Management of Reflux After Sleeve Using Stretta

NCT ID: NCT02637713

Last Updated: 2024-01-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2019-05-31

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.

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.

Conditions

GERD; Morbid Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Stretta

Intervention Type: DEVICE

Stretta is an FDA approved device that delivers Radiofrequency energy delivery to the lower esophageal sphincter. It is approved for the management of GRED.

Radiofrequency (RF) Energy to the LES (Stretta Procedure)

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Montefiore Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erin Moran-Atkin, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

Stanford University Medical Center

Stanford, California, United States

Norwalk Hospital

Norwalk, Connecticut, United States

Gastroenterology Clinic of Acadiana

Lafayette, Louisiana, United States

Brigham & Women's Hospital

Boston, Massachusetts, United States

Montefiore Medical Center

The Bronx, New York, United States

Duke University Health System

Durham, North Carolina, United States

University Hospitals Case Medical Center

Cleveland, Ohio, United States

Cleveland Clinic Health System

Cleveland, Ohio, United States

Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Houston Methodist Hospital

Houston, Texas, United States

Memorial Hermann-Texas Medical Center

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2015-5661a

Identifier Type: -

Identifier Source: org_study_id