Safety and efficacy of Tip-in endoscopic mucosal resection for large flat colorectal Adenomas: a Randomized control trial

Safety and efficacy of Tip-in endoscopic mucosal resection for large flat colorectal Adenomas: a Randomized control trial - STAR trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000025754

Enrollment

Registered

2017-02-14

Start date

2017-01-29

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

large flat colorectal adenomas

Interventions

conventional EMR Tip-in EMR technique

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with a large flat adenoma (15-25 mm in size) 2. Patients aged over 20 years old when consents to the participation is obtained 3. Ptients consented after full understanding of this study

Exclusion criteria

Exclusion criteria: 1. Cases with clinical diagnosis of T1 cancer 2. Cases with difficulties to interrupt intake of anticoagulant drugs 3. Inappropriate cases by investigators

Design outcomes

Primary

Measure	Time frame
En bloc resection rate in intention-to-treat analysis	—

Secondary

Measure	Time frame
1.En bloc resection rate in per-protocol analysis 2. Complete R0 resection rate 3. One-year accumulate recurrence rate 4. En bloc resection rate in group A (15-19 mm in diameter) and group B (20-24 mm in diameter) 5. One-year accumulate recurrence rate in group A (15-19 mm in diameter) and group B (20-24 mm in diameter) 6. Complete R0 resection rate in group A (15-19 mm in diameter) and group B (20-24 mm in diameter) 7. En bloc resection rate by lesion location 8. One-year accumulate recurrence rate in en bloc resection group and piecemeal resection group 9. One-year accumulate recurrence rate in R0 resection group and R1resection group 10. One-year accumulate recurrence rate in cases of RX resection 11. Rate of exclusion by poor lesion lifting in cases with previous biopsies 12. Complication rate 13. Accuracy of endoscopic diagnosis for residual adenomas during surveillance tests	—

Measure

Time frame

1.En bloc resection rate in per-protocol analysis 2. Complete R0 resection rate 3. One-year accumulate recurrence rate 4. En bloc resection rate in group A (15-19 mm in diameter) and group B (20-24 mm in diameter) 5. One-year accumulate recurrence rate in group A (15-19 mm in diameter) and group B (20-24 mm in diameter) 6. Complete R0 resection rate in group A (15-19 mm in diameter) and group B (20-24 mm in diameter) 7. En bloc resection rate by lesion location 8. One-year accumulate recurrence rate in en bloc resection group and piecemeal resection group 9. One-year accumulate recurrence rate in R0 resection group and R1resection group 10. One-year accumulate recurrence rate in cases of RX resection 11. Rate of exclusion by poor lesion lifting in cases with previous biopsies 12. Complication rate 13. Accuracy of endoscopic diagnosis for residual adenomas during surveillance tests

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Countries

Japan

Contacts

Public ContactKenichiro Imai

Shizuoka Cancer Center Division of Endoscopy

k.imai1977@gmail.com055-989-5222

Outcome results

None listed

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