Esophageal Motility Disorders
Conditions
Keywords
POEM, U-POEM, CO2-POEM, Esophageal motility
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).
Interventions
PROCEDUREU-POEM
Water immersion for luminal distension of the GI tract as opposed to carbon dioxide insufflation
PROCEDURECO2-POEM
POEM is routinely performed under carbon dioxide insufflation (CO2-POEM) as this gas is more rapidly absorbed than air.
Sponsors
AdventHealth
Mayo Clinic
University of South Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 clinical success between U-POEM vs. CO2-POEM. Clinical success will be defined as an Eckardt score ≤ 3 at the time of follow-up. Achalasia Severity is measured by the Eckardt Score which consists of 4 questions used to characterize the severity of achalasia. The questions include symptoms related to: * Dysphagia * Chest pain * Regurgitation * Weight loss. Each question is assigned a score from 0 to 3 based on the patient's self-reported response. The overall score ranges from 0-12, with anything less than 3 meaning no active symptoms, and anything higher than a 3 suggestive of active symptoms. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDennis Yang, MD
AdventHealth Medical Group
Outcome results
None listed