Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2026-01-02 @ 8:44 AM
Study NCT ID:
NCT04464135
Status:
UNKNOWN
Last Update Posted:
2020-07-09
First Post:
2020-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Water Exchange Plus Acetic Acid Staining on the Detection of Flat Polyps During Colonoscopy
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': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2021-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-07', 'studyFirstSubmitDate': '2020-07-07', 'studyFirstSubmitQcDate': '2020-07-07', 'lastUpdatePostDateStruct': {'date': '2020-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of flat polyps per patient', 'timeFrame': '9 months', 'description': 'average numbers of flat polyps, defined by Paris classification IIa/IIb/IIc, for each patient'}], 'secondaryOutcomes': [{'measure': 'Overall ADR', 'timeFrame': '9 months', 'description': 'Adenoma detection rate, defined as the proportion of subjects with at least one adenoma of any size, in each group.'}, {'measure': 'Advanced ADR', 'timeFrame': '9 months', 'description': 'Advanced adenoma detection rate. Advanced adenoma: any with 3 or more adenomas of any size, 1 or more large adenomas 1 cm, or 1 or more adenomas with villous architecture or highgrade dysplasia.'}, {'measure': 'SSA/P detection rate', 'timeFrame': '9 months', 'description': 'SSA/P detection rate, defined as the proportion of subjects with at least one sessile serrated adenoma/polyp (SSA/P) of any size, in each group.'}, {'measure': 'Flat neoplasms located in proximal colon', 'timeFrame': '9 months', 'description': 'Low-grade adenoma, adenoma with villous components, high-grade adenoma, noninvasive carcinoma, and invasive carcinoma in proximal colon'}, {'measure': 'Adverse events', 'timeFrame': '9 months', 'description': 'the rate of bleeding and perforation during colonoscopy procedure and abdominal pain, diarrhea, hematochezia and change of defecation habit Within one week.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Water exchange colonoscopy', 'Flat Polyps', 'Acetic Acid Staining'], 'conditions': ['Adenoma Colon']}, 'referencesModule': {'references': [{'pmid': '24804989', 'type': 'BACKGROUND', 'citation': 'Shibagaki K, Amano Y, Ishimura N, Yuki T, Taniguchi H, Fujita H, Kobayashi K, Kinoshita Y. Magnification endoscopy with acetic acid enhancement and a narrow-band imaging system for pit pattern diagnosis of colorectal neoplasms. J Clin Gastroenterol. 2015 Apr;49(4):306-12. doi: 10.1097/MCG.0000000000000148.'}, {'pmid': '27922025', 'type': 'RESULT', 'citation': 'Jia H, Pan Y, Guo X, Zhao L, Wang X, Zhang L, Dong T, Luo H, Ge Z, Liu J, Hao J, Yao P, Zhang Y, Ren H, Zhou W, Guo Y, Zhang W, Chen X, Sun D, Yang X, Kang X, Liu N, Liu Z, Leung F, Wu K, Fan D. Water Exchange Method Significantly Improves Adenoma Detection Rate: A Multicenter, Randomized Controlled Trial. Am J Gastroenterol. 2017 Apr;112(4):568-576. doi: 10.1038/ajg.2016.501. Epub 2016 Dec 6.'}, {'pmid': '30738046', 'type': 'RESULT', 'citation': 'Zhao S, Wang S, Pan P, Xia T, Chang X, Yang X, Guo L, Meng Q, Yang F, Qian W, Xu Z, Wang Y, Wang Z, Gu L, Wang R, Jia F, Yao J, Li Z, Bai Y. Magnitude, Risk Factors, and Factors Associated With Adenoma Miss Rate of Tandem Colonoscopy: A Systematic Review and Meta-analysis. Gastroenterology. 2019 May;156(6):1661-1674.e11. doi: 10.1053/j.gastro.2019.01.260. Epub 2019 Feb 6.'}, {'pmid': '28365356', 'type': 'RESULT', 'citation': 'Desai M, Sanchez-Yague A, Choudhary A, Pervez A, Gupta N, Vennalaganti P, Vennelaganti S, Fugazza A, Repici A, Hassan C, Sharma P. Impact of cap-assisted colonoscopy on detection of proximal colon adenomas: systematic review and meta-analysis. Gastrointest Endosc. 2017 Aug;86(2):274-281.e3. doi: 10.1016/j.gie.2017.03.1524. Epub 2017 Mar 29.'}]}, 'descriptionModule': {'briefSummary': 'Our previous study (Am. J. Gastroenterol. 2017 04;112(4)) showed that water exchange (WE) colonoscopy was able to increase the detection of flat adenomas as well as overall ADR. We hypothesized that WE based whole-colon acetic acid（AA） staining might be useful to improve the detection of flat lesions compared with WE alone.', 'detailedDescription': 'Water exchange colonoscopy was performed as described previously (Am. J. Gastroenterol. 2017 04;112(4)). Patients were randomly allocated to WE group or WE+AA group. In WE+AA group, water containing 1% of AA was used during insertion of colonoscopy instead of water alone. A bottle of 20ml pure AA was placed abutting the water pump, which make it possible to keep patients blinded to group allocation. Endoscopist using a high-definition wide-angle Olympus or Fujinum colonoscope performed all of the colonoscopies, with a withdrawal time of at least 6 min. The observation was initially performed without the assistance of cap or the use of magnification or electronic staining (NBI, BLI, LCI or AFI et al.). Scopolamine butylbromide or glucogon was not routinely administrated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 40-70\n* Undergoing colonoscopy after standard bowel preparation\n\nExclusion Criteria:\n\n* Known familial polyposis\n* Small amount of feces or semi-solid stool in last rectal effluent\n* Inflammatory Bowel Disease\n* Lactated or pregnant women\n* Unable to provide informed content'}, 'identificationModule': {'nctId': 'NCT04464135', 'briefTitle': 'Effect of Water Exchange Plus Acetic Acid Staining on the Detection of Flat Polyps During Colonoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Air Force Military Medical University, China'}, 'officialTitle': 'Effect of Water Exchange Plus Acetic Acid Staining on the Detection of Flat Polyps During Screening and Surveillance Colonoscopy: a Multi-centered, Randomized Controlled Study.', 'orgStudyIdInfo': {'id': 'KY20200706-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'WE+AA group', 'description': 'Water containing 1% of AA was used during insertion of colonoscopy using water exchange method.', 'interventionNames': ['Other: acetic acid staining']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'WE group', 'description': 'Water exchange colonoscopy was used for standard screening or surveillance colonoscopy.', 'interventionNames': ['Other: Water exchange colonoscopy']}], 'interventions': [{'name': 'acetic acid staining', 'type': 'OTHER', 'description': 'The water exchange colonoscopy is used during insertion procedure, in which the water contains 1% acetic acid, and the liquid is absorbed during the withdrawal process for observation.', 'armGroupLabels': ['WE+AA group']}, {'name': 'Water exchange colonoscopy', 'type': 'OTHER', 'description': 'The water exchange colonoscopy is used during insertion procedure, and the liquid is absorbed during the withdrawal process for observation.', 'armGroupLabels': ['WE group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '730030', 'city': 'Lanzhou', 'state': 'Gansu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaojun Huang, MD', 'role': 'CONTACT', 'email': 'haungxj62@163.com', 'phone': '+8609318942279'}], 'facility': 'Department of Gastroenterology, Second Affiliated Hospital, Lanzhou University', 'geoPoint': {'lat': 36.05701, 'lon': 103.83987}}, {'zip': '510000', 'city': 'Shenzhen', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaoying Zhang, MD', 'role': 'CONTACT', 'email': '13116950266@163.com', 'phone': '+8613116950266'}], 'facility': 'Department of Holistic Integrative Medicine, Shenzhen Hospital of Southern Medical University', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'zip': '475000', 'city': 'Kaifeng', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jianghai Zhao, MD', 'role': 'CONTACT', 'email': '493109907@qq.com', 'phone': '+8615191903630'}], 'facility': 'Department of Gastroenterology, Huaihe Hospital of Henan University', 'geoPoint': {'lat': 34.7986, 'lon': 114.30742}}, {'zip': '710005', 'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Limei Wang, MD', 'role': 'CONTACT', 'email': '15291680602@163.com', 'phone': '+8615291680602'}], 'facility': "Department of Gastroenterology, Shaanxi Second People's Hospital", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Gui Ren, MD', 'role': 'CONTACT', 'email': 'renguigz@hotmail.com', 'phone': '+86298477136'}, {'name': 'Yanglin Pan, MD', 'role': 'CONTACT', 'email': 'yanglinpan@hotmail.com', 'phone': '+862984771536'}], 'overallOfficials': [{'name': 'Yanglin Pan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xijing Hospital of Digestive Diseases'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Air Force Military Medical University, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associated professor', 'investigatorFullName': 'Yanglin Pan', 'investigatorAffiliation': 'Air Force Military Medical University, China'}}}}