Endoscopic Tattoo of Suspected Colon Cancer Clinical Trial
Official title:
EFFECT OF ENDOSCOPIC TATTOOING WITH CARBON BLACK SUSPENSION ON THE STAGING OF COLON CANCER
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Hungary | 1st Department of Medicine, University of Szeged | Szeged | Csongrád |
Lead Sponsor | Collaborator |
---|---|
Szeged University |
Hungary,
Askin 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of tumors visualised from peritoneal cavity/number of tattoos visualised form peritoneal cavity | 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 | 1 year |