Endoscopic Tattoo of Suspected Colon CancerNCT03705754
Carbon Black Tattoo in Colon Cancer
A study testing carbon black suspension colonic tattoo injection in people with Endoscopic Tattoo of Suspected Colon Cancer, run by Szeged University at 1 site in Hungary.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Endoscopic Tattoo of Suspected Colon Cancer
- What is being tested?
- carbon black suspension colonic tattoo injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteHungary
- Study dates
- 6 Feb 2019to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Hungary1 site, 1 recruiting
- Recruiting
1st Department of Medicine, University of Szeged
Szeged, Csongrád megye, 6720
Mátyás Czepán, +3662545189, czepanm@gmail.com
About this study
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.
Read the 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
- Being tested
- carbon black suspension colonic tattoo injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carbon black suspension colonic tattoo injectionDevice
Also called GI supply SPOT endoscopic marker
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.
| Study group | Role | What they receive |
|---|---|---|
| Tattoo arm | Active comparator | Tattoo will be placed by endoscopic submucosal injection of carbon black suspension Receives: Device: carbon black suspension colonic tattoo injection |
| Control arm | No intervention | Tattoo will not be placed but case will follow standard procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start6 Feb 2019
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endoscopic Tattoo of Suspected Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Tattoo arm vs. control arm
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Szeged University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matyas Czepan, Szeged University
- Investigators
- Matyas Czepan, MD, PhD, Principal investigator, Szeged University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03705754
- Sponsor's protocol ID
- 2019/CCT
- Status last verified
- May 2022
- First submitted
- 8 Oct 2018
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 12196769
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF ENDOSCOPIC TATTOOING WITH CARBON BLACK SUSPENSION ON THE STAGING OF COLON CANCER
- ClinicalTrials.gov ID
- NCT03705754
- Acronym / sponsor ID
- 2019/CCT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Szeged UniversityUniversity, hospital or other
- Study start
- 6 Feb 2019 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 15 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Tattoo arm vs. control arm
| Arm | Type | Receives |
|---|---|---|
| Tattoo arm | Active comparator | Device: carbon black suspension colonic tattoo injectionTattoo 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| carbon black suspension colonic tattoo injectionAlso: GI supply SPOT endoscopic markerExamine 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. | Device | Tattoo arm |
Primary outcome
Number of tumors visualised from peritoneal cavity/number of tattoos visualised form peritoneal cavity
Time frame: 1 year
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- Results publication: PubMed 12196769Askin 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.
Related trials for Endoscopic Tattoo of Suspected Colon Cancer
Enrolling by invitation
Confirming the Accuracy of Endoscopic Marking Using a New Marker, a Novel Luminomarker, in Lesion Marking Before Colorectal Cancer Surgery.
Colorectal Cancer, Endoscopic Tattoo of Suspected Colon Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matyas Czepan, MD, PhD principal investigator
Szeged University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing carbon black suspension colonic tattoo injection in people with Endoscopic Tattoo of Suspected Colon Cancer, run by Szeged University at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matyas Czepan, MD, PhD (+3662545189, czepan.matyas@med.u-szeged.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of tumors visualised from peritoneal cavity/number of tattoos visualised form peritoneal cavity (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03705754, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2022; AzTrials last refreshed its copy on 6 Nov 2026.