NIPH Clinical Trials Search

JRCT ID: jRCT1052230022

Registered date:17/05/2023

Validation study of watchful waiting for bleeding after colorectal endoscopic submucosal dissection

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedColorectal neoplasm
Date of first enrollment15/05/2023
Target sample size480
Countries of recruitment
Study typeInterventional
Intervention(s)Determination whether emergency endoscopy is indicated based on the "treatment policy for hematochezia after colorectal ESD"


Primary Outcome1. Receiving blood transfusion 2. Receiving colonoscopy within 48 hours after the end of ESD
Secondary Outcome1. Receiving hemostasis 2. Hospitalization days 3. Hb value 4. Presence or absence of complications other than bleeding 5. Presence or absence of hematochezia and receiving colonoscopy from 48 hours to 28 days after colorectal ESD

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
Include criteria1. Patients who plan to receive endoscopic submucosal dissection (ESD) for colorectal tumors. 2. Age at the time of registration is 18 years or older. 3. Performance status is 0-1 according to ECOG standards. 4. Written consent has been obtained from the patient to participate in the research.
Exclude criteria1. Having a colorectal disease that can cause hematochezia, e.g. advanced colorectal cancer, inflammatory bowel disease. 2. Anemia with Hb value less than 10g/dl. 3. Having serious diseases, e.g. liver cirrhosis, renal failure. 4. Taking antithrombotic drugs.

Related Information


Public contact
Name Takashi Kanesaka
Address 3-1-69, Otemae, Chuo-ku, Osaka 541-8567, Japan Osaka Japan 541-856
Telephone +81-6-6945-1181
Affiliation Department of Gastrointestinal Oncology, Osaka International Cancer Institute
Scientific contact
Name Tetsuo Takehara
Address 2-2 Yamadaoka, Suita, Osaka, Japan Osaka Japan 565-0871
Telephone +81-6-6879-3621
Affiliation Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine