Clinical Trial for Weight Regain Post-RYGB: APC Versus APC Plus Endoscopic Suture Technique

NCT03094936 | Unknown DMC FDA Device

• 1 other identifier: 43405415000000068
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Obesity is a worldwide health and sociopolitical problem. Excessive body-weight currently affects over 50% of the Brazilian population. It has been well established that obesity is an independent health risk. Obese individuals are at increased to extremely high risk for many diseases and for early death relative to those with normal weights and waist circumferences. The increased disease susceptibility for this subset of patients includes hypertension, stroke, hyperlipidemia, sleep apnea, Type 2 diabetes, neoplasms, Gastro-Esophageal Reflux Disease, and musculoskeletal disorders. Bariatric surgery is the most effective treatment for obesity. As bariatrics grow, the number of patients suffering from surgical-related complications also grows. One of the most worrisome long-term complications is weight regain, once the patient may be again affected by overweight-related comorbidities and face again pre-operative esthetic issues. This trial focus on testing efficacy and safety of two endoscopic revisional procedures in patients suffering from weight regain following Roux-en-Y Gastric Bypass: Ablation with Argon Plasma Coagulation (APC) versus APC plus Endoscopic Full-thickness Suture (with Apollo Overstitch device). Pouch volume, gastric emptying and gut hormones changes will also be assessed.

Conditions

Obesity

Outcome Measures

Primary Outcomes (5)

• Absolute Weight Loss

  Absolute Weight Loss will be assessed through subtraction of the pre-operative weight and the weight at follow-up, and will be measured in kilograms (kgs).

  This outcome will be assessed at 12 months after the procedure

• Excess Weight Loss

  Excess Weight Loss will be assessed through calculation of the percentage of the overweight lost after the procedure at follow-up. Excess Weight is defined as the weight over BMI of 25 for each patient. Excess Weight Loss will be expressed as percentage (%).

  This outcome will be assessed at 12 months after the procedure

• Abdominal Circumference Reduction

  Subtraction between baseline abdominal circumference and this measure at follow-up. This outcome will expressed in centimeters (cm).

  This outcome will be assessed at 12 months after the procedure

• BMI reduction

  Subtraction between baseline BMI and this measure at follow-up. This outcome will expressed in kg/m2.

  This outcome will be assessed at 12 months after the procedure.

• Diabetes improvement

  This outcome will be assessed through a glucose tolerance test performed at baseline and another one performed at 1 year follow-up.

  This outcome will be assessed at baseline and 12 months after the procedure.

Secondary Outcomes (6)

• Occurrence of Adverse Events

  This outcome will be assessed continually after the procedure.

• Quality of Life Improvement

  This outcome will be assessed at baseline and at 12 months.

• Eating Habits Evaluation

  This outcome will be assessed at baseline and at 12 months.

• Gut Hormones Response

  This outcome will be assessed at baseline and at 12 months.

• Gastric (Pouch) Emptying

  This outcome will be assessed at baseline and at 12 months.

Study Arms (2)

Group A

OTHER

This group own twenty patients who met all the inclusion criteria. These will be treated with APC.

Procedure: APC

Group B

ACTIVE COMPARATOR

This group own twenty patients who met all the inclusion criteria. These will be treated with APC plus Endoscopic Suture Technique (OverStitch TM).

Procedure: APC; Device: Endoscopic Suture Technique (OverStitch TM)

Interventions

APC PROCEDURE

Ablation of the dilated gastro-jejunal anastomosis with Argon Plasma Coagulation. This procedure induces cicatrization process around the stoma and propitiates its reduction.

Group A; Group B

Endoscopic Suture Technique (OverStitch TM) DEVICE

OverStitchTM Endoscopic Suturing System. Stitches will be placed per-orally with the aforementioned device around the dilated stoma in order to reduce the diameter of the anastomosis. In this group, ablation with APC will be done immediately before suturing.

Also known as: Apollo Overstitch

Group B

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subject has stoma dilation defined as greater than 12mm, assessed with an esophagogastroduodenoscopy performed pre-operatively
• Subject is ≥ 18 yrs. of age and ≤ 60 yrs. of age
• Subject has a BMI of \> 30
• Subject has history of obesity for \> 2 yrs
• Subject has had no significant weight change (\<5% of total body weight) in last 6 months
• Subject must have failed standard obesity therapy (diet, exercise, behavior modification, and pharmacologic agents either alone or in combination), which will be assessed through an interview performed by a team member of the study at baseline
• Subject is a reasonable candidate for general anesthesia
• Subject agrees not to have any additional weight loss surgery or reconstructive surgery that may affect body weight (i.e. mammoplasty, liposuction, lipoplasty, etc) during the trial
• Subject must be willing and able to participate in all aspects of the study and agree to comply with all study requirements for the duration of the study. This includes availability of reliable transportation and sufficient time to attend all follow-up visits.
• Subject must be able to fully understand and be willing to sign the informed consent.

You may not qualify if:

• Subject has had significant weight loss in the last 3 months, or between baseline and the study procedure
• Mallampati (intubation) score greater than 3
• Subject is observed during esophagogastroduodenoscopy to have heavily scarred, malignant or poor quality/friable tissue in areas of the stomach where sutures are to be placed
• Subject has history of inflammatory disease of GI tract
• Subject has a history of intestinal strictures or adhesions
• Subject has renal and/or hepatic insufficiency
• Subject has chronic pancreatic disease
• Subject has history of/or signs and/or symptoms of gastro-duodenal ulcer disease and/or active peptic ulcer
• Subject has significant esophageal disease including Zenker's diverticulum, grade 3-4 reflux esophagitis, stricture, Barrett's esophagus, esophageal cancer, esophageal diverticulum, dysphagia, achalasia, or symptoms of dysmotility
• Subject has a history of any significant abdominal surgery
• Subject has had previous bariatric, gastric or esophageal surgery; intestinal obstruction; portal gastropathy; gastrointestinal tumors; esophageal or gastric varices, or gastroparesis
• Subject has a hiatal hernia \> 2cm
• Subject has chronic/acute upper GI bleeding conditions
• Subject has severe coagulopathy (prothrombin time \> 3 seconds over control or platelet count \< 100,000) or is presently taking heparin, coumadin, warfarin, or other anticoagulants or other medications which impede coagulation or platelet aggregation, if they cannot be ceased for the procedure
• Female subject is of childbearing age and not practicing effective birth control, is pregnant or is lactating

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Hospital das Clinicas da Faculdade de Medicina da USP

São Paulo, São Paulo, 05403-000, Brazil

RECRUITING

Related Publications (1)

• Brunaldi VO, Farias GFA, de Rezende DT, Cairo-Nunes G, Riccioppo D, de Moura DTH, Santo MA, de Moura EGH. Argon plasma coagulation alone versus argon plasma coagulation plus full-thickness endoscopic suturing to treat weight regain after Roux-en-Y gastric bypass: a prospective randomized trial (with videos). Gastrointest Endosc. 2020 Jul;92(1):97-107.e5. doi: 10.1016/j.gie.2020.03.3757. Epub 2020 Mar 23.

  PMID: 32217111 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Vitor O Brunaldi, MD

  University of Sao Paulo General Hospital

  STUDY CHAIR

• Eduardo G Hourneaux de Moura, PhD

  University of Sao Paulo General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana C Cândido

CONTACT

55-11-26619577; ana.candido@hc.fm.usp.br

Vitor O Brunaldi, MD

CONTACT

55-11-26617579; vbrunaldi@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: September 3, 2015
• First Posted: March 29, 2017
• Study Start: April 1, 2017
• Primary Completion: September 1, 2018
• Study Completion: October 1, 2018
• Last Updated: March 29, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)