New procedure for treating achalasia to reduce reflux

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This international multicenter study investigates the efficacy of a novel procedure called per-oral endoscopic myotomy with fundoplication (POEM-F) for treating achalasia, a condition characterized by difficulty swallowing. The study aims to compare the incidence of gastroesophageal reflux disease (GERD) between patients undergoing POEM-F and those receiving conventional POEM. By performing both procedures in the same session, the researchers hope to minimize the risk of GERD, which is a common complication of POEM. The study will include adult patients aged 18 to 65 with symptomatic achalasia types I or II, and will assess outcomes through various questionnaires and clinical evaluations.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Chinese University of Hong Kong
  Hong Kong, Hong Kong Recruiting
• Johns Hopkins Hospital
  Baltimore, Maryland, United States Not yet recruiting
• Nanfang Hospital, Southern Medical University
  Guangzhou, China Not yet 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

Study contacts

• Principal investigator: Hon Chi Yip, FRCSEd — Chinese University of Hong Kong
• Study coordinator: Hon Chi Yip, FRCSEd
• Email: hcyip@surgery.cuhk.edu.hk
• Phone: 35052627

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Full-thickness vs progressive myotomy in POEM for achalasia

  This trial tests whether a full-thickness myotomy during POEM works better than a partial, progressive approach for people with achalasia, to see which method better relieves symptoms with fewer side effects.

  Recruiting at 2 sites Phase 2 Cairo University · Cairo and 1 other locations · NCT07875686

• Impact of Patient Position on EndoFLIP Measurements in Kids and Young Adults

  This study tests whether EndoFLIP measurements differ when patients are in the supine versus left-side position during the procedure.

  Recruiting Johns Hopkins University · Baltimore, Maryland · NCT07780981

• A registry for adults with esophageal movement and reflux problems.

  This project will collect esophageal function tests (manometry, pH-impedance, FLIP) and clinical data from adults with reflux or swallowing symptoms to see if combining these results helps guide diagnosis and long-term care.

  Recruiting IRCCS San Raffaele · Milan, Lombardy · NCT07506746

• Speedboat UltraSlim™ for POEM in adults with achalasia and other esophageal motility disorders.

  This registry will see if using the Speedboat UltraSlim™ device for POEM is safe and effective for adults with achalasia or other esophageal motility disorders.

  Recruiting Baylor College of Medicine · Houston, Texas · NCT07496840

• Using the SpydrBlade Flex device during POEM for achalasia and EGJ outflow obstruction

  This will test whether using the SpydrBlade Flex device during POEM is safe and effective for adults with achalasia or EGJ outflow obstruction.

  Recruiting at 2 sites Chinese University of Hong Kong · Guayaquil and 1 other locations · NCT07406945

• Indocyanine green fluorescence during laparoscopic Heller–Dor for achalasia

  This study will try using indocyanine green dye during laparoscopic Heller‑Dor in adults with type I or II achalasia to find mucosal leaks during surgery and help guide repairs.

  Recruiting Federico II University · Naples · NCT07181070

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.