Ignite Creation Date:
2025-12-24 @ 1:31 PM
Ignite Modification Date:
2026-02-03 @ 6:15 AM
Study NCT ID:
NCT04255095
Status:
UNKNOWN
Last Update Posted:
2020-02-05
First Post:
2020-01-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Intervention of High Tension in the Pancreatic Duct on the Outcome of Severe Biliary Pancreatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2021-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-02', 'studyFirstSubmitDate': '2020-01-30', 'studyFirstSubmitQcDate': '2020-02-02', 'lastUpdatePostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rehabilitation', 'timeFrame': '2 months', 'description': 'time from ERCP to ischarge'}, {'measure': 'complication rate', 'timeFrame': '1 months', 'description': 'Pancreatitis aggravation， hemorrhage，fistula'}], 'secondaryOutcomes': [{'measure': 'LOS(length of stay)', 'timeFrame': 'postoperative period（1 month ）', 'description': 'time from operation to discharge'}, {'measure': 'death rate', 'timeFrame': 'postoperative period（1 month ）', 'description': 'Mortality from the disease'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pancreatic duct negative-pressure suction'], 'conditions': ['ERCP']}, 'descriptionModule': {'briefSummary': 'The investigators hypothesized that naso-pancreatic duct suction could benefit for patients with severe biliary pancreatitis undergoing ERCP. So, the investigators designed this experiment to verify it.', 'detailedDescription': "This project intends to conduct treatment based on different interventions for enrolled subjects according to international and domestic standardized treatment procedures, including 1.ERCP stone extraction, duodenal papillary pressure measurement, bile duct pressure measurement, and nasal bile duct placement; 2.ERCP+ duodenal papillary pressure measurement, biliopancreatic duct pressure measurement + nasopancreatic duct + determine whether nasopancreatic duct negative pressure attraction.Compare the advantages of two different treatment methods.This paper attempts to explore new treatment methods that are more conducive to the rehabilitation of patients and provides an important preliminary research basis for the future clinical application of standardized treatment.\n\nPatients from the people's hospital of Wuhan university were recruited and selected into groups. The incidence, recurrence rate, operation time and hospital stay of the two independent samples will be compared."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAges 16 to 75. Apach-ii score of patients diagnosed with pancreatitis was greater than 8 points.\n\nLiver function can be damaged. Elevated indicators of pancreatitis (hematuria amylase, lipase). Identify patients with biliary tract infection or obstruction.\n\nExclusion Criteria:\n\nOlder than 75 or younger than 16. The duration of admission was more than 72 hours. Gastrointestinal obstruction endoscopy cannot be operated. Patients with duodenoscopy contraindications.'}, 'identificationModule': {'nctId': 'NCT04255095', 'briefTitle': 'Early Intervention of High Tension in the Pancreatic Duct on the Outcome of Severe Biliary Pancreatitis', 'organization': {'class': 'OTHER', 'fullName': 'Renmin Hospital of Wuhan University'}, 'officialTitle': 'Application of Negative Pressure Suction in Nasopancreatic Duct in Patients With Severe Biliary Pancreatitis', 'orgStudyIdInfo': {'id': 'ERCP-0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Nasobiliary drainage', 'interventionNames': ['Procedure: control']}, {'type': 'EXPERIMENTAL', 'label': 'Naso-pancreatic drainage(negative pressure)', 'interventionNames': ['Procedure: experiment']}], 'interventions': [{'name': 'experiment', 'type': 'PROCEDURE', 'otherNames': ['Naso-pancreatic duct negative pressure attraction'], 'description': 'Treatment was randomly selected according to preoperative grouping. After ERCP, naso-pancreatic drainage was chosen as treatment。', 'armGroupLabels': ['Naso-pancreatic drainage(negative pressure)']}, {'name': 'control', 'type': 'PROCEDURE', 'otherNames': ['naso-biliary drinage'], 'description': 'Treatment was randomly selected according to preoperative grouping. After ERCP, nasobiliary drainage was chosen as treatment。', 'armGroupLabels': ['Nasobiliary drainage']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430060', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qiong Gong, Doctor', 'role': 'CONTACT', 'email': 'gongq201919@163.com', 'phone': '+86 18086496360'}], 'facility': 'Renmin Hospital of Wuhan University', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Qiong Gong, Doctor', 'role': 'CONTACT', 'email': 'gongq2019@163.com', 'phone': '+8618086496360'}, {'name': "Z'hong'chao Zhu, Doctor", 'role': 'CONTACT', 'phone': '+8613995617151'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Renmin Hospital of Wuhan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}