Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06652672
NA

Sentinel Node and Organ-sparing Surgery in Stage I Colon Carcinoma

Sponsor: Meander Medical Center

View on ClinicalTrials.gov

Summary

The aim of this study is to reduce the need for colectomy and its' associated morbidity and mortality in patients with pT1-2 colon carcinoma after endoscopic resection and an estimated lymph node metastasis (LNM) risk of \>15%, or with macroscopically suspected T1 tumors, by performing an endoscopic-assisted laparoscopic/robotic wedge resection of the tumor or scar, along with sentinel node (SLN) biopsy using indocyanine green (ICG). This intervention will be compared to the standard-of-care segmental resection using a partially randomized patient preference design. The primary outcome is the 3-year recurrence rate.

Official title: Sentinel Node and Organ-sparing Surgery in Stage I Colon Carcinoma (SENTRY Trial)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

341

Start Date

2024-12-12

Completion Date

2032-12-12

Last Updated

2025-11-20

Healthy Volunteers

No

Interventions

PROCEDURE

Organ-sparing surgery

Endoscopy-assisted laparoscopic/robotic wedge resection and sentinel lymph node biopsy using submucosal injection of ICG.

PROCEDURE

Standard of care segmental resection

Standard of care segmental resection of the affected part of the colon including removal of regional lymph nodes.

Locations (1)

Meander Medisch Centrum

Amersfoort, Netherlands