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Clinical trial of submucosal injection color adjustment in POEM

A single center clinical trial to improve the treatment success rate by adjusting the color tone of submucosal injection material in Per-oral endoscopic myotomy (POEM)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs061210057
Enrollment
30
Registered
2021-12-09
Start date
2022-01-11
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 motility disorders

Interventions

Treatment is given during an Per-oral endoscopic myotomy using two submucosal injection materials (Sodium hyaluronate solution, sodium alginate solution, physiological saline, etc.) supplemented with

Sponsors

Ikeda Yoshio
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Cases diagnosed with esophageal motility disorders (esophageal achalasia and related disorders) by high resolution manometry (HRM), esophagography, upper gastrointestinal endoscopy, etc., for which POEM is indicated. It does not matter whether previous treatment was given or not.

Exclusion criteria

Exclusion criteria: 1)Patients with a history of hypersensitivity to carbazochrome sodium sulfonate 2)Cases of hereditary fructose intolerance 3)Cases in which general anesthesia is difficult to perform 4)Cases with infections requiring systemic treatment 5)Pregnancy, possible pregnancy, or breastfeeding 6)Patients with psychosis, psychiatric symptoms, or dementia for whom participation in the study is judged to be difficult 7)Patients with respiratory diseases requiring continuous oxygen administration 8)Patients with uncontrolled hypertension 9) Patients with uncontrolled diabetes mellitus 10) Other cases judged inappropriate by the investigator

Design outcomes

Primary

MeasureTime frame
Success rate of proper submucosal tunneling in POEM

Secondary

MeasureTime frame
1) LCI (Linked-Color Imaging) color recognition improvement 2) Incidence of perioperative adverse events 3) Treatment time 4) Symptom improve rate (Eckardt score) 5) Incidence of gastroesophageal reflux after POEM

Contacts

Public ContactHideomi Tomida

Ehime University Hospial

tomida.hideomi.xi@ehime-u.ac.jp+81-89-960-5596

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026