Carbon Black Tattoo in Colon Cancer

Not Applicable

• Conditions: Endoscopic Tattoo of Suspected Colon Cancer
• Interventions: Device: carbon black suspension colonic tattoo injection

• Registration Number: NCT03705754
• Lead Sponsor: Szeged University

Brief 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.

Detailed 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

Study Timeline

• Study First Submitted: 2018-10-08
• Study First Submitted QC: 2018-10-12
• Study First Posted: 2018-10-15
• Study Start: 2019-02-06
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-09
• Last Update Posted: 2022-05-10
• Primary Completion: 2022-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Male or female aged 18 years or above undergoing colonoscopy for suspected colonic malignancy
• 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 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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tattoo arm	carbon black suspension colonic tattoo injection	Tattoo will be placed by endoscopic submucosal injection of carbon black suspension

Primary Outcome Measures

Name	Time	Method
Number of tumors visualised from peritoneal cavity/number of tattoos visualised form peritoneal cavity	1 year	Distance in cm from tumor wich far carbon injection marked mucosa and adjacent tissues Number of inflammatory cells per field of view in injection site vs. non-injected mucosa Number of dissected total/normal/metastatic/carbon colored lymph nodes

Trial Locations

Locations (1)

1st Department of Medicine, University of Szeged; 🇭🇺 Szeged, Csongrád, Hungary