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Transoral Incisional Fundoplication (TIF) for Patients Suffering From Gastroesophageal Reflux Disease in an Asian Population

RecruitingPhase 2Ages 18 Years - 80 YearsAllChinese University of Hong Kong
NCT07556289 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Transoral incisionless fundoplication (TIF) has become a widely used intervention to restore the valve at the gastroesophageal junction in selected patients suffering from gastroesophageal reflux disease (GERD). More than 20,000 procedures have been performed worldwide. TIF with EsophyX device reconfigures the tissue to establish an omega-shaped full-thickness gastroesophageal valve from inside the stomach. The procedure creates serosa to serosa plications which include the muscle layers and constructs valves 3-5cm long, taking in 200-270 degrees of the circumference, and deploying multiple non-absorbable polypropylene fasteners through the two layers in a circumferential patten around the gastroesophageal junction. Data so far indicate that, in the majority of patients, the procedure achieves lasting improvement in GERD symptoms measured by either pH or impedance monitoring. The techniq

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📋 Eligibility rules (as published)
Inclusion Criteria: * 18 years - 80 years of age * More than 6 months of GERD symptoms and troublesome regurgitation, despite a minimum PPI dose of 40 mg daily. Troublesome regurgitation was defined as mild symptoms for 2 or more days per week or moderate to severe symptoms more than 1 day per week, per Montreal consensus criteria. Patients will be followed-up for 5 years. * Symptom assessment used the following 3 validated tools: the Reflux Disease Questionnaire (RDQ), and the GERD-QOL score on PPI and off PPI for at least 7 days. * Abnormal amounts of gastroesophageal reflux off PPI for 7 days was confirmed by distal esophageal pH \<4 for \>5.3% of at least 1 of the 2 days that pH was measured with a Bravo (radiotelemetry) probe (Given Imaging, Yoqneam, Israel). Exclusion Criteria: * Systemic disease not well controlled * Obesity determined by body mass index \>35 * Esophageal ulcer, stricture * Barrett's esophagus \>2 cm in length * Hiatal hernia \>2 cm in length * Los Angeles grade C or D esophagitis * Peptic ulcer disease * Gastroparesis * Pregnancy or plans for pregnancy in the next 12 months * Immunosuppression * Portal hypertension * Coagulopathy
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What it tests

  • Transoral incisional fundoplication
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Where

1 site
The Chinese University of Hong Kong, Shatin, HK
Hong Kong, Hong Kong
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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