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POEM-F for Achalasia International Study

RecruitingNAAges 18 Years - 65 YearsAllChinese University of Hong Kong
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In plain words

What the trial is, and whether it could suit you

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. Th

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion criteria: 1. Adult patient (age โ‰ฅ18 and โ‰ค65 years-old) and with symptomatic achalasia type I or II. 2. Capability of understanding and complying with the study requirements, including filling the Eckardt Score, GERD-HRQL and RSI questionnaire and signing the informed consent form. 3. Patients with achalasia type I, II or III who are one of the following: * Treatment naรฏve, or * Failed prior through-the-scope balloon dilation, Savary or pneumatic dilation Exclusion criteria: 1. Patients unable or unwilling to provide consent. 2. Previous esophageal or gastric surgery. 3. Prior achalasia treatment including Heller myotomy, POEM. 4. Sigmoid achalasia, or significant esophageal dilatation \>6cm in lower esophagus 5. Disrupted mucosal integrity at the distal esophagus, eg. Ulcer, fibrotic scars etc 6. Patients with large hiatal hernias (axial length \> 2 cm and Hill grade \>2). 7. Patients with significant cardiorespiratory comorbidities which may limit their ability to undertake general anesthesia for the procedure, including ASA grade III or above. 8. Patients with obesity (Body Mass Index (BMI) โ‰ฅ 30). 9. Pregnant women or those planning pregnancy or breastfeeding women. 10. Uncorrectable coagulopathy defined by international normalized ratio (INR) \> 1.5 or platelet count \< 50000/ยตl.
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What it tests

  • POEM-F
  • Conventional POEM
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Where

7 sites
Johns Hopkins Hospital
Baltimore, United States
Nanfang Hospital, Southern Medical University
Guangzhou, China
The Chinese University of Hong Kong
Hong Kong, Hong Kong
Post Graduate Institute of Medical Education and Research
Chandigarh, India
Asian Institute of Gastroenterology
Hyderabad, India
Baldota Institute of Digestive Sciences
Mumbai, India
Deenanath Mangeshkar Hospital & Research Center
Pune, India
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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