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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.
Other objectives are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tattoo arm | Active Comparator | Tattoo will be placed by endoscopic submucosal injection of carbon black suspension |
|
| Control arm | No Intervention | Tattoo will not be placed but case will follow standard procedure |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carbon black suspension colonic tattoo injection | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matyas Czepan, MD, PhD | Contact | +3662545189 | czepan.matyas@med.u-szeged.hu |
| Name | Affiliation | Role |
|---|---|---|
| Matyas Czepan, MD, PhD | Szeged University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1st Department of Medicine, University of Szeged | Recruiting | Szeged | Csongrád megye | 6720 | Hungary |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12196769 | Result | 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. doi: 10.1016/s0016-5107(02)70035-7. |
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Tattoo arm vs. control arm
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