Status:
WITHDRAWN
Endoscopic Cardiac Band Ligation for the Management of Refractory GERD After Laparoscopic Sleeve Gastrectomy
Lead Sponsor:
Johns Hopkins University
Conditions:
GERD
Bariatric Surgery
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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 unsuitable for trial participation.
- Pregnant or planning to become pregnant during period of study participation.
- Patient refuses or is unable to provide written informed consent.
- Prior surgical or endoscopic anti-reflux procedure.
- Persistent dysphagia score greater than 0.
- Vomiting more than once a week.
- Biopsy-proven Barrett's esophagus.
- HREM showing marked ineffective esophageal motility (defined by ≥ 5 weak or failed swallows per Chicago Classification v 3.0), esophagogastric outflow obstruction (EGJOO) or achalasia.
Key Trial Info
Start Date :
September 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04771247
Start Date
September 1 2021
End Date
September 1 2021
Last Update
September 28 2021
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