WithdrawnNot Applicable

Endoscopic Cardiac Band Ligation for the Management of Refractory GERD After Laparoscopic Sleeve Gastrectomy

Stopped: IRB approval withheld

0Started 2021-09

Plain-language summary

GERD is a prevalent condition worldwide, estimated to be around 20-30 % in North America. Obesity is rapidly increasing with an estimated prevalence of 66% in the adult population in the United States. Presently, bariatric interventions are the only sustainable method to address morbid obesity and its resulting comorbidities. One of the most common restrictive surgeries includes laparoscopic sleeve gastrectomy (LSG). Although very effective for treating obesity, some of these surgeries might cause deleterious effects regarding GERD, due to anatomical modifications. Refractory GERD is defined by lack of symptom control on maximum dose of PPI therapy. Cardia Band Ligation Anti-reflux (CLEAR) procedure utilizes multiple band ligations at the cardia in a 270-degree fashion, resulting in tissue necrosis and scar formation, narrowing the GE junction and enhancing the flap valve system. The investigators hypothesized that CLEAR can be a safe and efficient intervention to improve post bariatric GERD.

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Obese patients who underwent surgical bariatric weight loss procedures with post-surgical GERD (LSG), not responding to once daily PPI therapy. * Obese patients who underwent surgical bariatric weight loss procedures with post-surgical GERD (LSG) who respond to maximum therapy with PPI + H2 blocker but are PPI averse or who refuse surgical therapy (conversion to RYGBP). * Patients older than 18 years and younger than 75 years of age at time of consent. * Patients able to provide written informed consent on the IRB/EC-approved informed consent form * Patients willing and able to comply with study requirements for follow-up Exclusion Criteria: * Any patient with no prior surgical bariatric intervention. * Pre-existing esophageal stenosis/stricture preventing advancement of an endoscope during screening/baseline EGD. * Esophageal, gastric or duodenal malignancy. * Severe medical comorbidities precluding endoscopy, or limiting life expectancy to less than 2 years in the judgment of the endoscopist. * Uncontrolled coagulopathy or inability to be off anticoagulation or anti-platelet medication (ASA, Plavix) for 1 week prior to and 2 weeks after each endoscopy * Active fungal esophagitis, Grade C or D esophagitis. * Hiatal hernias \> 2 cm or para-esophageal hernias. * Known portal hypertension, visible esophageal or gastric varices, or history of esophageal varices. * General poor health, multiple co-morbidities placing the patient at risk, or otherwise unsu…

What they're measuring

Change in GERD-HQRL/RSI score

Timeframe: Baseline and 6 months

Change in pH monitoring

Timeframe: Baseline and 6 months

Trial details

NCT IDNCT04771247

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-09