Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2025-12-30 @ 4:26 AM
Study NCT ID:
NCT01828892
Status:
UNKNOWN
Last Update Posted:
2015-06-10
First Post:
2013-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glue Application in the Treatment of Low-Output Fistulas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007412', 'term': 'Intestinal Fistula'}], 'ancestors': [{'id': 'D016154', 'term': 'Digestive System Fistula'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000900', 'term': 'Anti-Bacterial Agents'}, {'id': 'D002442', 'term': 'Ceftazidime'}, {'id': 'D002439', 'term': 'Cefotaxime'}, {'id': 'D000077731', 'term': 'Meropenem'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}], 'ancestors': [{'id': 'D000890', 'term': 'Anti-Infective Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D002509', 'term': 'Cephaloridine'}, {'id': 'D002511', 'term': 'Cephalosporins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013843', 'term': 'Thiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002505', 'term': 'Cephacetrile'}, {'id': 'D013845', 'term': 'Thienamycins'}, {'id': 'D015780', 'term': 'Carbapenems'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-06-09', 'studyFirstSubmitDate': '2013-04-01', 'studyFirstSubmitQcDate': '2013-04-10', 'lastUpdatePostDateStruct': {'date': '2015-06-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Economic outcome', 'timeFrame': 'From fistula onset to the end of treatment, which is at least 180 days', 'description': 'Hospital cost upon enrollment, Hospital cost during entire hospital stay, Cost between fistula onset and final outcome'}], 'primaryOutcomes': [{'measure': 'Closure rates up to 14 days', 'timeFrame': '14 days', 'description': 'The fraction of patients with complete closure of fistula during 14 days'}], 'secondaryOutcomes': [{'measure': 'Number of adverse events', 'timeFrame': 'Participants will be followed for at least 180 days', 'description': 'Incidence of adverse events and severe adverse events up to 180 days (defined as an event that was fatal or life-threatening, led to additional hospitalization or disability, or required an intervention to prevent one of these outcomes)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Autologous platelet rich fibrin glue', 'Enterocutaneous fistulas', 'Single low output GI fistulas'], 'conditions': ['Low-output External Gastrointestinal Fistula']}, 'referencesModule': {'references': [{'pmid': '26445823', 'type': 'DERIVED', 'citation': 'Wu X, Ren J, Wang G, Wang J, Wang F, Fan Y, Li Y, Han G, Zhou Y, Song X, Quan B, Yao M, Li J. Evaluating the use of fibrin glue for sealing low-output enterocutaneous fistulas: study protocol for a randomized controlled trial. Trials. 2015 Oct 7;16:445. doi: 10.1186/s13063-015-0966-9.'}]}, 'descriptionModule': {'briefSummary': 'Adjuvant use of fibrin glue (FG) in the fistula tract has been shown to promote closure of low-output enterocutaneous fistulas (ECFs). The primary objectives of this study are to compare the clinical efficacy, safety of autologous platelet-rich fibrin glue (PRFG), commercial fibrin glue, and control therapy in the management of patients with low-output volume ECFs.', 'detailedDescription': '* This is a prospective, randomized, multi-centered study clinical, safety and economic outcome of ECFs patients.\n* Subjects are randomized to one of 3 groups:\n\n * Group 1: Autologous PRFG-treatment \\[PRFG + Standard of care (SOC)\\]\n * Group 2: Commercial FG-treatment \\[FG + Standard of care (SOC)\\]\n * Group 3: Control (SOC only)\n* Study will include three phases:\n\n * Phase 1: Screening, consent and enrollment\n * Phase 2: Patients will receive either PRFG, commercial FG, or SOC only for 14 days\n * Phase 3: Follow up: for patients with closed fistula within 14 days, we will follow up them for 6 months. For patients whose fistulas were still open will be treated with other therapeutic option and follow up for 6 months after closure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a single tubular ECF\n* Low output volume (\\<200 ml/24h)\n* Tract length \\>2cm\n* Tract diameter \\< 1cm\n\nExclusion Criteria:\n\n* Cancer-infiltrated fistula\n* Abscess\n* Foreign bodies\n* Distal bowel obstruction\n* Inflammatory Bowel Disease'}, 'identificationModule': {'nctId': 'NCT01828892', 'acronym': 'FG-treatment', 'briefTitle': 'Glue Application in the Treatment of Low-Output Fistulas', 'organization': {'class': 'OTHER', 'fullName': 'Jinling Hospital, China'}, 'officialTitle': 'A Randomized Controlled Trial to Evaluate Fibrin Glue Application in the Treatment of Low-Output Enterocutaneous Fistulas', 'orgStudyIdInfo': {'id': '20120819'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PRFG treatment', 'description': 'As described in our previous study, platelet-rich cryoprecipitate and thrombin were obtained from 300-400ml whole blood of each patient enrolled in the PRFG group and then frozen at -20°C for storage. Prior to application, frozen cryoprecipitate and thrombin stored were thawed in a 37°C water bath. Aminomethylbenzoic Acid (1ml: 1mg, Sigma-Aldrich, St Louis, MO) was added into the cryoprecipitate in the volume ratio of 1:10.', 'interventionNames': ['Procedure: Endoscopy exploration and glue application', 'Drug: Antibiotics (ceftazidime, cefotaxime, or meropenem, with or without vancomycin)', 'Dietary Supplement: Nutrition support']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control', 'description': 'Patients in this group only received standard of care when their fistula output \\< 200ml/24h.', 'interventionNames': ['Procedure: Endoscopy exploration', 'Drug: Antibiotics (ceftazidime, cefotaxime, or meropenem, with or without vancomycin)', 'Dietary Supplement: Nutrition support']}, {'type': 'EXPERIMENTAL', 'label': 'Commercial FG', 'description': 'Commercial FG (Zhejiang Puji Porcine fibrin sealant) was applied to close fistulas.', 'interventionNames': ['Procedure: Endoscopy exploration and glue application', 'Drug: Antibiotics (ceftazidime, cefotaxime, or meropenem, with or without vancomycin)', 'Dietary Supplement: Nutrition support']}], 'interventions': [{'name': 'Endoscopy exploration and glue application', 'type': 'PROCEDURE', 'description': 'A forward-viewing fistula-fiberscope (EndoView, Outai Medical Equipment, Shanghai, China), with 15cm length and 5mm width of fiber optical wire, was inserted into the fistula tract to accomplish endoscopic visualization. Briefly, the fistula-fiberscope assisted procedure was carried out percutaneously, allowing the exposure of internal hole and the whole tracts, followed by insertion of this catheter with distal mixing device.', 'armGroupLabels': ['Commercial FG', 'PRFG treatment']}, {'name': 'Endoscopy exploration', 'type': 'PROCEDURE', 'description': 'A forward-viewing fistula-fiberscope (EndoView, Outai Medical Equipment, Shanghai, China), with 15cm length and 5mm width of fiber optical wire, was inserted into the fistula tract to accomplish endoscopic visualization.', 'armGroupLabels': ['Control']}, {'name': 'Antibiotics (ceftazidime, cefotaxime, or meropenem, with or without vancomycin)', 'type': 'DRUG', 'otherNames': ['ceftazidime, cefotaxime, or meropenem, with or without vancomycin'], 'description': 'Antibacterial therapy in patients with signs of systemic sepsis or local inflammation with pain', 'armGroupLabels': ['Commercial FG', 'Control', 'PRFG treatment']}, {'name': 'Nutrition support', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Nutritional replacement and bowel rest via enteral or parenteral nutrition', 'armGroupLabels': ['Commercial FG', 'Control', 'PRFG treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210002', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jianan Ren, MD', 'role': 'CONTACT', 'email': 'Jiananr@gmail.com', 'phone': '862580860108'}], 'facility': 'Jinling Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Jianan Ren, MD', 'role': 'CONTACT', 'email': 'jiananr@gmail.com', 'phone': '862580860108'}, {'name': 'XIUWEN WU', 'role': 'CONTACT', 'email': 'xiuwenwoo@gmail.com', 'phone': '862580860008'}], 'overallOfficials': [{'name': 'Jianan Ren, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jinling Hospital, China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jinling Hospital, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice president of department of surgery, Jinling Hospital', 'investigatorFullName': 'Jianan Ren', 'investigatorAffiliation': 'Jinling Hospital, China'}}}}