Endoscopic Full Thickness Plication (GERD-X) for the Treatment of PPI Dependent GERD:

NCT03322553 | Completed

• 1 other identifier: GERDX01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Gastro-esophageal reflux disease (GERD) is a common gastrointestinal disorder with a significant proportion of patients becoming dependent on proton pump inhibitor (PPI) therapy. Long term use of PPI therapy can be associated with side effects such as osteoporosis, small intestinal bacterial overgrowth and renal failure. Moreover, some of the patients might be reluctant to take PPIs for long duration and prefer surgery over pharmacotherapy. Endoscopic plication (GERD-X) is an alternative and less invasive procedure compared to laparoscopic fundoplication for the treatment of GERD. In endoscopic plication, transmural sutures are applied at the gastro-esophageal (GE) junction thereby reconstructing the gastric cardia and accentuating the valvular mechanism to prevent reflux. Only few trials have evaluated the efficacy of endoscopic plication technique and reported encouraging results. In this study we aim to evaluate the efficacy of a similar endoscopic technique but with application of two transmural sutures in randomized controlled method.

Conditions

Gastro Esophageal Reflux Disease

Outcome Measures

Primary Outcomes (1)

• Improvement in GERD

  Improvement in GERD HRQL by more than 50% from baseline at 3 months GERD - Health Related Quality of Life Questionnaire (GERD-HRQL) : Total Score: Calculated by summing the individual scores toquestions 1-15 Greatest possible score ( worst symptoms)= 75 Lowest possible score ( no symptoms)= 0 Heartburn Score: Calculated by summing the individual scores to questions 1-6 . Worst heartburn symptoms = 30 No heartburn symptoms= 0 Scores of ≤ 12 with each individual question not exceeding 2 indicate heartburn elimination. Regurgitation Score: Calculated by summing the individual scores to questions10-15. Worst regurgitation symptoms = 30 No regurgitation symptoms = 0 Scores of ≤ 12 with each individual question not exceeding 2 indicate regurgitation elimination.

  3months

Secondary Outcomes (5)

• Improvement in GERD overall symptom and quality of life score

  12 months

• Improvement in GERD symptom sub-score

  12 months

• Requirement of PPI

  12 months

• Improvement in oesophageal acidification

  3 months

• Improvement in lower oesophageal sphincter pressure

  3 months

Study Arms (2)

Plication group

EXPERIMENTAL

In patients allocated to endoscopic plication, endoscopic full-thickness plication will be performed using the GERDX® system. All procedures will be performed under general anesthesia. Savary-guidewire will be placed into the stomach using a gastroscope. The GERDX® system will be introduced over the guidewire into the stomach and retroflexed. The GE junction will be visualized using another slim endoscope passed through a channel present in the GERD-X device. According to study protocol, at least 2 pretied transmural pledgeted sutures will be deployed to achieve a tight closure of GE junction around the GERD-X device

Device: GERD-X

Sham Group

SHAM COMPARATOR

In sham procedure, identical technique will be followed by positioning the plicator inside the stomach but sutures will not be applied.

Device: GERD-X

Interventions

GERD-X DEVICE

Endoscopic full-thickness plication will be performed using the GERDX® system. All procedures will be performed under general anesthesia. Savary-guidewire will be placed into the stomach using a gastroscope. The GERDX® system will be introduced over the guidewire into the stomach and retroflexed. The GE junction will be visualized using another slim endoscope passed through a channel present in the GERD-X device. According to study protocol, at least 2 pretied transmural pledgeted sutures will be deployed to achieve a tight closure of gastro-esophageal junction around the GERD-X device.

Plication group; Sham Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients (between 18 to 60 years of age) with PPI dependent GERD and pathologic esophageal acid exposure as documented by percentage time esophageal pH less than 4 of more than 4.2% on pH-metry during 24-h period while off PPI
• Patients who are willing to pay the expenses of the GERD-X procedure

You may not qualify if:

• Large Hiatal hernia \>3cm
• Gr C/D esophagitis
• Lower esophageal sphincter (LES) pressure \<5 or \>15 mm Hg
• Paraesophageal hernia
• GE flap valve grade IV (Hill's classification)
• Barretts esophagus
• Esophageal dysmotility
• ASA physical status \>II
• Previous esophageal or gastric surgery
• Pregnancy

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Study Sites (1)

Asian institute of Gastroenterology

Hyderabad, Telangana, 500082, India

Location

Related Publications (1)

• Kalapala R, Karyampudi A, Nabi Z, Darisetty S, Jagtap N, Ramchandani M, Gupta R, Lakhtakia S, Goud R, Venkat Rao G, Sharma P, Reddy DN. Endoscopic full-thickness plication for the treatment of PPI-dependent GERD: results from a randomised, sham controlled trial. Gut. 2022 Apr;71(4):686-694. doi: 10.1136/gutjnl-2020-321811. Epub 2021 Apr 13.

  PMID: 33849942 DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Dr. D. Nageshwar Reddy, MBBS

  Asian Institute of Gastroenterology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized, Double blinded, sham controlled trial

Study Record Dates

• First Submitted: October 17, 2017
• First Posted: October 26, 2017
• Study Start: November 15, 2017
• Primary Completion: August 30, 2019
• Study Completion: December 30, 2019
• Last Updated: January 22, 2020

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)