Clinical trial of submucosal injection color adjustment in POEM

JRCT ID: jRCTs061210057

Registered date:09/12/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Esophageal motility disorders
• Date of first enrollment: 11/01/2022
• Target sample size: 30
• Study type: Interventional
• 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

Outcome(s)

• Primary Outcome: Success rate of proper submucosal tunneling in POEM

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include 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.

Exclude 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

Related Information

• Primary Sponsor: Ikeda Yoshio
• Source(s) of Monetary Support: FUJIFILM Corporation