ASGE Bariatric Endoscopy Task Force systematic review and meta-analysis assessing the ASGE PIVI thresholds for adopting endoscopic bariatric therapies.

The increasing global burden of obesity and its associated comorbidities has created an urgent need for additional treatment options to fight this pandemic. Endoscopic bariatric therapies (EBTs) provide an effective and minimally invasive treatment approach to obesity that would increase treatment options beyond surgery, medications, and lifestyle measures. This systematic review and meta-analysis were performed by the American Society for Gastrointestinal Endoscopy (ASGE) Bariatric Endoscopy Task Force comprising experts in the subject area and the ASGE Technology Committee Chair to specifically assess whether acceptable performance thresholds outlined by an ASGE Preservation and Incorporation of Valuable endoscopic Innovations (PIVI) document for clinical adoption of available EBTs have been met. After conducting a comprehensive search of several English-language databases, we performed direct meta-analyses by using random-effects models to assess whether the Orbera intragastric balloon (IGB) (Apollo Endosurgery, Austin, Tex) and the EndoBarrier duodenal-jejunal bypass sleeve (DJBS) (GI Dynamics, Lexington, Mass) have met the PIVI thresholds. The meta-analyses results indicate that the Orbera IGB meets the PIVI thresholds for both primary and nonprimary bridge obesity therapy. Based on a meta-analysis of 17 studies including 1683 patients, the percentage of excess weight loss (%EWL) with the Orbera IGB at 12 months was 25.44% (95% confidence interval [CI], 21.47%-29.41%) (random model) with a mean difference in %EWL over controls of 26.9% (95% CI, 15.66%-38.24%; P ≤ .01) in 3 randomized, controlled trials. Furthermore, the pooled percentage of total body weight loss (% TBWL) after Orbera IGB implantation was 12.3% (95% CI, 7.9%­16.73%), 13.16% (95% CI, 12.37%­13.95%), and 11.27% (95% CI, 8.17%­14.36%) at 3, 6, and 12 months after implantation, respectively, thus exceeding the PIVI threshold of 5% TBWL for nonprimary (bridge) obesity therapy. With the data available, the DJBS liner does appear to meet the %EWL PIVI threshold at 12 months, resulting in 35% EWL (95% CI, 24%-46%) but does not meet the 15% EWL over control required by the PIVI. We await review of the pivotal trial data on the efficacy and safety of this device. Data are insufficient to evaluate PIVI thresholds for any other EBT at this time. Both evaluated EBTs had ≤5% incidence of serious adverse events as set by the PIVI document to indicate acceptable safety profiles. Our task force consequently recognizes the Orbera IGB for meeting the PIVI criteria for the management of obesity. As additional data from the other EBTs become available, we will update our recommendations accordingly.

Aspiration therapy leads to weight loss in obese subjects: a pilot study.

BACKGROUND & AIMS: Obese patients rarely achieve long-term weight loss with only lifestyle interventions. We evaluated the use of endoscopic aspiration therapy for obesity. Aspiration therapy involves endoscopic placement of a gastrostomy tube (A-Tube) and the AspireAssist siphon assembly (Aspire Bariatrics, King of Prussia, PA) to aspirate gastric contents 20 minutes after meal consumption. METHODS: We performed a pilot study of 18 obese subjects who were randomly assigned (2:1) to groups that underwent aspiration therapy for 1 year plus lifestyle therapy (n = 11; mean body mass index, 42.6 ± 1.4 kg/m(2)) or lifestyle therapy only (n = 7; mean body mass index, 43.4 ± 2.0 kg/m(2)). Lifestyle intervention comprised a 15-session diet and behavioral education program. RESULTS: Ten of the 11 subjects who underwent aspiration therapy and 4 of the 7 subjects who underwent lifestyle therapy completed the first year of the study. After 1 year, subjects in the aspiration therapy group lost 18.6% ± 2.3% of their body weight (49.0% ± 7.7% of excess weight loss [EWL]) and those in the lifestyle therapy group lost 5.9% ± 5.0% (14.9% ± 12.2% of EWL) (P < .04). Seven of the 10 subjects in the aspiration therapy group completed an additional year of therapy and maintained a 20.1% ± 3.5% body weight loss (54.6% ± 12.0% of EWL). There were no adverse effects of aspiration therapy on eating behavior and no evidence of compensation for aspirated calories with increased food intake. No episodes of binge eating in the aspiration therapy group or serious adverse were reported. CONCLUSIONS: In a pilot study, aspiration therapy appears to be a safe and effective long-term weight loss therapy for obesity.

The Bethesda ERCP Skills Assessment Tool (BESAT) can reliably differentiate endoscopists of different experience levels.

Background and study aims The Bethesda ERCP Skill Assessment Tool (BESAT) is a video-based assessment tool of technical endoscopic retrograde cholangiopancreatography (ERCP) skill with previously established validity evidence. We aimed to assess the discriminative validity of the BESAT in differentiating ERCP skill levels. Methods Twelve experienced ERCP practitioners from tertiary academic centers were asked to blindly rate 43 ERCP videos using the BESAT. ERCP videos consisted of native biliary cannulation and sphincterotomy and were recorded from 10 unique endoscopists of various ERCP experience (from advanced endoscopy fellow to > 10 years of ERCP experience). Inter-rater reliability, discriminative validity, and internal structure validity were subsequently assessed. Results The BESAT was found to reliably differentiate between endoscopists of varying levels of ERCP experience with experienced ERCPists scoring higher than novice ERCPists in 11 of 13 (85%) instrument items. Inter-rater reliability for BESAT items ranged from good to excellent (intraclass correlation range: 0.86 to 0.93). Internal structure validity was assessed with item-total correlations ranging from 0.53 to 0.83. Conclusions Study findings demonstrate that the BESAT, a video-based ERCP skill assessment tool, has high inter-rater reliability and has discriminative validity in differentiating novice from expert ERCP skill. Further investigations are needed to determine the role of video-based assessment in improving trainee learning curves and patient outcomes.

Long-term outcomes after single-balloon enteroscopy in patients with obscure gastrointestinal bleeding.

BACKGROUND: Limited data exists on the long-term outcomes of patients with obscure gastrointestinal bleeding (OGIB) following single-balloon enteroscopy (SBE). AIM: To examine the long-term outcomes of patients undergoing SBE for OGIB. METHODS: Consecutive patients undergoing SBE for OGIB at a tertiary care center between 2008 and 2010 were retrospectively identified. Clinical data and SBE findings were extracted from the medical record. Recurrence of OGIB during follow-up through 2012 was assessed by a combination of chart review and telephone interviews. RESULTS: One hundred and forty-seven patients were included in the study. The overall diagnostic yield of SBE was 64.6% (95/147 patients). Findings of SBE included vascular lesions (VLs, 53.7%), small bowel neoplasm (2.7%), inflammatory lesions (4.8%), and normal SBE (35.4%). One hundred and ten patients (56.4% female, mean age 70.6±11.3 years) were followed for an average 23.9 months after initial SBE. During follow-up, OGIB recurred in 39.5% of patients in whom a source of OGIB was identified on SBE and 55.9% of patients with normal findings on SBE. OGIB recurred in 47.6% of patients in whom small bowel VLs were treated endoscopically. None of the 13 patients in whom a non-VL lesion was identified as the source of bleeding on SBE experienced recurrent bleeding (p=0.019). CONCLUSIONS: SBE is a safe and valuable method for managing patients with OGIB. More than 50% of patients experienced no recurrent bleeding during 2 years of follow-up after SBE. The long-term management of OGIB due to small bowel VLs remains challenging.

Accuracy of in vivo optical diagnosis of colon polyp histology by narrow-band imaging in predicting colonoscopy surveillance intervals.

BACKGROUND: The American Society for Gastrointestinal Endoscopy (ASGE) recently developed thresholds for the performance characteristics of technologies for real-time assessment of histology of diminutive (≤ 5 mm) colon polyps. Narrow-band imaging (NBI) has been shown to predict polyp histology with moderate to high accuracy in several studies. OBJECTIVE: To determine whether in vivo optical diagnosis of polyp histology by using NBI can reach the 2 benchmarks set forth by the ASGE. DESIGN: Retrospective analysis of data from 3 prospective clinical trials. SETTING: Two tertiary referral centers. PATIENTS: Subjects undergoing screening or surveillance colonoscopy. INTERVENTIONS: In vivo optical diagnosis of polyp histology by using NBI. MAIN OUTCOME MEASUREMENT: Accuracy in predicting colonoscopy surveillance intervals, negative predictive value (NPV) for diagnosing adenomatous histology in the rectosigmoid. RESULTS: A total of 410 patients met the inclusion/exclusion criteria and had at least 1 polyp seen and resected during colonoscopy. Using in vivo optical diagnosis instead of histopathology for all diminutive polyps predicted the correct colonoscopy surveillance interval in 86% to 94% patients. When optical diagnosis was limited to diminutive polyps in the rectosigmoid only, the NPV for diagnosing adenomatous histology with NBI was 95%. LIMITATIONS: Retrospective analysis from tertiary referral centers. CONCLUSIONS: The threshold NPV for diagnosing adenomatous histology in diminutive rectosigmoid polyps recently set forth by the ASGE can be achieved by using NBI. The threshold accuracy rate for predicting surveillance interval recommendations can be reached by using NBI, but only if patients with 1 to 2 small adenomas without advanced features have a repeat colonoscopy in 10 years.

Prevalence of advanced histological features in diminutive and small colon polyps.

BACKGROUND: Investigators have proposed "predict, resect, and discard" strategies for diminutive (≤ 5 mm) or small (6-9 mm) polyps to reduce screening colonoscopy costs. Advanced histological features such as villous histology, high-grade dysplasia, and/or cancer in these polyps could deter adoption of these strategies. OBJECTIVE: Determine the prevalence of advanced histological features in diminutive and small colon polyps. DESIGN: Retrospective analysis of data from 3 prospective clinical trials. SETTING: Two tertiary-care referral centers. PATIENTS: This study involved patients undergoing screening or surveillance colonoscopy. INTERVENTION: The location, size, and morphology of each polyp detected was documented. Each polyp was then resected, placed in a unique specimen jar, and sent for histopathological evaluation. MAIN OUTCOME MEASUREMENTS: Rates of advanced histological features (villous histology, high-grade dysplasia, and cancer). RESULTS: A total of 2361 polyps were detected, removed, and retrieved. Both diminutive and small polyps had a lower frequency of any advanced histological features compared with large polyps (0.5% and 1.5%, respectively vs 15.0%; P < .001 for both comparisons). Polyps <10 mm in size had a lower frequency of advanced histology compared with polyps ≥ 10 mm (0.8% vs 15.0%; P < .001). During sensitivity analysis, the frequency of advanced histological features varied from 0.2% to 0.7% within diminutive polyps, 1.5% to 3.6% within small polyps, and 0.8% to 1.2% within polyps <10 mm. LIMITATIONS: Retrospective analysis from tertiary-care referral centers; predominantly white, male, veteran patient population resulting in limited generalizability of results. CONCLUSION: The prevalence of advanced histological features in colon polyps ≤ 5 mm is very low (0.5%). This has important implications for the potential practice of "predicting, resecting, and discarding" diminutive colon polyps.

Use of a pancreatic duct stent or guidewire facilitates bile duct access with low rates of precut sphincterotomy: a randomized clinical trial.

BACKGROUND AND STUDY AIMS: Among cases of difficult biliary cannulation, alternatives include use of a pancreatic duct stent (PDS) or guidewire (PDW) to facilitate access. We compared the effectiveness of a PDS versus a PDW to facilitate common bile duct (CBD) cannulation. PATIENTS AND METHODS: We conducted a randomized, crossover trial at two endoscopy referral centers, limited to patients undergoing ERCP without a history of biliary sphincterotomy. After meeting predefined criteria for difficult cannulation, patients were randomized to using a PDS or PDW to facilitate CBD cannulation. Outcomes included cannulation rate within 6 min, overall cannulation rate, frequency of precut, and complication rates. RESULTS: Among 442 eligible patients, 87 (19.7 %) met criteria for difficult cannulation. Forty two were randomized to PDW, 54 to PDS (including 9 PDW patients crossed over to PDS). The rate of CBD cannulation within 6 min was similar in the PDW (38.1 %) and PDS (51.9 %) groups (p = 0.18). In a secondary analysis limited to patients who successfully underwent PDW or PDS deployment, the rate was also comparable (PDW 59.3 %, PDS 65.1 %; p = 0.62). The overall frequency of CBD cannulation was 66.7 % in PDW and 90.7 % in PDS patients. Precut was required in 9.5 % of PDW and 25.9 % of PDS patients. Complication rates were similar, with 4 (4.6 %) patients having post-ERCP pancreatitis and 1 (1.1 %) having post-ERCP pain without confirmation of pancreatitis. CONCLUSIONS: Use of a PDS or PDW facilitates CBD cannulation while maintaining a low complication rate and reducing the need for precut sphincterotomy in the majority of cases.

Obesity as a risk factor for sedation-related complications during propofol-mediated sedation for advanced endoscopic procedures.

BACKGROUND: There are limited data on the safety of anesthesia-assisted endoscopy by using propofol-mediated sedation in obese individuals undergoing advanced endoscopic procedures (AEPs). OBJECTIVE: To study the association between obesity (as measured by body mass index [BMI]) and the frequency of sedation-related complications (SRCs) in patients undergoing AEPs. DESIGN: Prospective cohort study. SETTING: Tertiary referral center. PATIENTS: A total of 1016 consecutive patients undergoing AEPs (BMI <30, 730 [72%]; 30-35, 159 [16%]; >35, 127 [12%]). INTERVENTION: Monitored anesthesia sedation with propofol alone or in combination with benzodiazepines and/or opioids. MAIN OUTCOME MEASUREMENTS: SRCs, airway maneuvers (AMs), hypoxemia, hypotension requiring vasopressors, and early procedure termination were compared across 3 groups. RESULTS: There were 203 AMs in 13.9% of patients, hypoxemia in 7.3%, need for vasopressors in 0.8%, and premature termination in 0.6% of patients. Increasing BMI was associated with an increased frequency of AMs (BMI <30, 10.5%; 30-35, 18.9%; >35-26.8%; P < .001) and hypoxemia (BMI <30, 5.3%; 30-35, 9.4%; >35, 13.4%; P = .001); there was no difference in the frequency of need for vasopressors (P = .254) and premature termination of procedures (P = .401). On multivariable analysis, BMI (odds ratio [OR] 2.0; 95% CI, 1.3-3.1), age (OR 1.1; 95% CI, 1.0-1.1), and American Society of Anesthesiologists class 3 or higher (OR 2.4; 95% CI, 1.1-5.0) were independent predictors of SRCs. In obese individuals (n = 286), there was no difference in the frequency of SRCs in patients receiving propofol alone or in combination (P = .48). LIMITATIONS: Single tertiary center study. CONCLUSIONS: Although obesity was associated with an increased frequency of SRCs, propofol sedation can be used safely in obese patients undergoing AEPs when administered by trained professionals.

Randomized, controlled trial of standard-definition white-light, high-definition white-light, and narrow-band imaging colonoscopy for the detection of colon polyps and prediction of polyp histology.

BACKGROUND: Missing adenomas and the inability to accurately differentiate between polyp histology remain the main limitations of standard-definition white-light (SD-WL) colonoscopy. OBJECTIVE: To compare the adenoma detection rates of SD-WL with those of high-definition white-light (HD-WL) and narrow-band imaging (NBI) as well as the accuracy of predicting polyp histology. DESIGN: Multicenter, prospective, randomized, controlled trial. SETTING: Two academic medical centers in the United States. PATIENTS: Subjects undergoing screening or surveillance colonoscopy. INTERVENTION: Subjects were randomized to undergo colonoscopy with one of the following: SD-WL, HD-WL, or NBI. MAIN OUTCOME MEASUREMENTS: The proportion of subjects detected with adenomas, adenomas detected per subject, and the accuracy of predicting polyp histology real time. RESULTS: A total of 630 subjects were included. The proportion of subjects with adenomas was 38.6% with SD-WL compared with 45.7% with HD-WL and 46.2% with NBI (P = .17 and P = .14, respectively). Adenomas detected per subject were 0.69 with SD-WL compared with 1.12 with HD-WL and 1.13 with NBI (P = .016 and P = .014, respectively). HD-WL and NBI detected more subjects with flat and right-sided adenomas compared with SD-WL (all P values <.005). NBI had a superior sensitivity (90%) and accuracy (82%) to predict adenomas compared with SD-WL and HD-WL (all P values <.005). LIMITATIONS: Academic medical centers with experienced endoscopists. CONCLUSIONS: There was no difference in the proportion of subjects with adenomas detected with SD-WL, HD-WL, and NBI. However, HD-WL and NBI detected significantly more adenomas per subject (>60%) compared with SD-WL. NBI had the highest accuracy in predicting adenomas in real time during colonoscopy. ( CLINICAL TRIAL REGISTRATION NUMBER: NCT 00614770.).

Incidence of sedation-related complications with propofol use during advanced endoscopic procedures.

BACKGROUND & AIMS: Propofol is an effective sedative in advanced endoscopy. However, the incidence of sedation-related complications is unclear. We sought to define the frequency of sedation-related adverse events, particularly the rate of airway modifications (AMs), with propofol use during advanced endoscopy. We also evaluated independent predictors of AMs. METHODS: Patients undergoing sedation with propofol for advanced endoscopic procedures, including endoscopic retrograde cholangiopancreatography, endoscopic ultrasound, and small-bowel enteroscopy, were studied prospectively. Sedative dosing was determined by a certified registered nurse anesthetist with the goal of achieving deep sedation. Sedation-related complications included AMs, hypoxemia (pulse oximetry [SpO(2)] < 90%), hypotension requiring vasopressors, and early procedure termination. AMs were defined as chin lift, modified face mask ventilation, and nasal airway. We performed a regression analysis to compare characteristics of patients requiring AMs (AM+) with those who did not (AM-). RESULTS: A total of 799 patients were enrolled over 7 months. Procedures included endoscopic ultrasound (423), endoscopic retrograde cholangiopancreatography (336), and small-bowel enteroscopy (40). A total of 87.2% of patients showed no response to endoscopic intubation. Hypoxemia occurred in 12.8%, hypotension in 0.5%, and premature termination in 0.6% of the patients. No patients required bag-mask ventilation or endotracheal intubation. There were 154 AMs performed in 115 (14.4%) patients, including chin lift (12.1%), modified face mask ventilation (3.6%), and nasal airway (3.5%). Body mass index, male sex, and American Society of Anesthesiologists class of 3 or higher were independent predictors of AMs. CONCLUSIONS: Propofol can be used safely for advanced endoscopic procedures when administered by a trained professional. Independent predictors of AMs included male sex, American Society of Anesthesiologists class of 3 or higher, and increased body mass index.

A screening instrument for sleep apnea predicts airway maneuvers in patients undergoing advanced endoscopic procedures.

BACKGROUND & AIMS: Among patients undergoing advanced endoscopy, unrecognized obstructive sleep apnea (OSA) could predict sedation-related complications (SRCs) and the need for airway maneuvers (AMs). By using an OSA screening tool, we sought to define the prevalence of patients at high risk for OSA and to correlate OSA with the frequency of AMs and SRCs. METHODS: We enrolled 231 consecutive patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) (n = 176) and endoscopic ultrasound (n = 55). Propofol-based sedation and patient monitoring were performed by a nurse anesthetist and an anesthesiologist. A previously validated screening tool for OSA (STOP-BANG) was used to identify patients at high risk for OSA (score, > or =3 of 8; SB+) or low risk (SB-). AMs were defined as a chin lift, modified mask ventilation, nasal airway, bag-mask ventilation, and endotracheal intubation. SRCs were defined as any duration of pulse oximetry less than 90%, systolic blood pressure less than 90 mm Hg, apnea, or early procedure termination. RESULTS: The prevalence of SB+ was 43.3%. The frequency of hypoxemia was significantly higher among patients with SB+ than SB- (12.0% vs 5.2%; relative risk [RR], 1.83; 95% confidence interval [CI], 1.32-2.54). The rate of AMs was also significantly higher among SB+ (20.0%) compared with SB- (6.1%) patients (RR, 1.8; 95% CI, 1.3-2.4). These rates remained significant after adjusting for American Society of Anesthesiologists class 3 or higher (RR, 1.70; 95% CI, 1.28-2.2 for AMs; RR, 1.63; 95% CI, 1.19-2.25 for hypoxemia). Each element of the STOP-BANG was reported more commonly in SB+ patients (P < .0001 for each comparison). CONCLUSIONS: A significant number of patients undergoing advanced endoscopic procedures are at risk for OSA. AMs and hypoxemia occur at an increased frequency in these patients.

Difficult biliary cannulation: use of physician-controlled wire-guided cannulation over a pancreatic duct stent to reduce the rate of precut sphincterotomy (with video).

BACKGROUND: Successful cannulation of the common bile duct (CBD) remains the benchmark for ERCP. Use of a pancreatic duct (PD) stent to facilitate biliary cannulation has been described, although the majority of patients require precut sphincterotomy to achieve CBD cannulation. OBJECTIVE: To report the performance characteristics of using a PD stent in conjunction with physician-controlled wire-guided cannulation (WGC) to facilitate bile duct cannulation. DESIGN: Retrospective cohort. SETTING: Two tertiary care, academic medical centers. PATIENTS: All undergoing ERCP with native papillae. INTERVENTION: In cases of difficult biliary access in which the PD is cannulated, a pancreatic stent is placed. After this, physician-controlled WGC is attempted by using the PD stent to direct the sphincterotome into the biliary orifice. If cannulation is unsuccessful after several minutes, a precut sphincterotomy is performed over the PD stent or the procedure is terminated. MAIN OUTCOME MEASUREMENTS: Frequency of successful bile duct cannulation and precut sphincterotomy. RESULTS: A total of 2345 ERCPs were identified, 1544 with native papillae. Among these, CBD and PD cannulation failed in 16 (1.0%) patients, whereas 76 (4.9%) patients received a PD stent to facilitate biliary cannulation. Successful cannulation was achieved in 71 (93.4%) of 76 patients, 60 (78.9%) of whom did not require precut sphincterotomy. Complications included mild post-ERCP pancreatitis in 4 (5.3%) and aspiration in 1 (1.3%). Precut sphincterotomy was complicated by hemorrhage, controlled during the procedure in 2 (13.3%) of 15. CONCLUSIONS: Physician-controlled WGC over a PD stent facilitates biliary cannulation while maintaining a low rate of precut sphincterotomy.

Risk of post-ERCP pancreatitis with placement of self-expandable metallic stents.

BACKGROUND: There are conflicting data on the risk of post-ERCP pancreatitis (PEP) related to self-expandable metallic stents (SEMSs). OBJECTIVE: To compare rates of PEP in patients who undergo biliary drainage with SEMSs or polyethylene stents (PSs). DESIGN: Retrospective, cohort study. SETTING: Tertiary-care medical center. PATIENTS: This study involved patients undergoing ERCP for malignant biliary obstruction between January 2005 and October 2008. INTERVENTION: First-time placement of a SEMS or PS for biliary decompression. MAIN OUTCOME MEASUREMENTS: Early post-ERCP complications, particularly PEP. RESULTS: We identified 544 eligible patients, 248 SEMSs (102 covered), and 296 PSs. The etiology of malignant biliary obstruction was similar between groups, with 55% from pancreatic cancer. The frequency of PEP was significantly higher in the SEMS group (7.3%) versus the PS group (1.3%) (OR 5.7 [95% CI, 1.9-17.1]). On univariate analysis, patient age of <40 years, a history of PEP, and at least 1 pancreatic duct injection were also significant predictors of PEP, whereas female sex and having pancreatic cancer were not. When significant variables were added to a multiple-predictor regression model, the odds of PEP from SEMS placement increased to 6.8 (95% CI, 2.2, 21.4). However, the frequency of PEP was similar between covered (6.9%) and uncovered (7.5%) SEMSs (OR 0.9 [CI, 0.3-2.4]). Purported SEMS-specific risk factors, including the use of cSEMSs, overlapping SEMSs, or having a biliary sphincterotomy were not found to be significant contributors to the higher risk. LIMITATIONS: Retrospective design. CONCLUSION: After we controlled for confounding variables, the frequency of PEP was significantly higher with placement of a SEMS compared with a PS. Rates of PEP were comparable with use of covered and uncovered SEMSs.

A retrograde-viewing device improves detection of adenomas in the colon: a prospective efficacy evaluation (with videos).

BACKGROUND: Colonoscopy may fail to detect neoplasia located on the proximal sides of haustral folds and flexures. The Third Eye Retroscope (TER) provides a simultaneous retrograde view that complements the forward view of a standard colonoscope. OBJECTIVE: To evaluate the added benefit for polyp detection during colonoscopy of a retrograde-viewing device. DESIGN: Open-label, prospective, multicenter study evaluating colonoscopy by using a TER in combination with a standard colonoscope. SETTING: Eight U.S. sites, including university medical centers, ambulatory surgery centers, a community hospital, and a physician's office. PATIENTS: A total of 249 patients (age range 55-80 years) presenting for screening or surveillance colonoscopy. INTERVENTIONS: After cecal intubation, the disposable TER was inserted through the instrument channel of the colonoscope. During withdrawal, the forward and retrograde video images were observed simultaneously on a wide-screen monitor. MAIN OUTCOME MEASUREMENTS: The number and sizes of lesions (adenomas and all polyps) detected with the standard colonoscope and the number and sizes of lesions found only because they were first detected with the TER. RESULTS: In the 249 subjects, 257 polyps (including 136 adenomas) were identified with the colonoscope alone. The TER allowed detection of 34 additional polyps (a 13.2% increase; P < .0001) including 15 additional adenomas (an 11.0% increase; P < .0001). For lesions 6 mm or larger, the additional detection rates with the TER for all polyps and for adenomas were 18.2% and 25.0%, respectively. For lesions 10 mm or larger, the additional detection rates with the TER for all polyps and for adenomas were 30.8% and 33.3%, respectively. In 28 (11.2%) individuals, at least 1 additional polyp was found with the TER. In 8 (3.2%) patients, the polyp detected with the TER was the only one found. Every polyp that was detected with the TER was subsequently located with the colonoscope and removed. For all polyps and for adenomas, the additional detection rates for the TER were 9.7%/4.1% in the left colon (the splenic flexure to the rectum) and 16.5%/14.9% in the right colon (the cecum to the transverse colon), respectively. LIMITATIONS: There was no randomization or comparison with a separate control group. CONCLUSIONS: A retrograde-viewing device revealed areas that were hidden from the forward-viewing colonoscope and allowed detection of 13.2% additional polyps, including 11.0% additional adenomas. Additional detection rates with the TER for adenomas 6 mm or larger and 10 mm or larger were 25.0% and 33.3%, respectively. ( CLINICAL TRIAL REGISTRATION NUMBER: NCT00657371.).

Findings at endoscopic retrograde cholangiopancreatography after endoscopic treatment of postcholecystectomy bile leaks.

BACKGROUND: Although the endoscopic management of bile leaks after cholecystectomy (CCY) is well established, the yield of a routine endoscopic retrograde cholangiogram (ERC) with a bile duct sweep at the time of stent removal is unclear. This study aimed to describe the prevalence of abnormal findings at follow-up ERC to determine whether upper endoscopy with stent removal and without cholangiography would suffice. METHODS: A retrospective cohort analysis of all patients referred for initial and follow-up ERC with post-CCY bile leak was performed. The rate of abnormal findings was measured including choledocholithiasis, biliary strictures, and persistent bile leaks at follow-up ERC. Secondarily, the study sought to define the clinical characteristics of patients who demonstrated stones or sludge at follow-up assessment. RESULTS: Between January, 2003 and April, 2008, 105 patients underwent initial and follow-up ERC. After a mean interval of 6.9 +/- 2.7 weeks between endoscopies, 29 (27.6%) of the 105 patients demonstrated one or more abnormalities including persistent bile leak (n = 8), common bile duct (CBD) stones (n = 12), and CBD sludge alone (n = 9). In the subgroup analysis of the patients who underwent a balloon sweep at initial and follow-up ERC, the prevalence of CBD stones or sludge at the follow-up ERC was 17.6%. Besides stones during the initial ERC, no significant clinical predictors of CBD stones were found at follow-up ERC including surgical approach, interval between endoscopies, and location of bile leak. CONCLUSION: After endoscopic treatment of a bile leak, the prevalence of abnormalities at follow-up ERC is significant. A repeat cholangiogram with a balloon sweep is preferred at the time of stent removal.