Status:
RECRUITING
POEM-F for Achalasia International Study
Lead Sponsor:
Chinese University of Hong Kong
Collaborating Sponsors:
Deenanath Mangeshkar Hospital and Research Centre
Johns Hopkins University
Conditions:
Achalasia
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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 P...
Detailed Description
Achalasia is the most common esophageal motility disorder worldwide, with an annual incidence of 1.6 per 100'000 individual and prevalence of 10 per 100'000 population. The incidence of achalasia has ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Adult patient (age ≥18 and ≤65 years-old) and with symptomatic achalasia type I or II.
- 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.
- Patients with achalasia type I, II or III who are one of the following:
- Treatment naïve, or
- Failed prior through-the-scope balloon dilation, Savary or pneumatic dilation
- Exclusion criteria:
- Patients unable or unwilling to provide consent.
- Previous esophageal or gastric surgery.
- Prior achalasia treatment including Heller myotomy, POEM.
- Sigmoid achalasia, or significant esophageal dilatation \>6cm in lower esophagus
- Disrupted mucosal integrity at the distal esophagus, eg. Ulcer, fibrotic scars etc
- Patients with large hiatal hernias (axial length \> 2 cm and Hill grade \>2).
- Patients with significant cardiorespiratory comorbidities which may limit their ability to undertake general anesthesia for the procedure, including ASA grade III or above.
- Patients with obesity (Body Mass Index (BMI) ≥ 30).
- Pregnant women or those planning pregnancy or breastfeeding women.
- Uncorrectable coagulopathy defined by international normalized ratio (INR) \> 1.5 or platelet count \< 50000/µl.
Exclusion
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2026
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT06042127
Start Date
December 1 2023
End Date
October 31 2026
Last Update
December 3 2024
Active Locations (7)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
2
Nanfang Hospital, Southern Medical University
Guangzhou, China
3
The Chinese University of Hong Kong
Hong Kong, Hong Kong
4
Post Graduate Institute of Medical Education and Research
Chandigarh, India