Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2019-02-06
2023-12-31
Brief Summary
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Detailed Description
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* 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
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Tattoo arm
Tattoo will be placed by endoscopic submucosal injection of carbon black suspension
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.
Control arm
Tattoo will not be placed but case will follow standard procedure
No interventions assigned to this group
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
85 Years
ALL
No
Sponsors
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Szeged University
OTHER
Responsible Party
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Matyas Czepan
Head of Division of Internal Medicine 2/S
Principal Investigators
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Matyas Czepan, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Szeged University
Locations
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1st Department of Medicine, University of Szeged
Szeged, Csongrád megye, Hungary
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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2019/CCT
Identifier Type: -
Identifier Source: org_study_id
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