- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04781946
Management of Symptomatic Gastric Sleeve Stenosis After Laparoscopic Sleeve Gastrectomy
A Pilot Clinical Trial on the Management of Symptomatic Gastric Sleeve Stenosis After Laparoscopic Sleeve Gastrectomy
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Linda Zhang, MBCHB
- Phone Number: 4432871960
- Email: lzhan170@jhmi.edu
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment Arm
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.
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Using endoscopy, pneumatic balloon dilation may be used to treat stenosis of the gastric sleeve.
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.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of clinical success
Time Frame: 6 months post-procedure
|
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.
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6 months post-procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of technical success
Time Frame: Immediately post-procedure
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Defined as the completion of planned procedure.
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Immediately post-procedure
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Procedural success as assessed by the PAGI-SYM score
Time Frame: 8 weeks post-procedure
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Procedural success is defined as a 1-point reduction in PAGI-SYM score at 8 weeks following procedure.
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8 weeks post-procedure
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Degree of axial deviation per Endoscopic resolution of GSS-related findings
Time Frame: Up to 6 months post-procedure
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Degree of axial deviation post-treatment measured in degrees.
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Up to 6 months post-procedure
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Degree of luminal narrowing per Endoscopic resolution of GSS-related findings
Time Frame: Up to 6 months post-procedure
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Degree of luminal narrowing post-treatment measured as a ratio of the diameter of the narrowest portion over the widest portion of the sleeve.
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Up to 6 months post-procedure
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Degree of axial deviation per Radiologic resolution of GSS-related findings
Time Frame: Up to 6 months post-procedure
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Degree of axial deviation post-treatment measured categorically as: none, mild, moderate or severe.
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Up to 6 months post-procedure
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Degree of luminal narrowing per Radiologic resolution of GSS-related findings
Time Frame: Up to 6 months post-procedure
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Degree of luminal narrowing post-treatment measured as a ratio of the diameter of the narrowest portion over the widest portion of the sleeve.
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Up to 6 months post-procedure
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Presence of delayed contrast flow per Radiologic resolution of GSS-related findings
Time Frame: Up to 6 months post-procedure
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Presence of delayed contrast flow post-treatment measured as either a yes or no.
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Up to 6 months post-procedure
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Percentage of patients maintained off PPI therapy
Time Frame: Up to 6 months post-procedure
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Percentage of patients maintained off proton pump inhibitor (PPI) therapy.
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Up to 6 months post-procedure
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Time to recurrence of symptoms post-treatment in patients with recurrence
Time Frame: Up to 12months post-procedure
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Measured in days.
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Up to 12months post-procedure
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Rate of adverse events
Time Frame: Up to 6 months post-procedure
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Rate of adverse events will be determined by assessing the number of adverse events.
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Up to 6 months post-procedure
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mouen A Khashab, MD, Johns Hopkins University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00269201
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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