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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON37962
Enrollment
6
Registered
2008-12-31
Start date
2009-08-17
Completion date
Unknown
Last updated
2024-11-18

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

Conditions

colon cancer colon carcinoma

Interventions

Colonoscopy will be performed at the operating room when patients are under general anesthesia. When the tumor is localized, their will be one injection with the fluorescent tracer at the base of th

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
faesibility of the technique

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)