Management of Reflux After Sleeve Using Stretta

Not Applicable

Terminated

Conditions: GERD
Morbid Obesity

Interventions: Device: Stretta
Procedure: Radiofrequency (RF) Energy to the LES (Stretta Procedure)

Registration Number: NCT02637713

Lead Sponsor: 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.

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 5

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Radiofrequency Energy to the Lower Esophageal Sphincter (LES)	Stretta	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.
Radiofrequency Energy to the Lower Esophageal Sphincter (LES)	Radiofrequency (RF) Energy to the LES (Stretta Procedure)	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.

Primary Outcome Measures

Name	Time	Method
Number of Patients With Improved Symptoms Based on Reflux Symptom Index (RSI) Score	6 months	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.
Number of Patients With Improved Symptoms Based on Reflux Severity Index (RSI) Score	24 months	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.
Number of Patients With Improved Symptoms Based on GERD Health Related Quality of Life (GERD-HRQL) Questionnaire Score	24 months	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.

Secondary Outcome Measures

Name	Time	Method
Gastric Emptying Study	Baseline (up to 4 hours)	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
Determination of Gastric Dysmotility as a Contributory Factor in GERD Following Sleeve Gastrectomy	12 months	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.
EGD Abnormalities	12 months	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.
Esophageal pH Levels	12 months	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.
Use of Anti-reflux Medication	Baseline	The number of patients using anti-reflux medications will be tabulated.
Cessation or Decreased Use of Anti-reflux Medication	6 months	The number of patients who demonstrate a complete cessation or decrease in use of anti-reflux medications will be tabulated.

Trial Locations

Locations (13): Cleveland Clinic Health System
🇺🇸
Cleveland, Ohio, United States
Stanford University Medical Center
🇺🇸
Stanford, California, United States
Cedars-Sinai Medical Center
🇺🇸
Los Angeles, California, United States
Memorial Hermann-Texas Medical Center
🇺🇸
Houston, Texas, United States
Norwalk Hospital
🇺🇸
Norwalk, Connecticut, United States
Duke University Health System
🇺🇸
Durham, North Carolina, United States
Ohio State University Wexner Medical Center
🇺🇸
Columbus, Ohio, United States
University Hospitals Case Medical Center
🇺🇸
Cleveland, Ohio, United States
Houston Methodist Hospital
🇺🇸
Houston, Texas, United States
Penn State Milton S. Hershey Medical Center
🇺🇸
Hershey, Pennsylvania, United States
Brigham & Women's Hospital
🇺🇸
Boston, Massachusetts, United States
Gastroenterology Clinic of Acadiana
🇺🇸
Lafayette, Louisiana, United States
Montefiore Medical Center
🇺🇸
Bronx, New York, United States