Endoscopic Tattooing and Colorectal Cancer

Overview

Endoscopic tattooing to facilitate colorectal lesions' identification during laparoscopic surgery is a reliable and widely used technique.

India Ink is the standard option for colonic tattoing. Different studies have been reported significant complications, of which the most common is peritonitis, due to ethylene glycol, phenols and animal-derived gelatine contained in the ink. This local inflammatory reaction is the principal reason of the formation of the adhesions detected during the laparoscopy, that make the intervention more difficult. To prevent infection or inflammatory local reaction India ink solution has to be sterilized and diluted, a cumbersome process. In the last years wide diffusion of another endoscopic ink, Sterile Carbon Particle Suspension, has reduced these complications. Sterile Carbon Particle Suspension is a prepackaged, sterile, FDA-approved formulation of pure carbon particle in suspension, that eliminates the need for preinjection preparation.

In an attempt to evaluate safety and efficacy of endoscopic tattooing in colorectal surgery using two different types of ink, a randomized clinical trial has been designed. Two types of endoscopic ink were evaluated: Sterile Carbon Particle Suspension (Experimental group) and India Ink (Control group) and.

Full Title of Study: “Safety and Efficacy of Endoscopic Tattooing in Colorectal Surgery. India Ink vs Sterile Carbon Particle Suspension. Randomized Clinical Trial.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: Single (Participant)
  • Study Primary Completion Date: November 1, 2018

Interventions

  • Procedure: endoscopic tattooing
    • The tattoo has to be placed 1 or 2 cm distal to the lesion and tattooing has to be performed in at least 2 of the 4 quadrants of the bowel. A 0.5-1 mL saline bleb has to be raised submucosally and then a similar quantity of India Ink or Sterile Carbon Particle Suspension has to be injectiected into that bleb.

Arms, Groups and Cohorts

  • Active Comparator: India ink tattooing
    • Experimental group includes patients undergone to preoperative endoscopic tattooing with Sterile Carbon Particle Suspension.
  • Experimental: Sterile Carbon Particle Suspension tattooing
    • Control group includes patients undergone to preoperative endoscopic tattooing with India Ink.

Clinical Trial Outcome Measures

Primary Measures

  • Abdominal pain
    • Time Frame: 6 hours after tattooing
    • using VAS Scale (from 1 to 10)
  • Body Temperature
    • Time Frame: 6 hours after tattooing
  • Body Temperature
    • Time Frame: 24 hours after tattooing
  • White Blood Count
    • Time Frame: 6 hours after tattooing
  • White Blood Count
    • Time Frame: 24 hours after tattooing
  • C reactive protein
    • Time Frame: 6 hours after tattooing
  • C reactive protein
    • Time Frame: 24 hours after tattooing
  • Peritoneal adhesions
    • Time Frame: During operative colectomy
    • Intraoperative adhesions, detected during laparoscopy and classified using Z├╝hlke classification ranging from 0 to 4
  • Visibility of the tattoo
    • Time Frame: During operative colectomy

Participating in This Clinical Trial

Inclusion Criteria

histologically confirmed malignancy planned for an elective, segmental laparoscopic colectomy.

Exclusion Criteria

emergency surgery open surgery immune depressant disease immune depressant medication

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Federico II University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Marco Milone, Principal investigator – Federico II University

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