NCT04781946

Management of Symptomatic Gastric Sleeve Stenosis After Laparoscopic Sleeve Gastrectomy

Withdrawn NA Last updated 13 July 2023

What this trial tests

NA trial testing Endoscopic pneumatic balloon dilation in Gastric Stenosis. Withdrawn.

Timeline

30 August 2021

Primary endpoint
1 July 2023

1 July 2023

Quick facts

Lead sponsor	Johns Hopkins University
Phase	NA
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Start date	30 August 2021
Primary completion	1 July 2023
Estimated completion	1 July 2023
Sites	1 location across United States

Drugs / interventions tested

• Endoscopic pneumatic balloon dilation
• Gastric peroral endoscopic myotomy (G-POEM)
• Roux-en-Y gastric bypass (RYGB)

Conditions studied

• Gastric Stenosis — all drugs for Gastric Stenosis →

Sponsor

Johns Hopkins University

Who can join

18 and older, any sex, with Gastric Stenosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The global obesity epidemic has led to increasing popularity of bariatric surgeries and a parallel rise in the prevalence of related complications. Gastric sleeve stenosis (GSS) complicates 0.1-3.9% of cases after Sleeve Gastrectomy (SG) and can result in significant symptoms including nausea, vomiting, epigastric pain, dysphagia, reflux and regurgitation. There is no validated algorithm for the management of GSS, and available literature is retrospective.

The investigators hypothesize that the implementation of a predefined treatment algorithm for management of GSS post SG will effectively and safely manage patients with this condition. This single center, prospective, non-randomized pilot clinical trial to be performed at Johns Hopkins Medical Institutes will describe the efficacy and safety of endoscopic pneumatic balloon dilation (PBD), gastric peroral endoscopic myotomy (G-POEM) and Roux-en-Y gastric bypass (RYGB) for the management of post-LSG GSS using a predefined treatment algorithm. Patients with symptomatic, endoscopically or radiologically confirmed GSS greater than four weeks from laparoscopic sleeve gastrectomy (LSG) who are treatment naïve will be included.

The primary outcome is the rate of clinical success, defined an improvement in symptoms that allowed the patient to avoid further intervention (outside of the predefined treatment algorithm) with a resumption of adequate oral intake and at least 1-point reduction in the Patient Assessment of upper Gastrointestinal Symptoms (PAGI-SYM) questionnaire, at 6 months following last intervention. Secondary outcomes include rates of technical success (completion of planned procedure), procedural success (defined as a 1-point reduction in PAGI-SYM score at 8 weeks following procedure), endoscopic and radiologic resolution of GSS-related findings, percentage of patients maintained off proton pump inhibitor (PPI) therapy, time to recurrence of symptoms post-treatment in patients with recurrence, and rate of adverse events. The expected study population is 30 participants with a study duration of 18 months. This study can potentially validate a treatment algorithm, thereby assisting clinicians to select the most appropriate intervention for the treatment of post-LSG GSS. Moreover, it may help improve outcomes and prevent unnecessary procedures in patients with GSS.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.