Carbon Black Tattoo in Colon Cancer

Phase

N/A

Condition

Colon Cancer

Colorectal Cancer

Treatment

N/A

Clinical Study ID

NCT03705754

2019/CCT

Ages 18-85
All Genders

Study Summary

The study is designed to elucidate whether carbon black suspension endoscopic tattoo enhances visibility of lymph nodes or tumor tissue on dissection of colonic surgical specimen, thereby making improvement in staging defined as better pTNM stage via better visualisation of carbon marked metastatic or sentinel lymph nodes or marked primary tumor or adjacent tissues.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Male or female aged 18 years or above undergoing colonoscopy for suspected colonicmalignancy
Participant is able to give informed consent for participation in the study
Patient is presumably selected for surgery within 30 days following tattoo injection

Exclusion

Exclusion Criteria:

Patients under the age of 18
Patients unable to give informed consent or ineligible for surgery
Tumor in the coecum dome or in the rectum (<15 cm)
Known allergy to suspension ingredients

Study Design

February 06, 2019

December 31, 2023

Study Description

Other objectives are:

to assess intraoperative visibility of carbon black tattoo in the tumor region and surrounding tissues
to assess microscopic distribution of carbon ink in the layers of the colonic wall and adjacent tissues
to assess complications related to carbon black tattoo procedure like microscopic fibrosis, micro- or macroscopic scarring, inflammatory reactions
to assess long-term effects of ink injections on control endoscopies at 6 and 12 months
to assess dissection time in tattooed-non tattooed lymphatic tissues

Connect with a study center

1st Department of Medicine, University of Szeged
Szeged, Csongrád 6720
Hungary
Active - Recruiting

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