Evaluation of the efficacy of a peptide-derived absorbable haemostatic agent in the prevention of post-operative bleeding in artificial ulcers caused by colon and gastric submucosal dissection: a single-centre prospective observational study.

Evaluation of the efficacy of a peptide-derived absorbable haemostatic agent in the prevention of post-operative bleeding in artificial ulcers caused by colon and gastric submucosal dissection: a single-centre prospective observational study. - Evaluation of the efficacy of a peptide-derived absorbable haemostatic agent in the prevention of post-operative bleeding in artificial ulcers caused by colon and gastric submucosal dissection: a single-centre prospective observational study.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000050488

Enrollment

300

Registered

2023-03-10

Start date

2022-05-10

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

Early stage colorectal cancer, Early stage gastric cancer

Interventions

None listed

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: (1)Patients with a preoperative colonoscopy and endoscopic or histopathological diagnosis of early colorectal cancer with a predicted depth of Tis(intramucosal cancer) to T1a and who will undergo ESD. (2)Patients diagnosed with early gastric cancer or gastric adenoma who are considered eligible for ESD based on size, histological type and depth, and who will undergo ESD(eligibility is determined based on the ESD/EMR guidelines for gastric cancer, 2nd edition). (3)Patients regularly taking antiplatelet or anticoagulant medication. (4)Patients for whom informed written consent has been obtained.

Exclusion criteria

Exclusion criteria: (1)Patients with a history of hypersensitivity to peptide or protein preparations. (2) Patients who are considered by the investigator to be unsuitable for participation in this study.

Design outcomes

Primary

Measure	Time frame
Incidence of posterior bleeding after endoscopic submucosal dissection.	—

Countries

Japan

Contacts

Public ContactAkinari Takao

Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital Department of Gastroenterology

globes.and.maps.1228@gmail.com0338232101

Outcome results