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Retrospective observational study on the efficacy of PuraStat in preventing delayed bleeding after endoscopic treatment of the gastrointestinal tract

Retrospective observational study on the efficacy of PuraStat in preventing delayed bleeding after endoscopic treatment of the gastrointestinal tract - R-PPE

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000056957
Enrollment
110
Registered
2025-02-06
Start date
2024-06-25
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

Cases in which PuraStat was used during endoscopic resection of gastrointestinal tumors with a particularly high risk of delayed bleeding (cases in which the patient was taking antithrombotic medication, cases in which endoscopic resection of the duodenal bulb was performed and suture was not performed), cases in which PuraStat was used for gastroduodenal ulcer bleeding, cases in which PuraStat was used for bleeding after endoscopic treatment PuraStat was used for delayed bleeding after endoscop

Interventions

None listed

Sponsors

Keio University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Cases in which PuraStat was used during endoscopic resection of gastrointestinal tumors with a particularly high risk of delayed bleeding (cases in which patients were taking antithrombotic medications, cases in which endoscopic resection of the duodenal bulb was performed and suture was not performed), cases in which PuraStat was used for gastroduodenal ulcer bleeding, cases in which PuraStat was used for bleeding after endoscopic treatment PurStat was used for delayed bleeding after endoscopic treatment.

Exclusion criteria

Exclusion criteria: Cases in which the use of PuraStat was discontinued due to allergic reaction to PuraStat, etc., cases in which other hemostatic agents were used concomitantly, cases with hematological diseases, and cases in which refusal to participate in the study was made by the patient or his/her representative.

Design outcomes

Primary

MeasureTime frame
The incidence of delayed bleeding will be calculated and compared with previously reported cases and cases without PuraStat under similar conditions at our hospital.

Secondary

MeasureTime frame
Rate of delayed perforation, difference in rate of delayed bleeding by treatment site (duodenal vs. other), postoperative course, medical costs (calculated from devices used, labor costs, hospitalization costs, etc.)

Countries

Japan

Contacts

Public ContactAtsushi Nakayama

Keio University Hospital Cancer Center

anakayama34@keio.jp0333531211

Outcome results

None listed

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