NCT03322553|Completed
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Sponsor study identifier
interventional
70
1 country
1
Study Start
November 15, 2017
Actual (reported)Primary Completion
August 30, 2019
Actual (reported)Study Completion
December 30, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 30, 2019
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 17, 2017
Actual (reported)October 26, 2017
Actual (reported)November 15, 2017
Actual (reported)August 30, 2019
Actual (reported)December 30, 2019
Actual (reported)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
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
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
In sham procedure, identical technique will be followed by positioning the plicator inside the stomach but sutures will not be applied.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Asian institute of Gastroenterology
Hyderabad, Telangana, 500082, India
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.
Dr. D. Nageshwar Reddy, MBBS
Asian Institute of Gastroenterology, India
70 participants (actual enrollment reported by the registry).
First Submitted
October 17, 2017
First Posted
October 26, 2017
Study Start
November 15, 2017
Contact the study team to confirm eligibility.
Primary Completion
August 30, 2019
Actual (reported)Study Completion
December 30, 2019
Actual (reported)Last Updated
January 22, 2020
Record last verified: 2018-10
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