Lymph Node Mapping Via Flourescent Dye in Colon Cancer

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT04959604

Studienbeginn:
Mai 2021

Letztes Update:
23.05.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Lymphatic Metastasis

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Universitätsklinikum Hamburg-Eppendorf

Collaborator:
-

Studienleiter

Daniel Perez, Prof. Dr.
Principal Investigator
Dept of General Visceral and Thoracic Surgery

Kontakt

Katharina L Lucas, MD
Kontakt:
Phone: +4915779600815
E-Mail: katharina.lucas@uni-wh.de» Kontaktdaten anzeigen

Julia-Kristin Grass, Dr.
Kontakt:
Phone: +4915222815011
E-Mail: j.grass@uke.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

University of Hamburg Medical Institutions
Hamburg
(Hamburg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Julia-Kristin Grass, Dr.
E-Mail: j.grass@uke.de» Ansprechpartner anzeigen

Studien-Informationen

Detailed Description:

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Intraoperative ICG-positive lymph nodes in vivo after endoscopic marking of the tumour (Time Frame - intraoperative assessment):
Counting ICG-positive sites intraoperatively

2. Video-analysis of ICG-positive lymph nodes in vivo after endoscopic marking of the tumour (Time Frame - video-analysis within one week after surgery):
Counting ICG-positive sites video-analysis

3. Number of ICG-positive lymph nodes after endoscopic marking of the tumour (Time Frame - within one week after surgery):
Picking ICG-positive lymph nodes ex vivo in unfixed specimen, sending ICG positive nodes separately to pathological examination

4. Correlation of nodal-positive lymph nodes inside/outside the standard resection area (Time Frame - within one week after surgery):
ICG-positive sites outside standard resection area will be "cherry picked", sent to pathological examination separatively.

Geprüfte Regime

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

Quelle: ClinicalTrials.gov

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