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| Name | Class |
|---|---|
| Mayo Clinic | OTHER |
| University of South Florida | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CO2-POEM | Experimental | POEM is routinely performed under carbon dioxide insufflation (CO2-POEM) as this gas is more rapidly absorbed than air. |
|
| U-POEM | Experimental | Water immersion for luminal distension of the GI tract as opposed to carbon dioxide insufflation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| U-POEM | Procedure | Water immersion for luminal distension of the GI tract as opposed to carbon dioxide insufflation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain measurement outcomes post procedure: Numeric Pain Scale | 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) | Through study completion. Before Endoscopic Procedure (Day 1), Post Endoscopic Procedure (Day 1), and follow-up visit (Up to 6 months post procedure) |
| Pain measurement outcomes post procedure: Pain Quality Assessment Scale | 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) | Through study completion. Before Endoscopic Procedure (Day 1), Post Endoscopic Procedure (Day 1), and follow-up visit (Up to 6 months post procedure) |
| Measure | Description | Time Frame |
|---|---|---|
| Readmission rate | Compare the proportion of patients that require post-procedural admission for pain management. | 30 days post procedure (+- 7 days) |
| Analgesic medication needs | Compare the need for analgesic medications for pain control in patients undergoing U-POEM vs. CO2-POEM through electronic medical records. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dennis Yang, MD | AdventHealth Medical Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AdventHealth Orlando | Orlando | Florida | 32804 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31287522 | Background | Ponds FA, Fockens P, Lei A, Neuhaus H, Beyna T, Kandler J, Frieling T, Chiu PWY, Wu JCY, Wong VWY, Costamagna G, Familiari P, Kahrilas PJ, Pandolfino JE, Smout AJPM, Bredenoord AJ. Effect of Peroral Endoscopic Myotomy vs Pneumatic Dilation on Symptom Severity and Treatment Outcomes Among Treatment-Naive Patients With Achalasia: A Randomized Clinical Trial. JAMA. 2019 Jul 9;322(2):134-144. doi: 10.1001/jama.2019.8859. | |
| 31800987 |
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| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| CO2-POEM | Procedure | POEM is routinely performed under carbon dioxide insufflation (CO2-POEM) as this gas is more rapidly absorbed than air. |
|
| 30 days post procedure (+- 7 days) |
| Compare technical success between POEM procedures | 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:
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. | up to 6 months |
| Compare technical success between POEM procedures | Compare technical success between U-POEM vs. CO2-POEM. Technical success is defined as successful completion of the procedure. | up to 6 months |
| Background |
| Werner YB, Hakanson B, Martinek J, Repici A, von Rahden BHA, Bredenoord AJ, Bisschops R, Messmann H, Vollberg MC, Noder T, Kersten JF, Mann O, Izbicki J, Pazdro A, Fumagalli U, Rosati R, Germer CT, Schijven MP, Emmermann A, von Renteln D, Fockens P, Boeckxstaens G, Rosch T. Endoscopic or Surgical Myotomy in Patients with Idiopathic Achalasia. N Engl J Med. 2019 Dec 5;381(23):2219-2229. doi: 10.1056/NEJMoa1905380. |
| 39425737 | Background | Yang D, Bechara R, Dunst CM, Konda VJA. AGA Clinical Practice Update on Advances in Per-Oral Endoscopic Myotomy (POEM) and Remaining Questions-What We Have Learned in the Past Decade: Expert Review. Gastroenterology. 2024 Dec;167(7):1483-1490. doi: 10.1053/j.gastro.2024.08.038. Epub 2024 Oct 16. |
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| 42409294 | Derived | Yang D, Draganov PV, Hayat M, Abbasi A, Chandan S, Pathak SJ, Hasan MK, Bertran-Rodriguez C, Khan Z, Shariq Mohammed AS, Perananthan V, Gmehlin M, Swenson K, Buller KP, Binmoeller KF, Wong Kee Song LM. SINGLE-BLINDED RANDOMIZED CONTROLLED TRIAL COMPARING THE EFFECT OF UNDERWATER VERSUS CARBON DIOXIDE INSUFFLATION DURING PERORAL ENDOSCOPIC MYOTOMY ON POST-PROCEDURAL PAIN (U-POEM TRIAL). Gastrointest Endosc. 2026 Jul 6:S0016-5107(26)06878-1. doi: 10.1016/j.gie.2026.06.066. Online ahead of print. |