NIPH Clinical Trials Search

JRCT ID: jRCTs061210057

Registered date:09/12/2021

Clinical trial of submucosal injection color adjustment in POEM

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedEsophageal motility disorders
Date of first enrollment11/01/2022
Target sample size30
Countries of recruitment
Study typeInterventional
Intervention(s)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 indigo carmine and carbazochrome sodium sulfonate


Primary OutcomeSuccess rate of proper submucosal tunneling in POEM
Secondary Outcome1) 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

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
Include criteriaCases 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.
Exclude criteria1)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

Related Information


Public contact
Name Hideomi Tomida
Address Shitsukawa 454, Toon, Ehime, Japan Ehime Japan 791-0295
Telephone +81-89-960-5596
Affiliation Ehime University Hospial
Scientific contact
Name Yoshio Ikeda
Address Shitsukawa 454, Toon, Ehime Ehime Japan 791-0295
Telephone +81-89-960-5596
Affiliation Ehime University Hospital