Endoscopic retrograde cholangiopancreatography with per oral pancreatoscopy for calcific chronic pancreatitis using endoscope and catheter-based pancreatoscopes: a 10-year single-center experience.

OBJECTIVES: Per oral pancreatoscopy (POP) with electrohydraulic lithotripsy (EHL) or laser lithotripsy (LL) permits stone fragmentation and removal during endoscopic retrograde cholangiopancreatography. Our study evaluates the safety and efficacy of POP in patients with main pancreatic duct (PD) stones. METHODS: This was a cohort study of patients undergoing POP with EHL/LL for PD stones between January 2000 and March 2011. Technical success was defined as complete or partial stone clearance, and clinical success as greater than 50% reduction in opiate use, pain, or hospitalizations. RESULTS: Forty-six patients underwent POP for PD stones using a 10F cholangioscope (POP-Endo) (n = 31) or catheter-based system (POP-Cath, n = 15). Electrohydraulic lithotripsy/LL was performed in 39 (85%) of 46 patients. Stone extraction without EHL or LL was performed in 7 (15%) of 46 patients. Technical success for POP-Endo versus POP-Cath was 27 (87%) of 31 versus 15 (100%) of 15 patients (P = 0.29). Complete clearance was achieved in 21 (68%) of 31 versus 11 (73%) of 15 patients, respectively (P = 0.519). Per oral pancreatoscopy-related complications were found in 10%. Follow-up in 43 (93%) of 46 patients was a median of 18 months (range, 1-60 months). Overall clinical success was 74%. CONCLUSIONS: Per oral pancreatoscopy-guided endotherapy leads to partial or complete stone clearance in most patients with PD stones. The technical success rates between POP-Endo versus POP-Cath systems appear similar and are associated with clinical improvement in most patients.

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.

Endoscopic suturing for transoral outlet reduction increases weight loss after Roux-en-Y gastric bypass surgery.

BACKGROUND & AIMS: Weight regain or insufficient loss after Roux-en-Y gastric bypass (RYGB) is common. This is partially attributable to dilatation of the gastrojejunostomy (GJ), which diminishes the restrictive capacity of RYGB. Endoluminal interventions for GJ reduction are being explored as alternatives to revision surgery. We performed a randomized, blinded, sham-controlled trial to evaluate weight loss after sutured transoral outlet reduction (TORe). METHODS: Patients with weight regain or inadequate loss after RYGB and GJ diameter greater than 2 cm were assigned randomly to groups that underwent TORe (n = 50) or a sham procedure (controls, n = 27). Intraoperative performance, safety, weight loss, and clinical outcomes were assessed. RESULTS: Subjects who received TORe had a significantly greater mean percentage weight loss from baseline (3.5%; 95% confidence interval, 1.8%-5.3%) than controls (0.4%; 95% confidence interval, 2.3% weight gain to 3.0% weight loss) (P = .021), using a last observation carried forward intent-to-treat analysis. As-treated analysis also showed greater mean percentage weight loss in the TORe group than controls (3.9% and 0.2%, respectively; P = .014). Weight loss or stabilization was achieved in 96% subjects receiving TORe and 78% of controls (P = .019). The TORe group had reduced systolic and diastolic blood pressure (P < .001) and a trend toward improved metabolic indices. In addition, 85% of the TORe group reported compliance with the healthy lifestyle eating program, compared with 53.8% of controls; 83% of TORe subjects said they would undergo the procedure again, and 78% said they would recommend the procedure to a friend. The groups had similar frequencies of adverse events. CONCLUSIONS: A multicenter randomized trial provides Level I evidence that TORe reduces weight regain after RYGB. These results were achieved using a superficial suction-based device; greater levels of weight loss could be achieved with newer, full-thickness suturing devices. TORe is one approach to avoid weight regain; a longitudinal multidisciplinary approach with dietary counseling and behavioral changes are required for long-term results. ClinicalTrials.gov identifier: NCT00394212.

Single-step direct cholangioscopy by freehand intubation using standard endoscopes for diagnosis and therapy of biliary diseases.

OBJECTIVES: Commercially available 10F cholangioscope systems have limitations in examination of the biliary tree. Further, they are not readily available in all endoscopy units. Direct cholangioscopy (DC) using slim and ultraslim gastroscopes have been utilized to detect and treat bile duct (BD) diseases. It often requires initial duodenoscope introduction, followed by over-the-wire exchange to a gastroscope for BD intubation. We report a novel single-step DC technique using forward-viewing endoscopes without requiring tandem-scope exchange. METHODS: In patients with native papilla, a "J" maneuver, accomplished by retroflexing the endoscope in the second portion of the duodenum and withdrawing the retroflexed scope into the BD, was used to achieve free intubation. A variety of readily available standard endoscopes were used. For biliary-enteric anastomoses, balloon dilation, if necessary followed by enteroscope advancement, was utilized for BD visualization. RESULTS: A total of 18 patients underwent 22 DC procedures (8 male, 10 female, mean age 69 years). Direct intubation was successful in all procedures. Indications included BD stone (n=10), BD stricture or tumor (n=8). A native papilla was present in 13 patients and biliary-enteric anastomoses in 5; 8 patients had altered gastrointestinal anatomy. Sphincterotomy was required in 12/13 native papilla patients to facilitate DC. Free intubation of the BD was accomplished in 19 of 22 exams, and 3 facilitated by guidewire (over-the-wire in 2 and alongside a guidewire in 1). Overtube-assisted enteroscopy was used to reach the BD in four patients. The findings were stones (n=6), strictures or tumors (n=7), abnormal mucosa (n=5), a dilated duct confirming stone clearance without stricture (n=3), and retained stent (n=1). Interventions were biopsy (n=8), stone extraction (n=5), electrohydraulic lithotripsy (n=3), chromoendoscopy (n=2), narrow-band imaging (n=2), through the scope stricture dilation (n=2), and argon-plasma coagulation of biliary tumor (n=1). Complications were cholangitis managed with intavenous antibiotics (n=1). CONCLUSIONS: Single-step DC can be achieved without using tandem-scope exchange, and may be clinically useful for diagnostic and therapeutic purposes in managing select biliary tract diseases.

Direct visualization of indeterminate pancreaticobiliary strictures with probe-based confocal laser endomicroscopy: a multicenter experience.

BACKGROUND: Because of the low sensitivity of current ERCP-guided tissue sampling methods, management of patients with indeterminate pancreaticobiliary strictures is a challenge. Probe-based confocal laser endomicroscopy (pCLE) enables real-time microscopic visualization of strictures during an ongoing ERCP. OBJECTIVE: To document the utility, performance, and accuracy of real-time pCLE diagnosis compared with histopathology. DESIGN: Prospective observational study within the framework of a multicenter registry. SETTING: Five academic centers. PATIENTS: This study involved 102 patients with indeterminate pancreaticobiliary strictures. INTERVENTION: Clinical information, ERCP findings, tissue sampling results, and pCLE videos were collected prospectively. Investigators were asked to provide a presumptive diagnosis based on pCLE during the procedure before pathology results were available. All patients received at least 30 days of follow-up until definitive diagnosis of malignancy was established or 1-year follow-up if index tissue sampling was benign. MAIN OUTCOME MEASUREMENTS: Diagnostic accuracy, sensitivity, specificity of ERCP-guided pCLE compared with ERCP with tissue acquisition. RESULTS: There were no pCLE-related adverse events in the study. We were able to evaluate 89 patients, of whom 40 were proven to have cancer. The sensitivity, specificity, positive-predictive value, and negative-predictive value of pCLE for detecting cancerous strictures were 98%, 67%, 71%, and 97%, respectively, compared with 45%, 100%, 100%, and 69% for index pathology. This resulted in an overall accuracy of 81% for pCLE compared with 75% for index pathology. Accuracy for combination of ERCP and pCLE was significantly higher compared with ERCP with tissue acquisition (90% vs 73%; P = .001). LIMITATIONS: Investigators had access to all relevant clinical information, which may have biased the predictive characteristics of pCLE. CONCLUSION: Probe-based CLE provides reliable microscopic examination and has excellent sensitivity and negative predictive value. The significantly higher accuracy of ERCP and pCLE compared with ERCP with tissue acquisition may support supplementing ERCP with pCLE.

Single-operator cholangioscopy in patients requiring evaluation of bile duct disease or therapy of biliary stones (with videos).

BACKGROUND: The feasibility of single-operator cholangioscopy (SOC) for biliary diagnostic and therapeutic procedures was previously reported. OBJECTIVE: To confirm the utility of SOC in more widespread clinical use. DESIGN: Prospective clinical cohort study. SETTING: Fifteen endoscopy referral centers in the United States and Europe. PATIENTS: Two hundred ninety-seven patients requiring evaluation of bile duct disease or biliary stone therapy. INTERVENTIONS: SOC examination and, as indicated, SOC-directed stone therapy or forceps biopsy. MAIN OUTCOME MEASUREMENTS: Procedural success defined as ability to (1) visualize target lesions and, if indicated, collect biopsy specimens adequate for histological evaluation or (2) visualize biliary stones and initiate fragmentation and removal. RESULTS: The overall procedure success rate was 89% (95% CI, 84%-92%). Adequate tissue for histological examination was secured in 88% of 140 patients who underwent biopsy. Overall sensitivity in diagnosing malignancy was 78% for SOC visual impression and 49% for SOC-directed biopsy. Sensitivity was higher (84% and 66%, respectively) for intrinsic bile duct malignancies. Diagnostic SOC procedures altered clinical management in 64% of patients. Procedure success was achieved in 92% of 66 patients with stones and complete stone clearance during the study SOC session in 71%. The incidence of serious procedure-related adverse events was 7.5% for diagnostic SOC and 6.1% for SOC-directed stone therapy. LIMITATIONS: The study was observational in design with no control group. CONCLUSIONS: Evaluation of bile duct disease and biliary stone therapy can be safely performed with a high success rate by using the SOC system.

Esophageal cancer patients undergoing external beam radiation after placement of self-expandable metal stents: is there a risk of radiation dose enhancement?

BACKGROUND: Self-expandable metal stents (SEMSs) are used for palliation of malignant dysphagia. It is not known whether dose adjustments are required when there is a stent in the radiation field. OBJECTIVE: To measure the effects of esophageal stents of various designs and materials on radiation dose to the tissue adjacent to the stent in the radiation field to determine whether there should be any dose adjustment. DESIGN: Simulated clinical protocol. SETTING: Linear accelerator radiation treatment center. PATIENTS: Solid Water phantoms were used to mimic the tissue environment of the human esophagus as well as stents of various designs and materials and controls. INTERVENTIONS: Radiation beams composed of photons (x-rays) delivered in split dosing with energies of 6, 10, and 15 million volts. MAIN OUTCOME MEASUREMENTS: Film and image-based evidence of dose enhancement; Monte Carlo calculations. RESULTS: Dose enhancement from single beams was seen only on the anterior surface, particularly in the stainless steel Z-stent (3.5%-7.8%) and the nonmetal Polyflex stent (5.5%-8.8%); less dose enhancement was seen on the anterior surface of the Alimaxx and Ultraflex nitinol stents (2%-2.5%). A negligible dose effect was seen on the posterior wall of all the stents tested. Monte Carlo calculation results were roughly similar to actual dosimeter measurements. LIMITATIONS: Simulated clinical protocol. CONCLUSIONS: This tissue-mimicking model reveals that radiation dose enhancement is a function of stent design and material, and the dose reduction is unnecessary as long as multiple fields are used.

Prospective, randomized study of conventional versus HybridKnife endoscopic submucosal dissection methods for the esophagus: an animal study.

BACKGROUND: Endoscopic submucosal dissection (ESD) increases en bloc and histologically complete resection rate of neoplastic mucosal tumors but is technically more demanding than EMR. Limited data are available comparing the efficacy and safety of a new ESD designed to overcome these limitations and conventional ESD (C-ESD) techniques. OBJECTIVE: To compare the safety, efficacy, and operation time of the new HybridKnife ESD (HK-ESD) with C-ESD in the esophagus. DESIGN: Prospective, randomized, controlled study. SETTING: Animal research laboratory. SUBJECTS: Seventeen anesthetized Yorkshire pigs. INTERVENTIONS: Removal of a 4-cm length of half-circumference esophageal mucosa by C-ESD with Hook knife or Flexknife versus HK-ESD. MAIN OUTCOME MEASUREMENTS: Procedure time, en bloc and complete resection rate, and complications (bleeding and perforation). RESULTS: All resections were completed en bloc. Procedure time was shorter in C-ESD. However, it was similar after 12 procedures. Significantly more bleeding occurred during C-ESD (28 vs 12, P = .0007). Histological muscularis propria injuries occurred with equal frequency (16 vs 17) and were mostly seen during the first 11 procedures. There were 3 perforations (2 endoscopic, 1 histological), all with C-ESD. LIMITATIONS: Nonsurvival study, use of 2 conventional knives, no training period for a new procedure. CONCLUSIONS: The HK-ESD technique was equally effective as the C-ESD technique for successful en bloc resection and was safer with less bleeding and perforation. Although procedure time was longer in HK-ESD, the difference became nonsignificant after 12 procedures.

ERCP with cholangiopancreatoscopy may be associated with higher rates of complications than ERCP alone: a single-center experience.

BACKGROUND: Comparative data regarding complications associated with ERCP alone or when performed with cholangiopancreatoscopy (CP) are lacking. OBJECTIVE: To determine whether ERCP complications are more frequent when concomitant CP is performed. DESIGN: A retrospective query of a prospectively maintained database of ERCP, CP, and complications. MAIN OUTCOME MEASUREMENTS: Consensus criteria complications and additional adverse events (AEs), including unplanned medical evaluation, cardiopulmonary/sedation events, and others. SETTING: Academic, tertiary referral center. RESULTS: A total of 4214 ERCPs were performed (337 sphincter of Oddi manometry cases excluded) during the study period, of which 3475 ERCPs and 402 ERCPs with CP were analyzed. There were 28 of 402 AEs (7.0%) in the ERCP with CP group and 101 of 3475 (2.9%) in the ERCP-only group (odds ratio [OR], 2.50; 95% CI, 1.56-3.89). Subgroup analysis revealed a significantly higher rate of cholangitis in the CP group versus ERCP group (1.0% vs 0.2%; OR, 4.98; 95% CI, 1.06-19.67) and similar rates of pancreatitis (2.2% vs 1.3%; OR, 1.75; 95% CI, 0.74-3.65) and perforation (1.0% vs 0.3%; OR, 3.16; 95% CI, 0.73-10.75). LIMITATIONS: Retrospective review of a complications database that relies on physician self-reporting. CONCLUSIONS: AEs from CP may be more than double those of ERCP alone (when sphincter of Oddi manometry cases are excluded). CP appears to be associated with a significantly higher rate of cholangitis, possibly because of intermittent intraductal irrigation required during the procedure.

Is fatigue associated with short-term health-related quality of life in stroke?

UNLABELLED: Tang WK, Lu JY, Chen YK, Mok VC, Ungvari GS, Wong KS. Is fatigue associated with short-term health-related quality of life in stroke? OBJECTIVE: To evaluate the relation between poststroke fatigue and short-term health-related quality of life (HRQOL) in Chinese patients with first or recurrent stroke. DESIGN: Cross-sectional survey. SETTING: Acute stroke unit of a general hospital. PARTICIPANTS: A total of 458 patients with acute ischemic stroke admitted to the acute stroke unit of a university-affiliated regional hospital in Hong Kong. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: HRQOL was assessed with the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) at 3 months after the subjects' index stroke. Fatigue was evaluated by using the Fatigue Severity Scale (FSS). The correlation between the FSS and SF-36 scores was examined and adjusted for potential confounders, including age, sex, marital status, previous stroke, social support, global cognitive functions, neurologic deficits, and depressive symptoms. RESULTS: Univariate analysis revealed that fatigue was a significant correlate of all SF-36 domain scores. The magnitude of correlation was highest for the vitality domain (r=-.605, Bonferroni corrected P<.05) and lowest for the physical functioning domain (r=-.202, Bonferroni corrected P<.05). Canonic correlation analysis indicated that FSS was strongly related to the HRQOL with a loading of -.678. Increasing fatigue was associated with a lower HRQOL. The association between FSS and HRQOL remained significant in the subsequent multivariate regression analysis, having adjusted for possible confounders. CONCLUSIONS: These findings suggest that fatigue has an impact on short-term HRQOL in Chinese stroke patients. The early identification and treatment of fatigue may improve HRQOL of stroke patients.

EUS compared with endoscopy plus transabdominal US in the initial diagnostic evaluation of patients with upper abdominal pain.

BACKGROUND: Primary upper endoscopy (EGD) and transabdominal US (TUS) are often performed in patients with upper abdominal pain. OBJECTIVE: Primary: Determine whether the combination of EGD and EUS was equivalent to EGD plus TUS in the diagnostic evaluation of upper abdominal pain. Secondary: Compare EUS versus TUS in detecting abdominal lesions, and compare EGD by using an oblique-viewing echoendoscope versus the standard, forward-viewing endoscope in detecting mucosal lesions. DESIGN: Prospective, paired design. SETTING: Six academic endoscopy centers. PATIENTS: This study involved patients with upper abdominal pain referred for endoscopy. INTERVENTION: All patients had EGD, EUS, and TUS. The EGD was done using both an oblique-viewing echoendoscope and the standard, forward-viewing endoscope (randomized order) by two separate endoscopists in a blinded fashion, followed by EUS. TUS was performed within 4 weeks of EGD/EUS, also in a blinded fashion. FOLLOW-UP: telephone interviews and chart reviews. MAIN OUTCOME MEASUREMENTS: Diagnose possible etiology of upper abdominal pain and detect clinically significant lesions. RESULTS: A diagnosis of the etiology of upper abdominal pain was made in 66 of 172 patients (38%). The diagnostic rate was 42 of 66 patients (64%) for EGD plus EUS versus 41 of 66 patients (62%) for EGD plus TUS, which was statistically equivalent (McNemar test; P = .27). One hundred ninety-eight lesions were diagnosed with either EUS or TUS. EUS was superior to TUS for visualizing the pancreas (P < .0001) and for diagnosing chronic pancreatitis (P = .03). Two biliary stones were detected only by EUS. Two hundred fifty-one mucosal lesions were similarly diagnosed with EGD with either the standard, forward-viewing endoscope or the oblique-viewing echoendoscope (kappa = 0.48 [95% CI, .43-.54]). EGD with the standard, forward-viewing endoscope was preferred for biopsies. LIMITATIONS: No cost analysis. CONCLUSION: The combination of EGD with EUS is equivalent to EGD plus TUS for diagnosing a potential etiology of upper abdominal pain. EUS is superior to TUS for detecting chronic pancreatitis. EGD combined with EUS should be considered in the first-line diagnostic evaluation of patients with upper abdominal pain.

New kid on the block: development of a partially disposable system for cholangioscopy.

The SpyGlass Direct Visualization System is a significant step forward in bringing optical visualization to the pancreatobiliary system by providing dedicated irrigation and therapeutic channels and 4-way steerability. Peroral cholangioscopy using the SpyGlass System may be safely performed by a single operator and provides reliable access to target sites for visual inspection and stone therapy using electrohydraulic lithotripsy or holmium laser lithotripsy. In addition, the SpyBite Biopsy Forceps has been shown to obtain adequate histologic tissue specimens reliably.

Diagnostic value of image-enhanced video cholangiopancreatoscopy.

We summarized past and present results concerning the observation capability of cholangiopancratoscopy using chromoendoscopy, autofluorescence imaging (AFI), and narrow-band imaging (NBI). New generation peroral and percutaneous transhepatic video cholangiopancreatoscopes provide superior quality images. Pilot studies suggest that chromoendocholangioscopy using methylene blue or cholangioscopy using AFI can distinguish benign from malignant bile duct lesions. On the other hand, the NBI system enhances the imaging of certain features such as mucosal structures and microvessels in pancreatobiliary lesions. In patients with main-duct-type intraductal papillary mucinous neoplasm, peroral pancreatoscopy can be used to determine extent of tumor involvement. Although many technical hurdles still need to be overcome, image-enhanced cholangiopancratoscopy appears to be a promising modality to improve diagnostic accuracy of pancreatobiliary diseases, particularly in distinguishing benign from malignant lesions.

EUS-guided transesophageal, transgastric, and transcolonic drainage of intra-abdominal fluid collections and abscesses.

BACKGROUND: The therapeutic role of EUS is evolving. We report our experience with EUS-guided transesophageal, transgastric, and transcolonic drainage of various intra-abdominal fluid collections. OBJECTIVE: To determine the technical feasibility and clinical outcomes of EUS-guided drainage. DESIGN: Prospective case series. SETTING: Academic tertiary referral center. PATIENTS: Patients referred for endoscopic drainage of intra-abdominal fluid collections; pancreatic pseudocysts amenable to conventional transgastric or transduodenal drainage were excluded. INTERVENTIONS: Single-step EUS-guided drainage of fluid collections by using a therapeutic linear-array echoendoscope with fluoroscopic guidance. MAIN OUTCOME MEASUREMENTS: Technical success, relief of symptoms, and procedural complications. RESULTS: Nine consecutive patients deemed appropriate for EUS-guided drainage of intra-abdominal fluid collections included transesophageal drainage of pseudocysts (n = 2), transgastric drainage of biloma (n = 2) and upper intra-abdominal abscesses (n = 2), transcolonic drainage of diverticular abscess (n = 1), Crohn's abscess (n = 1), and postoperative hematoma (n = 1). Endoscopic drainage was successful in all patients. Confirmation of complete resolution of the target fluid collection and symptom relief was achieved in 8 (89%) of 9 patients. Pneumothorax and mediastinitis developed in 1 patient after transesophageal drainage, which resolved with chest tube and medical therapy. During multiple stent placement, one of the stents was fully deployed into the abscess cavity in 2 patients; both were successfully retrieved either endoscopically (Crohn's abscess) or at the time of primary colonic resection (diverticular abscess). LIMITATION: Limited number of patients. CONCLUSIONS: EUS-guided transenteric drainage of bilomas, hematomas, abscesses, and inflammatory fluid collections is technically feasible and generally results in complete drainage and symptom relief. Procedural complications may be minimized with more experience.

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.

Single-operator EUS-guided cholangiopancreatography for difficult pancreaticobiliary access (with video).

BACKGROUND: When conventional ERCP methods fail because of periampullary or ductal obstruction, EUS-guided cholangiopancreatography (EUS-CP) may aid in pancreaticobiliary access. OBJECTIVE: To report our experience when using single-operator EUS-CP. SETTING: An academic tertiary-referral center. METHODS: Consecutive patients undergoing EUS-CP were prospectively identified. These patients had undergone failed attempt(s) at therapeutic ERCP. A data sheet was used to record indications, reasons for failed ERCP, EUS-CP visualization of the duct of interest, transpapillary or transenteric intervention, clinical follow-up, and complications. MAIN OUTCOME MEASUREMENTS: Technical success was decompression of the duct of interest. Clinical success was resolution of jaundice or a > or = 50% reduction in pain or narcotics, as applicable. RESULTS: Between February 2003 and June 2007, EUS-CP was attempted in 20 patients (11 men, 9 women; mean [SD] age 58 +/- 14.9 years). Indications included jaundice (n = 8), biliary stones (n = 3), chronic pancreatitis (n = 6), acute pancreatitis (n = 2), and papillary stenosis (n = 1). Reasons for failed ERCP included periampullary mass (n = 8), intradiverticular papillae (n = 4), and pancreatic duct (PD) stricture (n = 7) or stone (n = 1). Technical success was achieved in 18 of 20 patients (90%). Biliary decompression was obtained in 11 of 12 patients (92%) (7 transpapillary and 4 transenteric-transcholedochal). Pancreatic decompression was obtained in 7 of 8 patients (88%) (3 transpapillary, 4 transgastric). On follow-up, clinical improvement was noted in 15 of 20 patients (70%). For treatment of pain associated with chronic pancreatitis, pain scores decreased by a mean of 1.75 (P = .18). Complications (in 2 of 20 [10%]) included perforation (n = 1) and respiratory failure (n = 1). LIMITATIONS: A single-center nonrandomized observational study with a small patient population. CONCLUSIONS: At our academic referral center, single-operator EUS-CP provided decompression of obstructed ducts and may be performed after a failed attempt at conventional ERCP during the same endoscopic session.

Efficacy of recombinant human interleukin-10 in prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis in subjects with increased risk.

OBJECTIVES: Pancreatitis is the most common major complication of endoscopic retrograde cholangiopancreatography (ERCP). Inflammatory cytokines are released during acute pancreatitis. Interleukin-10 (IL-10) is a potent inhibitor of cytokines and has been shown to attenuate pancreatitis in animal models and pilot human studies. This study aimed to determine whether prophylactic IL-10 administration reduces the frequency and/or severity of post-ERCP pancreatitis in high-risk patients. METHODS: A randomized, multicenter, double-blind, placebo-controlled study was conducted. Patients received IL-10 at a dose of either 8 or 20 microg/kg or placebo as a single intravenous injection 15 to 30 minutes before ERCP. Standardized criteria were used to diagnose and grade the severity of postprocedure pancreatitis. RESULTS: A total of 305 of the planned total enrollment of 948 patients were randomized. There was a 15%, 22%, and 14% incidence of post-ERCP pancreatitis in the IL-10 (8 microg/kg), IL-10 (20 microg/kg), and placebo treatment groups, respectively (P = 0.83 for IL-10 8 microg/kg vs placebo and 0.14 for IL-10 20 microg/kg vs placebo). Due to apparent lack of efficacy, the study was terminated at an interim analysis. CONCLUSIONS: : There was no apparent benefit of IL-10 treatment when compared with placebo in reducing the incidence of post-ERCP acute pancreatitis in subjects with increased risk.

Management of duodenal and pancreaticobiliary perforations associated with periampullary endoscopic procedures.

BACKGROUND: The purpose of this study was to determine the incidence and outcome of pancreaticobiliary and duodenal (PB/D) perforations from periampullary endoscopic procedures and to examine whether clinical indexes are predictive of the need for operative management. METHODS: A retrospective review compared patients who had operative intervention for PB/D perforation with those managed nonoperatively. RESULTS: Thirty-two PB/D perforations occurred in 4,919 procedures (.6%). Twelve (37%) required operation; 20 (63%) were successfully managed nonoperatively. Radiographic imaging was not helpful in predicting the need for operation. A clinical scoring system was predictive of the need for operative management. The length of stay and morbidity rates were higher in the operatively managed patients. CONCLUSIONS: Most endoscopic PB/D perforations can be successfully managed without operation and, clinical indices are most predictive in determining the need for surgery. Further prospective evaluation of this scoring system may help guide the need for and timing of operative intervention for PB/D perforations.