Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2026-03-02 @ 4:02 PM
Study NCT ID:
NCT03621033
Status:
UNKNOWN
Last Update Posted:
2020-02-25
First Post:
2018-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Methods of Colonic Transendoscopic Enteral Tubing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 207}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-08-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-05-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-22', 'studyFirstSubmitDate': '2018-08-05', 'studyFirstSubmitQcDate': '2018-08-05', 'lastUpdatePostDateStruct': {'date': '2020-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The second cecal intubation time', 'timeFrame': 'one day', 'description': 'Record the time of colonoscopy from the anus to the ileal flap in the second insertion.'}], 'secondaryOutcomes': [{'measure': 'Adverse events rate', 'timeFrame': 'All patients were followed up from date of intubation to one mouth after discharge', 'description': 'Procedure-related and tube-related adverse events after procedure'}, {'measure': 'TET success rate', 'timeFrame': 'one day', 'description': 'The success rate of of the TET procedure'}, {'measure': 'Maximum insertion pain score', 'timeFrame': 'one day', 'description': 'Using numerical rating scale to evaluate maximum insertion pain score in non anesthesia. The digital grading method uses 0-10 to represent different levels of pain, with 0 as painless and 10 as severe. The classification standard of pain degree is: 0: no pain; 1-3: mild pain; 4-6: moderate pain; 7-10: severe pain.'}, {'measure': 'Retention time of tube', 'timeFrame': 'three month', 'description': 'Retention time of colonic transendoscopic enteral tubing'}, {'measure': 'Tubing time', 'timeFrame': 'one day', 'description': 'The tubing time is from advancement of the TET tube through the channel to the end of the tubing.'}, {'measure': 'Titanium clip fixation time', 'timeFrame': 'one day', 'description': 'Record the time required for fixing a titanium clip.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['transendoscopic enteral tubing', 'Microbiota Transplantation', 'transparent cap-assisted colonoscopy'], 'conditions': ['Colonic Transendoscopic Enteral Tubing']}, 'referencesModule': {'references': [{'pmid': '27556065', 'type': 'RESULT', 'citation': 'Peng Z, Xiang J, He Z, Zhang T, Xu L, Cui B, Li P, Huang G, Ji G, Nie Y, Wu K, Fan D, Zhang F. Colonic transendoscopic enteral tubing: A novel way of transplanting fecal microbiota. Endosc Int Open. 2016 Jun;4(6):E610-3. doi: 10.1055/s-0042-105205. Epub 2016 Apr 28.'}, {'pmid': '22228167', 'type': 'RESULT', 'citation': 'Westwood DA, Alexakis N, Connor SJ. Transparent cap-assisted colonoscopy versus standard adult colonoscopy: a systematic review and meta-analysis. Dis Colon Rectum. 2012 Feb;55(2):218-25. doi: 10.1097/DCR.0b013e31823461ef.'}]}, 'descriptionModule': {'briefSummary': 'Colonic transendoscopic enteral tubing (TET) is a novel, safe, convenient, and reliable way for fecal microbiota transplantation (FMT) and the whole-colon enema treatment. The aim of this study was to evaluate the methodology, efficiency, feasibility and safety of using transparent cap-assisted endoscopy for colon TET implantation.', 'detailedDescription': "Our previous article has reported the method of colon TET. However, the investigators found that it was difficult to find the cavity because of the concentration of intestinal folds caused by the tube pulling after insertion of TET. It is well known that transparent cap-assisted colonoscopy is easier to flatten the semilunar folds and improve mucosal exposure. Here the investigators test the hypothesis that using transparent cap-assisted colonoscopy significantly decreases the second cecal intubation time which not only improve work efficiency, but also saves patients' anesthesia time and cost. Thus, the investigators design a prospective multicenter, randomized controlled trial. The aim of this study was to evaluate the methodology, efficiency, feasibility and safety of using transparent cap-assisted endoscopy for colon TET implantation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '7 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diseases requiring total colonic administration and fecal microbiota transplantation.\n* Patients and healthy Volunteers with the need to sample in deep colon .\n* Age \\> 7 years.\n* Must be able to Colonic Transendoscopic Enteral Tubing and no contraindication by endoscopic examination, consent colon TET implantation and not associated with severe intestinal lesions such as fistula, stenosis, complex perianal lesions, severe ileocecal or ascending colon lesions resulting in no proper site for titanium clip fixation.\n\nExclusion Criteria:\n\n* Data was not recorded as required; Before and after implantation is not the same physician operation.'}, 'identificationModule': {'nctId': 'NCT03621033', 'briefTitle': 'Methods of Colonic Transendoscopic Enteral Tubing', 'organization': {'class': 'OTHER', 'fullName': 'The Second Hospital of Nanjing Medical University'}, 'officialTitle': 'Methods of Colonic Transendoscopic Enteral Tubing: a Multicenter, Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'TET-CN-170803'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'non-transparent cap-assisted endoscopic intubation', 'description': 'we do not use transparent cap-assisted endoscopic intubation.', 'interventionNames': ['Procedure: colonic transendoscopic enteral tubing']}, {'type': 'OTHER', 'label': 'transparent cap-assisted endoscopic intubation', 'description': 'we use transparent cap-assisted endoscopic intubation in the second insertion.', 'interventionNames': ['Procedure: colonic transendoscopic enteral tubing']}], 'interventions': [{'name': 'colonic transendoscopic enteral tubing', 'type': 'PROCEDURE', 'description': 'The procedure colonic transendoscopic enteral tubing is as follows:The TET tube was inserted into the ileocecal junction through the endoscopy channel at the first time of the cecal intubation after examination and evaluation of the whole colon. Then, the colonoscope was removed from the colon while the TET tube was maintained at the ileocecal junction. Then the endoscopy was inserted into the ileocecum again for affixing the TET tube to cecum with titanium clips.', 'armGroupLabels': ['non-transparent cap-assisted endoscopic intubation', 'transparent cap-assisted endoscopic intubation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210011', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Faming Zhang, PhD,MD', 'role': 'CONTACT'}, {'name': 'Faming Zhang, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fmt-Dt-N-27/1350', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '210011', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Faming Zhang, MD, PhD', 'role': 'CONTACT', 'email': 'fzhang@njmu.edu.cn', 'phone': '086-25-58509883'}], 'facility': 'Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Faming Zhang, MD; PhD', 'role': 'CONTACT', 'email': 'fzhang@njmu.edu.cn', 'phone': '086-25-58509883'}], 'overallOfficials': [{'name': 'Faming Zhang, MD; PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Nanjing Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Second Hospital of Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Gastroenterology', 'investigatorFullName': 'Faming Zhang', 'investigatorAffiliation': 'The Second Hospital of Nanjing Medical University'}}}}