Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04781946
Status:
WITHDRAWN
Last Update Posted:
2023-07-13
First Post:
2021-03-01
Brief Title:
Management of Symptomatic Gastric Sleeve Stenosis After Laparoscopic Sleeve Gastrectomy
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
A Pilot Clinical Trial on the Management of Symptomatic Gastric Sleeve Stenosis After Laparoscopic Sleeve Gastrectomy
Status:
WITHDRAWN
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Decided not to move forward with the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 01-39 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
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
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 to asymmetric traction andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None