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

A multicenter prospective trial to verify the efficacy and safety of watchful waiting for bleeding after colorectal endoscopic submucosal dissection: a validation study

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1052230022
Enrollment
480
Registered
2023-05-17
Start date
2023-05-15
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal neoplasm Colorectal Neoplasms, Endoscopic Submucosal Dissections, Hematochezia

Interventions

Determination whether emergency endoscopy is indicated based on the "treatment policy for hematochezia after colorectal ESD"

Sponsors

Takehara Tetsuo
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. 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.

Exclusion criteria

Exclusion criteria: 1. 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.

Design outcomes

Primary

MeasureTime frame
1. Proportion of patients who avoided transfusion 2. Proportion of patients who avoided colonoscopy within 48 hours after ESD

Secondary

MeasureTime frame
1. 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

Contacts

Public ContactTakashi Kanesaka

Department of Gastrointestinal Oncology, Osaka International Cancer Institute

takashikanesaka@gmail.com+81-6-6945-1181

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026