Management of Reflux After Sleeve Using Stretta (MaRSS)

Radiofrequency Energy Delivery to the Lower Esophageal Sphincter (Stretta) in Sleeve Gastrectomy Patients With GERD

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.

Study Overview

• Status: Terminated
• Conditions: GERD; Morbid Obesity
• Intervention / Treatment: Device: Stretta; Procedure: Radiofrequency (RF) Energy to the LES (Stretta Procedure)

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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
    • Stanford, California, United States, 94305
      • Stanford University Medical Center
  • Connecticut
    • Norwalk, Connecticut, United States, 06856
      • Norwalk Hospital
  • Louisiana
    • Lafayette, Louisiana, United States, 70503
      • Gastroenterology Clinic of Acadiana
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham & Women's Hospital
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Health System
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Case Medical Center
    • Cleveland, Ohio, United States, 44119
      • Cleveland Clinic Health System
    • Columbus, Ohio, United States, 43210
      • Ohio State University Wexner Medical Center
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Milton S. Hershey Medical Center
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital
    • Houston, Texas, United States, 77030
      • Memorial Hermann-Texas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients With Improved Symptoms Based on Reflux Symptom Index (RSI) Score	RSI scores will be used to determine whether patients achieved at least a 50% reduction in symptoms as compared to baseline. Patients will be provided a 9-item questionnaire and asked to rate the score that best applies to their symptoms on a 6 point scale ranging from 0 = No Problem to 5 = Severe Problem.	6 months
Number of Patients With Improved Symptoms Based on Reflux Severity Index (RSI) Score	RSI scores will be used to determine whether patients achieved at least a 50% reduction in symptoms as compared to baseline. Patients will be provided a 9-item questionnaire and asked to rate the score that best applies to their symptoms on a 6 point scale ranging from 0 = No Problem to 5 = Severe Problem.	12 months
Number of Patients With Improved Symptoms Based on Reflux Severity Index (RSI) Score	RSI scores will be used to determine whether patients achieved at least a 50% reduction in symptoms as compared to baseline. Patients will be provided a 9-item questionnaire and asked to rate the score that best applies to their symptoms on a 6 point scale ranging from 0 = No Problem to 5 = Severe Problem.	24 months
Number of Patients With Improved Symptoms Based on GERD Health Related Quality of Life (GERD-HRQL) Questionnaire Score	GERD-HRQL scores will be used to determine whether patients achieved at least a 50% reduction in symptoms as compared to baseline. Patients will be provided a 15-item questionnaire and asked to rate the score that best applies to their symptoms on a 6 point scale ranging from 0 to 5 (overall range from 0-75) with higher scores indicative of worsening symptoms.	6 months
Number of Patients With Improved Symptoms Based on GERD Health Related Quality of Life (GERD-HRQL) Questionnaire Score	GERD-HRQL scores will be used to determine whether patients achieved at least a 50% reduction in symptoms as compared to baseline. Patients will be provided a 15-item questionnaire and asked to rate the score that best applies to their symptoms on a 6 point scale ranging from 0 to 5 (overall range from 0-75) with higher scores indicative of worsening symptoms.	12 months
Number of Patients With Improved Symptoms Based on GERD Health Related Quality of Life (GERD-HRQL) Questionnaire Score	GERD-HRQL scores will be used to determine whether patients achieved at least a 50% reduction in symptoms as compared to baseline. Patients will be provided a 15-item questionnaire and asked to rate the score that best applies to their symptoms on a 6 point scale ranging from 0 to 5 (overall range from 0-75) with higher scores indicative of worsening symptoms.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Esophageal pH Levels	All patients will have pH monitoring conducted at baseline pre-procedurally. The number of patients with abnormal pH levels will be tabulated. Bravo capsule monitoring will be used for evaluation.	Baseline
Esophageal pH Levels	If esophageal pH levels at baseline are determined to have been abnormal, the number of patients with symptomatic GERD demonstrating an improvement in esophageal pH exposure following sleeve gastrectomy will be assessed. Bravo capsule monitoring will be used for evaluation.	6 months
Esophageal pH Levels	If esophageal pH levels at baseline are determined to have been abnormal, the number of patients with symptomatic GERD demonstrating an improvement in esophageal pH exposure following sleeve gastrectomy will be assessed. Bravo capsule monitoring will be used for evaluation.	12 months
Use of Anti-reflux Medication	The number of patients using anti-reflux medications will be tabulated.	Baseline
Cessation or Decreased Use of Anti-reflux Medication	The number of patients who demonstrate a complete cessation or decrease in use of anti-reflux medications will be tabulated.	6 months
Gastric Emptying Study	A Gastric emptying study will be conducted for all patients at 1, 2, 3, and 4 hours. Patients with severe gastroparesis (>50% retention at 4 hours) will be excluded from study	Baseline (up to 4 hours)
Determination of Gastric Dysmotility as a Contributory Factor in GERD Following Sleeve Gastrectomy	If gastric dysmotility is determined to have been abnormal at baseline, the gastric emptying study will be repeated at 6 months to evaluate Gastric Dysmotility will be evaluated as a contributory factor in GERD following sleeve gastrectomy.	6 months
Determination of Gastric Dysmotility as a Contributory Factor in GERD Following Sleeve Gastrectomy	If gastric dysmotility is determined to have been abnormal at baseline, the gastric emptying study will be repeated at 12 months to evaluate Gastric Dysmotility will be evaluated as a contributory factor in GERD following sleeve gastrectomy.	12 months
EGD Abnormalities	An EGD will be obtained for all patients at baseline. Biopsies of any suspicious lesions and any evidence of esophagitis will be obtained and scored in accordance with Los Angeles classification as either Grade A, Grade B, Grade C, or Grade D lesions with each grade denoting progressively more severe pathophysiology.	Baseline
EGD Abnormalities	In those patients identified to have abnormal esophageal pathology at baseline, biopsies of any suspicious lesions and any evidence of esophagitis will be obtained and scored in accordance with Los Angeles classification as either Grade A, Grade B, Grade C, or Grade D lesions with each grade denoting progressively more severe pathology. The number of patients demonstrating objective histologic improvement or resolution of esophagitis will be determined.	6 months
EGD Abnormalities	In those patients identified to have abnormal esophageal pathology at baseline, biopsies of any suspicious lesions and any evidence of esophagitis will be obtained and scored in accordance with Los Angeles classification as either Grade A, Grade B, Grade C, or Grade D lesions with each grade denoting progressively more severe pathology. The number of patients demonstrating objective histologic improvement or resolution of esophagitis will be determined.	12 months

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Collaborators: Albert Einstein College of Medicine
• Investigators: Principal Investigator: Erin Moran-Atkin, MD, Assistant Professor

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): May 1, 2019

Study Registration Dates

• First Submitted: November 16, 2015
• First Submitted That Met QC Criteria: December 21, 2015
• First Posted (Estimated): December 22, 2015

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 2, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: GERD; reflux; sleeve gastrectomy; morbidly obese
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: 2015-5661a

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes