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

Phase 3

• Conditions: GERD
• Interventions: Device: Radio Frequency Ablation (RFA) (Stretta Procedure); Procedure: Sham Procedure

• Registration Number: NCT02935881
• Lead Sponsor: Asian Institute of Gastroenterology, India

Brief Summary

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.

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 Timeline

• Study Start: 2015-01
• Status Verified: 2016-10
• Study First Submitted: 2016-10-11
• Study First Submitted QC: 2016-10-14
• Last Update Submitted: 2016-10-14
• Study First Posted: 2016-10-18
• Last Update Posted: 2016-10-18
• Primary Completion: 2017-01
• Study Completion: 2017-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RFA (Stretta Procedure)	Radio Frequency Ablation (RFA) (Stretta Procedure)	Radio Frequency Ablation (RFA) using a Stretta device.
Placebo Arm	Sham Procedure	Stretta device used but RFA will not be generated.

Primary Outcome Measures

Name	Time	Method
Number of patients who report improvement in Quality of Life (QOL) post Stretta procedure as compared to Sham therapy.	1 year	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Asian insititute of gastroenterology somajiguda, hyderabad india; 🇮🇳 Hyderabad, Telangana, India