Clinical trial NCT02637713: Management of Reflux After Sleeve Using Stretta
Official title: Radiofrequency Energy Delivery to the Lower Esophageal Sphincter (Stretta) in Sleeve Gastrectomy Patients With GERD
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: GERD
Morbid Obesity
Keywords: GERD
sleeve gastrectomy
reflux
morbidly obese
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2015-12-22
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of Patients With Improved Symptoms Based on Reflux Symptom Index (RSI) Score
timeFrame: 6 months
measure: Number of Patients With Improved Symptoms Based on Reflux Severity Index (RSI) Score
timeFrame: 12 months
measure: Number of Patients With Improved Symptoms Based on Reflux Severity Index (RSI) Score
timeFrame: 24 months
measure: Number of Patients With Improved Symptoms Based on GERD Health Related Quality of Life (GERD-HRQL) Questionnaire Score
timeFrame: 6 months
measure: Number of Patients With Improved Symptoms Based on GERD Health Related Quality of Life (GERD-HRQL) Questionnaire Score
timeFrame: 12 months
measure: Number of Patients With Improved Symptoms Based on GERD Health Related Quality of Life (GERD-HRQL) Questionnaire Score
timeFrame: 24 months
Secondary outcomes:
measure: Esophageal pH Levels
timeFrame: Baseline
measure: Esophageal pH Levels
timeFrame: 6 months
measure: Esophageal pH Levels
timeFrame: 12 months
measure: Use of Anti-reflux Medication
timeFrame: Baseline
measure: Cessation or Decreased Use of Anti-reflux Medication
timeFrame: 6 months
measure: Gastric Emptying Study
timeFrame: Baseline (up to 4 hours)
measure: Determination of Gastric Dysmotility as a Contributory Factor in GERD Following Sleeve Gastrectomy
timeFrame: 6 months
measure: Determination of Gastric Dysmotility as a Contributory Factor in GERD Following Sleeve Gastrectomy
timeFrame: 12 months
measure: EGD Abnormalities
timeFrame: Baseline
measure: EGD Abnormalities
timeFrame: 6 months
measure: EGD Abnormalities
timeFrame: 12 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Norwalk
country: United States
facility: Norwalk Hospital
state: Connecticut
city: Lafayette
country: United States
facility: Gastroenterology Clinic of Acadiana
state: Louisiana
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Health System
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Wexner Medical Center
state: Ohio
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Houston
country: United States
facility: Memorial Hermann-Texas Medical Center
state: Texas
Study officials:
affiliation: Assistant Professor
name: Erin Moran-Atkin, MD
role: PRINCIPAL_INVESTIGATOR
References: