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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
Sponsor:
Collaborator:
Albert Einstein College of Medicine
Information provided by (Responsible Party):
Montefiore Medical Center

Brief Summary:
Gastroesophageal reflux disease (GERD) is a frequently seen entity after sleeve gastrectomy. Management of GERD after sleeve is difficult given limited treatment modalities. Stretta is an endoscopic FDA approved device that improves symptoms of GERD, there is minimal information about its use on patients after sleeve. This registry will attempt to get information regarding the treatment of reflux using Stretta after sleeve gastrectomy.

Condition or disease Intervention/treatment Phase
GERD Morbid Obesity Device: Stretta Procedure: Radiofrequency (RF) Energy to the LES (Stretta Procedure) Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arm Intervention/treatment
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.
Device: Stretta
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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Symptomatic reflux: (heartburn, chest discomfort, asthma/chronic cough, laryngitis, nocturnal aspiration or regurgitation)
  2. On a PPI with GERD-related symptoms
  3. On a PPI but like to discontinue them

Exclusion Criteria:

  1. Age <18 or > 80
  2. History of a severe psychiatric disorder: including suicidal ideation, or admission to a psychiatric institution.
  3. Unable or unwilling to consent for an invasive procedure.
  4. History of intestinal leak after surgery.
  5. History of revisional bariatric surgery
  6. Significant sleeve abnormalities such and twist or large fundus
  7. Hiatal hernia(>2cm)
  8. Pregnancy
  9. Inability to comply with study protocols and procedures
  10. Esophageal stricture, Eosinophilic Esophagitis or Achalasia
  11. Prior esophageal surgery or therapy for Barrett's Esophagus
  12. Grades 3 or 4 esophagitis
  13. Gastric or esophageal varices
  14. History of obstruction of the small bowel or inflammatory bowel disease
  15. Pacemaker or implanted cardiac defibrillator
  16. Coagulopathy or use of anticoagulants
  17. ASA classification >3
  18. Scleroderma or other connective diseases
  19. Use of immunosuppressive medications.

Information from the National Library of Medicine

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


Locations
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United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States
Stanford University Medical Center
Stanford, California, United States
United States, Connecticut
Norwalk Hospital
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
Sponsors and Collaborators
Montefiore Medical Center
Albert Einstein College of Medicine
Investigators
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Principal Investigator: Erin Moran-Atkin, MD Assistant Professor
Additional Information:

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Responsible Party: Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT02637713    
Other Study ID Numbers: 2015-5661a
First Posted: December 22, 2015    Key Record Dates
Last Update Posted: December 12, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Montefiore Medical Center:
GERD
sleeve gastrectomy
reflux
morbidly obese
Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight