Carbon Black Tattoo in Colon Cancer

Endoscopic Tattoo of Suspected Colon Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03705754
• Other study ID #: 2019/CCT
• Status: Recruiting
• Phase: N/A
• Start date: February 6, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2022
• Source: Szeged University
• Contact: Matyas Czepan, MD, PhD
• Phone: +3662545189
• Email: czepan.matyas[@]med.u-szeged.hu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Colonic Neoplasms
• Endoscopic Tattoo of Suspected Colon Cancer

Intervention

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.

Locations

Country	Name	City	State
Hungary	1st Department of Medicine, University of Szeged	Szeged	Csongrád

Sponsors (1)

Lead Sponsor	Collaborator
Szeged University

Country where clinical trial is conducted

Hungary, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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