Tokyo, March 19 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060971) titled 'A prospective study on the usefulness of the Temporary Narrowing Test for predicting the therapeutic efficacy of endoscopic antireflux mucosal resection' on March 18.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Hiroshima University

Condition: Condition - Gastroesophageal Reflux Disease : GERD Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aims to evaluate the usefulness of the Temporary Narrowing Test in predicting the therapeutic efficacy of endoscopic antireflux mucosal resection by simulating the procedure using the Temporary Narrowing Test prior to endoscopic antireflux mucosal resection in patients with GERD. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Acid-suppressive medications are discontinued for 14 days prior to the Temporary Narrowing Test (TNT), after which self-administered symptom questionnaires are obtained. During TNT, narrowing of the gastric cardia is achieved by approximating and fixing the mucosal folds of the anterior and posterior walls immediately below the gastric cardia (gastroesophageal flap valve). The detailed procedure is as follows:

A nylon thread approximately 2 m in length is tied and fixed to an endoscopic clip to create a thread-attached clip.

The thread-attached clip is passed through the endoscope working channel, deployed in the stomach, and fixed to the mucosal fold of the anterior wall immediately below the gastric cardia. The opposite end of the nylon thread remains outside the patient through the working channel.

The externalized nylon thread is passed through the jaws of another clip, which is then delivered into the stomach through the working channel, deployed, and fixed to the mucosal fold of the posterior wall immediately below the gastric cardia. By pulling the nylon thread from outside the patient, the clip fixed to the anterior wall mucosal fold is drawn toward the posterior wall.

For reinforcement, an additional clip is deployed to grasp and fix both the anterior and posterior mucosal folds approximated in step (3).

Finally, the nylon thread is cut and retrieved, and the procedure is completed.

With acid-suppressive medications discontinued, self-administered symptom questionnaires are obtained 3 days after TNT. In addition, 8 weeks after endoscopic antireflux mucosal resection, acid-suppressive medications are again discontinued for 14 days, followed by 24-hour pH monitoring, esophageal manometry, and upper gastrointestinal endoscopy, after which self-administered symptom questionnaires are obtained.

Eligibility: Age-lower limit - 18 years-old

Gender - Male and Female Key inclusion criteria - Individuals aged 18 years or older at the time of obtaining informed consent. Individuals with symptoms of GERD, including typical symptoms such as heartburn and acid regurgitation, as well as atypical symptoms such as chest pain, chronic cough, and laryngitis. Individuals who desire and are scheduled to undergo endoscopic antireflux mucosal resection, including those with a history of prior treatments. Individuals who are able to provide written informed consent to participate in this study. Key exclusion criteria - Individuals who are unable to undergo pre treatment evaluations, including upper gastrointestinal endoscopy, esophageal manometry, and 24 hour pH impedance monitoring. Individuals for whom completion of self administered symptom questionnaires is difficult. Individuals who are unable to discontinue acid suppressive medications, including proton pump inhibitors, potassium competitive acid blockers, and H2 receptor antagonists. Individuals who are pregnant or may be pregnant. Individuals deemed inappropriate for participation in this study by the principal investigator or co investigators. Target Size - 15

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 03 Month 18 Day Date of IRB - 2026 Year 03 Month 18 Day Anticipated trial start date - 2026 Year 03 Month 18 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069049

Disclaimer: Curated by HT Syndication.