U-POEM vs CO2-POEM

Not Applicable

Recruiting

• Conditions: Esophageal Motility Disorders

• Registration Number: NCT06918730
• Lead Sponsor: AdventHealth

Brief Summary

Multicenter randomized trial comparing post-procedural pain intensity after Per-Oral endoscopic myotomy (POEM) between two types of standard of care insufflation methods (CO2 vs Underwater).

POEM is routinely performed under carbon dioxide insufflation (CO2-POEM) as this gas is more rapidly absorbed than air, which has been shown to reduce gas-related complications.

Water immersion for luminal distension of the GI tract as opposed to carbon dioxide insufflation has been shown to be associated with improved patient satisfaction, safety profile and even higher detection of polyps during colonoscopy in randomized trials

Aim 1. The primary aim is to compare post-procedural pain following U-POEM vs. CO2-POEM.

Aim 2. Compare the proportion of patients that require post-procedural admission for pain management.

Aim 3. Compare the need for analgesic medications for pain control in patients undergoing U-POEM vs. CO2-POEM.

Aim 4. Compare technical and clinical success between U-POEM vs. CO2-POEM. Technical success is defined as successful completion of the procedure whereas clinical success will be defined as an Eckardt score ≤ 3 at the time of follow-up.

Aim 5. Compare and evaluate procedural characteristics between the two groups.

1. Compare procedural time between U-POEM and CO2-POEM.

2. Compare the mean number of coagulations with hemostatic forceps for active intraprocedural bleeding and the mean number of times in which a device besides an electrosurgical knife was required for prophylactic ablation of vessels.

3. Adverse event rate (i.e. bleeding, perforation).

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-21
• Study First Submitted QC: 2025-04-07
• Last Update Submitted: 2025-04-07
• Study First Posted: 2025-04-09
• Last Update Posted: 2025-04-09
• Study Start: 2025-05-23
• Primary Completion: 2026-01-23
• Study Completion: 2026-07-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Age 18 years or older
• Ability to provide informed consent
• Patient scheduled to undergo POEM procedure for esophageal dysmotility

Exclusion Criteria

• Inability to provide informed consent
• Any contraindication to POEM as per the endoscopist at the time of endoscopic evaluation (example: esophageal stricture, malignancy).
• Any standard contraindication, including pregnancy, to anesthesia and/or colonoscopy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain measurement outcomes post procedure: Numeric Pain Scale	Through study completion. Before Endoscopic Procedure (Day 1), Post Endoscopic Procedure (Day 1), and follow-up visit (Up to 6 months post procedure)	The primary aim is to compare post-procedural pain following U-POEM vs. CO2-POEM.; Using Numeric Pain Scale (NPS); NPS is a numeric scale ranging from 0 (no pain) to 10 (worst pain imaginable)
Pain measurement outcomes post procedure: Pain Quality Assessment Scale	Through study completion. Before Endoscopic Procedure (Day 1), Post Endoscopic Procedure (Day 1), and follow-up visit (Up to 6 months post procedure)	The primary aim is to compare post-procedural pain following U-POEM vs. CO2-POEM.; Pain Quality Assessment Scale (PQAS).; PQAS is a numeric scale ranging from 0 (no pain) to 10 (worst pain imaginable)

Secondary Outcome Measures

Name	Time	Method
Readmission rate	30 days post procedure (+- 7 days)	Compare the proportion of patients that require post-procedural admission for pain management.
Analgesic medication needs	30 days post procedure (+- 7 days)	Compare the need for analgesic medications for pain control in patients undergoing U-POEM vs. CO2-POEM through electronic medical records.
Compare technical success between POEM procedures	up to 6 months	Compare technical success between U-POEM vs. CO2-POEM. Technical success is defined as successful completion of the procedure.

Trial Locations

Locations (1)

AdventHealth Orlando; 🇺🇸 Orlando, Florida, United States