Status:
WITHDRAWN
Management of Symptomatic Gastric Sleeve Stenosis After Laparoscopic Sleeve Gastrectomy
Lead Sponsor:
Johns Hopkins University
Conditions:
Gastric Stenosis
Eligibility:
All Genders
18+ years
Phase:
NA
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% o...
Detailed Description
Gastric sleeve stenosis (GSS) can either be mechanical from a short, circumferential stricture (non-helical) or functional secondary to an axial deviation (helical). Helical GSS are believed to be due...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04781946
Start Date
August 30 2021
End Date
July 1 2023
Last Update
July 13 2023
Active Locations (1)
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1
Johns Hopkins University
Baltimore, Maryland, United States, 21287