Clinical trial NCT04781946: Management of Symptomatic Gastric Sleeve Stenosis After Laparoscopic Sleeve Gastrectomy
Official title: A Pilot Clinical Trial on the Management of Symptomatic Gastric Sleeve Stenosis After Laparoscopic Sleeve Gastrectomy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Gastric Stenosis
Keywords: gastric stenosis
laparoscopic sleeve gastrectomy
bariatric complications
endoscopy
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2021-03-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Eligibility criteria: 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

Primary outcomes:
measure: Rate of clinical success
timeFrame: 6 months post-procedure
Secondary outcomes:
measure: Rate of technical success
timeFrame: Immediately post-procedure
measure: Procedural success as assessed by the PAGI-SYM score
timeFrame: 8 weeks post-procedure
measure: Degree of axial deviation per Endoscopic resolution of GSS-related findings
timeFrame: Up to 6 months post-procedure
measure: Degree of luminal narrowing per Endoscopic resolution of GSS-related findings
timeFrame: Up to 6 months post-procedure
measure: Degree of axial deviation per Radiologic resolution of GSS-related findings
timeFrame: Up to 6 months post-procedure
measure: Degree of luminal narrowing per Radiologic resolution of GSS-related findings
timeFrame: Up to 6 months post-procedure
measure: Presence of delayed contrast flow per Radiologic resolution of GSS-related findings
timeFrame: Up to 6 months post-procedure
measure: Percentage of patients maintained off PPI therapy
timeFrame: Up to 6 months post-procedure
measure: Time to recurrence of symptoms post-treatment in patients with recurrence
timeFrame: Up to 12months post-procedure
measure: Rate of adverse events
timeFrame: Up to 6 months post-procedure
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Mouen A Khashab, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.