Management of Reflux After Sleeve Using Stretta (MaRSS)
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|ClinicalTrials.gov Identifier: NCT02637713|
Recruitment Status : Terminated (Low Accrual)
First Posted : December 22, 2015
Last Update Posted : December 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|GERD Morbid Obesity||Device: Stretta Procedure: Radiofrequency (RF) Energy to the LES (Stretta Procedure)||Not Applicable|
Gastroesophageal reflux disease (GERD) is a widely prevalent medical disorder in the United States with a spectrum of treatment options ranging from dietary modification, to various pharmacologic treatments, to an array of available surgical and endoscopic procedures. There is a well-described correlation between obesity and symptoms of GERD. The morbidly obese patients undergoing evaluation for bariatric surgery are to characterize any GERD-like symptoms as this will assist in directing surgical therapy. Generally, it is recommended that patients with severe GERD undergo Roux-en-Y gastric bypass(RYGB) rather than a sleeve gastrectomy (SG) as RYGB has proven to be the most effective surgical treatment for GERD in the morbidly obese patient. The number of bariatric procedures performed in the United States has increased significantly in the recent years. Out of all bariatric procedures SG is the most commonly performed in the United States, as it has proven to be a very safe procedure with excellent weight loss. However, the incidence of de novo GERD and the effect of SG on patients with preexisting GERD remain controversial. Although some authors report high incidence of de novo GERD and worsening of previous reflux symptoms, there is also data showing improvement of symptoms post SG. Management of GERD after SG poses an interesting challenge, as traditional invasive procedures like Nissen fundoplication are not available due to an altered gastric anatomy. The alternative is to perform a conversion to RYGB, which represents increased morbidity to patient and significant cost.
A large number of endoscopic procedures have been introduced in the past for the management of GERD as an alternative to the surgical anti-reflux procedures with various degrees of success. One of the few non-invasive methods for managing GERD that is still available on the market and widely used is Stretta. Stretta delivers Radio Frequency energy (RFe) to the LES resulting in increased LES pressure. In 2000, the FDA approved the Stretta system for treatment of GERD. Stretta allows an alternative for treatment in patients who are not willing or able to undergo surgery. The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) published clinical practice guidelines that endorsed Stretta as an appropriate therapy for treatment of GERD in patients >18, with at least 6 months of symptoms partially or completely responsive to pharmacotherapy and who are unable or unwilling to undergo laparoscopic Nissen fundoplication. There are to date no studies evaluating the use of Stretta in management of patients with GERD symptoms after sleeve gastrectomy.
The investigators will study sleeve gastrectomy patients with GERD symptoms and if considered candidates for Stretta all patients will be enrolled in data collection cohort and followed prospectively with symptom questionnaire and quality of life scores for improvement of symptoms.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Radiofrequency Energy Delivery to the Lower Esophageal Sphincter (Stretta) in Sleeve Gastrectomy Patients With GERD|
|Actual Study Start Date :||March 2016|
|Actual Primary Completion Date :||May 2019|
|Actual Study Completion Date :||May 2019|
Experimental: Radiofrequency Energy to the Lower Esophageal Sphincter (LES)
All patients that have undergone sleeve gastrectomy as treatment for obesity that have developed severe reflux symptoms will be treated with Stretta (FDA approved device for the management of GERD) and evaluated prospectively for resolution/improvement of reflux symptoms.
Stretta is an FDA approved device that delivers Radiofrequency energy delivery to the lower esophageal sphincter. It is approved for the management of GRED.
Procedure: Radiofrequency (RF) Energy to the LES (Stretta Procedure)
The Stretta procedure is performed endoscopically under moderate sedation or general anesthesia which uses radiofrequency (RF) energy applied to the lower esophagus over 14 minutes per FDA approved procedures.
- Reflux Severity Index (RSI) score [ Time Frame: 12 months ]will be a determination of whether the patient achieved at least a 50% reduction in symptoms during the initial 12 month as compared to baseline.
- GERD Health Related Quality of Life (GERD-HRQL) questionaire [ Time Frame: 12 months ]will be a determination of whether the patient achieved at least a 50% reduction in symptoms during the initial 12 month as compared to baseline.
- long term symptom resolution (RSI symptom score) after Stretta for GERD after sleeve gastrectomy [ Time Frame: 24 months ]follow the long term effect of Stretta treatment in patients with symptomatic GERD after sleeve gastrectomy
- Evaluation of Gastric Emptying Scintigraphy as contributory factor for reflux after sleeve [ Time Frame: 24 months ]Identify if there is any associations between the effects of gastric emptying and GERD in patients after sleeve gastrectomy
- Baseline for pathologic pH levels using bravo capsule monitoring in patients with GERD after sleeve [ Time Frame: 24 months ]Clarify what the levels of pathologic pH levels are in patients with symptomatic GERD after sleeve gastrectomy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02637713
|United States, California|
|Cedars-Sinai Medical Center|
|Los Angeles, California, United States|
|Stanford University Medical Center|
|Stanford, California, United States|
|United States, Connecticut|
|Norwalk, Connecticut, United States|
|United States, Louisiana|
|Gastroenterology Clinic of Acadiana|
|Lafayette, Louisiana, United States|
|United States, Massachusetts|
|Brigham & Women's Hospital|
|Boston, Massachusetts, United States|
|United States, New York|
|Montefiore Medical Center|
|Bronx, New York, United States|
|United States, North Carolina|
|Duke University Health System|
|Durham, North Carolina, United States|
|United States, Ohio|
|Cleveland Clinic Health System|
|Cleveland, Ohio, United States|
|University Hospitals Case Medical Center|
|Cleveland, Ohio, United States|
|Ohio State University Wexner Medical Center|
|Columbus, Ohio, United States|
|United States, Pennsylvania|
|Penn State Milton S. Hershey Medical Center|
|Hershey, Pennsylvania, United States|
|United States, Texas|
|Houston Methodist Hospital|
|Houston, Texas, United States|
|Memorial Hermann-Texas Medical Center|
|Houston, Texas, United States|
|Principal Investigator:||Erin Moran-Atkin, MD||Assistant Professor|