Roux-en-Y gastric bypass pouch outlet reduction using argon plasma coagulation to treat weight regain: a randomized controlled trial with a sham control group.

Background and study aims A comparative study was conducted to evaluate the efficacy of argon plasma coagulation (APC) therapy in treating post Roux-en-Y gastric bypass (RYGB) weight regain and the incidence of complications related to this procedure, using a sham treatment group as a control. Patients and methods Forty-one patients with a minimum weight regain of 10 kg and a minimum postoperative time of 36 months were randomized into two groups. Results In the APC group (n = 21), the mean initial weight was 100.4 kg and the mean weight regain was 24.94 kg. In the sham group (n = 20), the mean initial weight was 103.65 kg, and the mean weight regain was 25.18 kg. Anastomotic stenosis occurred only after the first APC session. The results for the comparison of APC with the sham group showed a percentage weight regain loss of 63.95 compared to -.65, and weight loss of 15.02 and -0.57), percentage total weight loss of 14.46 and -0.62, excess weight loss of 54.32 % and -2.34 %), and BMI reduction of 5.38 and -0.21, with P  < 0.0001 for all the comparisons. In the APC group, there was a significant reduction in HbA1c (5.66 % to 4.96 %) and triglycerides (153.20 mg/dL to 132.20 mg/dL). Conclusions This study indicates that APC outlet pouch reduction outperforms sham treatment in terms of weight loss for patients presenting weight regain after RYGB.

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.

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.

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.

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.

LAPAROENDOSCOPIC TRANSGASTRIC RESECTION OF SUBEPITHELIAL JUXTACARDIAC TUMORS.

BACKGROUND: With a prevalence of 0.4-3.5%, subepithelial lesions of the upper digestive tract are discovered during endoscopic procedures. Treatment depends on etiological and pathophysiological information, ability to diagnose and the different technical resources available. AIM: To demonstrate the effectiveness of a surgical technique that combines endoscopy and videolaparoscopy in the transgastric resection of subepithelial juxtacardic lesions. METHOD: The patients were assisted with a technical combination between endoscopy and laparoscopy. After diagnosis of subepithelial tumor, intraoperative endoscopy was performed after pneumoperitoneum and placement of laparoscopic tweezers. Through endoscopy, the following steps were performed: demarcation of surgical margins, visualization of the intragastric image for the laparoscopic procedure and removal of the surgical specimen. By laparoscopy the following steps were performed: intragastric intra-abdominal access, resection of the part and closure of the gaps. RESULTS: This technique was applied in two cases in order to evaluate its initial results. There were two videolaparoendoscopic resections of juxtacardiac gastric tumors of the posterior wall. Both had their endoscopic diagnosis confirmed. After laparoendoscopic and tomographic and/or ecoendoscopic diagnostic complementation and preoperative performance, the laparoendoscopic procedure was indicated. The patients had a good recovery, with a short hospitalization time and no complications. CONCLUSION: The combined use of videolaparoscopy and endoscopy is a safe and effective technique for transgastric resection of juxtacardiac subepithelial lesions. It may be important for definitive diagnosis of the tumor.

Laparoendoscopic transgastric resection of subepithelial juxtacardiac tumors / Laparoendoscopia e ressecção transgástrica de tumores subepiteliais justacárdicos

ABSTRACT Background: With a prevalence of 0.4-3.5%, subepithelial lesions of the upper digestive tract are discovered during endoscopic procedures. Treatment depends on etiological and pathophysiological information, ability to diagnose and the different technical resources available. Aim: To demonstrate the effectiveness of a surgical technique that combines endoscopy and videolaparoscopy in the transgastric resection of subepithelial juxtacardic lesions. Method: The patients were assisted with a technical combination between endoscopy and laparoscopy. After diagnosis of subepithelial tumor, intraoperative endoscopy was performed after pneumoperitoneum and placement of laparoscopic tweezers. Through endoscopy, the following steps were performed: demarcation of surgical margins, visualization of the intragastric image for the laparoscopic procedure and removal of the surgical specimen. By laparoscopy the following steps were performed: intragastric intra-abdominal access, resection of the part and closure of the gaps. Results: This technique was applied in two cases in order to evaluate its initial results. There were two videolaparoendoscopic resections of juxtacardiac gastric tumors of the posterior wall. Both had their endoscopic diagnosis confirmed. After laparoendoscopic and tomographic and/or ecoendoscopic diagnostic complementation and preoperative performance, the laparoendoscopic procedure was indicated. The patients had a good recovery, with a short hospitalization time and no complications. Conclusion: The combined use of videolaparoscopy and endoscopy is a safe and effective technique for transgastric resection of juxtacardiac subepithelial lesions. It may be important for definitive diagnosis of the tumor.

RESUMO Racional: Lesões subepiteliais do trato digestivo superior são descobertas durante procedimentos endoscópicos com prevalência de 0,40-3,5%. Seu tratamento parte de conhecimento etiológico, fisiopatológico, capacidade diagnóstica e recursos técnicos variados. Objetivo: Demonstrar a eficácia de técnica cirúrgica que combina videolaparoscopia e endoscopia para ressecção transgástrica de lesões subepiteliais justacárdicas e seus resultados preliminares. Método: Os pacientes foram assistidos com uma combinação técnica entre endoscopia e laparoscopia. Após o diagnóstico de tumor sub-epitelial justacárdico endoscopia intra-operatória foi realizada após confecção do pneumoperitônio e colocação das pinças laparoscópicas. Através da endoscopia realizou-se os seguintes passos: demarcação de margens cirúrgicas, visualização da imagem intragastrica para o procedimento laparoscópico e retirada de peça cirúrgica; pela laparoscopia realizou-se os seguintes passos: acesso intragástrico por via intra-abdominal, ressecção da peça e fechamento das brechas. Resultados: Esta técnica foi aplicada em dois casos afim de serem avaliados seus resultados inicias. Foram duas ressecções videolaparoendoscópica de tumores gástricos justacárdicos, de parede posterior. Ambos tiveram seu diagnóstico endoscópico de tumores subepiteliais justacárdicos. Após complementação diagnóstica tomográfica e/ou ecoendoscópica e realização de pré operatório foi indicado o procedimento laparoendoscópico. Os pacientes tiveram recuperação muito satisfatória, com pequeno tempo de internação e sem complicações. Conclusão: O uso combinado de videolaparoscopia e endoscopia constitui técnica segura e eficaz para a ressecção transgástrica de lesões subepiteliais justacárdicas. Pode ser importante para diagnóstico definitivo da tumoração.

Validation of a new method for the endoscopic measurement of post-bariatric gastric outlet using a standard guidewire: an observer agreement study.

BACKGROUND AND AIMS: Between 10 and 20% of all patients undergoing bariatric surgery procedures regain weight secondary to a gastrojejunostomy enlargement. The aim of this study was to validate the interobserver agreement while measuring gastric outlet diameters using a new standard guidewire. METHODS: We selected thirty-five videos of consecutive endoscopic procedures on patients undergoing esophagogastroduodenoscopy after a Roux-en-Y gastric bypass procedure. All videos were evaluated by four raters: two expert endoscopists and two trainees. We excluded videos having a slipped Fobi ring or a strictured gastric outlet. Anastomosis diameter was measured using a novel device with standardized markings on a guidewire (Hydra jagwire, Boston Scientific, Natick. MA) as well as the current gold standard defined as a calibrated endoscopic measuring instrument (Olympus America, Center Valley, PA). RESULTS: We obtained 272 measurements of the gastric outlet. Overall agreement measured through intra-class correlation coefficients for the gold standard was 0.84 (p < 0.01) and 0.83 (p < 0.01) for the new guidewire. Agreement among experts was 0.699 (p < 0.01), while among trainees it was 0.822 (p < 0.01). CONCLUSION: The new guidewire demonstrated a high degree of observer reliability, also presenting similar results between expert endoscopists and trainees.