NCT03705754

Carbon Black Tattoo in Colon Cancer

EFFECT OF ENDOSCOPIC TATTOOING WITH CARBON BLACK SUSPENSION ON THE STAGING OF COLON CANCER

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Szeged University · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Other objectives are: * to assess intraoperative visibility of carbon black tattoo in the tumor region and surrounding tissues * to assess microscopic distribution of carbon ink in the layers of the colonic wall and adjacent tissues * to assess complications related to carbon black tattoo procedure like microscopic fibrosis, micro- or macroscopic scarring, inflammatory reactions * to assess long-term effects of ink injections on control endoscopies at 6 and 12 months * to assess dissection time in tattooed-non tattooed lymphatic tissues

Conditions

• Endoscopic Tattoo of Suspected Colon Cancer

Interventions

Type	Name	Description
DEVICE	carbon black suspension colonic tattoo injection	Examine the SPOT syringe to verify that the pigment is fully suspended. A 23 or 25 G sclerotherapy needle is recommended for this procedure, attach the syringe and prime with SPOT. After injection catheter is primed, manoeuver with the endoscope for optimal injection position and inject tangentially, at a 30-40˚ angle to the mucosa and create a saline bleb to find the submucosal plane prior to injecting SPOT to reduce risk of intramural injection. Document both the depth of scope and anatomic location of each tattoo and the ink consumption as well. Place injection 2-3 cm distal (downstream) of the area of interest. Use 0.5-0.75 mL per injection site and no more than 8 mL per patient. Place SPOT tattoos in 3-4 quadrants around the lumen to increase likelihood of visualisation.

Timeline

• Start date: 2019-02-06
• Primary completion: 2022-12-31
• Completion: 2023-12-31
• First posted: 2018-10-15
• Last updated: 2022-05-10

Locations

1 site across 1 country: Hungary