Steroid infusion using a spray tube after ESD for esophageal cancer

JRCT ID: jRCT1061220099

Registered date:23/02/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: esophageal cancer
• Date of first enrollment: 26/10/2022
• Target sample size: 100
• Study type: Interventional
• Intervention(s): As a technical intervention, steroid infusion using a spraying tube or local steroid injection using a local injection needle is performed for postoperative esophageal ulcers immediately after ESD.

Outcome(s)

• Primary Outcome: Primary endpoint: stenosis rate in the spraying tube group and needle group
• Secondary Outcome: Secondary endpoints: rate of adverse events, number of endoscopic balloon dilatations

Key inclusion & exclusion criteria

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

Include criteria

1. Patients diagnosed with esophageal cancer or suspected esophageal cancer by endoscopy and biopsy
2. Esophageal cancer is diagnosed as confined to submucosal infiltration by preoperative endoscopic diagnosis.
3. Patients who are expected to undergo esophageal ESD for esophageal cancer and resection of 3/4 or more of the luminal circumference but less than the entire circumference
4. Written consent has been obtained from the patient or legally acceptable representative after receiving a sufficient explanation about study participation.

Exclude criteria

(1) Patients with esophageal cancer whose major axis exceeds 5 cm
(2) Patients taking steroids before esophageal ESD
(3) Patients judged by the researcher's doctor to be inappropriate for this study

Related Information

• Primary Sponsor: Goto Atsushi