Management of Symptomatic Gastric Sleeve Stenosis After Laparoscopic Sleeve Gastrectomy

NCT04781946 | Withdrawn DMC

• 1 other identifier: IRB00269201
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastric Stenosis

Keywords

gastric stenosis; laparoscopic sleeve gastrectomy; bariatric complications; endoscopy

Outcome Measures

Primary Outcomes (1)

• Rate of clinical success

  The rate of clinical success, defined as 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.

  6 months post-procedure

Secondary Outcomes (10)

• Rate of technical success

  Immediately post-procedure

• Procedural success as assessed by the PAGI-SYM score

  8 weeks post-procedure

• Degree of axial deviation per Endoscopic resolution of GSS-related findings

  Up to 6 months post-procedure

• Degree of luminal narrowing per Endoscopic resolution of GSS-related findings

  Up to 6 months post-procedure

• Degree of axial deviation per Radiologic resolution of GSS-related findings

  Up to 6 months post-procedure

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Endoscopic pneumatic balloon dilation (PBD), gastric peroral endoscopic myotomy (G-POEM) and Roux-en-Y gastric bypass (RYGB) will be used for the management of post-LSG GSS using a predefined treatment algorithm.

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

Interventions

Endoscopic pneumatic balloon dilation PROCEDURE

Using endoscopy, pneumatic balloon dilation may be used to treat stenosis of the gastric sleeve.

Treatment Arm

Gastric peroral endoscopic myotomy (G-POEM) PROCEDURE

Gastric per-oral endoscopic myotomy (G-POEM) is a recent innovation offering a minimally invasive endoscopic approach. G-POEM allows for the creation of a tunnel and subsequent myotomy from the gastric cardia to the gastric pylorus.

Treatment Arm

Roux-en-Y gastric bypass (RYGB) PROCEDURE

The Roux-en-Y gastric bypass is a type of weight-loss surgery that involves creating a small pouch from the stomach and connecting the newly created pouch directly to the small intestine.

Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with symptoms of dysphagia, abdominal pain, nausea, vomiting, heartburn or regurgitation after LSG that do not respond to standard medical therapies, such as proton pump inhibitors, anti-emetics, etc
• Patients with a confirmed sleeve stenosis by contrast study and/or upper endoscopy
• Adult patients aged greater than 18 years old at time of consent
• Patients able to provide written informed consent on the Institutional Review Board/Ethics Committee-approved informed consent form
• Patients willing and able to comply with study requirements for follow up

You may not qualify if:

• Presence of concomitant gastric leak or fistula
• Stenosis of non-gastric origin
• History of Roux-en-Y gastric bypass, or duodenal switch
• GSS within one month after sleeve gastrectomy
• Severe medical comorbidities precluding endoscopy or surgery, or limiting life expectancy to less than 2 years in the judgement of the endoscopist
• Uncontrolled coagulopathy or inability to be off anticoagulation or antiplatelet medication for 1 week prior to and after intervention
• Pregnant or planning to become pregnant during period of study participation
• Patient refuses or is unable to provide written informed consent

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

• Burgos AM, Csendes A, Braghetto I. Gastric stenosis after laparoscopic sleeve gastrectomy in morbidly obese patients. Obes Surg. 2013 Sep;23(9):1481-6. doi: 10.1007/s11695-013-0963-6.

  PMID: 23604695 BACKGROUND

MeSH Terms

Interventions

Pyloromyotomy; Gastric Bypass

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Digestive System Surgical Procedures; Surgical Procedures, Operative; Gastrectomy; Myotomy; Bariatric Surgery; Bariatrics; Obesity Management; Therapeutics; Gastroenterostomy; Anastomosis, Surgical

Study Officials

• Mouen A Khashab, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 4, 2021
• Study Start: August 30, 2021
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: July 13, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)