Clinical trial NCT06918730: U-POEM vs CO2-POEM
Official title: Prospective Randomized Controlled Trial (RCT)Comparing Clinical Outcomes Between Underwater Versus Carbon Dioxide Insufflation During Peroral Endoscopic Myotomy (U-POEM Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Esophageal Motility Disorders
Keywords: POEM
U-POEM
CO2-POEM
Esophageal motility
Lead sponsor: AdventHealth
Sponsor class: OTHER
Collaborators: name: University of Florida
name: California Pacific Medical Center
name: Mayo Clinic
First posted: 2025-04-09
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Pain measurement outcomes post procedure: Numeric Pain Scale
timeFrame: Through study completion. Before Endoscopic Procedure (Day 1), Post Endoscopic Procedure (Day 1), and follow-up visit (Up to 6 months post procedure)
measure: Pain measurement outcomes post procedure: Pain Quality Assessment Scale
timeFrame: Through study completion. Before Endoscopic Procedure (Day 1), Post Endoscopic Procedure (Day 1), and follow-up visit (Up to 6 months post procedure)
Secondary outcomes:
measure: Readmission rate
timeFrame: 30 days post procedure (+- 7 days)
measure: Analgesic medication needs
timeFrame: 30 days post procedure (+- 7 days)
measure: Compare technical success between POEM procedures
timeFrame: up to 6 months
measure: Compare technical success between POEM procedures
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Orlando
country: United States
facility: AdventHealth Orlando
state: Florida
Study officials:
affiliation: AdventHealth Medical Group
name: Dennis Yang, MD
role: PRINCIPAL_INVESTIGATOR
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