Lymph Node Mapping Via Flourescent Dye in Colon Cancer

NCT ID: NCT04959604

Last Updated: 2023-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-31

Study Completion Date

2026-12-30

Brief Summary

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The aim of the study is to evaluate whether lymph nodes draining the region of the carcinoma are located only inside the lines of standard resection or in some percentages are located outside as well. The visualized nodes draining the region of the carcinoma will be correlated to location, fluorescent yes/no and nodal positive/negative.

The draining lymph nodes will be visualized using the fluorescent dye indocyanine green.

The aim of the study is to evaluate whether lymph nodes draining the region of the carcinoma are located only inside the lines of standard resection or in some percentages are located outside as well. The visualized nodes draining the region of the carcinoma will be correlated to location, fluorescent yes/no and nodal positive/negative.

The draining lymph nodes will be visualized using the fluorescent dye indocyanine green.

Detailed Description

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Participants with a diagnosed (andeno)carcinoma of the ascending, transverse, descending and sigmoid colon will be included. Preoperatively the participants will receive an indocyanine green(ICG) injection at four points around the tumour endoscopically. The ICG marking will take place one to five days prior to surgery. In the draining lymph nodes of the specific region the ICG will accumulate and thus visible via fluorescence-camera during the surgery.

Intraoperatively, the precise locations of all fluorescent nodes will be documented photographically. A standard resection and lymph node dissection will be conducted, potential fluorescent nodes outside the standard resection lines will additionally be resected. The fresh specimen will then be measured, the fluorescent nodes marked and after the pathologic examination the nodes will be correlated to location, fluorescent yes/no and nodal positive/negative.

The aim ist not the visualization of the Sentinel node or the directly draining lymphatic vessel but all the nodes draining the peritumorous region at the point of surgery.

Conditions

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Colon Carcinoma Lymph Node Metastases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Intervention group. Participants will receive a state of the art surgical procedure with additional lymph node mapping
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ICG-marked Colon Carcinoma

The participants will receive an endoscopic marking via ICG preoperatively

Group Type EXPERIMENTAL

ICG-marking endoscopically

Intervention Type PROCEDURE

Preoperatively the participants will receive an endoscopic marking at four points around the tumour with the fluorescent dye indocyanine green.

Interventions

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ICG-marking endoscopically

Preoperatively the participants will receive an endoscopic marking at four points around the tumour with the fluorescent dye indocyanine green.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* histologically diagnosed carcinoma of the ascending, transverse, descending or sigmoid colon.

Exclusion Criteria

* not wanting to participate
* other carcinoma then adenocarcinoma
* endoscopic marking not possible
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel Perez, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Dept of General Visceral and Thoracic Surgery

Locations

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University of Hamburg Medical Institutions

Hamburg, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Katharina L Lucas, MD

Role: CONTACT

+4915779600815

Julia-Kristin Grass, Dr.

Role: CONTACT

+4915222815011

Facility Contacts

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Julia-Kristin Grass, Dr.

Role: primary

Other Identifiers

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CCLNM

Identifier Type: -

Identifier Source: org_study_id

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