NCT00826579

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 192 (actual)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Colonic Neoplasms

Interventions

Type	Name	Description
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.
PROCEDURE	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.

Timeline

• Start date: 2000-05-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2009-01-22
• Last updated: 2015-03-12

Locations

3 sites across 1 country: Switzerland