Carbon Black Tattoo in Colon Cancer

  • STATUS
    Recruiting
  • days left to enroll
    90
  • participants needed
    100
  • sponsor
    Szeged University
Updated on 27 May 2022

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

Details
Condition Endoscopic Tattoo of Suspected Colon Cancer
Treatment carbon black suspension colonic tattoo injection
Clinical Study IdentifierNCT03705754
SponsorSzeged University
Last Modified on27 May 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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