U-POEM vs CO2-POEM

AdventHealth

Status: Active, not recruiting

Conditions: Esophageal Motility Disorders

Treatments: Procedure: U-POEM; Procedure: CO2-POEM

Study type: Interventional

Funder types: Other

Identifiers

NCT06918730

2263975

Details and patient eligibility

About

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).

Enrollment: 36 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 2 patient groups

CO2-POEM

Experimental group

Description:

POEM is routinely performed under carbon dioxide insufflation (CO2-POEM) as this gas is more rapidly absorbed than air.

Treatment:

Procedure: CO2-POEM

U-POEM

Experimental group

Description:

Water immersion for luminal distension of the GI tract as opposed to carbon dioxide insufflation

Treatment:

Procedure: U-POEM