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 multi-centric 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 multi-centric 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 multi-centric prospective observational study.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000053488

Enrollment

200

Registered

2024-01-31

Start date

2024-02-01

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

PureStat is a peptide-derived absorbable haemostatic agent used to reduce the number of cauterisations with haemostatic forceps for leakage bleeding in artificial ulcers following endoscopic submucosal dissection (ESD) and other gastrointestinal endoscopic procedures. The aim of the study was to determine whether the use of PureStat on the ulcer bed following colorectal and gastric ESD in patients taking antiplatelet or anticoagulant medication can reduce the incidence of post-operative complica

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients must be at least 18 years of age at the time of obtaining consent. (2) Patients who have given a full explanation of their participation in this study, and who have given written consent of their own free will based on a full understanding of the study. (3) PS (ECOG) is 0, 1, or 2. (4) Patients can be followed for 28 days after treatment.

Exclusion criteria

Exclusion criteria: (1) Those with a history of hypersensitivity to peptide or protein preparations (2) Patients who are judged to be inappropriate to participate in this study by the principal investigator or research coordinator. (3) Patients who have been off antiplatelet agents or anticoagulants for more than 1 week during the perioperative period of ESD

Design outcomes

Primary

Measure	Time frame
Hemostatic time of gastrointestinal ulcer after ESD	—

Countries

Japan

Contacts

Public ContactAkinari Takao

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

globes.and.maps.1228@gmail.com03-3823-2101

Outcome results