In vivo study to determine the efficacy of sentinel node mapping in patients with colon carcinoma using near-infrared laparoscopy after submucosal injectio

Completed

Conditions: colon cancer
colon carcinoma
10017990
10017998

Registration Number: NL-OMON37962

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 6

Inclusion Criteria

- Oral and written Informed Consent (IC)
- Age 18 years and older
- Patients histologically or radiologically suspicion of colon cancer
- Regular Pre-operative work-up
- Surgical resection of the tumor

Exclusion Criteria

- gross lymph node involvement
- distant metastases
- advanced disease with invasion of adjacent structures
- prior colorectal surgery
- metastatic or T4 disease discovered during intraoperative staging
- contraindications to laparoscopy
- rectal cancer
- allergy to iodine
- Patients at higher risk for anaphylactic reactions

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- identification rate of SLN<br /><br>- Number of false-negative SLNs<br /><br>- Number of patients who are upstaged by ultrastaging techniques<br /><br>- Number and status of aberrant lymph nodes<br /><br>- Accuracy: conformity of the SLN status and the regional node status<br /><br>- Number of positive SLNs which are the only positive nodes found.<br /><br>- Number and status of SLNs detected only by the near-infrared scope in vivo<br /><br>and ex vivo<br /><br>- Number and status of SLNs detected only with Patent Blue ex vivo<br /><br>- Number and status of SLNs detected by the near-infrared<br /><br>scope and patent blue in vivo and ex vivo</p><br>

Secondary Outcome Measures