Good Clinical Practices on Argon Plasma Coagulation Treatment for Weight Regain Associated with Dilated Gastrojejunostomy Following Roux-en-Y Gastric Bypass: a Brazilian-Modified Delphi Consensus.

INTRODUCTION: Argon plasma coagulation (APC) alone is effective and safe at treating weight regain following Roux-en-Y gastric bypass (RYGB). However, technical details of the treatment vary widely among studies. Therefore, we aimed to create good clinical practice guidelines through a modified Delphi consensus, including experts from the collaborative Bariatric Endoscopy Brazilian group. METHODS: Forty-one locally renowned experts were invited to the consensus by email. Experiences of > 150 APC-treated cases or authorship of relevant articles were the eligibility criteria. An initial questionnaire with short-answer questions was distributed to the experts. The organizing committee converted the responses into statements for an online 2-day voting webinar. Consensus was defined as more than 67% of positive answers. Three consecutive voting rounds were planned with discussion and statement refinements between rounds. RESULTS: Thirty-seven experts fulfilled eligibility criteria and attended the live webinar voting. The total number of patients treated by the panel was 12,349. By the third round, all 79 statements reached consensus. The recommendations include the definition of dilated gastrojejunal anastomosis as ≥ 15 mm, minimum regain of 20% of the lost weight to indicate the APC therapy, 6 to 8 weeks as the ideal interval between ablation sessions, and stopping treatment when the stoma reaches < 12 mm of breadth. CONCLUSIONS: This consensus provides several recommendations based on a highly experienced panel of endoscopists. Although it covers most aspects of the treatment, the level of evidence is low for the majority of the statements. Therefore, bariatric endoscopists should be constantly attentive to new evidence on APC treatment.

Brazilian Consensus on Endoscopic Sleeve Gastroplasty.

PURPOSE: Bariatric endoscopy is a less invasive approach for obesity management, with better efficacy than pharmacological treatment and low morbidity. Endoscopic sleeve gastroplasty (ESG) is the remodeling of the stomach using a suturing device showing technical feasibility, safety, and sustained weight loss. With growing numbers of procedures worldwide, there is a need to standardize the procedure. MATERIALS AND METHODS: A consensus meeting was held in São Caetano do Sul-SP, Brazil, in June 2019, bringing together 47 Brazilian endoscopists with experience in ESG from all regions of the country. Topics on indications and contraindications of the procedure, pre-procedure evaluation and multidisciplinary follow-up, technique and post-procedure follow-up, and training requirements were discussed. An electronic voting was carried, and a consensus was defined as ≥ 70% agreement. RESULTS: The panel's experience consisted of 1828 procedures, with a mean percentage total body weight loss (TBWL) of 18.2% in 1 year. Adverse events happened in 0.8% of the cases, the most common being hematemesis. The selected experts discussed and reached a consensus on several questions concerning patient selection, contraindications for the procedure, technical details such as patient preparation, procedure technique, and patient follow-up. CONCLUSIONS: This consensus establishes practical guidelines for performance of ESG. The experience of 1828 procedures shows the expertise of the selected specialists participating in this consensus statement. The group's experience has a satisfactory weight loss with low adverse events rate. The main points discussed in this paper may serve as a guide for endoscopists performing ESG. Practical recommendations and technique standardization are described.

Randomized Prospective Clinical Study of Spatz3® Adjustable Intragastric Balloon Treatment with a Control Group: a Large-Scale Brazilian Experiment.

BACKGROUND: To analyze the results regarding weight loss and complications related to the Spatz3® adjustable intragastric balloon (IGB) in Brazil. METHODS: This randomized prospective study covered patients who had undergone treatment using a Spatz3® adjustable IGB between October 2016 and June 2018 at a private clinic in Rio de Janeiro, Brazil. The patients had a minimum body mass index (BMI) of 27 kg/m2. The study examined complications of Spatz3® treatment and BMI reduction, percentage of total weight loss (%TWL), and % of excess weight loss (%EWL). RESULTS: One hundred eighty patients underwent a Spatz3® balloon implant in the period. The patients were randomly divided into one group in which the Spatz balloon was kept at the same volume (600 mL) throughout treatment (Control Group), and another adjustment group with 250 mL greater volume. The complication rate was 16.14%. No death or major complication occurred during the study. Mean BMI decreased from 39.51 to 32.84 kg/m2 (p < 0.0001), bodyweight from 111.87 to 90.28 kg (p < 0.0001), and excess weight from 41.55 to 22.99 kg (p < 0.0001). The adjustment resulted in greater mean weight loss of 4.35 kg (- 8 to 17.6 kg), and the average time of the procedure was 7.12 ± 1.63 months. The upward adjustment group did not present greater %TWL, %EWL, or BMI reduction when compared with the control group (p = 0.4413, p = 0,9245, p = 0.2729, respectively). CONCLUSION: This study shows that Spatz3® IGB treatment is an effective procedure for weight reduction, with no mortality but higher morbidity compared with traditional IGBs. This procedure also enabled the balloon to stay in place for longer. The efficacy of upward adjustment still requires further confirmation.

Intragastric Balloon: a Retrospective Evaluation of 5874 Patients on Tolerance, Complications, and Efficacy in Different Degrees of Overweight.

BACKGROUND: Endoscopic methods, especially the intragastric balloon (IGB), have been shown to be effective for the treatment of excess weight. This study aimed to assess the tolerance, complications, and efficacy of excess weight treatment with a non-adjustable IGB during 6 months. METHODS: A total of 5874 patients treated with a liquid-filled IGB (600-700 mL) and followed up by a multidisciplinary team were evaluated. Participants presented an initial body mass index (BMI) ≥ 25 kg/m2 and were stratified according to sex and degree of overweight (overweight and obesity grades I, II, and III). RESULTS: The incidence of complications was 7.32% (n = 430): 6.10% (n = 357) early IGB removal, 0.20% (n = 12) gas production inside the balloon, 0.54% (n = 32) leakage, 0.32% (n = 19) pregnancy, 0.07% (n = 4) gastric perforation, 0.05% (n = 3) upper digestive bleeding, 0.01% (n = 1) Wernicke-Korsakoff syndrome due to excessive vomiting, and 0.02% each (n = 1) pancreatitis and esophagus perforation. The 5444 remaining patients (4081 women, 38 ± 38 years) presented a weight loss of 19.13 ± 8.86 kg and a BMI decreased significantly (p < 0.0001) (36.94 ± 5.67 vs. 30.08 ± 5.06 kg/m2). The % total weight loss (%TWL) was 18.42 ± 7.25%, and the % excess weight loss (%EWL) was 65.66 ± 36.24%. The treatment success rate (%TWL ≥ 10%) was 85%. The %EWL was higher in the pre-obese group (122.19%), followed by obesity grades I (76.67%), II (56.01%), and III (45.45%), with p < 0.0001 for each group. %EWL was higher in women (69.71%) than in men (53.39), with p < 0.0001 for each group. There was also a statistical difference between the TWL and EWL groups, with p < 0.001 for all analyses. CONCLUSION: Endoscopic IGB treatment for excess weight is an excellent therapeutic option for patients with different degrees of overweight.

Endoscopic sleeve gastroplasty in the management of weight regain after sleeve gastrectomy.

BACKGROUND: Sleeve gastrectomy is a well-standardized surgical treatment for obesity. However, rates of weight regain after sleeve gastrectomy in long-term follow-up are relatively high. This multicenter study is the first to evaluate the use of an endoscopic sleeve gastroplasty (ESG) technique for the management of this population. METHODS: This was a multicenter retrospective study, including patients with weight regain following sleeve gastrectomy who underwent ESG for weight loss. Primary outcomes included absolute weight loss, percent total weight loss (%TWL), change in body mass index (BMI), percent excess weight loss (%EWL) at 6 and 12 months, and safety profile. Clinical success was defined as achieving ≥ 25 % EWL at 1 year, ≤ 5 % serious adverse event (SAE) rate following society-recommended thresholds, and %TWL ≥ 10 %. RESULTS: 34 patients underwent ESG after sleeve gastrectomy. Technical success was 100 %. At 1 year, 82.4 % and 100 % of patients achieved ≥ 10 %TWL and ≥ 25 % EWL, respectively. Mean (SD) %TWL was 13.2 % (3.9) and 18.3 % (5.5), and %EWL was 51.9 % (19.1) and 69.9 % (29.9) at 6 months and 1 year, respectively. Mean (SD) %TWL was 14.2 % (12.5), 19.3 % (5.3), 17.5 % (5.2), and 20.4 % (3.3), and %EWL was 88.5 % (52.8), 84.4 % (22.4), 55.4 % (14.8), and 47.8 % (11.2) for BMI categories of overweight and obesity class I, II, and III, respectively, at 1 year. No predictors of success were identified in the multivariable regression analysis. No SAEs were reported. CONCLUSION: ESG appears to be safe and effective in the management of weight regain following sleeve gastrectomy.

Outcomes of a novel bariatric stent in the management of sleeve gastrectomy leaks: a multicenter study.

BACKGROUND: The management of laparoscopic sleeve gastrectomy leaks remains a challenge. This can be treated with placement of self-expandable metal stents, which are most effective in the acute and early settings. However, migration is a frequent adverse event (AE). Novel, fully covered stents with a larger proximal flare to limit migration designed specifically to treat postsleeve leaks were recently introduced. OBJECTIVES: The aim of this study was to evaluate the safety and efficacy of a novel stent specifically designed for postsleeve leaks treatment. SETTING: Multicenter retrospective study. METHODS: This is a multicenter study, including patients with acute and early post laparoscopic sleeve gastrectomy leaks, treated with a large bariatric stent. The outcomes include technical success, clinical success, and safety profile. A multivariable regression was performed to assess predictors of success. RESULTS: Thirty-seven patients were included (10 acute and 27 early leaks), with 30 stents in the postpyloric (POST) and 7 in the prepyloric position. Technical success was 100%. Mean stent dwell time was 29.08 days. Clinical success was achieved in 78.37%. Leak duration, leak size, and stent dwell time did not correlate with clinical success. During follow-up, 8 patients had stent migration (21.62%) and all were in a POST position. AE poststent removal were also evaluated (prepyloric: 57.14% vs POST: 33.3%, P = .45). There was no difference between prepyloric and POST position in the severe AE analysis. CONCLUSIONS: This novel, large-caliber, fully covered stent specifically designed for sleeve leaks appears to be effective at treating acute and early leaks. However, the large flanges and long stent length do not appear to reduce migration rate and may be associated with higher overall severe AE rates. Avoiding placement in the POST position may help mitigate migration risk; however, owing to the risk profile this stent should be used with caution.