International remote collaboration enabled inaugural endoscopic sleeve gastroplasty in Japan.

Obesity causes multiple conditions such as type 2 diabetes, cardiovascular disease, and so on, and an intervention is needed for controlling weight and improving metabolic syndrome. However, the effectiveness of lifestyle interventions and pharmacotherapy are restrictive for losing weight. Endoscopic sleeve gastroplasty (ESG) was developed as a new therapy, picking the best of both medication and surgery, less invasive and more effective. Recently, ESG is gradually spreading in Western countries, but there is Case report doesn't need conclusion/result for Japanese patients. We herein reported the first clinical case of ESG in Japan. Given the situation of the pandemic of COVID-19, we could not invite a proctor from Western countries and receive the instruction of the device setting and maneuver face to face. Thus, we conducted the training for device setting, maneuver, and operation under a web-based international remote collaboration. Eventually, we completed ESG without an adverse event. We could prove this web-based proctor system was useful through the introduction of ESG in Japan. The international remote collaboration could become a new normal even in the endoscopy field post-COVID-19 era.

Predictors of Jaundice Resolution and Survival After Endoscopic Treatment of Primary Sclerosing Cholangitis.

The benefit of endoscopic retrograde cholangiopancreatography (ERCP) for the treatment of primary sclerosing cholangitis (PSC) remains controversial. To identify predictors of jaundice resolution after ERCP and whether resolution is associated with improved patient outcomes, we conducted a retrospective cohort study of 124 patients with jaundice and PSC. These patients underwent endoscopic biliary balloon dilation and/or stent placement at an American tertiary center, with validation in a separate cohort of 102 patients from European centers. Jaundice resolved after ERCP in 52% of patients. Median follow-up was 4.8 years. Independent predictors of jaundice resolution included older age (P = 0.048; odds ratio [OR], 1.03 for every 1-year increase), shorter duration of jaundice (P = 0.059; OR, 0.59 for every 1-year increase), lower Mayo Risk Score (MRS) (P = 0.025; OR, 0.58 for every 1-point increase), and extrahepatic location of the most advanced biliary stricture (P = 0.011; OR, 3.13). A logistic regression model predicted jaundice resolution with area under the receiver operator characteristic curve of 0.67 (95% confidence interval, 0.5-0.79) in the validation set. Independent predictors of death or transplant during follow-up included higher MRS at the time of ERCP (P < 0.0001; hazard ratio [HR], 2.33 for every 1-point increase), lower total serum bilirubin before ERCP (P = 0.031; HR, 0.91 for every 1 mg/dL increase), and persistence of jaundice after endoscopic therapy (P = 0.003; HR, 2.30). Conclusion: Resolution of jaundice after endoscopic treatment of biliary strictures is associated with longer transplant-free survival of patients with PSC. The likelihood of resolution is affected by demographic, hepatic, and biliary variables and can be predicted using noninvasive data. These findings may refine the use of ERCP in patients with jaundice with PSC.

Randomized Phase II Trial of Polyphenon E versus Placebo in Patients at High Risk of Recurrent Colonic Neoplasia.

Polyphenon E (Poly E) is a green tea polyphenol preparation whose most active component is epigallocatechin gallate (EGCG). We studied the cancer preventive efficacy and safety of Poly E in subjects with rectal aberrant crypt foci (ACF), which represent putative precursors of colorectal cancers. Eligible subjects had prior colorectal advanced adenomas or cancers, and had ≥5 rectal ACF at a preregistration chromoendoscopy. Subjects (N = 39) were randomized to 6 months of oral Poly E (780 mg EGCG) daily or placebo. Baseline characteristics were similar by treatment arm (all P >0.41); 32 of 39 (82%) subjects completed 6 months of treatment. The primary endpoint was percent reduction in rectal ACF at chromoendoscopy comparing before and after treatment. Among 32 subjects (15 Poly E, 17 placebo), percent change in rectal ACF number (baseline vs. 6 months) did not differ significantly between study arms (3.7% difference of means; P = 0.28); total ACF burden was also similar (-2.3% difference of means; P = 0.83). Adenoma recurrence rates at 6 months were similar by arm (P > 0.35). Total drug received did not differ significantly by study arm; 31 (79%) subjects received ≥70% of prescribed Poly E. Poly E was well tolerated and adverse events (AE) did not differ significantly by arm. One subject on placebo had two grade 3 AEs; one subject had grade 2 hepatic transaminase elevations attributed to treatment. In conclusion, Poly E for 6 months did not significantly reduce rectal ACF number relative to placebo. Poly E was well tolerated and without significant toxicity at the dose studied. PREVENTION RELEVANCE: We report a chemoprevention trial of polyphenon E in subjects at high risk of colorectal cancer. The results show that polyphenon E was well tolerated, but did not significantly reduce the number of rectal aberrant crypt foci, a surrogate endpoint biomarker of colorectal cancer.

Efficacy of Difluoromethylornithine and Aspirin for Treatment of Adenomas and Aberrant Crypt Foci in Patients with Prior Advanced Colorectal Neoplasms.

Difluoromethylornithine (DFMO), an inhibitor of polyamine synthesis, was shown to act synergistically with a NSAID for chemoprevention of colorectal neoplasia. We determined the efficacy and safety of DFMO plus aspirin for prevention of colorectal adenomas and regression of rectal aberrant crypt foci (ACF) in patients with prior advanced adenomas or cancer. A double-blinded, placebo-controlled trial was performed in 104 subjects (age 46-83) randomized (1:1) to receive daily DFMO (500 mg orally) plus aspirin (325 mg) or matched placebos for one year. All polyps were removed at baseline. Adenoma number (primary endpoint) and rectal ACF (index cluster and total) were evaluated at a one year colonoscopy. ACF were identified by chromoendoscopy. Toxicity was monitored, including audiometry. Eighty-seven subjects were evaluable for adenomas or ACF modulation (n = 62). At one year of treatment, adenomas were detected in 16 (38.1%) subjects in the DFMO plus aspirin arm (n = 42) versus 18 (40.9%) in the placebo arm (n = 44; P = 0.790); advanced adenomas were similar (n = 3/arm). DFMO plus aspirin was associated with a statistically significant reduction in the median number of rectal ACF compared with placebo (P = 0.036). Total rectal ACF burden was also reduced in the treatment versus the placebo arm relative to baseline (74% vs. 45%, P = 0.020). No increase in adverse events, including ototoxicity, was observed in the treatment versus placebo arms. While adenoma recurrence was not significantly reduced by one year of DFMO plus aspirin, the drug combination significantly reduced rectal ACF number consistent with a chemopreventive effect.

An internal magnet traction device reduces procedure time for endoscopic submucosal dissection by expert and non-expert endoscopists: ex vivo study in a porcine colorectal model (with video).

BACKGROUND: Efficacy of an internal magnet traction device (MTD) for gastric endoscopic submucosal dissection (ESD) by an expert endoscopist has been reported. We hypothesized that use of the MTD would enhance the performance of colorectal ESD in a non-expert endoscopist in ESD compared to the conventional technique. Primary aim of this study was to compare procedure times between conventional ESD (C-ESD) and MTD-assisted ESD (MTD-ESD) by expert and non-expert endoscopists in ESD. Secondary aims included rate of en bloc resection, iatrogenic injury, visualization score of the submucosal layer, and endoscopist satisfaction score. METHODS: A total of 56 lesions were created in an ex vivo porcine colorectum. Two endoscopists completed C-ESD (n = 28) and MTD-ESD (n = 28). Lesions measured 3 cm in diameter and were located on either the anterior or posterior colorectal wall. The MTD consisted of a small neodymium magnet and nylon monofilament attached to a through-the-scope clip. The first MTD was deployed on the opposing colorectal wall of the target lesion and a second MTD was then deployed directly onto the distal margin of the lesion. RESULTS: Total procedure time for MTD-ESD was significantly shorter than C-ESD for both expert (median: 15.8 vs. 19.3 min, p < 0.05) and non-expert (median: 21.3 vs. 33.9 min, p < 0.001) endoscopists. All lesions were resected en bloc. There was no iatrogenic muscularis propria injury in the MTD-ESD group. For both the expert and non-expert, scores for MTD-ESD were significantly higher for submucosal layer visualization (p < 0.05) and endoscopist satisfaction (p < 0.001) compared to C-ESD. CONCLUSIONS: Use of the MTD significantly reduced procedure time for both expert and non-expert endoscopists performing ESD. Improving the efficiency, safety, and satisfaction of ESD with such a device particularly for non-expert endoscopists is appealing and could potentially minimize the complexity and duration of the procedure allowing for more widespread use of the technique.

Patient-oriented education and visual-aid intervention are inadequate to identify patients with potential capsule retention: a prospective randomized study.

Background/aims: The key procedure-related risk with video capsule endoscopy (VCE) is capsule retention, which should be suspected in patients who have not reported capsule passage. The study aims were to determine the frequency of capsule passage visualization and the difference in self-reporting of capsule passage between patients who receive patient-oriented education (POE) and patients who receive POE and a visual aid intervention in the form of a wrist band (WB). Methods: This was a prospective randomized study that enrolled patients undergoing VCE. Patients were randomly assigned to a POE group versus a POE and WB group. POE consisted of verbal education and an information booklet. Both groups received instructions to notify the study team regarding capsule passage. Results: Sixty patients (mean age 57 ± 18 years; 61% female) were included. A total of 57 patients were included in the analysis (3 lost to follow-up; 28 in POE group; 29 in WB group). Capsule passage status was reported by 68% without significant difference between POE and WB groups (72% vs. 64%; p = .51). Capsule passage status was obtained from all 57 patients with the addition of a proactive follow-up. Only 56% (n = 32) reported visualizing capsule passage. Of the remaining patients who did not visualize capsule passage, 60% (n = 15) reported on this without significant difference between the POE and WB groups (p = .23). Conclusions: Lack of visualization of capsule passage is a poor indicator of retention. Self-reporting of VCE passage status is suboptimal and the addition of a visual aid did not improve this parameter.

Narrow band imaging evaluation of duodenal villi in patients with and without celiac disease: A prospective study.

BACKGROUND: Duodenal biopsies are commonly obtained during esophagogastroduodenoscopy (EGD) but are very often histopathologically normal. Therefore, a more strategic method for evaluating the duodenal mucosa and avoiding unnecessary biopsies is needed. AIM: To examine the clinical utility of narrow band imaging (NBI) for evaluating duodenal villous morphology. METHODS: We performed a prospective cohort study of adult patients at Mayo Clinic Rochester from 2013-2014 who were referred for EGD with duodenal biopsies. A staff endoscopist scored, in real-time, the NBI-based appearance of duodenal villi into one of three categories (normal, partial villous atrophy, or complete villous atrophy), captured ≥ 2 representative duodenal NBI images, and obtained mucosal biopsies therein. Images were then scored by an advanced endoscopist and gastroenterology fellow, and biopsies (gold standard) by a pathologist, in a masked fashion using the same three-category classification. Performing endoscopist, advanced endoscopist, and fellow NBI scores were compared to histopathology to calculate performance characteristics [sensitivity, specificity, positive and negative, negative predictive value (NPV), and accuracy]. Inter-rater agreement was assessed with Cohen's kappa. RESULTS: 112 patients were included. The most common referring indications were dyspepsia (47%), nausea (23%), and suspected celiac disease (14%). Duodenal histopathology scores were: 84% normal, 11% partial atrophy, and 5% complete atrophy. Performing endoscopist NBI scores were 79% normal, 14% partial atrophy, and 6% complete atrophy compared to 91%, 5%, and 4% and 70%, 24%, and 6% for advanced endoscopist and fellow, respectively. NBI performed favorably for all raters, with a notably high (92%-100%) NPV. NBI score agreement was best between performing endoscopist and fellow (κ = 0.65). CONCLUSION: NBI facilitates accurate, non-invasive evaluation of duodenal villi. Its high NPV renders it especially useful for foregoing biopsies of histopathologically normal duodenal mucosa.

Efficacy and safety of an internal magnet traction device for endoscopic submucosal dissection: ex vivo study in a porcine model (with video).

BACKGROUND: Appropriate traction allows for safer and easier endoscopic submucosal dissection (ESD). The aim of this study was to evaluate the efficacy and safety of an internal magnet traction device (MTD) for ESD in an ex vivo porcine model. METHODS: The MTD consisted of a small neodymium magnet and a suture attached to a through-the-scope clip. A circumferential mucosal incision was completed around a 30-mm diameter template that served as the target lesion. The first MTD was deployed at the proximal edge of the lesion. A second MTD was deployed on the wall opposite the lesion. With both magnets connected, this created traction or lifting of the target lesion towards the opposing wall during submucosal dissection. Primary endpoint was comparison of submucosal dissection times between conventional ESD (C-ESD) and MTD-assisted ESD (MTD-ESD). RESULTS: Twenty lesions along the anterior wall, posterior wall and greater curvature were resected using either C-ESD or MTD-ESD. The submucosal dissection time in MTD-ESD was significantly shorter than C-ESD (median: 6.4 [interquartile range {IQR} 4.6-8.7] min vs. 14.4 min [IQR 11.8-18.0], p < 0.05). There was a significant difference between MTD-ESD and C-ESD in total procedure times for lesions on the posterior gastric wall and greater curvature (median: 23.0 min [IQR 21.1-24.5] vs. 29.2 min [IQR 24.8-33.2], p < 0.05) with no difference for lesions on the anterior gastric wall (median: 18.8 min [IQR 15.5-20.5] vs. 17.1 min [IQR 13.1-20.0], p = 0.5). The number of muscularis propria injuries per lesion was significantly lower in MTD-ESD than C-ESD (median: 0 [IQR 0-0] vs. 1 [IQR 0-2], p < 0.05). CONCLUSIONS: MTD for ESD is effective and safe when compared to C-ESD. This approach significantly reduced submucosal dissection times with less injury to the muscularis propria. Furthermore, MTD-ESD was particularly beneficial for more challenging gastric lesions located on the posterior wall and greater curvature.

Endoscopic magnet placement into subadventitial tunnels for augmenting the lower esophageal sphincter using submucosal endoscopy: ex vivo and in vivo study in a porcine model (with video).

BACKGROUND AND AIMS: Endolumenal therapies serve as a treatment option for GERD. This study aimed to determine if magnets could be placed endoscopically using the adventitial layer to create a subadventitial space near the esophagogastric junction to augment the lower esophageal sphincter using submucosal endoscopy. METHODS: This study consisted of 2 phases, ex vivo and in vivo, with domestic pig esophagus. A long submucosal tunnel was made at the mid to lower esophagus. The muscularis propria was incised by a needle-knife within the submucosal tunnel. A subadventitial tunnel was made by biliary balloon catheter blunt dissection, and a magnet was deployed in the subadventitial space. The same maneuver was done within the opposing esophageal wall, with magnet placement in the opposing subadventitial space. RESULTS: Submucosal tunnels and subadventitial tunnels were successful without perforation ex vivo in all attempts and in 9 of 10 cases, respectively. Magnets were deployed in the subadventitial space in 7 cases. Magnets connected and separated with atraumatic endoscope passage into the stomach and reconnected when the endoscope was withdrawn under fluoroscopy in 5 of 7 cases (71.4%). In vivo submucosal tunnels and subadventitial tunnels were successful in all 5 cases, and magnet augmentation was functionally active in 4 cases (80%). CONCLUSION: Subadventitial tunnels were feasible and could represent a new working space for endoscopic treatment. Endoscopic placement of magnets within the subadventitial space may be an attractive alternative endolumenal therapy for GERD.

Endoscopic augmentation of gastroesophageal junction using a full-thickness endoscopic suturing device.

Background and study aims This preliminary study was conducted to determine the feasibility and safety of endoscopic augmentation of the gastroesophageal junction (GEJ) using the Apollo OverStitch endoscopic suturing system in patients with gastroesophageal reflux disease (GERD) symptoms. Patients and methods Endoscopic augmentation of GEJ was performed on 10 consecutive patients and the data were analyzed retrospectively. Using a double-channel gastroscope affixed to the endoscopic suturing platform, interrupted sutures were placed on the gastric side of the GEJ in 2 layers in order to create a narrowed and elongated GEJ. Results Technical success was achieved in all patients, including those with a history of previous antireflux procedures (n = 7) and those with a hiatal hernia (n = 6). The median follow-up duration was 5 mo (range: 2 - 12). The median pre-procedure GERD-Health Related Quality of Life Questionnaire improved from 20 (range: 11 - 45) to a post-procedure score of 6 (range: 3 - 25) ( P  = 0.001). The median duration of GERD symptom improvement after the procedure was 1 mo (range: 0.5 - 4). Adverse events were limited to 1 patient who developed nausea and vomiting, which was self-limited. Conclusions The use of a novel endoscopic suturing technique for the treatment of GERD is feasible and safe. The procedure resulted in short-term GERD symptom improvement. Further prospective studies using refined techniques are currently underway to improve durability and to prove efficacy.

A novel percutaneous magnetically guided gastrostomy technique without endoscopy or imaging guidance: a feasibility study in a porcine model.

BACKGROUND: In order to simplify a percutaneous gastrostomy procedure and avoid the need of endoscopy or imaging methods, a novel percutaneous magnetically guided gastrostomy (PMG) technique was conceived. The aim of the present study is to evaluate the feasibility of a novel PMG technique with no endoscopy or any imaging guidance in a porcine model. METHODS: Fourteen crossbred domestic pigs were used for prototype development (cadaveric experiments) and proof-of concept, survival study. The magnetic device was conceived using commercially available rare-earth neodymium-based magnets. The experimental design consisted of developing an internal magnetic gastric tube prototype to be orally inserted and coupled to an external magnet placed on the skin, which facilitated stomach and abdominal wall apposition for blind percutaneous gastrostomy tube placement. Then, a gastrostomy tube was percutaneously and blindly placed. RESULTS: Twelve procedures were undertaken in animal cadavers and two in live models. The technique chosen consisted of using a magnetic gastric tube prototype using six 1 × 1-cm-ring magnets attached to its end. This device enabled successful magnetic coupling with a large (5 cm in diameter) magnet disc placed on the skin. For gastric tube placement, a direct trocar insertion allowed easier and safer placement of a gastric tube as compared to a needle-guide-wire dilation (Seldinger-based) technique. Gastropexy was added to avoid early gastric tube displacement. This novel PMG technique was feasible in a live model experiment. CONCLUSIONS: A novel magnetically guided percutaneous gastrostomy tube insertion technique without the use of endoscopy or image-guidance was successful in a porcine model. A non-inferiority experimental controlled study comparing this technique to percutaneous endoscopic gastrostomy is needed to confirm its efficacy and safety.

Dominant strictures in primary sclerosing cholangitis: A multicenter survey of clinical definitions and practices.

Dominant strictures (DSs) of the biliary tree occur in approximately 50% of patients with primary sclerosing cholangitis (PSC) and may cause significant morbidity. Nevertheless, the definition and management of DSs lacks consensus. We aimed to better understand current perceptions and practices regarding PSC-associated DSs. We conducted an anonymous, 23-question, survey-based study wherein electronic surveys were distributed to 131 faculty in the Division of Gastroenterology and Hepatology at the three Mayo Clinic campuses (Rochester, Scottsdale, and Jacksonville) as well as the affiliated practice network. Responses were aggregated and compared, where applicable, to practice guidelines of the American Association for the Study of Liver Diseases and European Association for the Study of the Liver. A total of 54 faculty (41.2%) completed the survey, of whom 24 (44.4%) were hepatologists, 21 (38.9%) gastroenterologists, and 9 (16.7%) advanced endoscopists. One of the major study findings was that there was heterogeneity among participants' definition, evaluation, management, and follow-up of DSs in PSC. The majority of participant responses were in accordance with societal practice guidelines, although considerable variation was noted. Conclusion: Despite the prevalence and morbidity of DSs in PSC, clinical perceptions and practices vary widely among hepatologists, gastroenterologists, and advanced endoscopists who manage these patients, even within a single health care system. Further studies are needed to address these variations, develop general and evidence-based consensus, and increase adherence to societal guidelines. (Hepatology Communications 2018;2:836-844).

Single Fluid-Filled Intragastric Balloon Safe and Effective for Inducing Weight Loss in a Real-World Population.

BACKGROUND & AIMS: The Orbera intragastric balloon (OIB) is a single fluid-filled intragastric balloon approved for the induction of weight loss and treatment of obesity. However, little is known about the effectiveness and safety of the OIB outside clinical trials, and since approval, the Food and Drug Administration has issued warnings to health care providers about risk of balloon hyperinflation requiring early removal, pancreatitis, and death. We analyzed data on patients who have received the OIB since its approval to determine its safety, effectiveness, and tolerance in real-world clinical settings. METHODS: We performed a postregulatory approval study of the safety and efficacy of the OIB, and factors associated with intolerance and response. We collected data from the Mayo Clinic's database of patient demographics, outcomes of OIB placement (weight loss, weight-related comorbidities), technical aspects of insertion and removal, and adverse events associated with the device and/or procedure, from 8 centers (3 academic, 5 private, 4 surgeons, and 4 gastroenterologists). Our final analysis comprised 321 patients (mean age, 48.1 ± 11.9 y; 80% female; baseline body mass index, 37.6 ± 6.9). Exploratory multivariable linear and logistic regression analyses were performed to identify predictors of success and early balloon removal. Primary effectiveness outcomes were percentage of total body weight lost at 3, 6, and 9 months. Primary and secondary safety outcomes were rates of early balloon removal, periprocedural complications, dehydration episodes requiring intravenous infusion, balloon migration, balloon deflation or hyperinflation, pancreatitis, or other complications. RESULTS: Four patients had contraindications for placement at the time of endoscopy. The balloon was safely removed in all instances with an early removal rate (before 6 months) in 16.7% of patients, at a median of 8 weeks after placement (range, 1-6 mo). Use of selective serotonin or serotonin-norepinephrine re-uptake inhibitors at the time of balloon placement was associated with increased odds of removal before 6 months (odds ratio, 3.92; 95% CI, 1.24-12.41). Total body weight lost at 3 months was 8.5% ± 4.9% (n = 204), at 6 months was 11.8% ± 7.5% (n = 199), and at 9 months was 13.3% ± 10% (n = 47). At 6 months, total body weight losses of 5%, 10%, and 15% were achieved by 88%, 62%, and 31% of patients, respectively. Number of follow-up visits and weight loss at 3 months were associated with increased weight loss at 6 months (ß = 0.5 and 1.2, respectively) (P < .05). Mean levels of cholesterol, triglycerides, low-density lipoprotein, and hemoglobin A1c, as well as systolic and diastolic blood pressure, were significantly improved at 6 months after OIB placement (P < .05). CONCLUSIONS: In an analysis of a database of patients who received endoscopic placement of the OIB, we found it to be safe, effective at inducing weight loss, and to reduce obesity-related comorbidities in a real-world clinical population. Rates of early removal (before 8 weeks) did not differ significantly between clinical trials and the real-world population, but were affected by use of medications.

Efficacy of Over-the-Scope Clips in Management of High-Risk Gastrointestinal Bleeding.

BACKGROUND & AIMS: Standard endoscopic therapies do not control bleeding or produce complications in as many as 20% of patients with nonvariceal gastrointestinal bleeding. Most bleeding comes from ulcers with characteristics such as high-risk vascular territories and/or large vessels. We evaluated the efficacy of using over-the-scope clips (OTSCs) as primary or rescue therapy for patients with bleeding from lesions that have a high risk for adverse outcomes. METHODS: We performed a retrospective analysis of data from 67 patients with gastrointestinal bleeding from high-risk lesions who were treated with OTSCs as primary (n = 49) or rescue therapy (n = 18) at a quaternary center, from December 2011 through February 2015. The definition of high-risk lesions was lesions that were situated in the area of a major artery and larger than 2 mm in diameter and/or a deep penetrating, excavated, fibrotic ulcer with high-risk stigmata, in which a perforation could not be ruled out or thermal therapy would cause perforation, or lesions that could not be treated by standard endoscopy. Clinical severity was determined based on the Rockall score and a modified Blatchford score. Our primary outcome was the incidence of rebleeding within 30 days after OTSC placement. We assessed risk factors for rebleeding using univariate hazard models followed by multivariable analysis. RESULTS: Of the 67 patients, 47 (70.1%) remained free of rebleeding at 30 days after OTSC placement. We found no difference in the proportion of patients with rebleeding who received primary or rescue therapy (hazard ratio, 0.639; 95% confidence interval, 0.084-4.860; P = .6653). Only 9 rebleeding events were linked clearly to OTSCs and required intervention, indicating an OTSC success rate of 81.3%. We found no significant associations between rebleeding and clinical scores. However, on multivariable analysis, patients with coronary artery disease had a higher risk of rebleeding after OTSC independent of international normalized ratio and antiplatelet use (hazard ratio, 7.30; P = .0002). CONCLUSIONS: In a retrospective analysis of 67 patients with bleeding from high-risk gastrointestinal lesions, we found OTSCs to prevent rebleeding in more than 80% of cases. In the past, these lesions were treated with surgical or radiologic interventions. Patients with coronary artery disease have an increased risk of rebleeding after OTSCs, suggesting the need for escalated therapies.

Endoscopic full-thickness resection using suture loop needle T-tag tissue anchors in the porcine stomach (with video).

BACKGROUND AND AIMS: Endoscopic full-thickness resection (EFTR) is still challenging, and a reliable technique is desirable. The aim of this study was to evaluate the feasibility of controlled EFTR using a pseudopolyp made from suture loop needle T-tag (SLNT) tissue anchors in ex vivo porcine stomachs. METHODS: Five pig stomachs were used. Two concentric circumferential border mucosal incisions were made to facilitate isolating a target lesion for full-thickness excision and pseudopolyp formation. SLNT tissue anchors were placed with a fishing line around the edges of the larger outer incision by endoscopic suturing. A suture pulley was created in the center of the targeted area and brought outside for traction. A large inverted pseudopolyp of the targeted lesion was made, visualizing apposing serosa with traction on the suture pulley while simultaneously cinching the encircling fishing line. EFTR was then performed on the isolated targeted tissue with the use of a needle-knife. RESULTS: Pseudopolyps were successful in all attempts. In the first attempt the encircling fishing line was cut, releasing the pseudopolyp during EFTR, with obvious leak. The remaining 4 EFTRs were performed with intact serosal apposing pseudopolyps and no air leaks. The median number of SLNT tissue anchors placed for a pseudopolyp was 5 (interquartile range, 4-5). The median size of full-thickness lesions was 37 mm (interquartile range, 29-49) and the median maximum pressure for the leak testing 9 mm Hg (interquartile range, 4-14) in the successful 4 attempts. CONCLUSION: This proof of principle study suggests that EFTR with SLNT-fashioned pseudopolyps is feasible.

Endoscopic muscle biopsy sampling of the duodenum and rectum: a pilot survival study in a porcine model to detect myenteric neurons.

BACKGROUND AND AIMS: Small bowel and colorectal muscle biopsy sampling requires a surgical approach. Advancing our understanding of the pathophysiology of motility disorders, such as functional bowel disorders, intestinal pseudo-obstruction, and slow-transit constipation, is hindered by our inability to noninvasively obtain muscularis propria (MP) for evaluation of multiple cell types, including myenteric neurons. The aims of this study were to determine (1) technical feasibility, reproducibility, and safety of performing duodenal endoscopic muscle biopsy sampling (dEMB) and rectal endoscopic muscle biopsy sampling (rEMB) using a clip-assist technique and (2) the presence of myenteric neurons in tissue samples. METHODS: Five 40-kg pigs were studied. Each animal underwent a dEMB and rEMB procedure. dEMB was performed using a single resection clip-assist technique. An over-the-scope clip was advanced to the duodenum. Tissue was suctioned into the cap and the clip deployed. The pseudopolyp of the duodenal wall created was then resected using snare electrocautery. rEMB was performed using a double resection clip-assist technique. EMR was initially performed to uncover the underlying MP using a band ligation technique. An over-the-scope clip was then advanced to the exposed MP. The MP was retracted and suctioned into the cap and the clip deployed. The pseudopolyp of the MP was resected using snare electrocautery. An antibody to protein gene product 9.5 was used to determine the presence of myenteric neurons in the samples. Animals were kept alive for 2 weeks, at which time an upper endoscopy and necropsy were performed. RESULTS: dEMB and rEMB were successfully performed in all animals with no procedural adverse events using this "no hole" (close then cut) approach. Mean procedure times for dEMB and rEMB were 23.7 ± 2.5 minutes and 13.25 ± 2.8 minutes, respectively. Mean length of resected full-thickness duodenal wall was 13.25 ± 4.3 mm and rectal MP was 12.5 ± 1.7 mm. Hematoxylin and eosin stain and antibody to protein gene product 9.5 confirmed the presence of MP with inner circular, outer longitudinal, and intermuscular layers, including myenteric neurons, in all samples. Clinical course was uneventful in all animals. Repeat upper endoscopy at 2 weeks showed well-healed dEMB sites. Necropsy in all animals showed no perforation, fluid collection, or abscess at the dEMB and rEMB sites. CONCLUSIONS: Based on this preclinical study, dEMB and rEMB appear to be technically feasible, reproducible, and safe. Sufficient MP tissue was obtained to identify myenteric neurons. These promising results are a step toward successful and safe implementation of these techniques into clinical practice for tissue diagnosis of muscle-based pathologies.

Transoral outlet reduction with full thickness endoscopic suturing for weight regain after gastric bypass: a large multicenter international experience and meta-analysis.

BACKGROUND AND AIMS: Many patients who undergo bariatric surgery will experience weight regain and effective strategies are needed to help these patients. A dilated gastrojejunal anastomosis (GJA) has been associated with weight recidivism after Roux-en-Y gastric bypass surgery (RYGB). Endoscopic transoral outlet reduction (TORe) with a full thickness endoscopic suturing device (Overstitch, Apollo Endosurgery, Austin, TX) is a minimally invasive therapeutic option. The primary aim of this project was to examine the safety and long-term efficacy data from three bariatric surgery centers and to conduct a systematic review and meta-analysis of the existing literature. METHODS: Patients who underwent TORe with the Overstitch device from Jan 2013 to Nov 2016 at 3 participating bariatric surgery centers were included in the multicenter analysis. For the systematic review and meta-analysis, a comprehensive search of multiple English databases was conducted. Random effects model was used. RESULTS: 130 consecutive patients across three centers underwent TORe with an endolumenal suturing device. These patients (mean age 47; mean BMI 36.8) had experienced 24.6% weight regain from nadir weight after RYGB. Average weight lost at 6, 12, and 18 months after TORe was 9.31 ± 6.7 kg (N = 84), 7.75 ± 8.4  kg (N = 70), 8 ± 8.8 kg (N = 46) (p < 0.01 for all three time points), respectively. The meta-analysis included 330 patients. The pooled weight lost at 12 months was 8.4 kg (95% CI 6.5-10.3) with no significant heterogeneity across included studies (p = 0.07). Overall, 14% of patients experienced nausea, 18% had pain and 8% required a repeat EGD. No serious adverse events reported. CONCLUSION: When implemented as part of a multidisciplinary intervention, TORe using endolumenal suturing is safe, reproducible, and effective approach to manage weight recidivism after RYGB and should be utilized early in the management algorithm of these patients.

Randomized controlled trial comparing submucosal endoscopy with mucosal resection and endoscopic submucosal dissection in the esophagus and stomach: Animal study.

BACKGROUND AND AIM: In Western countries, endoscopic submucosal dissection (ESD) has not prevailed as a result of training problems and a target patient population. We have previously reported a hybrid ESD technique, submucosal endoscopy with mucosal resection (SEMR), in which the submucosal dissection is carried out chiefly by blunt balloon dissection. We have also reported successful application in the porcine colon. In the present study, we compared the safety and efficacy of SEMR with ESD in the porcine esophagus and stomach. METHODS: SEMR and ESD were carried out in eight domestic pigs under general anesthesia. Resection sites were marked by circumferential coagulation. After circumferential ESD knife mucosal incision, submucosal fluid cushion (SFC) was created. In the SEMR group, the balloon catheter was inserted deep into the SFC. The balloon was then inflated and pulled back toward the endoscope tip repeatedly, altering the direction, to disrupt the submucosa. Residual strands were cut with an IT-knife. En bloc resection rates, procedure times, complications and dissection difficulty scales (DDS) were recorded prospectively. DDS were rated using a visual analog scale. RESULTS: Thirty-two resections (8 SEMR/8 ESD in the esophagus; 8 SEMR/8 ESD in the stomach) were done with no major adverse events. There was no statistical difference between the two techniques in either location in the above categories measured. CONCLUSIONS: SEMR and traditional ESD are comparable techniques in safety and effectiveness when carried out in the esophagus and stomach. SEMR may serve as a more appealing technical option for endoscopists who are unable to sustain a traditional ESD practice volume.

Large-caliber metal stents versus plastic stents for the management of pancreatic walled-off necrosis.

BACKGROUND AND AIMS: Symptomatic pancreatic walled-off necrosis (WON) may be managed by endoscopic transmural drainage and endoscopic transmural necrosectomy, with stent placement at endoscopic drainage sites. The optimal stent choice is yet to be determined. We compared outcomes after endoscopic management of WON using either large-caliber fully covered self-expandable metal stents (LC-SEMSs) or double-pigtail plastic stents (DPPSs). METHODS: We performed a retrospective comparison of outcomes among patients who received LC-SEMSs or DPPSs before endoscopic transmural necrosectomy for WON. RESULTS: Among 94 patients included, WON resolution rates did not differ between the DPPS (36 patients) and LC-SEMS (58 patients) groups, whether concomitant percutaneous drainage was considered a failure (75% vs 82.8%; P = .36) or not (91.7% vs 94.8%; P = .55). Of 75 patients (80%) successfully treated without percutaneous drainage, 37 (49%) underwent endoscopic transmural drainage without subsequent endoscopic transmural necrosectomy. WON was more likely to resolve without subsequent endoscopic transmural necrosectomy in the LC-SEMS group than the DPPS group (60.4% vs 30.8%; P = .01). WON resolution without subsequent endoscopic transmural necrosectomy remained more likely with LC-SEMSs (odds ratio, 4.5 [95% confidence interval, 1.5-15.5]) after adjusting for patient age and size and location of WON. Rates of adverse events were similar except for clinically significant bleeding requiring endoscopic intervention, which was higher with DPPSs than LC-SEMSs (14% vs 2%; P = .02). CONCLUSION: Management of pancreatic WON with LC-SEMSs appears to decrease both the need for repeated necrosectomy procedures and the risk of intervention-related hemorrhage.

Endoscopic sutured gastroplasty: procedure evolution from first-in-man cases through current technique.

BACKGROUND: Endoscopic sutured gastroplasty (ESG) has evolved over time. With the advent of full-thickness endoscopic suturing, an efficient technique for ESG was developed and refined. METHODS: This prospective first-in-man trial started in April 2012 and represents the first use of full-thickness endoscopic suturing for primary obesity therapy. The trial focused on procedure development, reproducibility, safety, and short-term efficacy. The trial was performed at centers in five countries, in three phases. Phase I was evaluation of safety and technical feasibility of various procedure techniques; stitch patterns and sequences were assessed for efficiency, safety, and feasibility. Phase II entailed continued procedure refinement to establish a standardized technique. Phase III entailed evaluation of technical feasibility and weight loss outcomes in 77 patients; the procedure was performed using the standardized technique, and there was no procedure development. Data were prospectively collected into a registry. RESULTS: In Phase I, the procedure was created and modified to improve time efficiency. Safety and technical feasibility were established, and short-term weight loss was demonstrated. In Phase II, a number of stitch patterns were attempted, and the stitch pattern was modified and finalized. 22 patients were included, and 1-year total weight loss was 17.3 ± 2.6%. In Phase III, conformity with the final technique was high. 77 patients were included, with a mean BMI of 36.1 ± 0.6 kg/m2. Mean weight loss was 16.0 ± 0.8% at 6 months and 17.4 ± 1.2% at 12 months (n = 44). Postprocedural nausea, vomiting, and epigastric pain were frequently reported; there were no reported significant adverse events post-procedure or during the follow-up period. CONCLUSIONS: Following a methodical procedure development phase, ESG demonstrated safety and short-term efficacy in this trial. The procedure also achieved meaningful weight loss during the follow-up period.