Clinical trial NCT02935881: STRETTA ,Radio Frequency Ablation (RFA) v/s Sham Therapy for the Treatment of Refractory GERD
Official title: A Prospective Randomized Trial Comparing Endoscopic Radio Frequency Ablation (RFA) - STRETTA vs Sham Therapy for the Treatment of Refractory Gastroesophageal Reflux Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: GERD
Lead sponsor: Asian Institute of Gastroenterology, India
Sponsor class: OTHER
First posted: 2016-10-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients who report improvement in Quality of Life (QOL) post Stretta procedure as compared to Sham therapy.
timeFrame: 1 year
Secondary outcomes:
measure: Number of patients who report independence from Proton Pump Inhibitor (PPI) drug post Stretta procedure as compared to Sham therapy.
timeFrame: 1 year
measure: Comparison of Increased Lower Esophageal Sphincter pressure among patients post Stretta procedure & Sham Therapy.
timeFrame: 1 year
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Asian insititute of gastroenterology somajiguda, hyderabad india
state: Telangana
Study officials:
affiliation: Asian Institute of Gastroenterology
name: Kalapala Rakesh, MD,DM
role: PRINCIPAL_INVESTIGATOR
References: