Minor papilla endotherapy in patients with ventral duct obstruction: identification and management.

BACKGROUND AND AIMS: Pancreatic duct (PD) cannulation via the major papilla may be compromised by downstream obstruction of the ventral PD from a stone or stricture. In patients with a patent accessory PD, cannulation of the minor papilla permits stenting or stone removal upstream of the ventral PD obstruction. Data on this technique are limited. METHODS: University of Colorado Hospital and Maine Medical Center endoscopy databases were queried for ERCPs with minor papilla cannulation. Technical success was defined as deep cannulation of the minor papilla. Minor papilla endotherapy included sphincterotomy, stricture dilation, stenting, or stone treatment. Clinical improvement was designated as >50% reduction in pain or narcotic analgesia. Follow-up was obtained by chart review and telephone contact. RESULTS: Over a 22-year period, 464 patients had minor papilla cannulation. Congenital and incomplete pancreas divisum were excluded, and 64 patients met study criteria. Technical success was achieved in 58 of 64 patients (91%). In patients with stones, 25 of 34 (74%) had clearance using endoscopic techniques. Median follow-up was 15.5 months. Twelve of 28 patients (43%) on chronic narcotic regimens reported a reduction in narcotic use by >50%, and 32 of 44 patients (73%) reached for discussion noted improved abdominal pain by >50%. Thirteen patients required surgery for symptom control. CONCLUSIONS: In this multicenter experience, 15% of patients undergoing minor papilla cannulation had acquired a ventral PD obstruction. Access via the minor papilla to the upstream main PD for endotherapy and clinical improvement was achieved in most patients. Increased and early recognition of these intensive therapeutic options may enhance treatment options for this complex group of patients.

A multicenter, U.S. experience of single-balloon, double-balloon, and rotational overtube-assisted enteroscopy ERCP in patients with surgically altered pancreaticobiliary anatomy (with video).

BACKGROUND: Data on overtube-assisted enteroscopy to facilitate ERCP in patients with surgically altered pancreaticobiliary anatomy, or long-limb surgical bypass, is limited. OBJECTIVE: To evaluate and compare ERCP success by using single-balloon (SBE), double-balloon (DBE), or rotational overtube enteroscopy. DESIGN: Consecutive patients identified retrospectively. SETTING: Eight U.S. referral centers. PATIENTS: Long-limb surgical bypass patients with suspected pancreaticobiliary diseases. INTERVENTION: Overtube-assisted enteroscopy ERCP. MAIN OUTCOME MEASUREMENTS: Enteroscopy success: visualizing the pancreaticobiliary-enteric anastomosis or papilla. ERCP success: completing the intended pancreaticobiliary intervention. Clinical success: greater than 50% reduction in abdominal pain or level of hepatic enzyme elevations or resolution of jaundice. RESULTS: From January 2008 through October 2009, 129 patients had 180 enteroscopy-ERCPs. Anatomy was Roux-en-Y: gastric bypass (n = 63), hepaticojejunostomy (n = 45), postgastrectomy (n = 6), Whipple procedure (n = 10), and other (n = 5). ERCP success was 81 of 129 (63%). Enteroscopy success: 92 of 129 (71%), of whom 81 of 92 (88%) achieved ERCP success. Reasons for ERCP failure (n = 48): afferent limb entered but pancreaticobiliary anastomosis and/or papilla not reached (n = 23), cannulation failure (n = 11), afferent limb angulation (n = 8), and jejunojejunostomy not identified (n = 6). Select interventions: anastomotic stricturoplasty (cautery ± dilation, n = 16), stone removal (n = 21), stent (n = 25), and direct cholangioscopy (n = 11). ERCP success rates were similar between Roux-en-Y gastric bypass and other long-limb surgical bypass and among SBE, DBE, and rotational overtube enteroscopy. Complications were 16 of 129, 12.4%. LIMITATIONS: Retrospective study. CONCLUSION: (1) ERCP is successful in nearly two-thirds of long-limb surgical bypass patients and in 88% when the papilla or pancreaticobiliary-enteric anastomosis is reached. (2) Enteroscopy success in long-limb surgical bypass is similar among SBE, DBE, and rotational overtube enteroscopy methods. (3) Referral of long-limb surgical bypass patients who require ERCP to high-volume institutions may be considered before more invasive percutaneous or surgical alternatives.

Effect of endoscopic stenting of malignant bile duct obstruction on quality of life.

BACKGROUND AND GOALS: Endoscopic stent insertion is considered the method of choice for palliation of malignant bile duct obstruction (MBDO). However, it can cause complications and requires periodic stent exchanges. Although endoscopic stenting is clearly indicated for relief of cholangitis or refractory pruritus, its role in patients with jaundice alone is less clear. Endoscopic stenting for this relative indication might be justified, if there is a significant improvement in quality of life (QOL) of such patients. The aim of our study was to determine whether endoscopic stenting for MBDO results in improved QOL. PATIENTS AND METHODS: Patients undergoing endoscopic retrograde cholangiopancreatography for MBDO and participating in a randomized trial comparing patency duration of 10 and 11.5-Fr biliary plastic stents, completed the Functional Assessment of Cancer Therapy-General questionnaire at baseline, at 1 month after stent insertion, and at 180 days after stent insertion. RESULTS: A total of 164 patients answered the QOL questionnaire at baseline, 95 patients answered the questionnaire at 30 days, and 54 patients answered the questionnaire at 180 days after stent insertion. Endoscopic biliary stenting resulted in a statistically significant improvement in overall score of QOL, and different aspects of QOL such as physical, emotional, and functional well-being. There was a statistically significant improvement in most of the symptoms specific for MBDO at 30 and 180 days after stenting. CONCLUSIONS: Endoscopic stenting significantly improves QOL in patients with MBDO, and, therefore, is an appropriate part of palliative treatment in this patient population.

Intraprocedural tissue diagnosis during ERCP employing a new cytology preparation of forceps biopsy (Smash protocol).

OBJECTIVES: Techniques of tissue sampling at endoscopic retrograde cholangiopancreatography (ERCP) have been underutilized due to technical demands, low yield, and lack of immediate intraprocedural diagnosis. The objective of this study was to describe a new inexpensive, highly efficient ERCP tissue processing, and interpretation technique to address these issues. METHODS: A retrospective, institutional review board approved, single-center study was done at a tertiary-care medical center. Between June 2004 and February 2009, 133 patients (age 38-95 years; men 53%) with suspicious biliary strictures underwent ERCP with tissue sampling using a new technique. Small forceps biopsy specimens were forcefully smashed between two dry glass slides, immediately fixed, stained with rapid Papanicolaou, and interpreted by an on-site pathologist during the procedure (Smash protocol). RESULTS: Of the 117 proven to have cancer, true-positive Smash preps included pancreatic cancer 49/66 (74%), cholangiocarcinoma 23/29 (79%), metastatic cancer 8/15 (53%), and other 4/7 (57%). The median number of Smash biopsies to diagnosis was 3 (range 1-17). Suspicious or atypical results were considered to be negative in this study. There were no false positives and no complications. Smash had an overall sensitivity of 89/117 (76%) for all cases. The true-positive yield of immediate Smash prep cytology, combined with ERCP fine needle aspirate (FNA) and forceps biopsy histology was 77/95 (81%) for primary pancreaticobiliary cancers. CONCLUSIONS: Immediate cytopathologic diagnosis at ERCP was established in 72% of patients presenting with suspected malignant biliary obstruction using a new cytological preparation of forceps biopsies. This approach to ERCP tissue sampling permits immediate diagnosis and avoids the need for subsequent procedures, adds little cost and time, and is safe to perform.

Endoscopic appearance of the minor papilla predicts findings at pancreatography.

BACKGROUND: The minor papilla serves as a site of alternative pancreatic duct drainage via the accessory pancreatic duct. AIMS: The objectives of this study were to assess the endoscopic appearance of the minor papilla for characteristics that might predict increased accessory pancreatic duct flow and hence suggest pathology of the downstream pancreatic ductal system. METHODS: This was a nonrandomized, prospective analysis of consecutively enrolled patients from a tertiary care medical center (Maine Medical Center, Portland, Maine). The study cohort consisted of consecutive patients presenting for endoscopic retrograde cholangiopancreatography (ERCP) without prior pancreaticobiliary endotherapy or ductography. RESULTS: Sixty-four patients received a minor papilla score prior to ERCP. A normal pancreatogram was found in 37 of 64 (57.8%) patients; the remaining 27 (42.2%) patients had an abnormal pancreatogram. The median minor papilla bulge score was 0.49 (range 0-3) in the normal pancreatogram group and 2 (range 0-3) in the abnormal pancreatogram group (P < 0.0001). The median minor papilla orifice score of those with a normal pancreatogram was 0 (range 0-2) compared to 2 (range 0-3) in the abnormal pancreatogram group (P < 0.001). The median minor papilla cumulative score of 1 (range 0-5) for the normal pancreatogram group was significantly less than that for the abnormal pancreatogram group (3, range 0-6, P < 0.0001), resulting in a sensitivity of 96.3% for an abnormal pancreatogram. The minor papilla orifice was noted to be either gaping or actively dripping pancreatic juice in four out of five patients with pancreas divisum. CONCLUSIONS: A minor papilla without bulging or a visible orifice would suggest a normal pancreatogram at ERP. Conversely, an abnormal minor papilla, particularly a patent minor papilla orifice, should raise suspicion of pancreatic ductal pathology and can help direct pancreatic endotherapy at the major or minor papillae.

ERCP in the very elderly: outcomes among patients older than eighty.

Life expectancy is rising, which is increasing the demand for endoscopic retrograde cholangiopancreatography (ERCP) in the elderly. Little data, particularly on complex procedures, has been reported. In this study, we compare the differences in the success and complications in ERCP between patients older and younger than 80 years old. We used a large endoscopic database reviewing the ERCPs performed and 30-day complications addressing age, degree of difficulty of procedures, and complications. A total of 2,606 patients underwent 3,924 ERCPs. Six hundred and twenty-eight were octogenarians undergoing 728 procedures. Mean age was 83.5 years in the octogenarian group and 59.0 years in the younger group. The endoscopic success rate was lower in octogenarians (96.9 vs. 98.3%, P = 0.004). Overall, complication rates between both groups was significantly less in older compared to younger patients (1.64 vs. 3.50%, P = 0.006). Complication and failure rates were higher as procedure complexity increased in all patients. ERCP in the elderly carries a high degree of success with low complication rates. Elderly patients carry similar risks of bleeding and perforation and a lower risk of pancreatitis.

Comparative performance of uncoated, self-expanding metal biliary stents of different designs in 2 diameters: final results of an international multicenter, randomized, controlled trial.

BACKGROUND: The Wallstent has remained the industry standard for biliary self-expanding metal stents (SEMSs). Recently, stents of differing designs, compositions, and diameters have been developed. OBJECTIVE: To compare the new nitinol 6-mm and 10-mm Zilver stents with the 10-mm stainless steel Wallstent and determine the mechanism of obstruction. DESIGN: Randomized, prospective, controlled study. SETTING: Nine centers experienced in SEMS placement during ERCP. PATIENTS: A total of 241 patients presenting between September 2003 and December 2005 with unresectable malignant biliary strictures at least 2 cm distal to the bifurcation. MAIN OUTCOME MEASUREMENT: Stent occlusions requiring reintervention and death. RESULTS: At interim analysis, a significant increase in occlusions was noted in the 6-mm Zilver group at the P = .04 level, resulting in arm closure but continued follow-up. Final study arms were 64, 88, and 89 patients receiving a 6-mm Zilver, 10-mm Zilver, and 10-mm Wallstent, respectively. Stent occlusions occurred in 25 (39.1%) of the patients in the 6-mm Zilver arm, 21 (23.9%) of the patients in the 10-mm Zilver arm, and 19 (21.4%) of the patients in the 10-mm Wallstent arm (P = .02). The mean number of days of stent patency were 142.9, 185.8, and 186.7, respectively (P = .057). No differences were noted in secondary endpoints, and the study was ended at the 95% censored study endpoints. Biopsy specimens of ingrowth occlusive tissue revealed that 56% were caused by benign epithelial hyperplasia. CONCLUSIONS: SEMS occlusions were much more frequent with a 6-mm diameter SEMS and equivalent in the two 10-mm arms despite major differences in stent design, material, and expansion, suggesting that diameter is the critical feature. Malignant tumor ingrowth produced only a minority of the documented occlusions.

Large-diameter biliary orifice balloon dilation to aid in endoscopic bile duct stone removal: a multicenter series.

BACKGROUND: The utility and safety of endoscopic biliary orifice balloon dilation (EBD) for bile duct stone removal (with use of large-diameter balloons) after biliary endoscopic sphincterotomy (BES) is currently not well established. OBJECTIVE: Our purpose was to evaluate the efficacy and complications of BES followed by > or = 12 mm diameter EBD for bile duct stone removal. DESIGN: Retrospective, multicenter series. SETTING: Five ERCP referral centers in the United States. PATIENTS AND INTERVENTIONS: Patients who underwent attempted removal of bile duct stones by BES followed by EBD with > or = 12 mm diameter dilating balloons were identified by searching the prospectively recorded endoscopic databases from 1999 to 2007. Clinical parameters, endoscopic data, and outcomes were collected and analyzed. RESULTS: One hundred three patients, mean age 70 +/- 17 years (range 23-98 years), with 56 (54%) women, underwent 107 procedures. Eleven patients (11%) had a prior history of acute pancreatitis. Pancreatogram was performed in 15 (14%) patients. Median stone size and median balloon diameter used was 13 mm. Complete stone removal in the first session of EBD was accomplished in 102 (95%) procedures, and mechanical lithotripsy was required in 29 (27%). Six patients (5.4%) had documented procedure-related complications including one patient with severe bleeding and one with severe cystic duct perforation. No acute pancreatitis occurred. CONCLUSION: EBD with a large-diameter balloon in conjunction with BES for bile duct stone removal is effective and relatively safe. This technique appears to be a reasonable alternative option when standard BES and basket or balloon sweep are inadequate to remove bile duct stones.

New technology for endoscopic retrograde cholangiopancreatography: improving safety, success, and efficiency.

Known and documented factors attributable to ERCP-related complications include the experience and technique of the endoscopist as well as anatomic and pathologic factors pertaining to the papilla. In an effort to minimize trauma, facilitate deep entry to the biliary system, and improve the efficiency of therapeutic ERCP, new cannulation, sphincterotomy, and guide wire devices have been developed, based on principles of safe and successful therapeutic ERCP learned over the years. By totally re-engineering familiar accessories into smaller, more flexible, and more versatile devices, the 0.025-inch guide wire-based DASH system attempts to minimize the trauma at deep CBD cannulation and thereby increase the safety and success of achieving deep cannulation and sphincterotomy. Limited clinical experience to date suggests that the DASH system can provide full-function ERCP while reducing risks and costs. Attention to cannulation has led to the development of the RX Biliary System which provides the endoscopist and the assistant with increased control of the guide wire and exchange compared with traditional devices, resulting in less stress, less hand and wrist force used for contrast injection, and easier guide wire management, all of which have been shown in clinical trials to improve the speed and efficiency of ERCP while reducing complications.

Multicenter Randomized Trial of 10-French versus 11.5-French Plastic Stents for Malignant Biliary Obstruction.

Background. There is little prospective data on whether bigger plastic stents are better for patients with malignant biliary obstruction with jaundice. Goals. Multicenter prospective study to compare technical success, clinical response, stent occlusion, and patient survival in patients with malignant biliary obstruction randomized to 10-French or 11.5-French plastic stent. Study. Patients with malignant biliary obstruction were randomized to 10-French or 11.5-French biliary stents. Patients were prospectively assessed for stent occlusion, stent-related interventions, hospital stay, and change in bilirubin. Main outcome measurements included technical success, clinical response, rates of stent occlusion, and survival. Results. 234 patients (47 hilar and 187 common bile duct strictures) were randomized. Outcomes were similar for the 10-French and 11.5-French groups (technical success 99.1% versus 97.4%, P = 0.37). Overall, median stent survival was 213 days, but there was no statistically significant difference in stent survival between 10-French and 11.5-French stents (149 versus 258 days, P = 0.16). Stent survival was significantly longer when placed for common bile duct versus hilar strictures (231 versus 115 days, P = 0.049). Conclusions. The theoretical advantage of improved bile flow for the 11.5-French stent does not translate into more prolonged patency, better clinical response, and longer patient survival than the 10-French stent.

Disconnected pancreatic tail syndrome: potential for endoscopic therapy and results of long-term follow-up.

BACKGROUND: Limited published data exist that address the incidence and outcomes of patients with complete pancreatic-duct disruption. OBJECTIVE: Report on a single-center experience with this entity that emphasizes the feasibility of endoscopic therapy and long-term outcomes. DESIGN: Retrospective analysis. SETTING: Tertiary-care medical center (Portland, Maine). PATIENTS: A total of 189 patients with pancreatic-fluid collections and/or pancreatic fistulas were retrospectively evaluated for the presence of a disconnected pancreatic tail. Patients meeting the definition of disconnected pancreatic tail syndrome (DPTS) with a minimum of 6 months' follow-up were analyzed. RESULTS: Thirty of 189 patients (16%) met criteria for DPTS. Thirty-six drainage procedures were performed on 29 patients (mean 1.2 procedures per patient). In 22 of 29 patients (76%), the initial drainage procedure was successful. However, recurrent fluid collection(s) developed in 11 of 22 patients (50%) and was seen in those treated surgically and endoscopically. Disruption in the tail (n = 3) was uncommon but invariably required no surgical intervention. The median follow-up was 38 months (range 3-94 months). Diabetes mellitus developed in 16 of 30 patients (53%); 15 of 30 patients (50%) had left-sided portal hypertension; 16 of 30 patients (53%) continue in active medical or surgical follow-up for recurrent symptoms attributable to the disconnected pancreatic tail. CONCLUSIONS: Of patients with a pancreatic-fluid collection and/or fistula, 16% will also have a disconnected pancreatic tail. Endoscopic and surgical drainage techniques are typically initially successful, but both suffer from a high rate of recurrence in the setting of DPTS. The majority of patients will require long-term follow-up because of complications and/or ongoing symptoms.

Mechanical lithotripsy of pancreatic and biliary stones: complications and available treatment options collected from expert centers.

INTRODUCTION: PD and common bile duct (CBD) stones often require mechanical lithotripsy (ML) at ERCP for successful extraction. The frequency and spectrum of complications is not well described in the literature. AIM: To describe the frequency and spectrum of complications of ML. METHODS: A comprehensive retrospective review of cases requiring ML of large or resistant PC and/or CBD stones using a 46-point data questionnaire on type(s) of complication, treatment attempted, and success of treatment. The study involved 7 tertiary referral centers with 712 ML cases (643 biliary and 69 pancreatic). RESULTS: Overall incidence of complications were: 4-4% (31/712); 23/643 biliary, 8/69 pancreatic; 21 single, 10 multiple. Biliary complications: trapped (TR)/broken (BR) basket (N = 11), wire fracture (FX) (N = 8), broken (BR) handle (N = 7), perforation/duct injury (N = 3). Pancreatic complications: TR/BR basket (N = 7), wire FX (N = 4), BR handle (N = 5), pancreatic duct leak (N = 1). Endoscopic intervention successfully treated complications in 29/31 cases (93.5%). Biliary group treatments: sphincterotomy (ES) extension (N = 7), electrohydraulic lithotripsy (EHL) (N = 11), stent (N = 3), per-oral Soehendra lithotripsy (N = 8), surgery (N = 1), extracorporeal lithotripsy (N = 5), and dislodge stones/change basket (N = 4). Pancreatic group treatments: ES extension (N = 3), EHL (N = 2), stent (N = 5), Soehendra lithotriptor (N = 4), dislodge stones/change basket (N = 2), extracorporeal lithotripsy (ECL) (N = 1), surgery (N = 1). Perforated viscus patient died at 30 days. CONCLUSION: The majority of ML in expert centers involved the bile duct. The complication rate of pancreatic ML is threefold greater than biliary lithotripsy. The most frequent complication of biliary and pancreatic ML is trapped/broken baskets. Extension of ES and EHL are the most frequently utilized treatment options.

Delayed pancreaticoduodenectomy for cancer patients with prior ERCP-placed, nonforeshortening, self-expanding metal stents: a positive outcome.

BACKGROUND: Self-expanding metal stents (SEMS) inserted for malignant biliary obstruction are felt to be contraindicated in patients with resectable disease. Anecdotally, we observed a number of "unresectable" patients eventually undergoing a "delayed" pancreaticoduodenectomy after additional surgical opinions. This has not been previously described in the literature. OBJECTIVE: To quantitate the frequency with which patients diagnosed with unresectable pancreaticobiliary malignancy (and hence undergoing SEMS placement) eventually undergo Whipple's resection, and to report on the outcomes in these patients. DESIGN AND SETTING: This retrospective, observational study was conducted at a single tertiary care medical center. PATIENTS AND INTERVENTIONS: One hundred consecutive patients who underwent non-foreshortening SEMS placement for presumed unresectable pancreaticobiliary malignancy were identified from our ERCP database. The clinical course and any subsequent operative interventions were reviewed. RESULTS: Despite apparent unresectability, 13 of 100 patients underwent delayed surgical exploration for an attempt at resection. Whipple's resection was successfully performed in 5 patients. No interference with the biliary anastomosis was noted. No unresectable patient required surgical biliary bypass because of the presence of the stent. No pre- or postoperative infections occurred. CONCLUSIONS: Non-foreshortening metal stents can be precisely positioned below the line of any potential surgical transection. The lower risk of preoperative metal stent occlusion, compared to plastic stents, minimizes the risk of postoperative infection. At surgery, unresectable patients do not require unnecessary biliary bypass if a properly positioned SEMS is in place. Properly placed non-foreshortening biliary metal stents are not a contraindication to delayed attempts at Whipple's resection and may be beneficial.

Success and complications of endoscopic removal of giant duodenal and ampullary polyps: a comparative series.

BACKGROUND: Increasing reports suggest that endoscopic removal of benign ampullary and duodenal polyps is safe and frequently definitive; however, most reported polyps have been small in size (<3 cm). We have developed experience with endoscopic removal of increasingly large and complex polyps. PATIENTS: Fifty-one cases of endoscopic removal were attempted and grouped according to size: group A (n = 22) polyps 1 to 3 cm and group B (n = 29) polyps 3 cm or larger, including 7 cases larger than 5 cm. When the ampulla was involved, biductal sphincterotomy and prophylactic pancreatic duct stent placement was performed first, followed by saline solution-assisted piecemeal polypectomy, argon plasma coagulation, selective endoclip placement, and recovery of all polyp fragments. INTERVENTIONS: Endoscopic removal of duodenal and ampullary adenomas. RESULTS: The outcomes of small and large adenoma removal include mean number of endoscopic retrograde cholangiopancreatographies required for complete removal (2.09 vs 2.56, P = .392), number of complications (4.5% vs 13.9%, P = .375), discovery of unsuspected cancer (0% vs 10.3%, P = .242), and final definitive resolution (100% vs 86.2%, P = .124). Complete removal was achieved in 92.2% of all patients. LIMITATIONS: This was a single center retrospective study. CONCLUSIONS: Large (>/=3 cm) ampullary and duodenal polyps comprised 56.9% of our endoscopically treated cases and present special challenges to definitive endoscopic removal. Successful removal of even very large sessile lesions is possible with minimal increase in risk.

Endoscopic management of adenoma of the major duodenal papilla.

BACKGROUND: It is well established that adenoma of the major duodenal papilla has a potential for malignant transformation. Standard treatment has been surgical (duodenotomy/local resection, pancreaticoduodenectomy). Endoscopic management is described, but there is no established consensus regarding the approach to papillectomy or the need for surveillance. This study describes endoscopic management and long-term follow-up of papillary tumors by 4 groups of expert pancreaticobiliary endoscopists. METHODS: Consecutive patients with papillary tumors referred to 4 pancreaticobiliary endoscopy centers for evaluation for endoscopic papillectomy were reviewed. For each patient, an extensive questionnaire was completed, which included 19 preoperative and 15 postoperative data points. A total of 103 patients (53 women, 50 men, age range 24-93) who underwent attempted endoscopic resection were included. Of these, 72 had sporadic adenoma, and the remaining patients had familial adenomatous polyposis, including Gardner's variant. Presenting symptoms were jaundice/cholangitis/pain (n=59), pancreatitis (n=18), and bleeding (n=12). Twenty-six patients were asymptomatic. RESULTS: Endoscopic treatment was successful, long term, in 83 patients (80%) and failed (initial failure or recurrent tumor) in 20 (20%) patients. Success was significantly associated with older age (54.7 [16.6] vs. 46.6 [21.7] years; p=0.08) and smaller lesions (21.1 [8.3] vs. 29.7 [7.2] mm; p<0.0001). Success rate was higher for sporadic lesions compared with genetically determined lesions (63 of 72 [86%] vs. 20 of 31 [67%]; p=0.02). There were 10 initial failures, which was more common for sporadic lesions (7 of 10). The overall success rate for papillectomy was similar in patients who had adjuvant thermal ablation (81%) compared with those who did not (78%). However, recurrence (n=10) was more common in the former group (9 of 10, [90%]; p=0.22). Complications (n=10) included acute pancreatitis (n=5), bleeding (n=2), and late papillary stenosis (n=3). Acute pancreatitis was more common in patients who did not have pancreatic duct stents placed (17% vs. 3.3%). Papillary stenosis was more frequent without short-term pancreatic duct stent placement (15.4% vs. 1.1%), although the difference was not statistically significant, because this complication was infrequent. CONCLUSIONS: Endoscopic treatment of papillary adenoma in selected patients appears to be highly successful. The majority can undergo complete resection after ERCP. In expert hands, complications are infrequent and may be avoided by routine placement of a pancreatic duct stent.

Analysis of cystic fibrosis gener product (CFTR) function in patients with pancreas divisum and recurrent acute pancreatitis.

BACKGROUND: The mechanism by which pancreas divisum may lead to recurrent episodes of acute pancreatitis in a subset of individuals is unknown. Abnormalities of the cystic fibrosis gene product (CFTR) have been implicated in the genesis of idiopathic chronic pancreatitis. The aim of this study was to determine if CFTR function is abnormal in patients with pancreas divisum and recurrent acute pancreatitis (PD/RAP). METHODS: A total of 69 healthy control subjects, 12 patients with PD/RAP, 16 obligate heterozygotes with a single CFTR mutation, and 95 patients with cystic fibrosis were enrolled. CFTR function was analyzed by nasal transepithelial potential difference testing in vivo. The outcomes of the PD/RAP patients following endoscopic and surgical treatments were concomitantly analyzed. FINDINGS: Direct measurement of CFTR function in nasal epithelium in response to isoproterenol demonstrated that the values for PD/RAP were intermediate between those observed for healthy controls and cystic fibrosis patients. The median value was 13 mV for PD/RAP subjects, which was statistically different from healthy controls (22 mV, p= 0.001) and cystic fibrosis pancreatic sufficient (-1 mV, p < 0.0001) and pancreatic insufficient (-3 mV, p < 0.0001) patients. INTERPRETATIONS: These results suggest a link between CFTR dysfunction and recurrent acute pancreatitis in patients with pancreas divisum and may explain why a subset of patients with pancreas divisum develops recurrent acute pancreatitis.

Multicenter randomized trial of the spiral Z-stent compared with the Wallstent for malignant biliary obstruction.

BACKGROUND: The industry standard since 1990 for self-expanding biliary metallic stents has been the Wallstent. In 1998 the Spiral Z-stent was released. This randomized trial compared the Z-stent with the Wallstent in the treatment of malignant biliary obstruction. METHODS: Patients with unresectable malignant biliary obstruction distal to the bile duct bifurcation were randomized to receive a 10-mm diameter Wallstent or a 10-mm diameter Z-stent. RESULTS: A total of 145 patients were randomized; 13 were excluded. Sixty-four patients who received a Z-stent and 68 who had a Wallstent are included in the analysis. Tumors responsible for bile duct obstruction were pancreatic cancer (108), cholangiocarcinoma (15), metastatic cancer (6), and papillary cancer (3). Metallic stents were successfully placed in all patients. Seven technical problems were encountered during placement of the Z-stent and 5 with the Wallstent. There were 21 occlusions requiring reintervention (8 Z-stent, 13 Wallstent; p = 0.30). Median time to reintervention was the following: Z-stent, 162 days; Wallstent, 150 days (p = 0.22). A total of 104 patients died of progressive disease or other cause; 7 patients remain alive with patent stents. The overall calculated median patency rates were: Z-stent, 152 days; Wallstent, 154 days (p = 0.90). CONCLUSIONS: The Spiral Z-stent is comparable with the Wallstent in terms of placement, occlusion rates, and overall patency. Occasional early occlusion of both stents suggests tumor characteristics instead of the size of the mesh openings in the stents as important factors.