Prospective Study of Intraductal Ultrasonography Before Biliary Drainage (IDUS-BD), Transpapillary Biopsy (TPB) and Peroral Cholangioscopy (POCS) in Assessment of the Longitudinal Extent of Bile Duct Cancer

Abstracts

in 5.6% of EST, hemorrhage in 2.2% of EST and cholangitis in 0.4% of EST. We observed a procedure related mortality of 0.43 % (2 deaths: 1 patient died of post EST pancreatitis and 1 patient died due to cardiorespiratory insufficiency with multiorgan failure after EST). There was a non-procedure related hospital mortality of 2.38 % (11 deaths: mainly patients with end stage cancer disease). The main risk factors for complications of EST were: former ERCP pancreatitis (CR: 66.7%), recent stone passage (CR: 29.2%), sphincter of Oddi dysfunction (CR: 20%), combined sedation with propofol, benzodiazepines and opiates (CR: 18.1%), precut sphincterotomy (CR: 19.2%), number and intensity of pancreas duct contrast injections (CR: up to 50% with contrast injections up to the pancreas tail). Conclusion: The study confirmed a considerable early and delayed procedure related complication rate of EST. We could identify specific risk factors for EST related complications. We conclude that there is a need for permanent quality control and outcome assessment for invasive procedures like EST.

S1520 EUS Rendezvous for Transpapillary Biliary Access After Unsuccessful ERCP; 9 Years’ Experience At a Single Center Yeonsuk Kim, J. Shawn Mallery, Rebecca Lai, Timothy P. Kinney, Kapil Gupta, Anhtung Chau, Oliver W. Cass, Kamran Safdar, Martin Freeman Background: EUS is increasingly used for bile duct access when ERCP fails, mostly involving direct transhepatic or transluminal bouginage and drainage, which is potentially risky. Biliary EUS rendezvous is a potentially safer alternative. We report our total experience with this technique. Methods: Patients included all failed ERCP for distal biliary obstruction over 9 years. All procedures were performed under general anesthesia with fluoroscopy. EUS-guided transduodenal bile duct puncture was performed via a diagnostic linear EUS scope with a 19 or 22 gauge needle, then a guidewire was advanced distally through papilla by fluoroscopy, mostly without injection of contrast. The EUS scope was removed leaving the guidewire in place, and ERCP performed immediately afterward with stent placement or other therapy. Results: EUS-ERCP rendezvous approach was attempted for biliary access in 12 patients after ERCP failed (mean age 68, malignant 9/benign 3). Diameter of bile ducts ranged from 4 to 20mm. Reason for initial ERCP failure included tumor infiltrating or edema compressing papilla (n Z 8), intradiverticular papilla (n Z 1), choledochocele (n Z 1), or other anatomic anomaly (n Z 2). Most had needle knife precut (n Z 6) and/or extramural wire passage (n Z 4). EUS rendezvous was performed at the same session as initial ERCP attempt in 10/12 patients. Needles used for EUS-guided transduodenal puncture were 19 gauge in 10, 22 gauge in 2, with 0.025 glidewires or 0.018 guidewires respectively. Successful bile duct puncture and wire passage was achieved in 12/12 (100%) patients, with ERCP drainage successfully completed in 10/12 (83%). Failures occurred because of inability to traverse biliary stricture or dissecting a choledochocele with guidewire; both were subsequently drained via PTC, neither had a complication. In 10 successful cases, ERCP cannulation was done next to the EUS-guided wire in 9 and over the wire in 1; biliary stents placed were metallic in 7 and plastic in 3. Complications occurred in 1/12 patients (moderate pancreatitis after difficult ERCP attempt in papillary stenosis), with no cholangitis or perforation. Mean hospitalization after procedure was 5.5 (0-33)days for preexisting medical problems in all but one case. Conclusions: EUS rendezvous technique through a transduodenal approach is a safe and feasible technique for transpapillary biliary drainage when conventional ERCP fails. Advantages over PTC include performance under the same anesthesia as initial ERCP attempt, and internal drainage with access achieved by a very small caliber needle puncture similar to EUS/FNA. This procedure has potential to replace PTC in cases of unsuccessful ERCP.

S1521 Deep Cannulation of Intra-Diverticular Papilla At ERCP: Advanced Techniques and Results Ramu Raju, Douglas a. Howell, Michele B. Delenick, Burr J. Loew, Daniel P. Hammond, Arathi Rao, Michael K. Sanders, Harsha Vittal Deep cannulation of the major papilla in the setting of associated duodenal diverticula (DD) is generally reported to be as successful as with normal anatomy. When the papilla lies within the DD itself, access is much more difficult but few studies detail this subgroup. We describe our experience. Patients and Methods: 200 pts with DD-associated ampulla. (FZ122, MZ78) were identified in a prospectively entered ERCP database (6/98-11/07). These were subdivided into two groups; those where the papilla lies on the edge of the DD, n Z 132 (Group A) and those located within the DD, n Z 68 (Group B). Indications for ERCP included CBD stones n Z 141, pancreatic endotherapy n Z 34, malignant strictures n Z 16 and other n Z 9. Indications for the procedure were not different amongst the two. 15 pts underwent unsuccessful ERCP elsewhere (Group A, n Z 8 (6%); Group B, n Z 7 (10%) (pZN.S.) Techniques to gain access were reviewed from detailed ERCP reports, graded by difficulty and potential risk; guidewire-sphincterotome cannulation with or without tip grooming (Level 1); needle knife (NK) (Level 2); NK inside the DD, metal-clip placement and dual device use (Level 3). Clip placement technique: Clips were used to gather tissue next to the papilla resulting in correcting orientation or in rolling it onto the edge for access. Dual device technique: A 5Fr rat-toothed forceps was used to grasp the base of the intradiverticular papilla and pull it out onto the duodenal wall to permit simultaneous

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cannulation with a 5Fr or 6Fr papillotome, with or without a preliminary NK. Results: Successful deep cannulation was 100% for both Group A and Group B. The techniques required to gain access were different between the two groups. In Group A, Level 1 technique was successful in 118/132(89%) and Level 2 NK technique was required in 12/132(9%). In Group B, Level 1 techniques succeeded in 49/68(72%), and Level 3 in 19/68 (28%) (p Z 0.0001). There were no complications associated with the Level 3 techniques: NK inside DD n Z 7/68 (10%), clip placement n Z 2/68(3%), and the dual device technique was used in 10/68 (15%). Overall complications were 2%; pancreatitis 4/200, bleeding 0, perforation 0 and were not different between the two groups. Conclusion: Intra-diverticular papillae present a particular access challenge which can be solved with advanced techniques, most often using a single endoscope with two small devices within the biopsy channel. Complications were not higher despite the need for frequent difficult needle-knife access papillotomy. Success in this subgroup of duodenal diverticulum-associated papillae may require expert center referral but should rarely need PTC.

S1522 ERCP Using the Double Balloon Enteroscope in Patients with Roux En Y Anastomosis Klaus Mo ¨Nkemu ¨Ller, Michael Bellutti, Helmut Neumann, Lucia C. Fry, Peter Malfertheiner Background: Endoscopic retrograde cholangiopancreatography (ERCP) is technically more challenging in patients with post-surgical anatomy. We assessed the technical success of performing ERCP with the double balloon enteroscope (DBE) in patients presenting with complex post-surgical anatomy having biliary problems. Patients and Methods: Prospective evaluation of patients with complex post-surgical anatomy (Roux-en-Y anastomosis) undergoing ERCP with the DBE. 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 were defined according to standard criteria (Cotton et al, 1991). Results: ERCP using the DBE was performed on 14 occasions in 10 patients (3 F, 7 M, mean age 67, range 35 to 79) with complicated post-surgical anatomy (roux-en-Y, n Z 10, with hepaticojejunostomy, n Z9). Indications for ERCP included biliary obstruction or cholestasis in all patients. The overall diagnostic success was 85%, and the therapeutic success was 58%. Reasons for failed biliary cannulation included: inability to reach the proximal end of the afferent loop (n Z 1), impossibility to advance the wire into the CDB despite adequate insertion of the biliary catheter into the distal CBD (n Z 2), inability to advance stent over adequately placed guidewire (n Z 1). One major complication occurred: perforation of the jejunum in a patient with a hepaticojejunostomy and choledocolithiasis, which was resolved surgically. Conclusions: ERCP using the DBE is feasible in patients with complex post-surgical anatomy, permitting diagnostic and therapeutic interventions in 85% and 58% of cases, respectively. Nevertheless, due to the complex anatomy, presence of adhesions and looping of the usually long limbs, complications can occur.

S1523 Prospective Study of Intraductal Ultrasonography Before Biliary Drainage (IDUS-BD), Transpapillary Biopsy (TPB) and Peroral Cholangioscopy (POCS) in Assessment of the Longitudinal Extent of Bile Duct Cancer Yutaka Noda, Naotaka Fujita, Go Kobayashi, Kei Ito, Jun Horaguchi, Osamu Takasawa, Takashi Obana, Takashi Tsuchiya, Takashi Sawai Aim: We prospectively evaluated the diagnostic efficacy of transpapillary intraductal ultrasonography before drainage (IDUS-BD), transpapillary biopsy (TPB) and peroral cholangioscopy (POCS) for the assessment of the longitudinal extent (LE) of bile duct (BD) cancer. Patients and Methods: Between August 1998 and August 2007, we performed preoperative IDUS-BD and TPB, surgery, and histological examination in 44 patients with carcinoma of the extrahepatic BD (hilar-upper BD, 9; middle BD, 18; lower BD, 17). IDUS-BD was performed by the ropeway method using a microscanner with a wire-guide. Following IDUS-BD, TPB was performed under fluoroscopic guidance immediately after endoscopic sphincterotomy (EST). POCS was also performed in 8 cases (including 3 in combination with narrow band imaging) after EST. The average number of biopsy specimens obtained per patient was 7.6 (1–26) by TPB and 3.7 (1–7) under POCS. The LE of cancer was diagnosed based on the findings of irregularity of the mucosal surface or localized thickening of the internal hypoechoic layer of the BD adjacent to the main tumor by IDUS-BD and irregular and/or reddish mucosa or abnormal vessels continuous with the tumor by POCS. When the hepatic or duodenal extent determined by IDUS-BD, TPB or POCS with biopsy corresponded to the histologically proven mucosal and/or intramural spread of BD cancer in the surgical specimen, the preoperative diagnosis for the LE of BD cancer by each examination was considered to be correct. UM-G20-29R, CHF-B20 and CHF-B260 manufactured by Olympus were mainly used in this study. Results: The accuracy of the assessment of the LE of BD cancer on the hepatic and duodenal sides were 77.3% (34/44) and 61.4% (27/44) by IDUS-BD; 93.2% (41/44) and 81.8% (36/44) by a combination of IDUS-BD and TPB; 71.4% (5/7) and 75% (6/8) by POCS; 85.7% (7/8) and 87.5% (7/8) by POCS with biopsy; 100% (8/8) and

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Abstracts

100% (8/8) by a combination of IDUS-BD, TPB and POCS with biopsy, respectively. Correct diagnosis of the LE of BD cancer by IDUS-BD was not obtained due to inflammation (sludge), intraepithelial cancer spread without mucosal thickening, or the presence of the papillary folds near the papilla of Vater. POCS failed to establish a correct diagnosis due to inability to pass through the stenosis and artifacts made by drainage tubes. Conclusions: A combination of IDUS-BD and TPB is, as well as POCS with biopsy, useful for preoperative evaluation of the LE of BD cancer. It can be reasonably expected that the combination of IDUS-BD, TPB and/or POCS with biopsy may improve preoperative diagnosis of the LE of BD cancer in selected cases.

S1524 Meta-Analysis of Magnetic Resonance Cholangiopancreatography (MRCP) Demonstrates High Predictive Value of MRCP for Primary Sclerosing Cholangitis (PSC) Maneesh Dave, B. Joseph Elmunzer, Ben a. Dwamena, Peter D. Higgins Background: PSC is often suspected in patients with inflammatory bowel disease and biochemical evidence of cholestasis. Endoscopic Retrograde CholangioPancreatography (ERCP) is the diagnostic gold standard for PSC, but ERCP has a greater risk of complications than MRCP. The predictive value of MRCP in patients in whom PSC is suspected is not well established, as varying sensitivities and specificities have been reported for MRCP for PSC. A better understanding of the likelihood ratios (LRs) of positive and negative MRCP in the setting of suspected PSC is needed. Aims: 1) To perform a meta-analysis of prospective studies of the diagnostic value of MRCP in cholestasis to determine the sensitivity, specificity, summary ROC curve, LRþ and LR- (with 95% confidence intervals) of MRCP in this setting; 2) To determine the post-test probability of PSC in patients with different levels of suspicion for PSC. Methods: Searches of Medline; EMBASE; DDW, UEGW, and ACG abstracts; and the bibliographies of relevant abstracts were used to identify papers. Two authors screened and excluded papers that included healthy controls, did not report raw numbers of results, and did not include cholangiography (ERCP or PTC) in the gold standard. Two authors independently abstracted data from each full manuscript. Data was analyzed in Stata 10 with the midas command. Results: Six manuscripts, with a total of 626 subjects, including 259 with PSC, met criteria for inclusion. The summary AuROC was 0.91 (0.88–0.93). Heterogeneity was not found, QZ1.68, p Z 0.22. There was not evidence of publication bias (p for bias coefficient 0.85). The sensitivity of MRCP for PSC was 0.84 (.79–.89), and the specificity 0.96 (0.90–0.98). The MRCP LRþ is 18.66 (8.50– 40.96), and the MRCP LR- is 0.16 (0.12–0.23). In patients with high pretest probabilities, MRCP can confirm PSC; in patients with low pretest probabilities, MRCP can readily rule out PSC. For a worst-case scenario (pretest probability 0.5), the post-test probabilities are 95% for a positive MRCP and 14% for a negative MRCP. Conclusions: Our study shows that MRCP has a high sensitivity and a very high specificity for diagnosis of PSC. This should eliminate the use of confirmatory ERCP in patients who have an appropriate clinical picture and a MRCP consistent with PSC. A negative MRCP can be considered sufficient to rule out PSC in a patient with low clinical suspicion. In the worst-case scenario of a patient with a pre-test probability of PSC of 0.5, MRCP is still a powerful diagnostic tool. In many cases of suspected PSC, MRCP will be sufficient for diagnosis, and the risk of ERCP can be avoided.

S1525 Internal Biliary Drainage Is Superior to External Drainage in Reversal of the Elevated Serum Endotoxin, Interlukin-2 and Interlukin-6 in Rats with Obstructive Jaundice Yichun Gong, Wen Li Backgrounds: The roles of preoperative relief of obstructive jaundice by internal or external biliary drainage in prevention of postoperative complications remain controversial. Aims: To investigate the effects of biliary drainage on reversion of the abnormal serum endotoxin, interlukin-2 (IL-2) and interlukin-6 (IL-6) in rats with obstructive jaundice. Methods: Sixty male adult Sprague-Dawley rats were randomly assigned to four groups: obstructive jaundice (OJ; n Z 15) by bile duct liagation and resection for 7 days and re-operation for sham drainage for another 7 days; internal biliary drainage (ID; n Z 15) by bile duct ligation and resection for 7 days and re-operation for planting a stent between the dilated bile duct and the duodenum for another 7 days; external drainage (ED; n Z 15) by bile duct ligation and resection for 7 days and re-operation for exteriorizing a drainage tube from the common bile duct through the subcutaneous channel to the nape of the neck; and sham operation (SH; n Z 15). On the day 7after the second operation (14 days following the first operation), the rats were succumbed and blood specimens were collected. The concentrations of serum IL-2 and IL-6 were measured with enzyme linked immunosorbent assay (ELISA) and serum endotoxin level was measured by limulus test. Results: Endotoxemia was found in rats with OJ and the concentration of serum endotoxin in jaundiced rats (42.5  3.5 pg/ml) was significantly higher than that in sham operation rats (4.1  2.0 pg/ml) (P!0.01). After bile duct ligation, the

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concentration of serum IL-6 (212.9  56.5 pg/ml) was significantly increased comparing with that in sham rats (145.3  38.7pg/ml) (P!0.01). The level of serum IL-2 (212.7  62.4 pg/ml) was also elevated, but the difference was not statistically significant comparing with that in sham rats (183.2  59.6pg/ml). After relief of the biliary obstruction by ED, the endotoxemia was reversed (6.2  2.9pg/ml) (ED vs OJ, P!0.01). The levels of interlukin-6 and interlukin-2 could not be decreased, on the contrary, they were significantly increased (269.4  76.2 pg/ml and 264.9  62.3pg/ml respectively) (ED vs OJ, P!0.01 and P!0.05 respectively). However, internal drainage could suppressed not only the endotoxemia (4.2  2.0pg/ml), but also the serum IL-6 (169.7  49.1 pg/ml) and IL-2 (184.3  52.4 pg/ml) (ID vs OJ, P ! 0.01, P ! 0.05 and PO0.05 respectively). Conclusions: Internal biliary drainage is superior to external drainage in terms of reversal of the abnormal serum endotoxin, interlukin-2 and interlukin-6 in rats with obstructive jaundice.

S1526 Hospitalization and In-Hospital Mortality of Cholangitis in the Advent of Therapeutic Biliary ERCP M Mazen Jamal, Zarema Singson, David Yamini, Kenneth J. Vega Background: The severity of cholangitis can range from mild to fatal. In recent years there has been increasing recognition of cholangitis and increasing utilization of endoscopic biliary drainage procedures. The purpose of this study was to determine national trends in the hospitalization and in-hospital mortality of cholangitis in the advent of the utilization of therapeutic biliary ERCP. Methods: The Nationwide Inpatient Sample database was utilized to determine the ageadjusted hospitalization rate and in-hospital mortality of cholangitis (ICD-9-CM 576.1) for each year between 1988 and 2004. Age-adjusted procedure rates for biliary stent placement and sphincterotomy were also analyzed. Results: The Nationwide Inpatient Sample database contained 115,518 patients who were diagnosed with cholangitis. The mean age of the patients was 65.47  17.87 years old and was composed of 49.9% males and 50.1% females. The age-adjusted hospitalization rate of cholangitis increased 18% from 6.5 per 100,000 in 1988 to 7.7 per 100,000 in 1997 (P!0.01). The age-adjusted hospitalization rate then declined slightly and stabilized at 7.6 per 100,000 in 2004. The age-adjusted hospitalization rate increased steadily in males from 1988 to 2004 (59.8%). Hospitalization rates were highest among Asian/Pacific Islanders (18.4 per 100,000) followed by Hispanic Americans (10.9 per 100,000) and was lowest in African Americans (5.7 per 100,000). In-hospital mortality data from 1988-2004 included 6,174 patients. The mean age of the patients was 72.19  15.28 years old and was composed of 51.6% males and 48.5% females. The age-adjusted inhospital mortality of cholangitis was 2.2 per 1,000 in the 1988-1992 time period which peaked at 2.9 per 1,000 in the period 1993-1996 (P ! 0.01). The mortality rate declined to 2.4 per 1,000 in the 1997-2000 (P ! 0.01) time period and stabilized to 2.5 per 1,000 in 2001-2004. The age-adjusted procedure rates for ERCP with biliary stenting increased from 5.4 per 100,000 in 1989 to 113.8 per 100,000 in 2002 (increase by 150%) (P!0.01). The age-adjusted procedure rates for ERCP with sphincterotomy also increased from 10.6 per 100,000 in 1989 to 315.8 per 100,000 in 2002. Conclusions: The overall trend in the hospitalization of cholangitis has been increasing over the last two decades, particularly in male patients. Hospitalization rates were highest among Asian/Pacific Islanders and lowest among African Americans. The overall trend in mortality peaked between 1993 and 1996 with a subsequent decline that is most likely secondary to the widespread utilization of therapeutic biliary endoscopy.

S1527 Safety of Non-Anesthetist Sedation with Propofol During Endoscopic Retrograde Cholangiopancreatography (ERCP): 10 Years of Experience Marcello Orlandi, Manuela Noesberger, Daniel Kuelling, Christophe Petrig, Werner Inauen Background: There is still limited data on the safety of propofol sedation during ERCP, where deep sedation is mandatory.Objective: We asked if non-anesthetist sedation with propofol is safe for ERCP. Setting: A hospital-based gastroenterology center in Switzerland. Patients and Design: Between November 1997 and October 2007, all ERCP procedures were prospectively assessed regarding patient characteristics, American Society of Anesthesiologists (ASA) status, dosage of propofol, fall of oxygen saturation, need to increase nasal oxygen administration above 2 L/min, need for assisted ventilation, need for endotracheal intubation, feasibility of the ERCP procedure, sedation-related adverse events or death. Intervention: ERCP procedures were performed under deep sedation with propofol, administered by the endoscopy team consisting of 1 physician endoscopist, 1 endoscopy assistant and 1 radiology assistant. Patient monitoring consisted of pulse oxymetry, breathing frequency, electrocardiogram and clinical assessment. Results: During the 10 years period, 1305 ERCP procedures (9 % diagnostic, 91 % therapeutic) were performed (mean patient age 64 years, range 1698 years). In 36 ERCP procedures (2.7 %, all patients ASA III and IV), sedation was administered by an anesthesiology team. In the remaining 1269 ERCP procedures

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