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Phase II study of Cold Snare Polypectomy for Superficial Non-Ampullary Duodenal Epithelial Tumor

Phase II study of Cold Snare Polypectomy for Superficial Non-Ampullary Duodenal Epithelial Tumor - Phase II study of Cold Snare Polypectomy for Superficial Non-Ampullary Duodenal Epithelial Tumor (D-CSP)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000019157
Enrollment
19
Registered
2015-09-29
Start date
2015-10-01
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

Superficial Non-Ampullary Duodenal Epithelial Tumor (SNADET) &lt

Interventions

Cold Snare Polypectomy (CSP)

Sponsors

Division of Endoscopy, Shizuoka Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) superficial non-ampullary duodenal epithelial tumor <= 10mm 2) bulbs~3rd part of deudenum 3) one lesion 4) elevated lesion expected to remove en-block using snare 5) 20 years old and more 6) can be followed for 3 months 7) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Impossible to suspend anticoagulant or antiplatelet medications (except low-dose aspirin) 2) Infectious disease with systemic therapy indicated 3) Women during pregnancy or breast-feeding 4) Psychosis 5) Systemic steroids medication 6) History of myocardial infarction within 6 months or unstable angina pectoris within 3 weeks 7) Severe respiratory disease requiring continuous oxygen therapy 8) Uncontrollable hypertension 9) Uncontrollable diabetes millutus 10) others

Design outcomes

Primary

MeasureTime frame
Delayed perforation and bleeding

Secondary

MeasureTime frame
The rate of spurting bleeding just after CSP, en-block resection, R0 resection, residual tumor 3 months after CSP, adverse events

Countries

Japan

Contacts

Public ContactKohei Takizawa

Shizuoka Cancer Center Division of Endoscopy

k.takizawa@scchr.jp055-989-5222

Outcome results

None listed

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