developed recurrent common bile duct stone disease. No patients in either group subsequently required additional biliary surgery. Two patients in the ERCP/S group and one patient in the LCBDE group required repeat ERCP with stent placement after laparascopic cholecystectomy because of a bile leak. No other biliary complications were reported. CONCLUSIONS: Long-term follow-up does not demonstrate any significant difference in long-term outcome between ERCP/S and LCBDE with respect to clearance of common bile duct stones.
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Mo1443 A Single Session of Supervised ERCP Mechanical Simulator (EMS) Practice Prepares Novice Trainees for Superior Clinical Performance Wei-Chih Liao1, Joseph W. Leung2,3, Hsiu-Po Wang1, Wen-Hsiung Chang4, Cheng-Hsin Chu4, Jaw-Town Lin1,5, Catherine Ngo3, Brian S. Lim6, Felix W. Leung7,8 1 Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan; 2Section of Gastroenterology, Sacramento VA Medical Center, Mather, CA; 3Gastroenterology, University of California Davis Medical Center, Sacramento, CA; 4Gastroenterology, Mackay Memorial Hospital, Taipei, Taiwan; 5Internal Medicine, E-DA Hospital and IShou University, Kaohsiung, Taiwan; 6Gastroenterology, Riverside Kaiser Permanente Medical Center, Riverside, CA; 7Gastroenterology, Sepulveda Ambulatory Care Center, VAGLAHS, North Hills, CA; 8 Gastroenterology, David Geffen School of Medicine at UCLA, Los Angeles, CA
Single EMS
Clinical performance
Year 2009 Multiple EMS
Control
Control
CBD cannulation success, n(%) 31/40 (77.5) 20/39 (51.3) 40/58 (69.0) 23/53 (43.4) Steps* accomplished (%), 75 (35) 53 (45) 80 (32) 53 (41) mean (SD) Performance score, mean (SD) 3.8 (0.9) 3.2 (0.7) 4.0 (0.7) 3.2 (0.7) *Steps: selective CBD cannulation, ampullary/biliary dilation, biliary stenting. Table 2. Effects of single/multiple EMS practices on clinical performance: pooled analysis Cannulation success GEE analysis Single EMS Multiple EMS Per 1 ERCP Easy papilla 2009 vs 2007 *P⫽.83; **P⫽.74.
Performance score
OR
95% CI
P
OR
95% CI
P
3.80* 3.33* 1.01 4.01 0.58
2.07-6.96 1.27-8.76 0.99-1.03 2.66-6.05 0.27-1.24
⬍.001 .015 .245 ⬍.001 .160
3.82** 6.19** 1.03 1.16 0.73
1.60-9.10 2.98-12.86 1.00-1.06 0.85-1.58 0.31-1.74
.003 ⬍.001 .022 .341 .483
Mo1444 Air Cholangiogram Is Not Inferior to Dye Cholangiogram: A Randomized Study Randhir Sud1, Rajesh Puri1, Parvesh Kumar Jain2, Smruti R. Mishra1 1 Department of Digestive and Hepatobiliary Sciences, Medanta, The Medicity, Gurgaon, India; 2Victoria Hospital, Bangalore, India Background and Aims: Endoscopic biliary drainage is the palliative treatment of choice in patients with malignant hilar biliary obstruction, but contrast injection
Volume 73, No. 4S : 2011
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