A multicenter observational prospective study to evaluate the efficacy of a thin therapeutic endoscope in per-oral endoscopic myotomy (POEM)

A multicenter observational prospective study to evaluate the efficacy of a thin therapeutic endoscope in per-oral endoscopic myotomy (POEM) - Study to evaluate the efficacy of thin therapeutic endoscope in POEM

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000056081

Enrollment

150

Registered

2024-11-06

Start date

2024-09-21

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal achalasia and related disorders

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with esophageal achalasia and related diseases by high resolution manometry (HRM), esophagography, or esophagogastroduodenoscopy. 2. Patients must be at least 18 years old and less than 95 years old at the time of consent. 3. Patients must have a performance status (ECOG) of 0, 1, or 2. 4. Patients may or may not have received prior treatment for esophageal achalasia. 5. Patients must be able to follow their progress from 49 to 98 days after treatment. 6. Patients whose participation in the study has been fully explained and whose written consent has been obtained from the study subjects themselves.

Exclusion criteria

Exclusion criteria: 1. Cases in which general anesthesia is difficult to administer 2. Patients with infectious diseases requiring systemic treatment 3. Patients who are pregnant, may become pregnant, or are breastfeeding. 4. patients with psychosis, psychiatric symptoms, or dementia that would make participation in the study difficult 5. patients with respiratory disease requiring continuous oxygen administration 6. patients with uncontrolled hypertension 7. Patients with uncontrolled diabetes mellitus. 8. 8. Other cases that the investigator deems inappropriate

Design outcomes

Primary

Measure	Time frame
Procedural success rate of POEM performed with a thin therapeutic endoscope	—

Secondary

Measure	Time frame
Procedure time, submucosal tunnel creation time, muscle layer incision time, number of clips required for entry closure, postoperative pain, postoperative inflammation, perioperative adverse event incidence, symptom improvement rate (using Eckardt score), incidence of gastroesophageal reflux disease after POEM, difference in treatment outcome between the normal therapeutic endoscopy treatment group	—

Measure

Time frame

Procedure time, submucosal tunnel creation time, muscle layer incision time, number of clips required for entry closure, postoperative pain, postoperative inflammation, perioperative adverse event incidence, symptom improvement rate (using Eckardt score), incidence of gastroesophageal reflux disease after POEM, difference in treatment outcome between the normal therapeutic endoscopy treatment group

—

Countries

Japan

Contacts

Public ContactHideomi Tomida

Ehime University Graduate School of Medicine Department of Gastroenterology and Metabology

hideomi.tomida.epch@hotmail.com089-960-5308

Outcome results