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

Colonic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00826579
• Other study ID #: Rhein4031
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 13, 2009
• Last updated: March 11, 2015
• Start date: May 2000
• Est. completion date: January 2009

Study information

• Verified date: March 2015
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

The study is a feasibility and validation study of the sentinel lymph node (SLN) procedure in all stages of colon cancer. If the SLN can be reliably identified, it could be submitted to a more accurate histopathological examination (multiple sections, special staining). The detection of micrometastases in the SLN (occult stage III, upstaging) is possible. Patients with micrometastases should be considered at higher risk.

Additionally, a search for occult metastatic tumor cells in the bone marrow is performed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Colonic Neoplasms

Intervention

Procedure:
• Sentinel lymph node procedure
After careful mobilization of the affected colon segment, isosulfan blue 1% is injected in vivo into the subserosa circumferentially around the tumor. Lymph nodes in the mesentery staining blue within the first minutes are marked as SLN. The procedure is followed by a resection of the affected colon segment with standard lymphadenectomy.
• Bone marrow aspiration
Prior to surgery, bone marrow is aspirated from both iliac crests. Bone marrow aspirates are analyzed for the presence of occult metastatic colon cancer cells.

Locations

Country	Name	City	State
Switzerland	Carsten T. Viehl, MD	Basel
Switzerland	Urban Laffer, MD	Biel
Switzerland	Markus Zuber, MD	Olten

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the extent of upstaging due to the SLN procedure for colon cancer.		1 month	No
Secondary	To evaluate the accuracy of the SLN procedure for colon cancer. To identify factors influencing the success of the procedure. To correlate SLN results with the presence of colon cancer cell in bone marrow aspirates. To assess OS and DFS.		1 month, 3 and 5 years after surgery	No