Clinical trial · Interventional
Endoscopic Tattooing and Colorectal Cancer
Safety and Efficacy of Endoscopic Tattooing in Colorectal Surgery. India Ink vs Sterile Carbon Particle Suspension. Randomized Clinical Trial.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Safety and Efficacy of Tattooing Substance | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| endoscopic tattooing | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- India ink tattooing
- description
- Experimental group includes patients undergone to preoperative endoscopic tattooing with Sterile Carbon Particle Suspension.
- interventionNames
- Procedure: endoscopic tattooing
- type
- EXPERIMENTAL
- label
- Sterile Carbon Particle Suspension tattooing
- description
- Control group includes patients undergone to preoperative endoscopic tattooing with India Ink.
- interventionNames
- Procedure: endoscopic tattooing
Primary outcomes (9)
- measure
- Abdominal pain
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: histologically confirmed malignancy planned for an elective, segmental laparoscopic colectomy. Exclusion Criteria: emergency surgery open surgery immune depressant disease immune depressant medication
References
Publications (1)
- DERIVEDMilone 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. PMID 31667693