STRETTA ,Radio Frequency Ablation (RFA) v/s Sham Therapy for the Treatment of Refractory GERD (STRETTAGERD)

A Prospective Randomized Trial Comparing Endoscopic Radio Frequency Ablation (RFA) - STRETTA vs Sham Therapy for the Treatment of Refractory Gastroesophageal Reflux Disease

Gastro-esophageal reflux disease (GERD) is a chronic disorder with significant impact on the quality of life of patients. It may also lead to several complications like peptic strictures, ulcerations, Barrett 's disease and subsequently adenocarcinoma of the esophagus. Proton pump inhibitors (PPIs) are the mainstay of GERD treatment, with up to 90 % of patients with reflux disease becoming asymptomatic while taking PPIs. Several studies have demonstrated that RF delivery at the gastro-esophageal junction(GEJ), also called the Stretta procedure, induces symptom relief and decreases need of PPI intake in GERD. The investigators propose to perform a sham-controlled randomized study to evaluate the influence of the Stretta procedure on symptoms and esophageal acid exposure in patients of refractory GERD.

Study Overview

• Status: Unknown
• Conditions: GERD
• Intervention / Treatment: Device: Radio Frequency Ablation (RFA) (Stretta Procedure); Procedure: Sham Procedure

Detailed Description

Gastro-esophageal reflux disease (GERD) is a chronic disorder with significant impact on the quality of life of patients. It may also lead to several complications like peptic strictures, ulcerations, Barrett 's disease and subsequently adenocarcinoma of the esophagus. Proton pump inhibitors (PPIs) are the mainstay of GERD treatment, with up to 90 % of patients with reflux disease becoming asymptomatic while taking PPIs. However, the treatment of patients with proven GERD, who have an unsatisfactory response to high doses of PPIs remains a challenge. A number of endoscopic procedures, aimed at improvement of the barrier function of the lower esophageal sphincter (LES), have emerged over the last decade. Several studies have demonstrated that RF delivery at the gastro-esophageal junction(GEJ), also called the Stretta procedure, induces symptom relief and decreases need of PPI intake in GERD. The investigators propose to perform a sham-controlled randomized study to evaluate the influence of the Stretta procedure on symptoms and esophageal acid exposure in patients of refractory GERD.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 3

Contacts and Locations

Study Locations

• India
  • Telangana
    • Hyderabad, Telangana, India, 500082
      • Recruiting
      • Asian insititute of gastroenterology somajiguda, hyderabad india
      • Contact: Kalapala Dr Rakesh, consultant; Phone Number: 040-23378482 9989211034; Email: drkalapala@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age > 18years
• Small hiatus hernia (< 2-3 cm)
• Los Angeles Grade 'A' or 'B' Reflux Esophagitis
• LES pressure : 5 - 15 mm Hg
• PPI dependent / refractory GERD
• 24 hr acid exposure study showing abnormal esophageal acid exposure > 4%
• DeMeester Score >14.7
• Esophageal manometry showing normal peristalsis

Exclusion Criteria

• Age < 18 years
• Large hiatus hernia (> 3 cm)
• Los Angeles Grade 'C' or 'D' Reflux Esophagitis
• LES pressure : < 5 or > 15 mm Hg
• Underlying coagulation disorder
• Previous Esophageal or Gastric surgery
• H/o coronary artery disease (CAD)
• Esophageal manometry showing ineffective peristalsis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: RFA (Stretta Procedure); Radio Frequency Ablation (RFA) using a Stretta device.	Device: Radio Frequency Ablation (RFA) (Stretta Procedure); Radio Frequency Ablation (RFA) for the treatment of refractory gastroesophageal reflux disease.
Sham Comparator: Placebo Arm; Stretta device used but RFA will not be generated.	Procedure: Sham Procedure; Stretta device will be used but Radio Frequency Ablation (RFA) will not be generated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients who report improvement in Quality of Life (QOL) post Stretta procedure as compared to Sham therapy.	6 point GERD Likert Scale will be used to assess the improvement in frequency and severity of GERD symptoms post Stretta procedure & Sham therapy amongst patients.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients who report independence from Proton Pump Inhibitor (PPI) drug post Stretta procedure as compared to Sham therapy.	Questionnaire will be provided to each participant to report no further requirement of PPI drug post procedure.	1 year
Comparison of Increased Lower Esophageal Sphincter pressure among patients post Stretta procedure & Sham Therapy.	High Resolution Esophageal Manometry will be performed after the procedure in each patient to compare the LES pressure between the two groups.	1 year

Collaborators and Investigators

• Sponsor: Asian Institute of Gastroenterology, India
• Investigators: Principal Investigator: Kalapala Rakesh, MD,DM, Asian Institute of Gastroenterology

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): January 1, 2017
• Study Completion (Anticipated): January 1, 2017

Study Registration Dates

• First Submitted: October 11, 2016
• First Submitted That Met QC Criteria: October 14, 2016
• First Posted (Estimate): October 18, 2016

Study Record Updates

• Last Update Posted (Estimate): October 18, 2016
• Last Update Submitted That Met QC Criteria: October 14, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: aigstretta 001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO