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Clinical Outcomes Between Underwater versus Carbon Dioxide Insufflation During Per-Oral Endoscopic Myotomy

Overview

About this study

The purpose of this study is to evaluate immediate post-procedure pain ratings and need for hospital admission for pain management between U-POEM vs. CO2-POEM. Evaluate and compare technical and clinical success, procedural time, hemostasis, changes in procedural hemodynamics, and adverse event rates between U-POEM and CO2-POEM.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Age 18 years or older
  • Ability to provide informed consent
  • Patients with diagnosis of achalasia type I or 2 based on high-resolution manometry (HRM) using the Chicago classification V4.020 6

Exclusion Criteria

  • Patients unable to provide informed consent.
  • Any contraindication to POEM as per the endoscopist (e.g. benign esophageal stricture, pseudoachalasia from malignancy) at the time of evaluation or any standard contraindication to anesthesia or endoscopy.
  • Patients with chronic pain taking regular opioids (requiring daily opioid therapy > 30 mg morphine or equivalent).
  • Prior POEM or laparoscopic Heller myotomy
  • Diverticulum (> 2 cm) in the distal esophagus.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 1/20/2025. Questions regarding updates should be directed to the study team contact.
 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Louis Wong Kee Song, M.D.

Open for enrollment

Contact information:

Kevin Buller

(507) 255-5476

Buller.Kevin@mayo.edu

More information

Publications

Publications are currently not available

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CLS-20583541

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