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

NCT ID: NCT00654342

Last Updated: 2008-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Brief Summary

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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

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Conditions

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Sentinel Lymph Node Biopsy Colon Cancer

Keywords

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Sentinel lymph node-colon cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Study Groups

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1

In vivo injection group

Group Type OTHER

Intraoperative injection (in vivo)

Intervention Type PROCEDURE

Intraoperative injection

2

Ex vivo injection group

Group Type OTHER

Postoperative injection (ex vivo)

Intervention Type PROCEDURE

postoperative injection

Interventions

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Intraoperative injection (in vivo)

Intraoperative injection

Intervention Type PROCEDURE

Postoperative injection (ex vivo)

postoperative injection

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chung-Ang University

OTHER

Sponsor Role lead

Responsible Party

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Chung-Ang University Hospital

Locations

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Department of Surgery, Chung-Ang university Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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In-Taik Chang, M.D., Ph.D.

Role: CONTACT

Phone: 82-2-6299-1562

Email: [email protected]

Jun Seok Park, M.D.

Role: CONTACT

Phone: 82-2-6299-1548

Email: [email protected]

Other Identifiers

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caugs_01

Identifier Type: -

Identifier Source: org_study_id