Comparison Between ex Vivo and in Vivo Injection of Blue Dye in Sentinel Lymph Node Mapping for Colon Cancer

Not Applicable

• Conditions: Sentinel Lymph Node Biopsy; Colon Cancer
• Interventions: Procedure: Intraoperative injection (in vivo); Procedure: Postoperative injection (ex vivo)

• Registration Number: NCT00654342
• Lead Sponsor: Chung-Ang University

Brief Summary

The technique of sentinel lymph node mapping in patients with colon cancer varies among reports, and the optimal method remain to be established. The purpose of this study was to determine the optimal injection technique for sentinel lymph node mapping for colon cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Status Verified: 2008-04
• Study First Submitted: 2008-04-02
• Study First Submitted QC: 2008-04-02
• Last Update Submitted: 2008-04-02
• Study First Posted: 2008-04-08
• Last Update Posted: 2008-04-08
• Primary Completion: 2009-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Stage I - III colon cancer patients

Exclusion Criteria

• cancer located at the low rectum which were located within 10 cm of the dentate, recurrent or metastatic colon carcinoma, adjacent organ invasion tumor, prior chemotherapy or radiation, cancer with intestinal obstruction, past intestinal surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Intraoperative injection (in vivo)	In vivo injection group
2	Postoperative injection (ex vivo)	Ex vivo injection group

Primary Outcome Measures

Name	Time	Method
Accuracy & sensitivity of sentinel lymph node mapping	After confirmed pathological report

Trial Locations

Locations (1)

Department of Surgery, Chung-Ang university Hospital; 🇰🇷 Seoul, Korea, Republic of