Clinical trial · Interventional
Carbon Black Tattoo in Colon Cancer
EFFECT OF ENDOSCOPIC TATTOOING WITH CARBON BLACK SUSPENSION ON THE STAGING OF COLON CANCER
NCT03705754CI-TRIAL-00058380unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
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.
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 |
|---|---|---|---|
| Endoscopic Tattoo of Suspected Colon Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carbon black suspension colonic tattoo injection | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Tattoo arm
- description
- Tattoo will be placed by endoscopic submucosal injection of carbon black suspension
- interventionNames
- Device: carbon black suspension colonic tattoo injection
- type
- NO_INTERVENTION
- label
- Control arm
- description
- Tattoo will not be placed but case will follow standard procedure
Primary outcomes (1)
- measure
- Number of tumors visualised from peritoneal cavity/number of tattoos visualised form peritoneal cavity
- timeFrame
- 1 year
- description
- Distance in cm from tumor wich far carbon injection marked mucosa and adjacent tissues Number of inflammatory cells per field of view in injection site vs. non-injected mucosa Number of dissected total/normal/metastatic/carbon colored lymph nodes
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTAskin MP, Waye JD, Fiedler L, Harpaz N. Tattoo of colonic neoplasms in 113 patients with a new sterile carbon compound. Gastrointest Endosc. 2002 Sep;56(3):339-42. doi: 10.1016/s0016-5107(02)70035-7. PMID 12196769