Competence in Endoscopic Ultrasound and Endoscopic Retrograde Cholangiopancreatography, From Training Through Independent Practice.

BACKGROUND & AIMS: It is unclear whether participation in competency-based fellowship programs for endoscopic ultrasound (EUS) and endoscopic retrograde cholangiopancreatography (ERCP) results in high-quality care in independent practice. We measured quality indicator (QI) adherence during the first year of independent practice among physicians who completed endoscopic training with a systematic assessment of competence. METHODS: We performed a prospective multicenter cohort study of invited participants from 62 training programs. In phase 1, 24 advanced endoscopy trainees (AETs), from 20 programs, were assessed using a validated competence assessment tool. We used a comprehensive data collection and reporting system to create learning curves using cumulative sum analysis that were shared with AETs and trainers quarterly. In phase 2, participating AETs entered data into a database pertaining to every EUS and ERCP examination during their first year of independent practice, anchored by key QIs. RESULTS: By the end of training, most AETs had achieved overall technical competence (EUS 91.7%, ERCP 73.9%) and cognitive competence (EUS 91.7%, ERCP 94.1%). In phase 2 of the study, 22 AETs (91.6%) participated and completed a median of 136 EUS examinations per AET and 116 ERCP examinations per AET. Most AETs met the performance thresholds for QIs in EUS (including 94.4% diagnostic rate of adequate samples and 83.8% diagnostic yield of malignancy in pancreatic masses) and ERCP (94.9% overall cannulation rate). CONCLUSIONS: In this prospective multicenter study, we found that although competence cannot be confirmed for all AETs at the end of training, most meet QI thresholds for EUS and ERCP at the end of their first year of independent practice. This finding affirms the effectiveness of training programs. Clinicaltrials.gov ID NCT02509416.

Setting minimum standards for training in EUS and ERCP: results from a prospective multicenter study evaluating learning curves and competence among advanced endoscopy trainees.

BACKGROUND AND AIMS: Minimum EUS and ERCP volumes that should be offered per trainee in "high quality" advanced endoscopy training programs (AETPs) are not established. We aimed to define the number of procedures required by an "average" advanced endoscopy trainee (AET) to achieve competence in technical and cognitive EUS and ERCP tasks to help structure AETPs. METHODS: American Society for Gastrointestinal Endoscopy (ASGE)-recognized AETPs were invited to participate; AETs were graded on every fifth EUS and ERCP examination using a validated tool. Grading for each skill was done using a 4-point scoring system, and learning curves using cumulative sum analysis for overall, technical, and cognitive components of EUS and ERCP were shared with AETs and trainers quarterly. Generalized linear mixed-effects models with a random intercept for each AET were used to generate aggregate learning curves, allowing us to use data from all AETs to estimate the average learning experience for trainees. RESULTS: Among 62 invited AETPs, 37 AETs from 32 AETPs participated. Most AETs reported hands-on EUS (52%, median 20 cases) and ERCP (68%, median 50 cases) experience before starting an AETP. The median number of EUS and ERCPs performed per AET was 400 (range, 200-750) and 361 (range, 250-650), respectively. Overall, 2616 examinations were graded (EUS, 1277; ERCP-biliary, 1143; pancreatic, 196). Most graded EUS examinations were performed for pancreatobiliary indications (69.9%) and ERCP examinations for ASGE biliary grade of difficulty 1 (72.1%). The average AET achieved competence in core EUS and ERCP skills at approximately 225 and 250 cases, respectively. However, overall technical competence was achieved for grade 2 ERCP at about 300 cases. CONCLUSION: The thresholds provided for an average AET to achieve competence in EUS and ERCP may be used by the ASGE and AETPs in establishing the minimal standards for case volume exposure for AETs during their training. (Clinical trial registration number: NCT02509416.).

Endoscopic versus surgical ampullectomy: an algorithm to treat disease of the ampulla of Vater.

OBJECTIVE: The objective of this study was to compare the effectiveness, morbidity, and mortality associated with endoscopic ampullectomy (EA) and surgical ampullectomy (SA). BACKGROUND: The proposed management of benign ampullary lesions includes local resection (EA or SA) and en bloc resection (pancreaticoduodenectomy). Most agree that en bloc resection entails a significant morbidity and mortality. No study has previously compared EA and SA for the treatment of benign ampullary lesions. METHODS: Medical records of patients selected for ampullectomy at Duke University Medical Center from 1991 to 2010 were reviewed. RESULTS: After review, 109 patients were confirmed to have undergone ampullectomy for a suspected benign ampullary lesion. Sixty-eight patients underwent EA, whereas 41 patients underwent SA. Patients in each group were identical in terms of age, sex, race, and comorbid conditions, except that EA had a higher rate of severe obesity (body mass index >35). Endoscopic ampullectomy was found to have a significantly reduced length of stay, lower morbidity, and readmission rates, but it had similar rates of mortality, margin-positive excisions, and reinterventions. CONCLUSIONS: In patients selected for ampullectomy for benign ampullary lesions, EA was found to have equivalent efficacy when compared with SA. Moreover, EA had lower morbidity and identical mortality. These findings suggest that patients would likely benefit from an aggressive endoscopic approach before consideration for surgery.

Pilot study of aprepitant for prevention of post-ERCP pancreatitis in high risk patients: a phase II randomized, double-blind placebo controlled trial.

CONTEXT: Animal studies have demonstrated a role for substance P binding to neurokinin-1 receptor in the pathogenesis of acute pancreatitis. OBJECTIVE: Our aim was to assess the efficacy of a neurokinin-1 receptor antagonist (aprepitant) at preventing post-ERCP pancreatitis in high risk patients. DESIGN: Randomized, double-blind, placebo controlled trial at a single academic medical center. INTERVENTION: Patients at high risk for post-ERCP pancreatitis received either placebo or oral aprepitant administered 4 hours prior to ERCP, 80 mg 24 hours after the first dose, and then 80 mg 24 hours after the second dose. PATIENTS: Thirty-four patients received aprepitant and 39 patients received placebo. STATISTICS: Fisher's exact test was used to compare incidence of post-ERCP pancreatitis in the two groups. RESULTS: Baseline characteristics were similar between the two groups. Incidence of acute pancreatitis was 7 in the aprepitant group and 7 in the placebo group. Hospitalization within 7 days post-procedure for abdominal pain that did not meet criteria for acute pancreatitis occurred in 6 and 9 patients in the aprepitant and placebo groups respectively (P=0.772). CONCLUSIONS: Aprepitant did not lower incidence of post-ERCP pancreatitis in this preliminary human study. Larger studies potentially using the recently available intravenous formulation are necessary to conclusively clarify the efficacy of aprepitant in this setting.  

For patients with predicted low risk for choledocholithiasis undergoing laparoscopic cholecystectomy, selective intraoperative cholangiography and postoperative endoscopic retrograde cholangiopancreatography is an effective strategy to limit unnecessary procedures.

BACKGROUND: There is debate about whether intraoperative cholangiography (IOC) should be performed routinely or selectively during laparoscopic cholecystectomy (LC) in patients with suspected choledocholithiasis. The timing of endoscopic retrograde cholangiopancreatography (ERCP) in these patients also is an issue. We reviewed the experience in our center, where a management algorithm limiting ERCP in relation to LC was adopted. METHODS: We retrospectively reviewed every LC performed by one surgeon during 6 years and the related ERCPs. RESULTS: A total of 264 LCs were performed. In 30 patients, stones were cleared or excluded by preoperative ERCP. In the remaining 234 LCs, 31 of 34 IOCs were successfully performed. Two of 31 IOCs were positive for bile duct stones; stone removal was successful in each patient at subsequent ERCP. Only 10 of 201 patients who did not have IOC required postsurgical ERCP within 10 weeks of LC, 3 of whom had common bile duct stones at ERCP. CONCLUSIONS: For patients who underwent LC, we performed selective IOC with postoperative ERCP for positive studies. Review of our experience using this algorithm showed it to be a powerful tool in limiting unnecessary ERCPs. Our data suggest that routine preoperative ERCP cannot be justified. Selective IOC during LC misses relatively few cases of biliary stones; these can be managed quickly by experienced endoscopists.

Focal or diffuse "fullness" of the pancreas on CT. Usually benign, but EUS plus/minus FNA is warranted to identify malignancy.

CONTEXT: The role of EUS to evaluate subtle radiographic abnormalities of the pancreas is not well defined. OBJECTIVE: To assess the yield of EUS+/-FNA for focal or diffuse pancreatic enlargement/fullness seen on abdominal CT scan in the absence of discrete mass lesions. DESIGN: Retrospective database review. SETTING: Tertiary referral center. PATIENTS AND INTERVENTIONS: Six hundred and 91 pancreatic EUS exams were reviewed. Sixty-nine met inclusion criteria of having been performed for focal enlargement or fullness of the pancreas. Known chronic pancreatitis, pancreatic calcifications, acute pancreatitis, discrete mass on imaging, pancreatic duct dilation (greater than 4 mm) and obstructive jaundice were excluded. MAIN OUTCOME MEASUREMENT: Rate of malignancy found by EUS+/-FNA. RESULTS: FNA was performed in 19/69 (27.5%) with 4 new diagnoses of pancreatic adenocarcinoma, one metastatic renal cell carcinoma, one metastatic colon cancer, one chronic pancreatitis and 12 benign results. Eight patients had discrete mass lesions on EUS; two were cystic. All malignant diagnoses had a discrete solid mass on EUS. CONCLUSIONS: Pancreatic enlargement/fullness is often a benign finding related to anatomic variation, but was related to malignancy in 8.7% of our patients (6/69). EUS should be strongly considered as the next step in the evaluation of patients with focal enlargement of the pancreas when clinical suspicion of malignancy exists.

Top Ten Tips Palliative Care Clinicians Should Know About Interventional Symptom Management Options When Caring for Patients with Gastrointestinal Malignancies.

Patients diagnosed with advanced stages of gastrointestinal (GI) malignancies are often quite symptomatic, with symptoms primarily related to anatomic sites of obstruction. Endoscopic approaches to the palliation of GI malignancies have begun to overtake surgical approaches as first line in interventional management. We brought together a team of interventional gastroenterologists and palliative care experts to collate practical pearls for the types of endoscopic interventions used for symptom management in patients with GI malignancies. In this article, we use a "Top 10" format to highlight issues that may help palliative care physicians recognize common presentations of advanced GI malignancies, address interventional approaches to improve symptom burden, and improve the quality of shared decision making and goals-of-care discussions.

Endoscopic ultrasound-guided fine-needle aspiration for non-small cell lung cancer staging: A systematic review and metaanalysis.

BACKGROUND: Endoscopic ultrasound (EUS)-guided fine-needle aspiration (FNA) is a minimally invasive alternative technique for mediastinal staging of non-small cell lung cancer. A metaanalysis was performed to estimate the diagnostic accuracy of EUS-FNA for staging mediastinal lymph nodes (N2/N3 disease) in patients with lung cancer. METHODS: Relevant studies were identified using Medline (1966 to November 2005), CINAHL, and citation indexing. Included studies used histology or adequate clinical follow-up (> 6 months) as the "gold standard," and provided sufficient data for calculating sensitivity and specificity. Summary receiver operating characteristic curves metaanalysis was performed to estimate the pooled sensitivity and specificity. RESULTS: In 18 eligible studies, EUS-FNA identified 83% of patients (95% confidence interval [CI], 78 to 87%) with positive mediastinal lymph nodes (pooled sensitivity) and 97% of patients (95% CI, 96 to 98%) with negative mediastinal lymph nodes (pooled specificity). In eight studies that were limited to patients who had abnormal mediastinal lymph nodes seen on CT scans, the sensitivity was 90% (95% CI, 84 to 94%) and the specificity was 97% (95% CI, 95 to 98%). In patients without abnormal mediastinal lymph nodes seen on CT scans (four studies), the pooled sensitivity was 58% (95% CI, 39 to 75%). Minor complications were reported in 10 cases (0.8%). There were no major complications. CONCLUSIONS: EUS-FNA is a safe modality for the invasive staging of lung cancer that is highly sensitive when used to confirm metastasis to mediastinal lymph nodes seen on CT scans. In addition, among lung cancer patients with normal mediastinal adenopathy seen on CT scans, despite lower sensitivity, it has the potential to prevent unnecessary surgery in a large proportion of cases missed by CT scanning.

Does ampullary adenoma size predict invasion on EUS? Does invasion on EUS predict presence of malignancy?

Background and study aims: It is common practice to perform ampullectomy without endoscopic ultrasound (EUS) for ampullary lesions < 1 cm but no data exists to support it. No studies have explored whether EUS findings of invasion correlate with malignancy or high-grade dysplasia (HGD) on pathology. We explored the association between adenoma size, pathology results, and invasion on EUS.  Patients and methods: This was a single-center retrospective cohort study at a large tertiary care academic hospital. Chart review was performed for 161 patients with benign ampullary lesions on endoscopic biopsy (identified by pathology records). The primary outcomes were mean size (mm) of adenomas and pathology findings with and without intraductal and/or duodenal wall invasion on EUS.  Results: Invasion was identified by EUS in 41 (34.1 %) of 120 patients who underwent EUS. The mean size of the lesion in these patients was 20.9 mm (±â€Š11.6 mm) compared to 13.9 mm (±â€Š11.3 mm, P = 0.0001) in patients without invasion. A receiver operating characteristic (ROC) curve (AUC 0.73, 95 % CI 0.63 - 0.83) revealed 100 % sensitivity for absence of invasion on EUS in lesions less than 6.5 mm. Invasion on EUS had sensitivity of 63.0 % (95 % CI 47.0 % - 77.0 %) and specificity 88.0 % (95 % CI 78.0 % - 95.0 %) for presence of malignancy, HGD or invasion on pathology. Conclusions: EUS should be considered for ampullary lesions > 6.5 mm. This study provides evidence to support the practice of ampullectomy without EUS for smaller adenomas. EUS evidence of invasion is highly specific for pathologic malignancy, HGD, or invasion (which preclude endoscopic ampullectomy).

The impact of cystic fibrosis and PSTI/SPINK1 gene mutations on susceptibility to chronic pancreatitis.

This article reviews current concepts regarding the pathobiology of cystic fibrosis pancreatic disease. It summarizes recent studies on the relationship between CFTR mutations and pancreatitis, and it reviews several unresolved issues in the field.

Proximal migration of a 3 French pancreatic stent in a patient with pancreas divisum: suggested technique for successful retrieval.

CONTEXT: Pancreatic stents may be placed during therapeutic ERCP for a variety of indications. One such indication is to prophylax against the development of pancreatitis following sphincterotomy of the minor papilla in patients with recurrent acute pancreatitis and pancreas divisum. Increasingly, endoscopists that perform pancreatic ERCP are placing small caliber (3 Fr), unflanged, single pigtail stents into the long axis of the pancreatic duct with the expectation that these stents will only stay in place for a few days and the majority will pass spontaneously on their own without the need for follow-up endoscopic retrieval. As such, these stents are generally regarded as safer and associated with a lower rare of complication than larger (5 and 7 Fr), double flanged pancreatic stents. CASE REPORT: We present the case of a 3 Fr stent that migrated proximally into the dorsal duct in a patient with recurrent pancreatitis and pancreas divisum. Due to the small size of the patient's dorsal duct, it was difficult to pass appliances alongside the stent to facilitate retrieval and a variety of appliances were used before success was achieved. DISCUSSION: The medical literature contains series of proximally migrated larger caliber flanged, pancreatic stents but proximal migration of small caliber, unflanged, pigtail stents has not yet been reported. As the use of these small stents increases, we feel that it is important to highlight the potential for this complication and discuss how we successfully treated our patient.

Rotational assisted endoscopic retrograde cholangiopancreatography in patients with reconstructive gastrointestinal surgical anatomy.

AIM: To evaluate the success rates of performing therapy utilizing a rotational assisted enteroscopy device in endoscopic retrograde cholangiopancreatography (ERCP) in surgically altered anatomy patients. METHODS: Between June 1, 2009 and November 8, 2012, we performed 42 ERCPs with the use of rotational enteroscopy for patients with altered anatomy (39 with gastric bypass Roux-en-Y, 2 with Billroth II gastrectomy, and 1 with hepaticojejunostomy associated with liver transplant). The indications for ERCP were: choledocholithiasis: 13 of 42 (30.9%), biliary obstruction suggested on imaging: 20 of 42 (47.6%), suspected sphincter of Oddi dysfunction: 4 of 42 (9.5%), abnormal liver enzymes: 1 of 42 (2.4%), ascending cholangitis: 2 of 42 (4.8%), and bile leak: 2 of 42 (4.8%). All procedures were completed with the Olympus SIF-Q180 enteroscope and the Endo-Ease Discovery SB overtube produced by Spirus Medical. RESULTS: Successful visualization of the major ampulla was accomplished in 32 of 42 procedures (76.2%). Cannulation of the bile duct was successful in 26 of 32 procedures reaching the major ampulla (81.3%). Successful therapeutic intervention was completed in 24 of 26 procedures in which the bile duct was cannulated (92.3%). The overall intention to treat success rate was 64.3%. In terms of cannulation success, the intention to treat success rate was 61.5%. Ten out of forty two patients (23.8%) required admission to the hospital after procedure for abdominal pain and nausea, and 3 of those 10 patients (7.1%) had a diagnosis of post-ERCP pancreatitis. The average hospital stay was 3 d. CONCLUSION: It is reasonable to consider an attempt at rotational assisted ERCP prior to a surgical intervention to alleviate biliary complications in patients with altered surgical anatomy.

Percutaneous cholecystostomy in patients with acute cholecystitis: experience of 45 patients at a US referral center.

BACKGROUND: Standard treatment for acute cholecystitis is cholecystectomy, but some patients are at high risk for immediate surgery. Percutaneous cholecystostomy might be the procedure of choice in this group. We reviewed the experience of percutaneous cholecystostomy in a large tertiary center population. STUDY DESIGN: We performed a retrospective analysis of patients who underwent percutaneous cholecystostomy, and recorded indications for cholecystostomy, duration of tube placement, clinical outcome, death within 30 days of procedure, complications, bacteriology of aspirated bile, gallbladder contents, and performance of interval cholecystectomy. RESULTS: Forty-five patients (mean age 63 years) had cholecystostomy tubes placed from July 1999 to March 2002. All had confirmed or presumed acute cholecystitis. Mean duration of tube insertion was 54.3 days. Thirty-six patients improved clinically within 5 days. Nine patients died within 30 days; only one death was directly related to gallbladder sepsis. Nine patients subsequently had laparoscopic cholecystectomy, eight had open cholecystectomy, and two had cholecystoenterostomy. Cholecystectomy was planned in another five patients. Cholecystostomy tubes leaked in two patients, blocked in four, and dislodged in one. One patient developed a hemoperitoneum. Bile aspirated at cholecystostomy was culture positive in 12 patients, negative in 16, and not sent or recorded in 17. Twenty-two patients had gallstones, 10 had sludge, 9 had both, and 4 had neither. CONCLUSIONS: In experienced hands, percutaneous cholecystostomy is easy to perform, with low complication and high success rates. It is the procedure of choice in patients with acute cholecystitis unfit for emergency surgery. Patients often improve clinically, so that cholecystectomy can be done electively.

Idiopathic pancreatitis related to CFTR: complex inheritance and identification of a modifier gene.

Idiopathic chronic pancreatitis (ICP) is the leading cause of nonalcoholic chronic pancreatitis. This study examined a series of patients with ICP to determine the prevalence and role of mutations of the cystic fibrosis gene (CFTR) and of a trypsin inhibitor gene (PSTI). Genetic testing was done in 39 patients with ICP. In this series, 17 patients had CFTR mutations and 9 had PSTI mutations. Pancreatitis risk was increased 14-fold by having the N34S PST1 mutation, 40-fold by having two abnormal copies of CFTR, and 600-fold by having both. In patients with two CFTR mutations, extrapancreatic clinical findings and nasal bioelectric responses suggested reduced residual CFTR protein function. Thus, pancreatitis risk showed complex inheritance and was highest in individuals who have abnormalities in both the pancreatic ducts (CFTR) and acini (PSTI). These findings indicate that PSTI is a modifier gene for CFTR-related ICP and have implications for the classification, diagnosis, and pathogenesis of pancreatitis.

Extensive investigation of patients with mild elevations of serum amylase and/or lipase is 'low yield'.

BACKGROUND: Serum amylase and lipase levels are widely used as markers of pancreatic inflammation. However, it would seem that mild elevations of amylase and lipase rarely predict significant pancreatic pathology. Pancreatic imaging tests are expensive. The gold standard, endoscopic retrograde cholangiopancreatography, carries risk of morbidity and mortality. OBJECTIVE: To determine whether extensive investigation of patients with mild, nonspecific abdominal symptoms and mild elevations of amylase and/or lipase results in a significant diagnostic yield. METHODS: Outpatient evaluations were retrospectively analyzed over 12 months. Inclusion criteria were nonspecific abdominal pain, and mild elevations (less than three times the upper limit of normal) of serum amylase or lipase, or both. Exclusion criteria included a history of chronic pancreatitis, elevation of liver tests and acute pain syndromes. RESULTS: Nineteen patients over the study period met the criteria. Of the nineteen patients, 58% had elevation of lipase alone, 21% amylase alone and 21% had elevations of both. In addition, 89.5% of the patients had nonspecific abdominal pain. After imaging with one or more of ultrasound, computed tomography, magnetic resonance cholangiopancreatography, endoscopic ultrasound and endoscopic retrograde cholangiopancreatography, small bowel follow through or hepatobiliary scanning, 78.9% patients were thought to have a normal pancreas. Of the remaining patients, 15.8% had mild or equivocal changes of chronic pancreatitis, and one patient was found to have a pancreatic tail pseudocyst. The average cost of investigation was US$2,255, taking only direct procedural costs into account. No patient was found to have malignancy. CONCLUSIONS: The majority of patients with nonspecific abdominal pain and isolated elevations of amylase and/or lipase (less than three times the upper limit of normal) had no identifiable pancreatic pathology. The diagnostic yield in patients with mild elevations of lipase alone was particularly poor. The cost effectiveness and risk-benefit ratio of extensive investigation of this group of patients warrants further study.

Outcome of endoscopic minor papillotomy in patients with symptomatic pancreas divisum.

CONTEXT: Pancreas divisum has been associated with recurrent acute pancreatitis, chronic abdominal pain without elevated pancreatic enzymes, and chronic pancreatitis. Prior studies suggest that endoscopic minor papillotomy benefits certain symptomatic pancreas divisum patients. However, the data are quite limited and there is a lack of long-term follow-up. OBJECTIVE: To describe a retrospective study of endoscopic minor papillotomy for pancreas divisum. PATIENTS: Eighty-nine adult patients who underwent endoscopic minor papillotomy at our referral center were included in the study. Median follow-up was 29 months. INTERVENTION: We conducted a telephone survey. Fifty-three patients were available for the telephone survey. RESULTS: Thirty-two patients (60.4%) reported immediate improvement: however, symptoms recurred in 17 (53.1% of the immediate responders). Repeat endoscopic interventions were performed in 8 patients, with long-term improvement in two. Overall long-term improvement was achieved in 17 patients (32.1%). Results of minor papillotomy were more favorable for patients with recurrent, well-defined bouts of pancreatitis (immediate improvement: P=0.036; long-term improvement: P=0.064) compared to those with pancreatitis who reported continuous pain and those without clinical evidence of pancreatitis (immediate improvement: 73.3%, 42.9% and 44.4%, respectively; long-term improvement: 43.3%, 21.4%, and 11.1%, respectively). CONCLUSIONS: The long-term benefit from endoscopic minor papillotomy using strict criteria is poorer than suggested from previous studies. However, pancreas divisum patients with well-defined bouts of pancreatitis are more likely to benefit from endoscopic minor papillotomy than those without symptom-free intervals between "attacks" and those with pain that is not associated with elevated pancreatic enzymes.

A wolf in sheep's clothing: a non-functioning islet cell tumor of the pancreas masquerading as a microcystic (serous cystic) adenoma.

CONTEXT: The endosonographic appearance of a microcystic "honeycomb" lesion of the pancreas usually indicates a serous cystic adenoma. CASE REPORT: We report a case of a non-functioning islet cell tumor that has the typical microcystic "honeycomb" appearance of a serous cystic adenoma. The implications for endoscopic ultrasound diagnosis and management of cystic pancreatic lesions are discussed. CONCLUSION: Islet cell tumors are a rare differential diagnosis of microcystic pancreatic lesions. If fine needle aspiration remains non-diagnostic preoperative distinction from serous cystic adenomas may be impossible.

A multicenter, prospective study of a new fully covered expandable metal biliary stent for the palliative treatment of malignant bile duct obstruction.

Background and Study Aims. Endoscopic placement of self-expanding metal stents (SEMSs) is indicated for palliation of inoperable malignant biliary obstruction. A fully covered biliary SEMS (WallFlex Biliary RX Boston Scientific, Natick, USA) was assessed for palliation of extrahepatic malignant biliary obstruction. Patients and Methods. 58 patients were included in this prospective, multicenter series conducted under an FDA-approved IDE. Main outcome measurements included (1) absence of stent occlusion within six months or until death, whichever occurred first and (2) technical success, need for reintervention, bilirubin levels, stent patency, time to stent occlusion, and adverse events. Results. Technical success was achieved in 98% (57/58), with demonstrated acute removability in two patients. Adequate clinical palliation until completion of followup was achievedin 98% (54/55) of evaluable patients, with 1 reintervention due to stent obstruction after 142 days. Mean total bilirubin decreased from 8.9 mg/dL to 1.2 mg/dL at 1 month. Device-related adverse events were limited and included 2 cases of cholecystitis. One stent migrated following radiation therapy. Conclusions. The WallFlex Biliary fully covered stent yielded technically successful placement with uncomplicated acute removal where required, appropriate reduction in bilirubin levels, and low rates of stent migration and occlusion. This SEMS allows successful palliation of malignant extrahepatic biliary obstruction.

Repeat Procedures Within 30 days in Patients Stented for Malignant Distal Biliary Strictures: Experience of 508 Patients at a Tertiary Referral Center.

BACKGROUND: Stent related occlusion and migration remains a problem despite attempts to improve stent design over this time period. Flanged polyethylene plastic stents (FPS) remains the stent of choice in most centers. Early failure of stents placed for malignant extrahepatic biliary strictures (MEBS) has not previously been studied in detail. We set out to determine the incidence and reasons for biliary stent change within 30 days of the index procedure in a large tertiary center population during a period where (FPS) was the sole plastic stent used. METHODS: Retrospective analysis of endoscopic retrograde cholangiography (ERCP) was undertaken in patients who were stented for presumed or known MEBS between 1993 and 2001. Patients who required repeat stenting within 30 days were identified. RESULTS: All 508 patients were stented for MEBS. 5.7% of patients had a total of 34 repeat stenting procedures within 30 days of the index procedure; 27of 29 index stents were plastic, 2 were self-expandable metal stents (SEMS), 20 (3.9%) patients had stent failure as the reason for a stent exchange (plastic stent occlusion n = 15, mean time to stent change 14 ± 8.3 days; metal stent occlusion n = 2, mean time to stent change 24.5 ± 7.8 days; plastic stent migration n = 3, mean time to stent change 25 ± 5.3 days). There was a statistically significant difference in the time to stent change between the occluded plastic stent and migrated plastic stent cases (P = 0.045, 95% CI -21.7 to -0.29). 6 patients spent at least 2 additional days in hospital as a result of stent failure. CONCLUSIONS: Early stent failure is an uncommon problem, especially in patients with SEMS. Early plastic stent failure appears to occur sooner with stent occlusion than with stent migration. Early stent failure is associated with significant morbidity and bears an economic impact in additional procedures and hospital stay.