Endoscopic Tattooing and Colorectal Cancer

Safety and Efficacy of Endoscopic Tattooing in Colorectal Surgery. India Ink vs Sterile Carbon Particle Suspension. Randomized Clinical Trial.

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.

Study Overview

• Status: Completed
• Conditions: Safety and Efficacy of Tattooing Substance
• Intervention / Treatment: Procedure: endoscopic tattooing

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy, 80131
    • University of Naples Federico II

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

emergency surgery open surgery immune depressant disease immune depressant medication

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: India ink tattooing; Experimental group includes patients undergone to preoperative endoscopic tattooing with Sterile Carbon Particle Suspension.	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.
Experimental: Sterile Carbon Particle Suspension tattooing; Control group includes patients undergone to preoperative endoscopic tattooing with India Ink.	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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Federico II University

Publications and helpful links

General Publications

• Milone M, Vignali A, Manigrasso M, Velotti N, Sarnelli G, Aprea G, De Simone G, Maione F, Gennarelli N, Elmore U, De Palma GD. Sterile carbon particle suspension vs India ink for endoscopic tattooing of colonic lesions: a randomized controlled trial. Tech Coloproctol. 2019 Nov;23(11):1073-1078. doi: 10.1007/s10151-019-02101-y. Epub 2019 Oct 30.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: August 16, 2018
• First Submitted That Met QC Criteria: August 16, 2018
• First Posted (Actual): August 20, 2018

Study Record Updates

• Last Update Posted (Actual): December 20, 2018
• Last Update Submitted That Met QC Criteria: December 19, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: tattooingunina

Drug and device information, study documents

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