POEM-F for Achalasia International Study

Launched by CHINESE UNIVERSITY OF HONG KONG · Sep 11, 2023

Keywords

ClinConnect Summary

The POEM-F for Achalasia International Study is investigating a new treatment option for a condition called achalasia, which affects how food moves from the esophagus to the stomach. The standard procedure, known as POEM, is effective but can lead to a common side effect called gastroesophageal reflux disease (GERD), where stomach acid flows back into the esophagus. This trial is comparing POEM with a modified version called POEM-F, which includes an additional step to help reduce the risk of GERD after the procedure. Researchers hope that POEM-F will lead to fewer patients experiencing GERD.

To participate in this trial, you must be an adult aged 18 to 65 with a confirmed diagnosis of achalasia. You should be experiencing symptoms and may be new to treatment or have failed previous therapies. Participants will receive care from experienced doctors and will be monitored for one year to see how well each procedure works in preventing GERD. If you're considering joining, you will need to understand the study requirements and complete some questionnaires. This study is being conducted across several countries, including the USA, India, and China, and aims to determine if POEM-F can become the preferred treatment for achalasia.

Gender

ALL

Eligibility criteria

• Inclusion criteria:
• • 1. Adult patient (age ≥18 and ≤65 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 naïve, 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) ≥ 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/µl.