Clinical trial of submucosal injection color adjustment in POEM

Phase 2

Recruiting

• Conditions: Esophageal motility disorders; D015154

• Registration Number: JPRN-jRCTs061210057
• Lead Sponsor: Ikeda Yoshio

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-09
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified