CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 64 enrolled
Drug / intervention
Peroral endoscopic myotomyprocedure
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04951739
NCT04951739N/ACompleted

To Investigate the Incidence of Reflux in Patients After Per-oral Endoscopic Myotomy in Achalasia Cardia Patients

Asian Institute of Gastroenterology, India·observational·Posted Jul 7, 2021·Updated Jan 31, 2023

In Brief

An observational study evaluating Peroral endoscopic myotomy for Achalasia Cardia and Gastroesophageal Reflux. Completed, enrolled 64 participants across 1 site.

Detailed Summary

Achalasia is a rare motility disorder of the oesophagus that is characterized by aperistalsis of the oesophagal body and dysrelaxation of the lower oesophagal sphincter (LES). Current treatment is palliative, and the aim of the treatment is to diminish the obstructive function of the esophagogastric junction (EGJ). Due to this approach, the most frequent complication post-treatment is gastroesophageal reflux (GER). However, not every treated patient develops GER symptoms and the mechanism behind the occurrence of GER in treated achalasia are unclear. In this study, we aim to Investigate the incidence of reflux in patients after peroral endoscopic myotomy in patients with achalasia cardia.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesIndia
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJul 7, 2021
Enrollment StartJul 1, 2021
Primary CompletionDec 15, 2021
Study CompletionMar 15, 2022
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 5.0 years ago

Interventions

Peroral endoscopic myotomyprocedure

Peroral endoscopic myotomy involves an initial incision on the internal lining of the oesophagus. This permits entry of the endoscope to within the wall of the oesophagus, where the muscle will be exposed. The inner layer of the muscle near the lower oesophagal sphincter will be cut (this is termed myotomy). At the conclusion of the procedure, the oesophagal incision will be closed with standard endoscopic clips.