International Prospective Observational Cohort Study for Optimal Bowel Resection Extent and Central Radicality for Colon Cancer

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02938481

Acronym

T-REX

Enrollment

3647

Registered

2016-10-19

Start date

2013-05-30

Completion date

2025-01-31

Last updated

2026-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Cancer

Keywords

colon cancer, lymph node, extent of bowel resection

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Distribution of metastatic LNs	At the time of patient registry in

Secondary

Measure	Time frame
Prognostic outcomes according to the length of bowel resection	4 years
Prognostic outcomes according to the central radicality	4 years

Countries

Germany, Japan, Lithuania, Russia, South Korea, Taiwan, United Kingdom

Contacts

STUDY_DIRECTORKenichi Sugihara, M.D., Ph.D

Tokyo Medical and Dental University, Japan

Outcome results