IMited wEdge ResectIon for Colonic T1 cancer - a prospective multicenter cohort study

• Conditions: T1 coloncarcinoma; 10017990; 10017991

• Registration Number: NL-OMON55909
• Lead Sponsor: Isala Klinieken

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 143

Inclusion Criteria

• Lesion macroscopic suspect for T1 colon carcinoma during endoscopy (Hiroshima
2-3)
o Or histologically proven T1 colon carcinoma
• Size < 40mm
• Localized at least > 25cm proximal from the anus (measured endoscopically)
• > 18 years old

Exclusion Criteria

• Rectal carcinoma
• Distant metastasis at baseline
• > 50% circumferential growth of the lesion
- Prior endoscopic resection or attempt, lifting not included

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Reduction of oncologic resections for low-risk T1 colon carcinomas by using<br /><br>CAL-WR as primary treatment. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Effectiveness (technically success and macroscopic- and microscopic R0<br /><br>resection) of limited<br /><br>treatment approach<br /><br>- 3-year overall and disease free survival<br /><br>- 5-year overall and disease free survival<br /><br>- 30-day postoperative morbidity and mortality rate according to the<br /><br>Clavien-Dindo classification I-V<br /><br>- Total procedure related costs and cost effectiveness<br /><br>- Postoperative quality of life</p><br>