Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2025-12-28 @ 6:44 PM
Study NCT ID:
NCT06979232
Status:
RECRUITING
Last Update Posted:
2025-10-02
First Post:
2025-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enhanced White Light Endoscopy Versus Conventional White Light Endoscopy for Colorectal Adenoma Detection: A Randomized Controlled Trial
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': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-25', 'studyFirstSubmitDate': '2025-05-11', 'studyFirstSubmitQcDate': '2025-05-11', 'lastUpdatePostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adenoma detection rate (ADR)', 'timeFrame': '14 days', 'description': 'ADR was calculated by dividing the total number of patients detected with adenomas by the total number of patients who underwent colonoscopy'}], 'secondaryOutcomes': [{'measure': 'Polyp Detection Rate(PDR)', 'timeFrame': '14 days', 'description': 'Calculated by dividing the total number of patients with detected polyps by the total number of patients undergoing colonoscopy.'}, {'measure': 'Sessile serrated lesion detection rate (SDR)', 'timeFrame': '14 days', 'description': 'SSLDR was calculated by dividing the total number of patients detected with sessile serrated lesions by the total number of patients who underwent colonoscopy.'}, {'measure': 'Advanced Adenoma Detection Rate (aADR)', 'timeFrame': '14 days', 'description': 'Calculated by dividing the total number of patients with detected advanced adenomas by the total number of patients undergoing colonoscopy.'}, {'measure': 'Mean number of polyps per patient (MPP)', 'timeFrame': '14 days', 'description': 'Calculated by dividing the total number of detected polyps by the total number of patients undergoing colonoscopy.'}, {'measure': 'Mean number of Adenomas per patient(MAP)', 'timeFrame': '14 days', 'description': 'Calculated by dividing the total number of detected adenomas by the total number of patients undergoing colonoscopy.'}, {'measure': 'Detection Rate of Polyps of Different Sizes', 'timeFrame': '14 days', 'description': 'lt is calculated by dividing the number of patients with polyps with different sizes by the total number of patients undergoing colonoscopy.'}, {'measure': 'Detection Rate of Adenomas with Different Morphologies', 'timeFrame': '14 days', 'description': 'lt is calculated by dividing the number of patients with adenomas of different morphologies by the total number of patients undergoing colonoscopy.'}, {'measure': 'Average Number of Adenomas with Different Morphologies', 'timeFrame': '14 days', 'description': 'lt is calculated by dividing the number of adenomas with different morphologies by the total number of patients undergoing colonoscopy.'}, {'measure': 'Average Number of Polyps of Different Sizes', 'timeFrame': '14 days', 'description': 'lt is calculated by dividing the number of polyps with different sizes by the total number of patients undergoing colonoscopy.'}, {'measure': 'Detection Rate of Adenomas of Different Sizes', 'timeFrame': '14 days', 'description': 'lt is calculated by dividing the number of adenomas with different sizes by the total number of patients undergoing colonoscopy.'}, {'measure': 'Average Number of Adenomas of Different Sizes', 'timeFrame': '14 days', 'description': 'lt is calculated by dividing the number of adenomas with different sizes by the total number of patients undergoing colonoscopy.'}, {'measure': 'Detection Rate of Adenomas in Different Locations', 'timeFrame': '14 days', 'description': 'lt is calculated by dividing the number of patients with detected adenomas in different locations by the total number of patients undergoing colonoscopy.'}, {'measure': 'Average Number of Adenomas in Different Locations', 'timeFrame': '14 days', 'description': 'lt is calculated by dividing the number of detected adenomas in different locations by the total number of patients undergoing colonoscopy.'}, {'measure': 'Detection Rate of Polyps in Different Locations', 'timeFrame': '14 days', 'description': 'lt is calculated by dividing the number of patients with polyps in different locations by the total number of patients undergoing colonoscopy.'}, {'measure': 'Average Number of Polyps in Different Locations', 'timeFrame': '14 days', 'description': 'lt is calculated by dividing the number of detected polyps in different locations by the total number of patients undergoing colonoscopy.'}, {'measure': 'Detection Rate of Polyps with Different Morphologies', 'timeFrame': '14 days', 'description': 'lt is calculated by dividing the number of patients with polyps of different morphologies by the total number of patients undergoing colonoscopy.'}, {'measure': 'Average Number of Polyps with Different Morphologies', 'timeFrame': '14 days', 'description': 'lt is calculated by dividing the number of polyps with different morphologies by the total number of patients undergoing colonoscopy.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Enhanced white light endoscopy', 'Adenoma detection rate', 'Randomized controlled trial'], 'conditions': ['Colorectal Adenoma']}, 'descriptionModule': {'briefSummary': '1. Study on Adenoma Detection Rate (ADR) Comparing Enhanced White Light Endoscopy (E-WLI) versus Conventional White Light Endoscopy (WLI);\n2. Study Comparing Enhanced White Light Endoscopy (E-WLI) versus Conventional White Light Endoscopy (WLI) for Detection Rates of Sessile Serrated Lesions (SSLs), Total Polyp Detection Rate, and Advanced Adenoma Detection Rate;\n3. Study on Polyp Characteristics (Size, Location, etc.) Observed Using Conventional White Light Endoscopy (WLI) and Enhanced White Light Endoscopy (E-WLI).', 'detailedDescription': 'Before colonoscopy, gastroenterology specialists stratified eligible patients according to 1) colorectal cancer screening, 2) positive fecal immunochemical test (FIT) results or gastrointestinal symptoms, and 3) follow-up colonoscopy after colorectal polyp treatment. Patients were then randomized in a 1:1 ratio to receive either colonoscopy with enhanced white light imaging (E-WLI group) or high-definition conventional white light imaging (WLI group) during both insertion and withdrawal phases. Randomization was based on random number lists generated by the coordinating center for each participating site. Endoscopists performing the procedures were not involved in generating the randomization sequence. All procedures were performed by experienced endoscopists at participating centers (\\>2000 colonoscopy screenings). All procedures utilized endoscopes with "Xiaohua Tanying" technology that incorporated E-WLI functionality. Bowel preparation was assessed and graded by the performing endoscopist using the Boston Bowel Preparation Scale (BBPS). Endoscopy specialists and healthcare facility staff followed standard procedures for patient management and monitoring, including anesthesia. Cecal intubation was verified by the endoscopist through photographic documentation identifying the ileocecal valve and appendiceal orifice. Insertion and withdrawal times were measured through video recording analysis, excluding time spent on therapeutic interventions and washing. Endoscopists were required to maintain a minimum withdrawal inspection time of 6 minutes (with at least 2 minutes each for right colon, transverse colon, and left colon). Regardless of group assignment (E-WLI or WLI), when polyps were detected during the procedure, they were observed using both WLI and E-WLI (2 modes), with images captured in each mode. The location, size, and morphology (Paris classification) of all polyps were documented. All polyps were removed (or biopsied if unresectable), and pathological results were obtained. For hyperplastic polyps in the rectum, if more than 3 diminutive polyps were present, only the first 3 detected polyps required management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Male or female aged 45 to 85\n* 2\\. Patients undergoing colonoscopy for colorectal cancer screening, positive fecal immunochemical test (FIT) results, gastrointestinal symptoms, or follow-up examination after colorectal polyp treatment\n* 3\\. Capable of providing informed consent and agreeing to participate\n* 4\\. Able and willing to follow all research processes\n\nExclusion Criteria:\n\n* 1\\. Participated in other clinical trials, signed informed consent form, and in the follow-up period of other clinical trials;\n* 2\\. Participated in clinical trials of drugs and is in the discontinuation period of experimental or control drugs;\n* 3\\. Have had drug or alcohol abuse or psychological disorders in the past five years.\n* 4\\. Pregnant or lactating patients;\n* 5\\. Known to have polyposis syndrome;\n* 6\\. Patients with gastrointestinal bleeding;\n* 7\\. Previous history of inflammatory bowel disease, colorectal cancer, or colorectal surgery;\n* 8.Patients with contraindications to tissue biopsy;\n* 9\\. History of allergies to the ingredients in intestinal cleansers;\n* 10\\. Individuals with conditions such as intestinal obstruction or perforation, toxic megacolon, heart failure (grade III or IV), severe cardiovascular disease, severe liver failure, or renal insufficiency, among others.\n* 11\\. Researchers believe that patients are not suitable to participate in the trial.'}, 'identificationModule': {'nctId': 'NCT06979232', 'briefTitle': 'Enhanced White Light Endoscopy Versus Conventional White Light Endoscopy for Colorectal Adenoma Detection: A Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'Enhanced White Light Endoscopy Versus Conventional White Light Endoscopy for Colorectal Adenoma Detection: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'LY2024-320-C'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'E-WLI', 'description': 'Enhanced White Light Imaging', 'interventionNames': ['Device: Enhanced White Light Imaging']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'WLI', 'description': 'White Light lmaging', 'interventionNames': ['Device: White Light lmaging']}], 'interventions': [{'name': 'Enhanced White Light Imaging', 'type': 'DEVICE', 'description': 'Use of E-WLI for colon inspection during both insertion and withdrawal phase of colonoscopy', 'armGroupLabels': ['E-WLI']}, {'name': 'White Light lmaging', 'type': 'DEVICE', 'description': 'Use of WLl for colon inspection during both insertion and withdrawal phase of colonoscopy', 'armGroupLabels': ['WLI']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'Chongqing General Hospital', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'zip': '730050', 'city': 'Lanzhou', 'state': 'Gansu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weichun Zhai', 'role': 'CONTACT', 'email': '277086741@qq.com', 'phone': '15095321372'}], 'facility': "The First People's Hospital of Lanzhou City", 'geoPoint': {'lat': 36.05701, 'lon': 103.83987}}, {'zip': '150030', 'city': 'Harbin', 'state': 'Heilongjiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhe Wang', 'role': 'CONTACT', 'email': 'cjwdwz@126.com', 'phone': '15804514492'}], 'facility': 'The Third Affiliated Hospital of Heilongjiang University of Chinese Medicine', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'city': 'Leshan', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ruilan Wang', 'role': 'CONTACT', 'email': '364589229@qq.com', 'phone': '13881368101'}], 'facility': 'Armed Police Forces Hospital of Sichuan', 'geoPoint': {'lat': 29.56227, 'lon': 103.76386}}, {'zip': '841000', 'city': 'Korla', 'state': 'Xinjiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hongli Tian', 'role': 'CONTACT', 'email': '1281987347@qq.com', 'phone': '18099966639'}], 'facility': "People's Hospital of Bayingolin Mongol Autonomous Prefecture", 'geoPoint': {'lat': 41.76055, 'lon': 86.15231}}, {'city': 'Ningbo', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jian Huang', 'role': 'CONTACT', 'email': 'huanghuaijian@126.com', 'phone': '13819448881'}], 'facility': 'Ningbo Ninth Hospital', 'geoPoint': {'lat': 29.87819, 'lon': 121.54945}}, {'zip': '318020', 'city': 'Taizhou', 'state': 'Zhejiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xinyuan Shi', 'role': 'CONTACT', 'email': '18724213582@163.com', 'phone': '15157628698'}], 'facility': "Taizhou First People's Hospital", 'geoPoint': {'lat': 28.66266, 'lon': 121.43312}}], 'centralContacts': [{'name': 'Qing-Wei Zhang, MD', 'role': 'CONTACT', 'email': 'zhangqingweif@hotmail.com', 'phone': '021-68383015'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief physician', 'investigatorFullName': 'Xiaobo Li', 'investigatorAffiliation': 'RenJi Hospital'}}}}