Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-01-24 @ 3:43 AM
Study NCT ID:
NCT02595151
Status:
UNKNOWN
Last Update Posted:
2015-11-03
First Post:
2015-10-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real-time Observation of Microcirculatory Hemodynamics in Gastric Intestinal Metaplasia by Confocal Laser Endomicroscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': "Targeted fresh biopsy samples from each examined site were fixed in 10% pH neutral formalin, and embedded in paraffin. Slides of 4-um sections were deparaffinized and hydrated. After antigen retrieval and blocking procedures, Immunology and Histology Chemistry (IHC) staining for CD34 was performed by mouse anti-CD34 monoclonal antibody (ZM-0046, ZSGB-BIO, Beijjing, China) as per the manufacturers' instructions."}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 94}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2015-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-11-01', 'studyFirstSubmitDate': '2015-10-29', 'studyFirstSubmitQcDate': '2015-11-01', 'lastUpdatePostDateStruct': {'date': '2015-11-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-11-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'blood flow state', 'timeFrame': '5 months', 'description': 'Flow determination cannot yet be done automatically. It requires a semi-quantitative analysis involving subjective assessment. Assessment of flow determination was based on the previously published consensus criteria, in which flow was classified into seven grades.\n\nFlow was categorized as: "linear flow" (fast and continuous flow, like plastic tape without grainy), "linear particle flow"(fast and continuous flow, like ribbon with mild grainy), "particle linear flow"(fast and continuous flow, like cotton tape with obvious grainy), "particle flow"(sluggish flow like mud-sand flow), "slowly particle flow"(slow but continuous), "particle of pendulum flow"(swinging silt flow) and "stagnate"(no flow).'}, {'measure': 'microvascular area in μm2', 'timeFrame': '5 months', 'description': "We analyzed the CLE images by using Adobe PhotoShop CS6 software. Ten images selected randomly and good displays of the vascular network were chosen from each sample for the analysis of the vascular structures. The Picture Cutout Guide and straight line tool were used to manually measure the area and length of each vascular segment. Each vascular segment was labeled and measured. We defined the microvascular length as the ratio of microvascular area to the microvascular diameter. The final measurement results of the microvascular area and diameter are the average of the 10 groups' testing values, respcetively. The results were exported in an Excel file and reported as the mean ± standard error (SD) for each individual case."}, {'measure': 'microvascular diameter in μm', 'timeFrame': '5 months', 'description': "We analyzed the CLE images by using Adobe PhotoShop CS6 software. Ten images selected randomly and good displays of the vascular network were chosen from each sample for the analysis of the vascular structures. The Picture Cutout Guide and straight line tool were used to manually measure the area and length of each vascular segment. Each vascular segment was labeled and measured. We defined the microvascular length as the ratio of microvascular area to the microvascular diameter. The final measurement results of the microvascular area and diameter are the average of the 10 groups' testing values, respcetively. The results were exported in an Excel file and reported as the mean ± standard error (SD) for each individual case."}], 'secondaryOutcomes': [{'measure': 'vascular morphology', 'timeFrame': '5 months', 'description': 'It included normal or tortuous and dilation.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Probe-based confocal laser endomicroscopy', 'chronic atrophic antral gastritis', 'microcirculatory dynamics'], 'conditions': ['Flow Determination']}, 'descriptionModule': {'briefSummary': 'The morphologic change of microvessels has the clinical value to distinguish cancerous from non-cancerous mucosa. The aim of this study was to observe gastric mucosa microcirculatory hemodynamic changes real-time using pCLE, compare the differences between chronic nonatrophic gastritis and GIM; then evaluate the possible mechanisms associated with gastric mucosal blood flow in GIM.', 'detailedDescription': 'Consecutive patients with GIM under endoscopic surveillance or examination at Qilu Hospital from March 1 to September 31, 2015 were recruited into this study. Before the endomicroscopic examination, 20,000 U α-chymotrypsin and 80 mg dimethylpolysiloxane were given orally to remove gastric mucus. All patients were given intravenous injections of 1 ml of 2% fluorescein sodium (Baiyunshan Mingxing Pharmaceutical, Guangzhou, China) as an allergy test before procedures were carried out. Conscious sedation was achieved for each patient by using propofol and fentanyl, and vital signs were monitored during the entire procedure. After successful intubation of the endoscope into the gastric antrum, 1 mL fluorescein sodium solution was applied intravenously as a contrast dye. The CLE procedure did not differ from that of conventional colonoscopy, except for the additional storage of pCLE images and videos in the gastric antrum. Finally, targeted biopsy of the examined site was performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients with GIM under endoscopic surveillance or examination at Qilu Hospital from March 1 to September 31, 2015 were recruited into this study. 94 patients were eligible for analysis (50 males and 44 females; average age 53 years, range 22-80 years).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or Female aged 18-80 ;\n2. Those fulfilling the criteria of GIM according to the study by Yuting Guo et al were included.\n\nExclusion Criteria:\n\n1. patients younger than 18 years or older than 80 years;\n2. finding of acute GI bleeding, gastrectomy or known upper gastrointestinal cancer;\n3. unwillingness to participate in this study;\n4. contraindications to CLE, such as fluorescein allergy, hepatic or renal dysfunction, jaundice, pregnancy and/or breast feeding, coagulopathy.'}, 'identificationModule': {'nctId': 'NCT02595151', 'briefTitle': 'Real-time Observation of Microcirculatory Hemodynamics in Gastric Intestinal Metaplasia by Confocal Laser Endomicroscopy', 'organization': {'class': 'OTHER', 'fullName': 'Shandong University'}, 'officialTitle': 'Real-time Observation of Microcirculatory Hemodynamics in Gastric Intestinal Metaplasia by Confocal Laser Endomicroscopy: a Feasibility Study', 'orgStudyIdInfo': {'id': '2015SDU-QILU-G001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'gastric intestinal metaplasia', 'description': 'Those fulfilling the criteria of GIM by CLE according to the study by Yuting Guo et al were included.', 'interventionNames': ['Device: CLE']}, {'label': 'normal gastric', 'description': 'diagnosed during routine colonoscopy procedures.', 'interventionNames': ['Device: CLE']}], 'interventions': [{'name': 'CLE', 'type': 'DEVICE', 'description': 'The CLE procedure did not differ from that of conventional colonoscopy, except for the additional storage of pCLE images and videos in the gastric antrum.', 'armGroupLabels': ['gastric intestinal metaplasia', 'normal gastric']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250012', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiuli Zuo, PhD', 'role': 'CONTACT', 'email': 'xiulizuo@gmail.com', 'phone': '15588818685', 'phoneExt': '15588818685'}, {'name': 'Yafei Yin, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Qilu Hospital, Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Xiuli Zuo, PhD', 'role': 'CONTACT', 'email': 'xiulizuo@gmail.com', 'phone': '15588818685', 'phoneExt': '0531-88369277'}], 'overallOfficials': [{'name': 'Xiuli Zuo, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Qilu Hospital of Shandong University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'director of Qilu Hospital', 'investigatorFullName': 'Xiuli Zuo', 'investigatorAffiliation': 'Shandong University'}}}}