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

Primary Purpose

Colonic Neoplasms

Status
Completed
Phase
Phase 1
Locations
Switzerland
Study Type
Interventional
Intervention
Sentinel lymph node procedure
Bone marrow aspiration
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colonic Neoplasms focused on measuring Sentinel lymph node, Lymph node analysis, Bone marrow analysis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Carsten T. Viehl, MD
  • Urban Laffer, MD
  • Markus Zuber, MD

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Colon cancer

Arm Description

Colon cancer patients of all stages

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
January 13, 2009
Last Updated
March 11, 2015
Sponsor
University Hospital, Basel, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT00826579
Brief Title
Swiss Prospective, Multicenter Study Sentinel Lymph Node Procedure in Colon Cancer
Official Title
Swiss Prospective, Multicenter Study Sentinel Lymph Node Procedure in Colon Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
May 2000 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Neoplasms
Keywords
Sentinel lymph node, Lymph node analysis, Bone marrow analysis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
192 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Colon cancer
Arm Type
Experimental
Arm Description
Colon cancer patients of all stages
Intervention Type
Procedure
Intervention Name(s)
Sentinel lymph node procedure
Other Intervention Name(s)
Lymphazurin 1%, Ben Venue Labs Inc., Bedford OH
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Bone marrow aspiration
Intervention Description
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.
Primary Outcome Measure Information:
Title
To assess the extent of upstaging due to the SLN procedure for colon cancer.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
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.
Time Frame
1 month, 3 and 5 years after surgery

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carsten T. Viehl, MD
Organizational Affiliation
aktuell: Spitalzentrum Biel-Bienne
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Markus Zuber, MD
Organizational Affiliation
Kantonsspital Olten
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carsten T. Viehl, MD
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Urban Laffer, MD
City
Biel
ZIP/Postal Code
2501
Country
Switzerland
Facility Name
Markus Zuber, MD
City
Olten
ZIP/Postal Code
4600
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
28593306
Citation
Weixler B, Viehl CT, Warschkow R, Guller U, Ramser M, Sauter G, Zuber M. Comparative Analysis of Tumor Cell Dissemination to the Sentinel Lymph Nodes and to the Bone Marrow in Patients With Nonmetastasized Colon Cancer: A Prospective Multicenter Study. JAMA Surg. 2017 Oct 1;152(10):912-920. doi: 10.1001/jamasurg.2017.1514.
Results Reference
derived
PubMed Identifier
23354923
Citation
Viehl CT, Guller U, Langer I, Laffer U, Oertli D, Zuber M. Factors influencing the success of in vivo sentinel lymph node procedure in colon cancer patients: Swiss prospective, multicenter study sentinel lymph node procedure in colon cancer. World J Surg. 2013 Apr;37(4):873-7. doi: 10.1007/s00268-013-1910-3.
Results Reference
derived

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

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