Carbon Black Tattoo in Colon Cancer
Primary Purpose
Endoscopic Tattoo of Suspected Colon Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
carbon black suspension colonic tattoo injection
Sponsored by
About this trial
This is an interventional diagnostic trial for Endoscopic Tattoo of Suspected Colon Cancer
Eligibility Criteria
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
Sites / Locations
- 1st Department of Medicine, University of SzegedRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Tattoo arm
Control arm
Arm Description
Tattoo will be placed by endoscopic submucosal injection of carbon black suspension
Tattoo will not be placed but case will follow standard procedure
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03705754
Brief Title
Carbon Black Tattoo in Colon Cancer
Official Title
EFFECT OF ENDOSCOPIC TATTOOING WITH CARBON BLACK SUSPENSION ON THE STAGING OF COLON CANCER
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 6, 2019 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Szeged University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endoscopic Tattoo of Suspected Colon Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Tattoo arm vs. control arm
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tattoo arm
Arm Type
Active Comparator
Arm Description
Tattoo will be placed by endoscopic submucosal injection of carbon black suspension
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
Tattoo will not be placed but case will follow standard procedure
Intervention Type
Device
Intervention Name(s)
carbon black suspension colonic tattoo injection
Other Intervention Name(s)
GI supply SPOT endoscopic marker
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of tumors visualised from peritoneal cavity/number of tattoos visualised form peritoneal cavity
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
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matyas Czepan, MD, PhD
Phone
+3662545189
Email
czepan.matyas@med.u-szeged.hu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matyas Czepan, MD, PhD
Organizational Affiliation
Szeged University
Official's Role
Principal Investigator
Facility Information:
Facility Name
1st Department of Medicine, University of Szeged
City
Szeged
State/Province
Csongrád
ZIP/Postal Code
6720
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mátyás Czepán
Phone
+3662545189
Email
czepanm@gmail.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
12196769
Citation
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.
Results Reference
result
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Carbon Black Tattoo in Colon Cancer
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