Carbon Black Tattoo in Colon Cancer

EFFECT OF ENDOSCOPIC TATTOOING WITH CARBON BLACK SUSPENSION ON THE STAGING OF COLON CANCER

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.

Study Overview

• Status: Recruiting
• Conditions: Endoscopic Tattoo of Suspected Colon Cancer
• Intervention / Treatment: Device: carbon black suspension colonic tattoo injection

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Matyas Czepan, MD, PhD; Phone Number: +3662545189; Email: czepan.matyas@med.u-szeged.hu

Study Locations

• Hungary
  • Csongrád
    • Szeged, Csongrád, Hungary, 6720
      • Recruiting
      • 1st Department of Medicine, University of Szeged
      • Contact: Mátyás Czepán; Phone Number: +3662545189; Email: czepanm@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tattoo arm; Tattoo will be placed by endoscopic submucosal injection of carbon black suspension	Device: carbon black suspension colonic tattoo injection; Examine the SPOT syringe to verify that the pigment is fully suspended. A 23 or 25 G sclerotherapy needle is recommended for this procedure, attach the syringe and prime with SPOT. After injection catheter is primed, manoeuver with the endoscope for optimal injection position and inject tangentially, at a 30-40˚ angle to the mucosa and create a saline bleb to find the submucosal plane prior to injecting SPOT to reduce risk of intramural injection. Document both the depth of scope and anatomic location of each tattoo and the ink consumption as well. Place injection 2-3 cm distal (downstream) of the area of interest. Use 0.5-0.75 mL per injection site and no more than 8 mL per patient. Place SPOT tattoos in 3-4 quadrants around the lumen to increase likelihood of visualisation.; Other Names: GI supply SPOT endoscopic marker
No Intervention: Control arm; Tattoo will not be placed but case will follow standard procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of tumors visualised from peritoneal cavity/number of tattoos visualised form peritoneal cavity	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	1 year

Collaborators and Investigators

• Sponsor: Szeged University
• Investigators: Principal Investigator: Matyas Czepan, MD, PhD, Szeged University

Publications and helpful links

General Publications

• Askin MP, Waye JD, Fiedler L, Harpaz N. Tattoo of colonic neoplasms in 113 patients with a new sterile carbon compound. Gastrointest Endosc. 2002 Sep;56(3):339-42. doi: 10.1016/s0016-5107(02)70035-7.

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2019
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: October 8, 2018
• First Submitted That Met QC Criteria: October 12, 2018
• First Posted (Actual): October 15, 2018

Study Record Updates

• Last Update Posted (Actual): May 10, 2022
• Last Update Submitted That Met QC Criteria: May 9, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: 2019/CCT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No