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Swiss Prospective, Multicenter Study Sentinel Lymph Node Procedure in Colon Cancer


Phase 1/Phase 2
N/A
N/A
Open (Enrolling)
Both
Colonic Neoplasms

Thank you

Trial Information

Swiss Prospective, Multicenter Study Sentinel Lymph Node Procedure in Colon Cancer


Inclusion Criteria:



- Colon cancer at any stage diagnosed histologically or high degree of suspicion for
colon cancer at endoscopy, which cannot be confirmed with certainty in the biopsy.
The diagnosis of cancer must be certain in the definitive histology.

- Possibility of transabdominal injection of the dye (cancers below the peritoneal
reflection in which the injection of dye must be carried out through rectoscopy, are
therefore excluded).

- Patient's informed consent

Exclusion Criteria:

- Prior intrabdominal tumor surgery

- Other preexisting malignancies

- Hypersensitivity/allergy to dye (isosulfan blue)

- Pregnancy

- Breast-feeding

- No patient's informed consent

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

To assess the extent of upstaging due to the SLN procedure for colon cancer.

Outcome Time Frame:

1 month

Safety Issue:

No

Principal Investigator

Carsten T. Viehl, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital, Basel, Switzerland

Authority:

Switzerland: Ethikkommission

Study ID:

Rhein4031

NCT ID:

NCT00826579

Start Date:

May 2000

Completion Date:

December 2011

Related Keywords:

  • Colonic Neoplasms
  • Sentinel lymph node
  • Lymph node analysis
  • Bone marrow analysis
  • Neoplasms
  • Colonic Neoplasms

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