Management of Reflux After Sleeve Using Stretta (MaRSS)

Montefiore Medicine Academic Health System

Status: Terminated

Conditions: Morbid Obesity; GERD

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02637713

2015-5661a

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

5 participants in 1 patient group

Radiofrequency Energy to the Lower Esophageal Sphincter (LES)

Experimental group

Description:

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.

Treatment:

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

Device: Stretta