This study is not yet accepting patients

PREcision MEDicine In Achalasia (PREMEDIA) - Cohort

a study on Type III Achalasia Jackhammer Esophagus Distal Esophageal Spasm

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
study ends around

Description

Summary

The goal of this observational study is to learn about how the doctor decides how long to cut t the esophageal muscle during Per-Oral Endoscopic Myotomy (POEM) in patients with difficulty swallowing due to certain conditions. The main question it aims to answer is: does pre-POEM testing help the physician choose how long to cut the muscle.

Participants will allow researchers to access their standard of care information in their medical record, complete questionnaires at up to 6 times over a 2-year period.

Official Title

PREcision MEDicine In Achalasia - A Multicenter Randomized Non-Inferiority Clinical Trial of Short Tailored POEM vs. Standard POEM for Non-Spastic Achalasia and A Multicenter Prospective Cohort Study of Long Tailored POEM for Spastic Esophageal Motility Disorders

Keywords

Type III Achalasia, EGJ Outflow Obstruction With Spastic/Hypercontractile Features, Jackhammer Esophagus, Distal Esophageal Spasm, achalasia, EGJOO, Esophageal Achalasia

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Age ≥ 18
  2. Type III achalasia or EGJOO with spastic/hypercontractile features or Jackhammer Esophagus or Distal Esophageal Spasm
  3. Eckardt Score > 3

You CAN'T join if...

  • Exclusion:
    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

Locations

  • University of California San Diego
    La Jolla California 92093 United States
  • Mayo Clinic Arizona
    Scottsdale Arizona 85259 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Northwestern University
ID
NCT07293689
Study Type
Observational
Participants
Expecting 200 study participants
Last Updated