Shorter POEM vs longer POEM for achalasia and EGJOO

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 randomized, controlled trial compares two Per-Oral Endoscopic Myotomy approaches for treating achalasia types I/II and EGJOO. Participants undergo either a standard 9 cm myotomy or a tailored 4 cm myotomy and are followed with symptom questionnaires over two years. The study aims to see if the shorter cut provides similar symptom relief with potentially fewer side effects, such as reflux or myotomy-related complications. Enrollment targets 370 patients across multiple sites, with data collection from medical records and patient surveys. The trial is conducted with oversight from Northwestern University and NIDDK, involving Mayo Clinic Arizona, UC San Diego, and University of Colorado Denver.

Why it matters

Who can join: the full rules

Inclusion Criteria

1. Age ≥ 18
2. Type I achalasia or type II achalasia or cEGJOO
3. Eckardt score \> 3

Exclusion Criteria

The following exclusion criteria are for the RCT, but 1-13 below also pertain to the observational study:

1. Prior POEM
2. Prior surgical treatment for achalasia
3. Endoscopic pneumatic dilation or lower esophageal sphincter botulinum toxin (botox) injection within 6 months
4. Prior unrelated esophageal or upper gastric surgery, including Roux-en-Y gastric bypass and sleeve gastrectomy
5. Prior endoscopic gastroesophageal intervention for obesity or GERD, such endoscopic sleeve gastroplasty or transoral incisionless fundoplication
6. Known secondary achalasia related to malignancy (pseudoachalasia)
7. Known eosinophilic esophagitis
8. Diverticulum (\> 2 cm) in distal esophagus
9. Megaesophagus
10. Fibroinflammatory stricture of the esophagus due to any etiology (e.g., peptic, radiation, eosinophilic)
11. Pregnancy
12. Standard contraindications to general anesthesia
13. Standard contraindications to endoscopic myotomy in the esophagus (e.g. untreated varices)
14. Unwillingness or inability to consent for the study
15. Anticipated inability to follow protocol
16. Weekly (or more frequent) opioid medication use in the last 2 years

Where it's running

• University of California San Diego
  La Jolla, California, United States Recruiting
• University of Florida
  Gainesville, Florida, United States Recruiting
• Emory University
  Atlanta, Georgia, United States Recruiting
• Northwestern University
  Chicago, Illinois, United States Recruiting
• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting
• Washington University
  St Louis, Missouri, United States Recruiting

Study contacts

• Study coordinator: Elizabeth Yan, BS
• Email: premedia.dcc@northwestern.edu
• Phone: 312-908-1723

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.