Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2026-03-02 @ 3:59 PM
Study NCT ID:
NCT03637933
Status:
COMPLETED
Last Update Posted:
2018-12-20
First Post:
2018-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endoscopic Tattooing and Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-19', 'studyFirstSubmitDate': '2018-08-16', 'studyFirstSubmitQcDate': '2018-08-16', 'lastUpdatePostDateStruct': {'date': '2018-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Abdominal pain', 'timeFrame': '6 hours after tattooing', 'description': 'using VAS Scale (from 1 to 10)'}, {'measure': 'Body Temperature', 'timeFrame': '6 hours after tattooing'}, {'measure': 'Body Temperature', 'timeFrame': '24 hours after tattooing'}, {'measure': 'White Blood Count', 'timeFrame': '6 hours after tattooing'}, {'measure': 'White Blood Count', 'timeFrame': '24 hours after tattooing'}, {'measure': 'C reactive protein', 'timeFrame': '6 hours after tattooing'}, {'measure': 'C reactive protein', 'timeFrame': '24 hours after tattooing'}, {'measure': 'Peritoneal adhesions', 'timeFrame': 'During operative colectomy', 'description': 'Intraoperative adhesions, detected during laparoscopy and classified using Zühlke classification ranging from 0 to 4'}, {'measure': 'Visibility of the tattoo', 'timeFrame': 'During operative colectomy'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Safety and Efficacy of Tattooing Substance']}, 'referencesModule': {'references': [{'pmid': '31667693', 'type': 'DERIVED', 'citation': 'Milone M, Vignali A, Manigrasso M, Velotti N, Sarnelli G, Aprea G, De Simone G, Maione F, Gennarelli N, Elmore U, De Palma GD. Sterile carbon particle suspension vs India ink for endoscopic tattooing of colonic lesions: a randomized controlled trial. Tech Coloproctol. 2019 Nov;23(11):1073-1078. doi: 10.1007/s10151-019-02101-y. Epub 2019 Oct 30.'}]}, 'descriptionModule': {'briefSummary': "Endoscopic tattooing to facilitate colorectal lesions' identification during laparoscopic surgery is a reliable and widely used technique.\n\nIndia Ink is the standard option for colonic tattoing. Different studies have been reported significant complications, of which the most common is peritonitis, due to ethylene glycol, phenols and animal-derived gelatine contained in the ink. This local inflammatory reaction is the principal reason of the formation of the adhesions detected during the laparoscopy, that make the intervention more difficult. To prevent infection or inflammatory local reaction India ink solution has to be sterilized and diluted, a cumbersome process. In the last years wide diffusion of another endoscopic ink, Sterile Carbon Particle Suspension, has reduced these complications. Sterile Carbon Particle Suspension is a prepackaged, sterile, FDA-approved formulation of pure carbon particle in suspension, that eliminates the need for preinjection preparation.\n\nIn an attempt to evaluate safety and efficacy of endoscopic tattooing in colorectal surgery using two different types of ink, a randomized clinical trial has been designed. Two types of endoscopic ink were evaluated: Sterile Carbon Particle Suspension (Experimental group) and India Ink (Control group) and."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nhistologically confirmed malignancy planned for an elective, segmental laparoscopic colectomy.\n\nExclusion Criteria:\n\nemergency surgery open surgery immune depressant disease immune depressant medication'}, 'identificationModule': {'nctId': 'NCT03637933', 'briefTitle': 'Endoscopic Tattooing and Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Federico II University'}, 'officialTitle': 'Safety and Efficacy of Endoscopic Tattooing in Colorectal Surgery. India Ink vs Sterile Carbon Particle Suspension. Randomized Clinical Trial.', 'orgStudyIdInfo': {'id': 'tattooingunina'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'India ink tattooing', 'description': 'Experimental group includes patients undergone to preoperative endoscopic tattooing with Sterile Carbon Particle Suspension.', 'interventionNames': ['Procedure: endoscopic tattooing']}, {'type': 'EXPERIMENTAL', 'label': 'Sterile Carbon Particle Suspension tattooing', 'description': 'Control group includes patients undergone to preoperative endoscopic tattooing with India Ink.', 'interventionNames': ['Procedure: endoscopic tattooing']}], 'interventions': [{'name': 'endoscopic tattooing', 'type': 'PROCEDURE', 'description': 'The tattoo has to be placed 1 or 2 cm distal to the lesion and tattooing has to be performed in at least 2 of the 4 quadrants of the bowel. A 0.5-1 mL saline bleb has to be raised submucosally and then a similar quantity of India Ink or Sterile Carbon Particle Suspension has to be injectiected into that bleb.', 'armGroupLabels': ['India ink tattooing', 'Sterile Carbon Particle Suspension tattooing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80131', 'city': 'Naples', 'country': 'Italy', 'facility': 'University of Naples Federico II', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federico II University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Marco Milone', 'investigatorAffiliation': 'Federico II University'}}}}