Randomized Comparison of 3 High-Level Disinfection and Sterilization Procedures for Duodenoscopes.

BACKGROUND AND AIMS: Duodenoscopes have been implicated in the transmission of multidrug-resistant organisms (MDRO). We compared the frequency of duodenoscope contamination with MDRO or any other bacteria after disinfection or sterilization by 3 different methods. METHODS: We performed a single-center prospective randomized study in which duodenoscopes were randomly reprocessed by standard high-level disinfection (sHLD), double high-level disinfection (dHLD), or standard high-level disinfection followed by ethylene oxide gas sterilization (HLD/ETO). Samples were collected from the elevator mechanism and working channel of each duodenoscope and cultured before use. The primary outcome was the proportion of duodenoscopes with an elevator mechanism or working channel culture showing 1 or more MDRO; secondary outcomes included the frequency of duodenoscope contamination with more than 0 and 10 or more colony-forming units (CFU) of aerobic bacterial growth on either sampling location. RESULTS: After 3 months of enrollment, the study was closed because of the futility; we did not observe sufficient events to evaluate the primary outcome. Among 541 duodenoscope culture events, 516 were included in the final analysis. No duodenoscope culture in any group was positive for MDRO. Bacterial growth of more than 0 CFU was noted in 16.1% duodenoscopes in the sHLD group, 16.0% in the dHLD group, and 22.5% in the HLD/ETO group (P = .21). Bacterial growth or 10 or more CFU was noted in 2.3% of duodenoscopes in the sHLD group, 4.1% in the dHLD group, and 4.2% in the HLD/ETO group (P = .36). MRDOs were cultured from 3.2% of pre-procedure rectal swabs and 2.5% of duodenal aspirates. CONCLUSIONS: In a comparison of duodenoscopes reprocessed by sHLD, dHLD, or HLD/ETO, we found no significant differences between groups for MDRO or bacteria contamination. Enhanced disinfection methods (dHLD or HLD/ETO) did not provide additional protection against contamination. However, insufficient events occurred to assess our primary study end-point. ClinicalTrials.gov no: NCT02611648.

Increased detection of Barrett's esophagus-associated neoplasia using wide-area trans-epithelial sampling: a multicenter, prospective, randomized trial.

BACKGROUND AND AIMS: Wide-area transepithelial sampling (WATS) with computer-assisted 3-dimensional analysis is a sampling technique that combines abrasive brushing of the Barrett's esophagus (BE) mucosa followed by neural network analysis to highlight abnormal-appearing cells. METHODS: We performed a randomized trial of referred BE patients undergoing surveillance at 16 medical centers. Subjects received either biopsy sampling followed by WATS or WATS followed by biopsy sampling. The primary outcome was rate of detection of high-grade dysplasia/esophageal adenocarcinoma (HGD/EAC) using WATS in conjunction with biopsy sampling compared with biopsy sampling alone using standard histopathologic criteria. Secondary aims included evaluating neoplasia detection rates based on the procedure order (WATS vs biopsy sampling first), of each procedure separately, and the additional time required for WATS. RESULTS: One hundred sixty patients (mean age, 63.4 years; 76% men; 95% white) completed the trial. The median circumferential and maximal BE extents were 1.0 cm (interquartile range: .0-5.0) and 4.0 cm (interquartile range, 2.0-8.0), respectively. The diagnostic yield for biopsy sampling alone was as follows: HGD/EAC, 7 (4.4%); low-grade dysplasia (LGD), 28 (17.5%); nondysplastic BE (NDBE), 106 (66.25%); and no BE, 19 (11.9%). The addition of WATS to biopsy sampling yielded an additional 23 cases of HGD/EAC (absolute increase, 14.4%; 95% confidence interval, 7.5%-21.2%). Among these 23 patients, 11 were classified by biopsy sampling as NDBE and 12 as LGD/indefinite for dysplasia (IND); 14 received biopsy sampling first and 9 WATS first (not significant) and most (n = 21; 91.7%) had a prior dysplasia history. WATS added an average of 4.5 minutes to the procedure. CONCLUSION: Results of this multicenter, prospective, randomized trial demonstrate that the use of WATS in a referral BE population increases the detection of HGD/EAC. (Clinical trial registration number: NCT03008980.).

"Apple Far from the Tree": comparative effectiveness of fiberoptic single-operator cholangiopancreatoscopy (FSOCP) and digital SOCP (DSOCP).

BACKGROUND: While the fiberoptic single-operator cholangiopancreatoscopy (FSOCP) system has demonstrated efficacy in the diagnosis and management of pancreaticobiliary diseases, the digital SOCP (DSOCP) appears to provide higher resolution digital imaging, however a comparison of these devices has not been established. The aim of this work was to compare the efficacy of FSOCP and DSOCP in biliary stone disease and indeterminate biliary strictures. METHODS: A retrospective analysis of a prospective cohort was performed in patients undergoing FSOCP or DSOCP demographics included indication, diagnostic yield, procedure time, radiation dose, and complications. RESULTS: 324 patients underwent cholangioscopy. FSOCP and DSOCP were utilized in 198 and 126 patients respectively. Male/female ratio was similar and mean age was 66 ± 13 years. Indications included stone disease, indeterminate stricture evaluation and "other" were 47%, 42% and 11% respectively. Mean procedure time for stone disease and the amount of radiation doses in DSOCP group were lower than the FSOCP group (P = 0.032 and P = 0.02, respectively). Diagnostic yield in indeterminate strictures was higher 78% with DSOCP system compared to 37% with FSOCP system (P = 0.004). Complication were low and similar between the groups. CONCLUSIONS: DSOCP system provides enhanced diagnostic yield, shorter procedure times and less radiation exposure compared to FSOCP system.

Elipse, the first procedureless gastric balloon for weight loss: a prospective, observational, open-label, multicenter study.

Background and study aims Conventional gastric balloons for weight loss require endoscopy for placement and removal. The Elipse device is swallowed, resides in the stomach for 4 months, and is then expelled. The objectives of this study were to assess the safety of Elipse and to measure its effects on weight loss, metabolic parameters, and quality of life. Methods Each participant swallowed one Elipse device, which was filled with 550 mL of filling fluid through a thin delivery catheter that was then removed. Weight was measured every 2 weeks, and metabolic parameters and quality of life were assessed at baseline and at trial exit. Results 34 patients, with a mean body mass index of 34.8 kg/m2, were enrolled. All 34 patients successfully swallowed the Elipse device. All adverse events were either self-limiting or resolved with medication. All balloons were safely excreted. At 4 months, the mean percent total body weight loss was 10 %. Mean waist circumference was reduced by 8.4 cm. Improvements were also seen in hemoglobin A1c, triglycerides, low density lipoprotein, and blood pressure. At trial exit, quality of life measures had improved across all domains. Conclusion These results demonstrate clinically significant weight loss with the Elipse, the first procedureless gastric balloon. The weight loss was similar to that seen in previous studies of endoscopically placed balloons. In addition, Elipse therapy led to improvements in waist circumference, several metabolic parameters, and overall quality of life.ClinicalTrials.gov identifier: NCT 02802007.

Pregnancy is a Risk Factor for Pancreatitis After Endoscopic Retrograde Cholangiopancreatography in a National Cohort Study.

BACKGROUND & AIMS: There are limited data on the safety of endoscopic retrograde cholangiopancreatography (ERCP) during pregnancy, only data from observational series (approximately 350 cases) have been published. We aimed to evaluate the safety of ERCP in pregnant women by evaluating a large nationwide database. METHODS: We performed a retrospective matched-cohort study, collecting data from the National Inpatient Sample from 2008 through 2009. We compared data from pregnant women who underwent ERCP (n = 907) with those from nonpregnant women who underwent ERCP (controls, n = 2721). Complications related to ERCP were measured against the matched controls. Obstetric and fetal complications were measured against the national average of all obstetric admissions. RESULTS: ERCP-associated complications of perforation, infection, and bleeding were infrequent in both cohorts (P > .05). Post-ERCP pancreatitis (PEP) occurred in 12% of pregnant women and in 5% of controls (P < .001). There was a significantly lower rate of PEP in teaching hospitals (9.6%) than in nonteaching hospitals (14.6%; P < .001). The adjusted odds ratio for developing PEP among pregnant women vs controls was 2.8 (95% confidence interval [CI], 2.1-3.8). This risk of PEP was higher among nonteaching hospitals (adjusted odds ratio, 3.5; 95% CI, 2.3-5.2) than teaching hospitals (adjusted odds ratio, 2.5; 95% CI, 1.6-3.9). CONCLUSIONS: Pregnancy is an independent risk factor for PEP; PEP and PEP among pregnant women are each more prevalent in community hospitals than teaching centers. Proper precautions therefore should be considered for pregnant women undergoing ERCP, including transfer to a tertiary care center if appropriate.

Minor Anesthesia-Related Events During Radiofrequency Ablation for Barrett's Esophagus Are Associated with an Increased Number of Treatment Sessions.

BACKGROUND: There is limited data regarding the prevalence and clinical impact of sedation-related adverse events (SRAEs) during radiofrequency ablation (RFA) for dysplastic Barrett's esophagus (BE). AIM: Our primary aim was to measure SRAE during RFA. Secondary aims were to identify risk factors for adverse events, and to determine whether SRAEs impacted the number of RFA treatments to achieve complete eradication of dysplasia (CE-D). METHODS: We conducted a retrospective analysis of 120 consecutive patients undergoing initial RFA for dysplastic BE between 2008 and 2014. The main outcome measures were SRAEs and the number of RFA sessions required to achieve CE-D. RESULTS: Of 120 initial RFA procedures, 83 % were performed with MAC and 17 % with GET. SRAEs occurred in 32 %, including 25 % of MAC patients (25/100) and 65 % (12/20) GET patients. The most frequent SRAE was hypotension (23 %, n = 27/120), followed by hypoxia (n = 9/120), arrhythmia (n = 4/120), and one unplanned intubation. There were no premature procedure terminations. After adjusting for length of BE mucosa and ASA score, the occurrence of a SRAE was associated with requiring more (>4) RFA sessions to achieve CE-D, OR 3.45 (95 % CI 1.49-7.99). Mean RFA sessions required to achieve CE-D was 5 ± 1 in patients with SRAE, compared to 3 ± 0.7 in patients without SRAE during the first treatment session (p < 0.001). CONCLUSIONS: SRAE during RFA for dysplastic BE occurs at a rate typical of other advanced endoscopic procedures. Patients who experience minor events related to anesthesia during the first RFA are likely to require more RFA treatment sessions to achieve CE-D.

Prospective assessment of consensus criteria for evaluation of patients with suspected choledocholithiasis.

BACKGROUND AND AIM: American Society for Gastrointestinal Endoscopy (ASGE) guidelines have proposed criteria to stratify patients into low, intermediate and high risk of choledocholithiasis. The criteria include variables that are readily available in clinical practice. The objective of the present study was to prospectively assess the accuracy of these criteria. METHODS: A prospective observational cohort study was conducted at Beth Israel Deaconess Medical Center. All adult patients referred for endoscopic retrograde cholangiopancreatography (ERCP) with suspected choledocholithiasis were considered for inclusion. ASGE criteria were applied, and each patient was categorized as high, intermediate or low risk for choledocholithiasis. Presence of stone at ERCP served as criteria standard. RESULTS: During the study period, 402 patients met study inclusion criteria and 336 were reported in the final analysis. Of the 244 patients in the high risk for choledocholithiasis group, 185 were found to have stones at ERCP (75.8%, 95% CI 70.2-80.1%). Of the 92 patients in the intermediate risk for choledocholithiasis group, 45 had stones at ERCP (48.9%, 95% CI 38.8-59.1%); P-value for difference between groups = 0.001. Diagnostic accuracy for choledocholithiasis in the high-risk group was 69.05%, and for the intermediate group was 39.95%. Presence of choledocholithiasis on pre-ERCP imaging (OR: 3.6; 95% CI 2.2-6.0; P < 0.01), and bilirubin >1.8 but <4 mg/dL (OR: 1.69; 95% CI 1.0-2.8; P < 0.04) were the strongest predictors of choledocholithiasis. No additional variable that improved accuracy of ASGE criteria was identified. CONCLUSION: ASGE criteria stratify patients by risk for choledocholithiasis and can be used in routine clinical practice.

Salvage cryotherapy after failed radiofrequency ablation for Barrett's esophagus-related dysplasia is safe and effective.

BACKGROUND: Radiofrequency ablation (RFA) is an effective treatment for Barrett's esophagus (BE) dysplasia. For patients with dysplasia refractory to RFA, data are limited regarding efficacy of endoscopic therapy. OBJECTIVE: To assess the efficacy and safety of cryotherapy in patients with BE dysplasia who failed RFA. DESIGN: Single-center, retrospective, cohort study. SETTING: Tertiary-care center between 2006 and 2013. PATIENTS: Patients with BE and low-grade dysplasia (LGD), high-grade dysplasia (HGD), or intramucosal carcinoma (IMC) were referred for RFA every 2 to 3 months. Response was determined by complete eradication of dysplasia (CE-D). INTERVENTIONS: Patients without CE-D or those with recurrent dysplasia after initial eradication were offered cryotherapy. MAIN OUTCOME MEASUREMENTS: Eradication of dysplasia and/or cancer. Secondary outcome, eradication of intestinal metaplasia. RESULTS: A total of 121 patients underwent RFA for BE dysplasia (55% HGD, 26% LGD, 17% IMC, 2% indefinite dysplasia). After a median of 3 RFA sessions, 75% (n = 91) had CE-D. Patients without CE-D were more likely to have a longer BE length (7 cm vs 4 cm; P = .004) and a hiatal hernia (83% vs 55%; P = .005). Sixteen patients (14 with failed CE-D and 2 with recurrent dysplasia) were offered cryotherapy and had endoscopic follow-up. Seven (57%) had HGD before cryotherapy (6 with LGD, 2 with IMC, and 1 with indefinite dysplasia). After cryotherapy, 12 (75%) had CE-D, and 5 (31%) had eradication of intestinal metaplasia. Of patients with IMC, 100% had CE-D. Three patients developed strictures that responded to dilation. LIMITATIONS: Single center, retrospective nature of study. CONCLUSION: For patients with refractory dysplasia or recurrent dysplasia after RFA, salvage cryotherapy is a safe and effective endoscopic therapy.

Outcomes of intragastric balloon placements in a private practice setting.

BACKGROUND AND STUDY AIM: Intragastric balloons are used as a treatment for obesity. Much of the data collected on balloons has been in the context of clinical trials in academic medical centers or as a bridge to bariatric surgery in obesity centers. The aim of this study was to investigate the efficacy and safety of balloon treatment in private practice. PATIENTS AND METHODS: This was a retrospective analysis of 6-month weight loss data and balloon-related complications of patients referred to three private centers for obesity treatment. RESULTS: A total of 815 patients (131 males) were referred for balloon treatment (mean age 36.5 years, mean body weight 111.7 kg, mean body mass index [BMI] 38.1 kg/m(2)). The 6-month weight loss data were available for 672 patients. Mean weight loss was 20.9 kg (7.2 BMI units). A total of 372 patients visited the center only once following balloon placement (i. e. for balloon removal), but these patients still achieved a mean weight loss of 19.4 kg (6.6 BMI units). Successful weight loss (i. e. ≥ 10 %) was achieved in 85.0 %. Severe complications consisted of dehydration requiring hospital admission (n = 2; 0.2 %), and intestinal obstruction caused by balloon deflation, which required surgery (n = 2; 0.2 %). A total of 35 deflated balloons (4.3 %) were passed rectally without any adverse events. Severe esophagitis following balloon placement was diagnosed in 12 patients (1.5 %). A total of 53 patients (6.5 %) requested balloon removal during the first month. Nine balloons (1.1 %) were removed for medical reasons. CONCLUSION: In the private practice setting, intragastric balloons on their own, without an intensive lifestyle program and supportive consultations, resulted in safe and substantial weight losses, and may fill the therapeutic gap between pharmacotherapy and surgery.

Use of a cap in single-balloon enteroscopy-assisted endoscopic retrograde cholangiography.

BACKGROUND AND STUDY AIM: Cannulation of the native papilla in surgically altered anatomy is difficult in endoscopic retrograde cholangiography (ERC). There are limited data regarding the success of single-balloon enteroscopy-assisted ERC (SBE-ERC) in patients with a native papilla and Roux-en-Y gastric bypass. Use of a plastic cap may assist cannulation in these cases. The aim of the current study was to investigate the use of SBE-ERC with a cap (Cap-SBE-ERC) in patients with surgically altered anatomy referred for ERC. PATIENTS AND METHODS: Patients with surgically altered anatomy (hepaticojejunostomy, gastric bypass surgery, and Whipple's surgery) who underwent Cap-SBE-ERC were identified from a prospectively maintained database. Outcomes were diagnostic and procedural success. Patients with a native papilla were compared with those with a biliary-enteric anastomosis. RESULTS: Among 56 patients with surgically altered anatomy, high rates of diagnostic and procedural success were observed (78.6 % and 71.4 %, respectively). High diagnostic and procedural success rates of 72.7 % and 65.9 %, respectively, were also observed for patients with Roux-en-Y gastric bypass anatomy with a native papilla (n = 44). CONCLUSION: High rates of diagnostic and procedural success were reported for SBE-ERC with the use of a cap, including a large subgroup of patients with Roux-en-Y gastric bypass and a native papilla.

Assessment of the length of myotomy in peroral endoscopic pyloromyotomy (G-POEM) using a submucosal tunnel technique (video).

BACKGROUND: Peroral endoscopic pyloromyotomy is a novel technique that has recently been described in the literature. There is little data to guide the length of myotomy created. The aim of study was to evaluate the proper incision length of the muscular layer during peroral endoscopic pyloromyotomy using a submucosal tunnel technique. METHODS: The study was designed as a prospective ex vivo study. Fresh ex vivo porcine stomachs from animals weighing 80-100 kg and porcine stomachs from animals weighing 15-25 kg were used for pyloromyotomy. Four different myotomy lengths (1, 2, 3, and 4) were compared in the large animal series and three different myotomy lengths (1, 2, and 3) were compared in the small series. A total of 23 cases of the submucosal tunnel technique were performed by two endoscopists using 12 large stomachs and 11 small stomachs. RESULTS: The mean overall procedure time (± SD) of pyloromyotomy was 65.7 (± 14.3) min. In the large stomach series, the mean pyloric diameter (± SD) and change from baseline (as percentage) following a 1, 2, 3, and 4 pyloromyotomy were 13.3 ± 9.5 mm (7.1 %), 20.7 ± 11.7 mm (10.6 %), 31.1 ± 15.0 mm (15.2 %), and 33.0 ± 15.0 mm (16.0 %), respectively. In the small stomach series, the changes of mean pyloric diameter following a 1, 2, and 3 cm pyloromyotomy were 12.2 ± 5.6 mm (7.5 %), 23.1 ± 7.6 mm (13.1 %), and 28.0 ± 10.4 mm (15.5 %), respectively. CONCLUSIONS: A 3 cm pyloromyotomy for a large animal series and 2 cm for the small animal series appeared to be most appropriate for enlargement of the pylorus.

Double-duct sign in the era of endoscopic ultrasound: the prevalence of occult pancreaticobiliary malignancy.

BACKGROUND AND AIM: Simultaneous dilatation of the common bile duct and pancreatic duct, "double-duct sign" (DDS), is an ominous finding concerning for pancreaticobiliary malignancy. Little evidence exists to guide the initial evaluation and subsequent follow-up for patients with DDS in the absence of jaundice or focal mass noted on computed tomography (CT)/ magnetic resonance imaging (MRI). Endoscopic ultrasound (EUS) is often recommended in the evaluation of such patients, however, the prevalence of malignancy remains unclear. We sought to determine the prevalence of pancreaticobiliary neoplasm in this patient group on initial EUS evaluation and on subsequent clinical follow-up. METHODS: We performed a retrospective analysis of a prospective database at a tertiary-care academic medical center between 2010 and 2012. Eighty-two patients were identified who underwent EUS evaluation for DDS without evidence of a mass on CT/MRI and without jaundice. RESULTS: Sixty-eight of 82 patients had confirmed DDS on EUS with biductal dilation. Six (9 %) of 68 patients were found to have a mass lesion on EUS. In these patients, final diagnoses were pancreatic carcinoma (n = 4), ampullary carcinoma (n = 1) and ampullary adenoma (n = 1). In the 62 patients without evidence of a focal mass on initial EUS, the most common diagnoses were benign ductal dilation (n = 42), chronic pancreatitis (n = 9) and choledocholithiasis (n = 8). Fifty-eight (94 %) of 62 patients had documented median follow-up of 13 months, and none developed subsequent evidence of previously unrecognized malignancy. CONCLUSIONS: The presence of double-duct sign on EUS in patients without jaundice or mass lesion on CT/MRI is most frequently associated with benign conditions. When a mass is not detected on EUS, subsequent evidence of malignancy is unlikely.

Prior capsule endoscopy improves the diagnostic and therapeutic yield of single-balloon enteroscopy.

BACKGROUND AND AIMS: Although there is substantial literature addressing double-balloon enteroscopy, evidence is more limited with regard to the clinical utility of single-balloon enteroscopy (SBE) in evaluating and treating small-bowel diseases. We sought to determine the diagnostic and therapeutic yield of SBE in patients with suspected small-bowel disorders, as well as the impact of preceding capsule endoscopy (CE) on these outcomes. METHODS: We performed a retrospective analysis of a prospectively collected database at a tertiary-care academic medical center between 2011 and 2013 for all patients referred for SBE. RESULTS: A total of 150 patients underwent 170 SBE procedures during the study period. The most frequent indications for SBE included anemia, overt or occult gastrointestinal bleeding, and suspected mass. CE was performed prior to SBE in 113 of 150 patients (75%). The overall diagnostic yield for small-bowel disease by CE was 62%. Therapeutic interventions included hemostasis, polypectomy, and foreign body removal. Total diagnostic and therapeutic yield of SBE was 60 and 28%, respectively. The diagnostic yield of SBE with prior CE was 68 versus 44% for SBE without prior CE (P = 0.002). The therapeutic yield of SBE with prior CE was 35 versus 12% without prior CE (P = 0.001). One endoscopic complication was observed out of 170 procedures, and there were no deaths. CONCLUSIONS: SBE appears to be a safe and effective technique for the diagnosis and treatment of small-bowel disease; however, we recommend performing a CE prior to SBE to improve the diagnostic and therapeutic yield of the procedure.

Monitored anesthesia care without endotracheal intubation is safe and efficacious for single-balloon enteroscopy.

BACKGROUND: General endotracheal (GET) anesthesia is often used during single-balloon enteroscopy (SBE). However, there is currently limited data regarding monitored anesthesia care (MAC) without endotracheal intubation for this procedure. AIMS: The aim of the study was to determine the safety and efficacy of MAC sedation during SBE and to identify risk factors for adverse events. METHODS: All patients who underwent SBE and SBE-assisted endoscopic retrograde cholangiopancreatography between June 2011 and July 2013 at a tertiary-care referral center were studied in a retrospective analysis of a prospectively collected database. Patients received MAC anesthesia or GET. The main outcome measurements were sedation-related adverse events, diagnostic yield, and therapeutic yield. RESULTS: Of the 178 cases in the study, 166 cases (93 %) were performed with MAC and 12 (7 %) with GET. Intra-procedure sedation-related adverse events occurred in 17 % of cases. The most frequent event was transient hypotension requiring pharmacologic intervention in 11.8 % of procedures. In MAC cases, the diagnostic yield was 58.4 % and the therapeutic yield was 30.1 %. Anesthesia duration was strongly associated with the occurrence of a sedation-related adverse event (P = 0.005). CONCLUSIONS: MAC is a safe and efficacious sedation approach for most patients undergoing SBE. Sedation-related complications in SBE are uncommon, but are more frequent in longer procedures.

Propofol versus traditional sedative agents for advanced endoscopic procedures: a meta-analysis.

BACKGROUND AND AIM: The optimum method for sedation for advanced endoscopic procedures is not known. Propofol deep sedation has a faster recovery time than traditional sedative agents, but may be associated with increased complication rates. The aim of the present study was to pool data from all available studies to systematically compare the efficacy and safety of propofol with traditional sedative agents for advanced endoscopic procedures. METHODS: Databases including PubMed, Embase, Web of Science and the Cochrane Central Register of Controlled Trials updated as of January 2013 were searched. Main outcome measures were procedure duration, recovery time, incidence of complications (hypotension, hypoxia), sedation level, patient cooperation and amnesia during advanced endoscopic procedures such as endoscopic retrograde cholangiopancreatography, endoscopic ultrasonography, and deep small bowel enteroscopy. RESULTS: Nine prospective randomized trials with a total of 969 patients (485 propofol, 484 conscious sedation) were included in the meta-analysis. Pooled mean difference in procedure duration between propofol and traditional sedative agents was -2.3 min [95% CI: -6.36 to 1.76, P = 0.27], showing no significant difference in procedure duration between the two groups. Pooled mean difference in recovery time was -30.26 min [95% CI: -46.72 to -13.80, P < 0.01], showing significantly decreased recovery time with propofol. There was also no significant difference between the two groups with regard to hypoxia and hypotension. CONCLUSIONS: Propofol for advanced endoscopic procedures is associated with shorter recovery time, better sedation and amnesia level without an increased risk of cardiopulmonary complications. Overall patient cooperation was also improved with propofol sedation.

Location of bile leak predicts the success of ERCP performed for postoperative bile leaks.

BACKGROUND: ERCP is effective for treating a bile leak (BL) after cholecystectomy (CCY), but few data exist on its effectiveness after hepatobiliary surgery (HBS). OBJECTIVE: To determine the effectiveness of ERCP for treating BLs after HBS compared with BLs after cholecystectomy and to identify factors associated with treatment success. DESIGN: Retrospective cohort. SETTING: Academic tertiary-care referral center. PATIENTS: Patients referred from 2001 to 2009 for ERCP treatment of BL after cholecystectomy or HBS. INTERVENTIONS: ERCP. MAIN OUTCOME MEASUREMENTS: Resolution of BL after a single ERCP. RESULTS: A total of 223 patients were identified and 46 were excluded. Fifty underwent ERCP for treatment of BL after HBS and 127 after CCY. A single ERCP was successful at resolving BL in 89% of patients. Failure occurred in 7 HBS patients (14%) and 12 CCY patients (9%) (P = .379). After multiple ERCPs, success improved to 95% of the CCY group and 86% of the HBS group (P = .033). HBS patients underwent 30% more ERCPs (P = .049). ERCP was 3.3 times more likely to be successful in patients with cystic duct or duct of Luschka BLs (P = .028). Patients undergoing biliary stent placement were significantly more likely to have successful outcomes (odds ratio 71.0, P < .001). Surgical history or biliary sphincterotomy did not affect outcome. Odds of treatment failure were 3.5 times higher for each additional ERCP performed (P < .001). LIMITATIONS: Single-center, retrospective study. CONCLUSIONS: ERCP is effective for treating postoperative BLs. Location of a BL and placement of a biliary stent are the best predictors of endoscopic treatment success.

Prospective, randomized comparison of a prototype endoscope with deflecting working channels versus a conventional double-channel endoscope for rectal endoscopic submucosal dissection in an established experimental simulation model (with video).

BACKGROUND: A prototype endoscope was designed to improve visualization and dissection of tissue with the use of 2 working channels with different deflections. OBJECTIVE: To evaluate the efficacy and operability of a prototype endoscope in comparison with a conventional double-channel endoscope for rectal endoscopic submucosal dissection (ESD). DESIGN: Randomized, prospective, controlled, ex vivo study. SETTING: Academic medical center. METHODS: A total of 80 standardized artificial lesions measuring 3 × 3 cm were created approximately 5 cm from the anal verge in fresh ex vivo porcine colorectal specimens. Two endoscopists each completed 20 cases with the prototype endoscope and 20 cases with the conventional endoscope. MAIN OUTCOME MEASUREMENTS: An independent observer recorded procedure time, specimen size, en bloc resection, and perforation rate. RESULTS: For the ESD novice, the mean submucosal dissection time (10.5 ± 3.8 vs 14.9 ± 7.3 minutes; P = .024) and total procedure time (18.1 ± 5.2 vs 23.6 ± 8.2 minutes; P = .015) were significantly shorter in the prototype group in comparison with the conventional group. For the ESD expert, there was no significant difference between the mean circumferential resection, submucosal dissection, and total procedure time (prototype group 14.2 ± 6.0 minutes, conventional group 14.2 ± 8.8 minutes; P = .992). The overall perforation and en bloc resection rates were not significantly different between groups. LIMITATIONS: Ex vivo study. CONCLUSION: In this ex vivo prospective comparison study, there was a technical advantage for the ESD novice with the prototype endoscope that resulted in a shorter procedure time, which was not observed for cases performed by the ESD expert.

The learning curve for endoscopic submucosal dissection in an established experimental setting.

INTRODUCTION: Endoscopic submucosal dissection (ESD) has become a standard therapy for early gastric neoplasia, particularly in Asian countries. From a safety and efficacy standpoint, simulation training may empower the endoscopist to be able to learn the basic tenets of ESD in a safe, controlled and supervised setting before attempting first in humans. METHODS AND PROCEDURES: This study was designed as a prospective ex vivo study. Ex vivo porcine organs were utilized in the EASIE-R endoscopic simulator. A total of 150 artificial lesions, each 2 × 2 cm in size, were created in fresh ex vivo porcine stomachs at six different anatomical sites (fundus anterior and posterior, body anterior and posterior, antrum anterior and posterior). Three examiners (2 beginners, 1 expert) participated in this study. All parameters (procedure time, specimen size, en-bloc resection status, perforation) were recorded by an independent observer for each procedure. RESULTS: All 150 lesions were successfully resected using the ESD technique by the three endoscopists. After 30 ESD cases, the two novices performed ESD with a 100% en-bloc resection rate and without perforation. For the procedures performed by the novices, the total procedure time and perforation rate in the last 30 cases were significantly lower than during the first 30 cases (p < 0.05). CONCLUSIONS: Our study suggests that performing 30 ESD resections in an ex vivo simulator leads to a significant improvement in safety and efficiency of performing the ESD technique.

Deep sedation without intubation for ERCP is appropriate in healthier, non-obese patients.

BACKGROUND: Providing the appropriate anesthesia for endoscopic retrograde cholangiopancreatography (ERCP) cases is challenging. AIM: The aim of our study was to prospectively assess the safety of anesthesia directed deep sedation (ADDS) in non-intubated patients compared to general endotracheal anesthesia (GET) during an ERCP. METHODS: We conducted a prospective observational study in patients undergoing an ERCP. The choice of anesthetic-ADDS or GET-was made by the anesthesiologist. The pre-anesthesia assessment, intraoperative vital signs, and medications administered were collected. A standardized study instrument was used to record the number of procedure interruptions, intraprocedure and recovery room adverse events (AE). RESULTS: A total of 393 (89.7 %) patients received ADDS (no intubation) and 45 (10.2 %) received a GET. Age and comorbidities were similar in ADDS and GET groups. BMI was higher in the GET (32.6 ± 9.5) versus in the ADDS (27.3 ± 6.1) group; p < 0.001. The number of ASA 2 patients was higher in the ADDS versus the GET group (38.7 versus 22.2 %; p < 0.04); the number of ASA 4 patients was 15.6 % of GET versus 6.6 % of the ADDS cases (p = 0.05). During the procedure 16 (3.7 %) ADDS patients were intubated and converted to a GET anesthetic; 4 (25 %) of the converted ADDS cases were ASA 4 versus 6.4 % of ADDS patients (p = 0.006). Intraprocedure events occurred in 35.6 % of GET and 25.7 % of ADDS cases, without significant complications. CONCLUSION: Our data suggest that the administration of anesthesia without intubation for prone ERCP cases is feasible especially in non-obese, healthier patients.

Prospective, randomized comparison of 3 different hemoclips for the treatment of acute upper GI hemorrhage in an established experimental setting.

BACKGROUND: Recently, endoscopic clip application devices have undergone redesign and improvements to optimize their clinical use and effectiveness. Initially designed for the treatment of bleeding nonvariceal lesions, these devices are also increasingly used for the closure of perforations, fistulas, and anastomotic leaks. Several clinical studies, both randomized and nonrandomized, have used endoscopic hemoclips for hemostasis. However, no comparative studies have yet been reported in the literature comparing the latest endoscopic clip devices for usability and effectiveness for hemostasis of acute upper GI hemorrhage. OBJECTIVE: We aimed to compare the usability and efficacy of 3 different types of endoscopic clip application devices in an established experimental setting by using a porcine ex-vivo simulator of upper GI hemorrhage. DESIGN: Randomized, controlled, ex-vivo study. SETTING: Academic medical center. METHODS: Spurting vessels were created within ex-vivo porcine stomachs as published in prior studies. The vessels were attached to a pressure transducer to record the pressure of the circulating blood replacement. Before the initiation of bleeding, each vessel was randomized to 1 of 3 endoscopic clipping devices: 2 different commonly used hemoclips deployed through the working channel and 1 novel clip deployed via an over-the-scope applications device. Two investigators treated 45 bleeding sites (15 bleeding sites for each device at various randomized locations in the stomach: fundus, body, and antrum). MAIN OUTCOME MEASUREMENTS: Usability was measured via the endpoints of procedure time and quantity of clips required to achieve hemostasis. Efficacy was measured via the endpoint of pressure increase (Δp) from baseline to after treatment. RESULTS: All of the 45 hemostasis treatments were carried out successfully. The mean procedure times were significantly different among the hemoclips, with the clip deployed in an over-the-scope fashion requiring significantly less time to attain hemostasis compared with the other 2 clips. For number of clips needed to attain hemostasis, the clip deployed in an over-the-scope fashion was significantly superior to the others. There were also significant differences among the changes in pressure (Δp ± SD) among the different hemoclips tested. LIMITATIONS: Ex-vivo study. CONCLUSIONS: In this prospective, randomized ex-vivo study, we observed significant differences in the usability (time to achieve hemostasis and number of clips required) and the efficacy (change in pressure achieved by the hemoclips) among the 3 clips. The clip applied in the over-the-scope fashion was superior to the other 2 tested clips with regard to time to achieve hemostasis and number of clips required.