Condition: Achalasia · Sponsor: Chinese University of Hong Kong
Per-oral endoscopic myotomy (POEM) has emerged as the endoscopic treatment of choice for achalasia, offering comparable symptom relief with laparoscopic Heller's cardiomyotomy. The main concern with POEM is the higher incidence of post-procedure gastroesophageal reflux disease (GERD), occurring in up to 50-60% of patients. In order to reduce the risk of GERD, endoscopic fundoplication has been developed as a novel procedure mimicking surgical anterior partial fundoplication that can be performed in the same session as POEM (POEM-F). Case series of POEM-F in patients with achalasia reported encouraging outcomes of low GERD rate of \~12% at 1 year. Prospective comparative data between POEM-F and conventional POEM on post-procedure GERD is current lacking. The investigators therefore designed an international multicenter prospective randomized study to investigate the efficacy of POEM-F. The investigators postulate that POEM-F could reduce the incidence of post-procedure GERD when compared with conventional POEM. This is an international multicenter randomized controlled trial conducted between high volume expert centers from Hong Kong SAR, China, India and United States of America. Adult patients with manometry confirmed achalasia would be randomised to undergo POEM-F or POEM. The procedure would be performed by experts with vast experience in POEM. The primary outcome is the incidence of post-procedure GERD at 1 year, defined by the updated Lyon consensus. Secondary outcomes …
This description comes directly from the study's public registry record.
Hon Chi Yip, FRCSEd · 35052627 · hcyip@surgery.cuhk.edu.hk
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| Johns Hopkins Hospital | Baltimore, Maryland, United States | Not Yet Recruiting |
| Nanfang Hospital, Southern Medical University | Guangzhou, China | Not Yet Recruiting |
| The Chinese University of Hong Kong | Hong Kong, Hong Kong | Recruiting |
| Post Graduate Institute of Medical Education and Research | Chandigarh, India | Not Yet Recruiting |
| Asian Institute of Gastroenterology | Hyderabad, India | Not Yet Recruiting |
| Baldota Institute of Digestive Sciences | Mumbai, India | Not Yet Recruiting |
| Deenanath Mangeshkar Hospital & Research Center | Pune, India | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT06042127