Ignite Creation Date:
2025-12-24 @ 3:23 PM
Ignite Modification Date:
2025-12-29 @ 8:20 AM
Study NCT ID:
NCT06333392
Status:
RECRUITING
Last Update Posted:
2025-12-19
First Post:
2024-03-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Total Underwater Colonoscopy (TUC) for Improved Colorectal Cancer Screening: A Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D019462', 'term': 'Syncope, Vasovagal'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D054971', 'term': 'Orthostatic Intolerance'}, {'id': 'D054969', 'term': 'Primary Dysautonomias'}, {'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D013575', 'term': 'Syncope'}, {'id': 'D014474', 'term': 'Unconsciousness'}, {'id': 'D003244', 'term': 'Consciousness Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1070}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-12', 'studyFirstSubmitDate': '2024-03-20', 'studyFirstSubmitQcDate': '2024-03-20', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proximal sessile serrated lesion detection rate', 'timeFrame': 'when histopathology report is clear, about 4 weeks after colonoscopy', 'description': 'The proportion of colonoscopies where at least one proximal SSL is detected'}], 'secondaryOutcomes': [{'measure': 'Complete resection rate for lesions > 10mm', 'timeFrame': '4 weeks after colonoscopy', 'description': 'see above'}, {'measure': 'Rate of painful procedures and vasovagal reactions', 'timeFrame': 'during and immediately after colonoscopy', 'description': 'se above'}, {'measure': 'Leakage after colonoscopy', 'timeFrame': 'Questionnaire 1-7 days after colonoscopy', 'description': 'water leakage on the way home after colonoscopy'}, {'measure': 'Detection rate for other neoplasia than SSL', 'timeFrame': 'about 4 weeks after colonoscopy', 'description': 'see above'}, {'measure': 'Withdrawal time', 'timeFrame': 'immediately after colonoscopy', 'description': 'see above'}, {'measure': 'Total procedure time', 'timeFrame': 'immediately after colonoscopy', 'description': 'see above'}, {'measure': 'Bowel cleansing quality', 'timeFrame': 'immediately after colonoscopy', 'description': 'with help of BBPS'}, {'measure': 'Complications', 'timeFrame': 'within 30 days after colonoscopy', 'description': 'Significant bleedings and perforations'}, {'measure': 'Number of colonoscopies to achieve polyp free colon', 'timeFrame': 'after last colonoscopy per patient', 'description': 'see above'}, {'measure': 'Single use accessories for the procedure', 'timeFrame': 'immediately after colonoscopy', 'description': 'number of single use accesoires per colonoscopy'}, {'measure': 'Willingness to repeat colonoscopy', 'timeFrame': 'questionnaire 1-2 weeks after colonoscopy', 'description': 'Willingness to repeat colonoscopy the same way if new colonoscopy is necessary'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['colorectal cancer screening', 'screening colonoscopy', 'underwater colonoscopy'], 'conditions': ['Colorectal Neoplasia', 'Screening Colonoscopy', 'Colorectal Cancer', 'Colorectal Cancer Screening', 'Vasovagal Reaction']}, 'descriptionModule': {'briefSummary': 'Colorectal cancer (CRC), the third most diagnosed cancer and second most common cause of cancer death. CRCs develop from precursors like adenomas (about 70% of CRCs) or serrated lesions (SSLs) (about 25-30% of CRCs). Colonoscopy is the cornerstone in CRC screening, in screening programmes often as a work-up examination after a positive primary screening test such as faecal immunochemical test (FIT). Norway and Sweden have recently launched a nationwide faecal haemoglobin CRC screening programmes. Recently, both a Dutch and an Austrian study showed that SSL detection rate (SSLDR) is inversely correlated to CRC at follow-up. Consequently, improved SSLDR can reduce the risk of post-colonoscopy CRC. SSLs are typically located in the right colon. They are flat, with indistinctive boarders, and consequently easily missed or incompletely resected. A Norwegian study showed incomplete resection of 40% of proximal SSLs. The prevalence of SSLs is higher in women than in men, with women being on a threefold risk of developing CRC from SSLs. It seems like post-colonoscopy CRC more often is caused by SSLs than by adenomas. Total underwater colonoscopy (TUC) is a technique replacing conventional CO2 insufflation by water infusion to distend the lumen and visualise the mucosa during withdrawal of the colonoscope and simultaneously removal of water. There are several reasons to advocate TUC:\n\n1. SSLs will be more visible as they "float" on the submucosa and contract into the lumen, while full distension by gas stretches the mucosa, making detection of flat lesions more difficult.\n2. Water works like a magnifying lens, making detection and detailed characterisation of lesions easier.\n3. uEMR is eased.\n4. Improved bowel cleansing\n\nThe goal of this clinical trial is to compare colonoscopy outcomes for standard gas (CO2) insufflation and TUC during withdrawal in patients participating in colonoscopy in the Norwegian and Swedish colorectal cancer screening programme after a positive fecal immunochemical test.\n\nThe overarching research questions of the present trial is whether colonoscopy outcomes are improved when CO2 insufflation is replaced by TUC during withdrawal and whether the new technique reduces the ecological footprint of the colonoscopy examination.\n\nThe project has five main hypotheses:\n\n1. TUC is superior to the standard approach (CO2 withdrawal) regarding detection of proximal SSLs.\n2. TUC increases the rate of complete resection of lesions \\>= 10mm.\n3. TUC reduces the rate of painful colonoscopies and vasovagal reactions.\n4. TUC reduces the health care costs by reduced use of single use accessories and reduced number of redundant colonoscopies to obtain polypfree colon.\n5. TUC reduces the carbon footprint by reduced use of single use accessories.\n\nIf TUC is superior to gas insufflation, the technique may be implemented rapidly since the technique is easy to learn. This study will increase endoscopy competence at participating centres. The centres are involved in national colonoscopy training programs, so the technique will quickly be passed on to other hospitals and screening centres.\n\nThe trial can be linked to three of the Global Goals:\n\n* Good health and well-being: The increased detection and improved complete removal of sessile serrated lesions can subsequently decrease the risk of CRC and CRC mortality during follow-up. TUC will probably reduce the rate of painful procedures and vasovagal reactions and thus increase the acceptance of a screening programme. Consequently, the project can contribute significantly to improve screening effectiveness in Norway and Sweden, particularly in women (women have a higher risk for SSLs and a higher risk of colorectal cancer developing from this type of precursor).\n* Gender equality: Women have a similar lifetime risk for CRC as men but less benefit of screening regardless of whether they are screened by sigmoidoscopy, FIT or colonoscopy. The reason is probably missed sessile serrated lesions in the proximal colon. If TUC improves SSLDR and complete lesion resection, this may lead to an equal benefit from CRC screening for women and men. Women have also a higher risk of discomfort and pain during colonoscopy than men. It has been shown that women prefer non-invasive screening modalities, potentially to avoid pain during colonoscopy, even if colonoscopy may be the most beneficial screening method for women. If TUC reduces the rate of painful colonoscopies, it can reduce women\'s barriers to attend screening.\n* Responsible consumption and production: The TUC technique will also reduce the ecological footprint of colonoscopy activity due to reduced consumption of single use accessories and reduced number of colonoscopies to achieve polyp free colon. Furthermore, the cost for the health care system will be substantially reduced.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All individuals referred to colonoscopy after a positive FIT screening at the participating screening centres\n\nExclusion Criteria:\n\n* Individuals with a CRC diagnosis within the last 10 years.'}, 'identificationModule': {'nctId': 'NCT06333392', 'briefTitle': 'Total Underwater Colonoscopy (TUC) for Improved Colorectal Cancer Screening: A Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Vestre Viken Hospital Trust'}, 'officialTitle': 'Total Underwater Colonoscopy (TUC) for Improved Colorectal Cancer Screening: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'TotalUnderwater_REK577567'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional colonoscopy (CO2) group', 'description': 'this groups receives conventional colonoscopy with CO2 withdrawal', 'interventionNames': ['Procedure: Conventional colonoscopy']}, {'type': 'EXPERIMENTAL', 'label': 'Total underwater colonoscopy (TUC) group', 'description': 'This group receives total underwater colonoscopy', 'interventionNames': ['Procedure: Total underwater colonoscopy']}], 'interventions': [{'name': 'Total underwater colonoscopy', 'type': 'PROCEDURE', 'description': 'one grooup will be randomized to receive a total underwater colonoscopy', 'armGroupLabels': ['Total underwater colonoscopy (TUC) group']}, {'name': 'Conventional colonoscopy', 'type': 'PROCEDURE', 'description': 'one group will be randomized to undergo a conventional colonoscopy with CO2 withdrawal', 'armGroupLabels': ['Conventional colonoscopy (CO2) group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3004', 'city': 'Drammen', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Anna Lisa Schult, MD PhD', 'role': 'CONTACT', 'email': 'anschu@vestreviken.no', 'phone': '0047413930003'}, {'name': 'Stine Hvattum, MD', 'role': 'CONTACT'}], 'facility': 'Vestre Viken Health Trust, Bærum Hospital', 'geoPoint': {'lat': 59.74389, 'lon': 10.20449}}, {'zip': '1714', 'city': 'Grålum', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Dung H Nguyen, MD', 'role': 'CONTACT', 'email': 'dung.hong.nguyen@so-hf.no', 'phone': '004769860000'}], 'facility': 'Østfold Hospital Health Trust', 'geoPoint': {'lat': 59.29048, 'lon': 11.06668}}, {'zip': '1478', 'city': 'Lørenskog', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Jan Henrik Rydning, MD', 'role': 'CONTACT', 'email': 'jan.henrik.rydning@ahus.no', 'phone': '0047 67 96 00 00'}, {'name': 'Stephan Brackmann', 'role': 'CONTACT'}], 'facility': 'Akershus University Hospital Health Trust'}, {'zip': '0424', 'city': 'Oslo', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Ingrid M Mikalsen, MD', 'role': 'CONTACT', 'email': 'inmika@ous-hf.no', 'phone': '004722118080'}, {'name': 'Marte L Høivik, MD PhD', 'role': 'CONTACT', 'email': 'm.l.hoivik@medisin.uio.no'}], 'facility': 'Ullevål University Hospital Health Trust', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'city': 'Gothenburg', 'status': 'NOT_YET_RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Thomas de Lange, Associate professor', 'role': 'CONTACT', 'email': 'thomas.de.lange@gu.se', 'phone': '+46702794054'}], 'facility': 'Sahlgrenska University Hospital, Gothenburg, Region Västra Götaland, Sweden, Department of Medicine, Geriatrics and Emergency Care Mölndal', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}], 'centralContacts': [{'name': 'Anna Lisa Schult, MD, PhD', 'role': 'CONTACT', 'email': 'anschu@vestreviken.no', 'phone': '+47 67 80 94 00'}, {'name': 'Thomas de Lange, MD, associate prof', 'role': 'CONTACT', 'email': 'thomas.de.lange@gu.se'}]}, 'ipdSharingStatementModule': {'url': 'http://notavailableyet.no', 'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'ipdSharing': 'YES', 'accessCriteria': 'Access to research data for external investigators, or use outside of the current protocol, will require approval from the Norwegian Regional Committee for Medical and Health Research Ethic. Research data are not openly available because of the principles and conditions set out in articles 6\\[1\\] (e) and 9 \\[2\\] (j) of the General Data Protection Regulation (GDPR).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vestre Viken Hospital Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ullevaal University Hospital', 'class': 'OTHER'}, {'name': 'Sahlgrenska University Hospital', 'class': 'OTHER'}, {'name': 'Ostfold Hospital Trust', 'class': 'OTHER'}, {'name': 'University Hospital, Akershus', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}