Endoscopic Tattooing and Colorectal Cancer

Safety and Efficacy of Tattooing Substance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03637933
• Other study ID #: tattooingunina
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: December 1, 2018

Study information

• Verified date: December 2018
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 1, 2018
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

emergency surgery open surgery immune depressant disease immune depressant medication

Related Conditions & MeSH terms

• Safety and Efficacy of Tattooing Substance

Intervention

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.

Locations

Country	Name	City	State
Italy	University of Naples Federico II	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

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