"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.

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.).

Multispectral light scattering endoscopic imaging of esophageal precancer.

Esophageal adenocarcinoma is the most rapidly growing cancer in America. Although the prognosis after diagnosis is unfavorable, the chance of a successful outcome increases tremendously if detected early while the lesion is still dysplastic. Unfortunately, the present standard-of-care, endoscopic surveillance, has major limitations, since dysplasia is invisible, often focal, and systematic biopsies typically sample less than one percent of the esophageal lining and therefore easily miss malignancies. To solve this problem we developed a multispectral light scattering endoscopic imaging system. It surveys the entire esophageal lining and accurately detects subcellular dysplastic changes. The system combines light scattering spectroscopy, which detects and identifies invisible dysplastic sites by analyzing light scattered from epithelial cells, with rapid scanning of the entire esophageal lining using a collimated broadband light beam delivered by an endoscopically compatible fiber optic probe. Here we report the results of the first comprehensive multispectral imaging study, conducted as part of routine endoscopic procedures performed on patients with suspected dysplasia. In a double-blind study that characterized the system's ability to serve as a screening tool, 55 out of 57 patients were diagnosed correctly. In addition, a smaller double-blind comparison of the multispectral data in 24 patients with subsequent pathology at locations where 411 biopsies were collected yielded an accuracy of 90% in detecting individual locations of dysplasia, demonstrating the capability of this method to serve as a guide for biopsy.

Light scattering spectroscopy identifies the malignant potential of pancreatic cysts during endoscopy.

Pancreatic cancers are usually detected at an advanced stage and have poor prognosis. About one fifth of these arise from pancreatic cystic lesions. Yet not all lesions are precancerous, and imaging tools lack adequate accuracy for distinguishing precancerous from benign cysts. Therefore, decisions on surgical resection usually rely on endoscopic ultrasound-guided fine needle aspiration (EUS-FNA). Unfortunately, cyst fluid often contains few cells, and fluid chemical analysis lacks accuracy, resulting in dire consequences, including unnecessary pancreatic surgery for benign cysts and the development of cancer. Here, we report an optical spectroscopic technique, based on a spatial gating fibre-optic probe, that predicts the malignant potential of pancreatic cystic lesions during routine diagnostic EUS-FNA procedures. In a double-blind prospective study in 25 patients, with 14 cysts measured in vivo and 13 postoperatively, the technique achieved an overall accuracy of 95%, with a 95%confidence interval of 78-99%, in cysts with definitive diagnosis.

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.

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.

The location of obstruction predicts stent occlusion in malignant gastric outlet obstruction.

BACKGROUND: Gastric outlet obstruction (GOO) can occur with locally invasive or metastatic cancer involving the upper gastrointestinal tract at the pylorus or the duodenum. Endoscopic management with self-expanding metal stents (SEMSs) is often the preferred palliative approach. Stent occlusion is a common reason for failure and reintervention. We set out to determine whether the location of the malignant obstruction is associated with the angulation of the stent and can predict stent occlusion. METHODS: We performed a retrospective review of consecutive patients who underwent successful duodenal stenting with SEMS for malignant GOO between 2006 and 2015 at a large advanced endoscopy referral center. We determined the location of obstruction, the stent angle, and the rate of technical and clinical success of stent placement. We then identified cases of subsequent stent occlusion confirmed by endoscopic evaluation. RESULTS: A total of 100 consecutive patients were included in the study; 91 of these patients had enough data to evaluate SEMS occlusion. A total of 21 patients (23%) developed stent occlusion with a median time of 39 days. The risk of occlusion sequentially increased as the obstruction occurred more distally from the antrum to the third or fourth portion of the duodenum (p = 0.006). This relationship was maintained after controlling for stent angle (p = 0.05). CONCLUSIONS: A distal location of malignant GOO was strongly predictive of stent occlusion, independent of stent angle. This may be due to longer and more complex distal obstructions, along with foreshortening of the stent during placement and tumor infiltration. If replicated, these results will have implications for endoscopic practice and future device development.

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.

Elipse™, a Procedureless Gastric Balloon for Weight Loss: a Proof-of-Concept Pilot Study.

BACKGROUND: Endoscopic gastric balloons have been used effectively as weight loss devices for decades, but the requirement for endoscopy and sedation poses several limitations. The goal of this pilot study was to evaluate the safety and performance of a prototype version of Elipse™, a procedureless gastric balloon. METHODS: Eight patients (mean BMI = 31.0 kg/m(2)) participated in this study. Each patient swallowed one Elipse™ balloon intended to remain in the stomach for 6 weeks, self-empty, and then pass. Each balloon was filled with 450 mL of filling fluid. Patients returned every 2 weeks for abdominal ultrasound. No specific diet or exercise plan was prescribed. RESULTS: All eight patients successfully swallowed the device. The most common adverse events were nausea and vomiting. There were no serious adverse events, and all balloons were excreted safely. Despite not being prescribed a diet or exercise plan, all eight patients lost weight. In 6/8 patients, the balloon remained full through 6 weeks, self-emptied, and passed. In one patient, the balloon appeared partially collapsed on ultrasound after 11 days and was endoscopically punctured. One asymptomatic patient elected to have the balloon endoscopically punctured after 19 days. Both balloons passed in the stool after 4 days. In both cases, endoscopic examination of the upper GI tract showed no abnormalities. CONCLUSIONS: This pilot study demonstrates the safety and performance of Elipse™, a procedureless gastric balloon for weight loss. Future studies will test a commercial design filled to 550 mL intended to last in the stomach for at least 12 weeks.

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.

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.

Prospective randomized comparison of gastrotomy closure associating tunnel access and over-the-scope clip (OTSC) with two other methods in an experimental ex vivo setting.

BACKGROUND: Safe transgastric natural orifice transluminal endoscopic surgery (NOTES) procedures require a reliable closure of the gastrotomy. Recently a novel peritoneal access method via a submucosal tunnel has been described with encouraging preliminary results. AIM: The aim is to compare a submucosal tunnel access plus over-the-scope clip (OTSC) system for closure with two other closure modalities. PATIENTS AND METHODS: This is a prospective ex vivo study conducted on 42 porcine stomach models equally randomized into three groups in an academic medical center. The procedures performed in each group included: (1) Tunnel (6 cm) + endoclips; (2) Knife + balloon dilation access + OTSC; and (3) Tunnel + OTSC. A pressurized air-leak test was performed to evaluate the strength of the closure. Stomach volumes, procedure times, number of clips, and incision sizes were also registered. RESULTS: The mean air-leak pressure was statistically higher in Group 3 than in Groups 1 and 2-95.2 ±â€Š19.3 mmHg versus 72.5 ±â€Š35.2 and 79.0 ±â€Š24.5 mmHg (P < 0.05). The gastrotomy creation times for Groups 1, 2, and 3 were 28.0 ±â€Š10.1, 4.3 ±â€Š1.4, and 20.1 ±â€Š10.6 minutes, respectively, with significantly lower time in Group 2 (P < 0.001). The closure times were 16.1 ±â€Š6.1, 6.5 ±â€Š1.2, and 5.3 ±â€Š3.0 minutes, respectively, and significantly longer in the endoclip group (P < 0.001). There were no differences in the volumes and the incision sizes among the three groups. CONCLUSION: The combination of a submucosal tunnel access and OTSC offers a stronger closure than the other methods studied.

Erratum: Prospective randomized comparison of gastrotomy closure associating tunnel access and over-the-scope clip (OTSC) with two other methods in an experimental ex vivo setting.

[This corrects the article DOI: 10.1055/s-0034-1390794.].

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.

A meta-analysis on efficacy and safety: single-balloon vs. double-balloon enteroscopy.

BACKGROUND AND AIM: Double-balloon enteroscopy (DBE) and single-balloon enteroscopy (SBE) are new techniques capable of providing deep enteroscopy. Results of individual studies comparing these techniques have not been able to identify a superior strategy. Our aim was to systematically pool all available studies to compare the efficacy and safety of DBE with SBE for evaluation of the small bowel. METHODS: Databases were searched, including PubMed, Embase, and the Cochrane Central Register of Controlled Trials. The main outcome measures were complete small-bowel visualization, diagnostic yield, therapeutic yield, and complication rate. Statistical analysis was performed using Review Manager (RevMan version 5.2). Meta-analysis was performed using fixed-effect or random-effect methods, depending on the absence or presence of significant heterogeneity. We used the χ(2) and I(2) test to assess heterogeneity between trials. Results were expressed as risk ratios (RR) or mean differences with 95% confidence intervals (CI). RESULTS: Four prospective, randomized, controlled trials with a total of 375 patients were identified. DBE was superior to SBE for visualization of the entire small bowel [pooled RR = 0.37 (95% CI: 0.19-0.73; P = 0.004)]. DBE and SBE were similar in ability to provide diagnosis [pooled RR = 0.95 (95% CI: 0.77-1.17; P = 0.62)]. There was no significant difference between DBE and SBE in therapeutic yield [pooled RR = 0.78 (95% CI: 0.59-1.04; P = 0.09)] and complication rate [pooled RR = 1.08 (95% CI: 0.28-4.22); P = 0.91]. CONCLUSIONS: DBE was superior to SBE with regard to complete small bowel visualization. DBE was similar to SBE with regard to diagnostic yield, ability to provide treatment and complication rate, but these results should be interpreted with caution as they is based on very few studies and the overall quality of the evidence was rated as low to moderate, due to the small sample size.

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.

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.