## Protocol Section
### Identification Module
**NCT ID:** 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

#### Organization Study ID Info
**ID:** Rhein4031
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Basel, Switzerland
### Status Module
#### Completion Date
**Date:** 2009-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2015-03-12

**Type:** ESTIMATED

**Last Update Submit Date:** 2015-03-11

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2009-01

**Type:** ACTUAL

#### Start Date
**Date:** 2000-05

**Status Verified Date:** 2015-03

#### Study First Post Date
**Date:** 2009-01-22
**Type:** ESTIMATED
**Study First Submit Date:** 2009-01-13
**Study First Submit QC Date:** 2009-01-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University Hospital, Basel, Switzerland

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Colonic Neoplasms

**Keywords:**

- Sentinel lymph node

- Lymph node analysis

- Bone marrow analysis

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 192

**Type:** ACTUAL

**Phases:**

- PHASE1

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Colon cancer patients of all stages

**Intervention Names:**

- Procedure: Sentinel lymph node procedure

- Procedure: Bone marrow aspiration

**Label:** Colon cancer

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Colon cancer

**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.

**Name:** Sentinel lymph node procedure

**Other Names:**

- Lymphazurin 1%, Ben Venue Labs Inc., Bedford OH

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Colon cancer

**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.

**Name:** Bone marrow aspiration

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

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

**Time Frame:** 1 month

#### Secondary Outcomes

**Measure:** 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

### Eligibility Module

**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

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Basel

**Country:** Switzerland

**Facility:** Carsten T. Viehl, MD

**Zip:** 4031

**Location 2:**

**City:** Biel

**Country:** Switzerland

**Facility:** Urban Laffer, MD

**Zip:** 2501

**Location 3:**

**City:** Olten

**Country:** Switzerland

**Facility:** Markus Zuber, MD

**Zip:** 4600

#### Overall Officials

**Official 1:**

**Affiliation:** aktuell: Spitalzentrum Biel-Bienne

**Name:** Carsten T. Viehl, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Kantonsspital Olten

**Name:** Markus Zuber, MD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**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.

**PMID:** 28593306

**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.

**PMID:** 23354923

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000015179

- Term: Colorectal Neoplasms

- ID: D000007414

- Term: Intestinal Neoplasms

- ID: D000005770

- Term: Gastrointestinal Neoplasms

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000003108

- Term: Colonic Diseases

- ID: D000007410

- Term: Intestinal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M6338

- Name: Colonic Neoplasms

- Relevance: HIGH

- As Found: Colonic Neoplasms

- ID: M17890

- Name: Colorectal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M10448

- Name: Intestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6336

- Name: Colonic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10444

- Name: Intestinal Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003110

- Term: Colonic Neoplasms

### Intervention Browse Module - Browse Branches

- Abbrev: HB

- Name: Herbal and Botanical

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: T120

- Name: Cola

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
