Carbon Black Tattoo in Colon Cancer

NCT03705754 | Unknown

• 1 other identifier: 2019/CCT
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Endoscopic Tattoo of Suspected Colon Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Tattoo arm

ACTIVE COMPARATOR

Tattoo will be placed by endoscopic submucosal injection of carbon black suspension

Device: carbon black suspension colonic tattoo injection

Control arm

NO INTERVENTION

Tattoo will not be placed but case will follow standard procedure

Interventions

carbon black suspension colonic tattoo injection DEVICE

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.

Also known as: GI supply SPOT endoscopic marker

Tattoo arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Szeged University: lead

Study Sites (1)

1st Department of Medicine, University of Szeged

Szeged, Csongrád megye, 6720, Hungary

RECRUITING

Related 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. doi: 10.1016/s0016-5107(02)70035-7.

  PMID: 12196769 RESULT

Study Officials

• Matyas Czepan, MD, PhD

  Szeged University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matyas Czepan, MD, PhD

CONTACT

+3662545189; czepan.matyas@med.u-szeged.hu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Division of Internal Medicine 2/S

Model Details: Tattoo arm vs. control arm

Study Record Dates

• First Submitted: October 8, 2018
• First Posted: October 15, 2018
• Study Start: February 6, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: May 10, 2022

Record last verified: 2022-05

Locations

HU (1)