International Prospective Observational Cohort Study for Optimal Bowel Resection Extent and Central Radicality for Colon Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 3,647
- Locations
- 36
- Primary Endpoint
- Distribution of metastatic LNs
Study Overview
Brief Summary
The T-REX study aims to clarify the actual status of metastatic lymph node (LN) distribution in colon cancer and provide reliable evidence regarding the optimal length of bowel resection and the extent of central lymph node dissection in colon cancer surgery.
Detailed Description
In colon canser, the incidence of metastasis in the pericolic lymph nodes (LNs) located along the bowel and marginal artery is high. The optimal extent of bowel resection is closely associated with how we define 'regional' pericolic LNs, which should be resected because of the risk of metastasis. However, there are no standardised criteria for 'regional' LNs in the pericolic area.
To establish a consensus for the extent of bowel resection and appropriate central LN dissection, international prospective stdies focusing on the distribution of metastatic LNs along the bowel and the primary feeding artery are conducted.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histologically proven colon adenocarcinoma
- •Pathological stage Ⅰ, Ⅱ or Ⅲ
- •Potentially curative surgery
- •Informed consent for observational data collection
Exclusion Criteria
- •Tis (mucosal cancer)
- •Multiple colon cancers
- •All patients with preoperative adjuvant therapy
Outcomes
Primary Outcomes
Distribution of metastatic LNs
Time Frame: At the time of 4 years after surgery
Distribution of metastatic LNs
Time Frame: At the time of patient registry in
Secondary Outcomes
- Prognostic outcomes according to the length of bowel resection(4 years)
- Prognostic outcomes according to the central radicality(4 years)