Water pressure method in Esophageal ESD study

UMIN ID: UMIN000046632

Registered date:14/01/2022

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Epithelial esophageal cancer, esophagogastric junction cancer
• Date of first enrollment: 2022/01/14
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: Percentage of endoscopic ESD completed with the water pressure method
• Secondary Outcome: 1) Enblock resection rate 2) R0 resection rate 3) Resection time 4) Incidental disease rate (pneumonia, intraoperative perforation, delayed perforation, bleeding) 5) Hospitalization period 6) Number of intraoperative hypoxia (SpO2 less than 85) 7) Volume of water injected and suctioned

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) Cervical and upper esophageal cases 2) Patients with severe respiratory failure (on home oxygen, severe asthma, etc.) 3) Cases of systemic administration of immunosuppressive drugs (not including topical drugs) 4) Post esophageal CRT, post ESD scar, post surgical cases 5) Patients refusing KEIO-GI 6) Patients under general anesthesia 7) Other cases judged by the physician in charge to be unsuitable for registration)

Related Information

• Primary Sponsor: Keio University
• Source(s) of Monetary Support: no