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Self-assembling peptide for local hemostasis during Endoscopic Treatment of Duodenum: A Observation Study

Self-assembling peptide for local hemostasis during Endoscopic Treatment of Duodenum: A Observation Study - SAMPLE study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000046432
Enrollment
30
Registered
2022-04-01
Start date
2022-05-09
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

Non-papillary superficial duodenal tumor

Interventions

None listed

Sponsors

Kyoto Prefectural University of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1)The patient has a lesion diagnosed as a superficial tumor (adenoma or intramucosal carcinoma) of the non-papillary part of the duodenum by endoscopy and is scheduled for CSP or ESD. (2) The lesion is located in the bulb, descending part, or horizontal part of the duodenum, and there is no continuity with the papilla. (3) In case of multiple lesions, the maximum number of lesions to be treated is 10. (4) The patient's age at the time of enrollment should be 20 years or older. (5) The patient has been fully informed about the participation in the study and has given his/her consent.

Exclusion criteria

Exclusion criteria: (1) In accordance with the "Guidelines for Gastrointestinal Endoscopy for Patients Taking Antithrombotic Drugs (2017 Supplement on Anticoagulants)", temporary discontinuation of antithrombotic medication is not possible and endoscopic treatment cannot be performed (discontinuation of medication is not mandatory if endoscopic treatment is possible). (2) Patients with infections that require systemic treatment (3) Pregnant or lactating women (4) Patients for whom follow-up after 4 weeks is not possible (5) Patients who are judged inappropriate by the investigator.

Design outcomes

Primary

MeasureTime frame
Hemostasis rate of bleeding during duodenal CSP and ESD using Self-assembling peptide

Countries

Japan

Contacts

Public ContactOsamu Dohi

Kyoto Prefectural University of Medicine Gastroenterology

osamu-d@koto.kpu-m.ac.jp075-251-5519

Outcome results

None listed

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