An interventional study of Endoscopic pneumatic balloon dilation and Gastric peroral endoscopic myotomy (G-POEM) in Gastric Stenosis, sponsored by Johns Hopkins University. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-13.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment
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.
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 to asymmetric traction and/or misalignment while stapling, causing a rotated gastric sleeve and functional obstruction to flow. Current treatment options include: endoscopic pneumatic balloon dilation (PBD), endoscopic stenting and revision surgery. Endoscopic balloon dilation demonstrates an overall clinical success rate of 76%[ and usually requires more than one session. However, the optimal size and type of balloon used, as well as the frequency of dilations remains unclear. Additionally, the accessibility and length of the GSS will also impact balloon choice and can occasionally prohibit balloon placement or distension. Endoscopic placement of fully covered self-expanding metal stents (FCSEMS) are effective in 70% of EBD failures. However, FCSEMS have a migration risk of up to 62% in the post-bariatric stricture setting, which may be reduced by suturing. Further, both of these treatment modalities have limited long term success in the setting of helical GSS. Revision surgery, usually a conversion to RYGB is effective in 91% of EBD failures - however can be associated with high adverse event rates. 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. Initially developed for the treatment of gastroparesis, case reports have now demonstrated its successful use in post-LSG GSS. A modification to the original technique allows the staple line to be targeted for myotomy, relieving the tortuosity seen in a helical GSS. Case reports and retrospective studies have been supportive of this but there is no prospective data. Currently, there are no clear guidelines on the management of GSS post-LSG and available literature is largely retrospective. Hence, we sought to prospectively evaluated the use of G-POEM for management of patients with symptomatic, endoscopically or radiologically confirmed helical GSS
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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)
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.
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.
Time frame: 6 months post-procedure
Rate of technical success
Defined as the completion of planned procedure.
Time frame: Immediately post-procedure
Procedural success as assessed by the PAGI-SYM score
Procedural success is defined as a 1-point reduction in PAGI-SYM score at 8 weeks following procedure.
Time frame: 8 weeks post-procedure
Degree of axial deviation per Endoscopic resolution of GSS-related findings
Degree of axial deviation post-treatment measured in degrees.
Time frame: Up to 6 months post-procedure
Degree of luminal narrowing per Endoscopic resolution of GSS-related findings
Degree of luminal narrowing post-treatment measured as a ratio of the diameter of the narrowest portion over the widest portion of the sleeve.
Time frame: Up to 6 months post-procedure
Degree of axial deviation per Radiologic resolution of GSS-related findings
Degree of axial deviation post-treatment measured categorically as: none, mild, moderate or severe.
Time frame: Up to 6 months post-procedure
Degree of luminal narrowing per Radiologic resolution of GSS-related findings
Degree of luminal narrowing post-treatment measured as a ratio of the diameter of the narrowest portion over the widest portion of the sleeve.
Time frame: Up to 6 months post-procedure
Presence of delayed contrast flow per Radiologic resolution of GSS-related findings
Presence of delayed contrast flow post-treatment measured as either a yes or no.
Time frame: Up to 6 months post-procedure
Percentage of patients maintained off PPI therapy
Percentage of patients maintained off proton pump inhibitor (PPI) therapy.
Time frame: Up to 6 months post-procedure
Time to recurrence of symptoms post-treatment in patients with recurrence
Measured in days.
Time frame: Up to 12months post-procedure
Rate of adverse events
Rate of adverse events will be determined by assessing the number of adverse events.
Time frame: Up to 6 months post-procedure
Plan to share: No
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