Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-29 @ 4:09 AM
Study NCT ID:
NCT05473260
Status:
UNKNOWN
Last Update Posted:
2023-04-25
First Post:
2022-07-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Home Monitoring Vs. Hospitalization for Mild Acute Pancreatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010195', 'term': 'Pancreatitis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 308}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2025-07-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-22', 'studyFirstSubmitDate': '2022-07-11', 'studyFirstSubmitQcDate': '2022-07-21', 'lastUpdatePostDateStruct': {'date': '2023-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '7-day (after randomization) treatment failure rate', 'timeFrame': '7 days', 'description': 'Treatment failure is defined as a VAS \\>3 and/or oral feeding intolerance (nausea, repeated vomiting episodes, early satiety).'}], 'secondaryOutcomes': [{'measure': 'Cumulative incidence of complications secondary to acute pancreatitis during the first 30 days after diagnosis', 'timeFrame': '30 days', 'description': 'Complications include, but are not limited to, abscess formation, pseudocysts, local necrosis, kidney failure, respiratory failure.'}, {'measure': 'Hospital readmission during the first 30 days after diagnosis', 'timeFrame': '30 days', 'description': 'Number of patients readmitted to the hospital during the first 30 days after diagnosis.'}, {'measure': 'Cumulative incidence of mortality during the first 30 days after diagnosis', 'timeFrame': '30 days', 'description': '30-day mortality'}, {'measure': 'Estimated costs of each intervention', 'timeFrame': '7 days'}, {'measure': 'Median (95%CI) Charlson Comorbidity Score per group', 'timeFrame': '7 days'}, {'measure': 'Median (95%CI) EuroQoL 5 Dimensions Quality of Life Score', 'timeFrame': '7 days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acute pancreatitis', 'mild pancreatitis', 'outpatient protocol'], 'conditions': ['Acute Pancreatitis']}, 'descriptionModule': {'briefSummary': 'Acute pancreatitis accounts for a large number of hospital admissions every year. Some studies have shown that early oral feeding protocols are safe, and one previous study suggests the possibility of home care for mild acute pancreatitis.', 'detailedDescription': 'Approximately 80% of all cases of acute pancreatitis are mild and only require supportive care for pain and nausea control and an adequate fluid replacement. Currently, all patients in our setting diagnosed with mild acute pancreatitis are admitted to a conventional hospitalization ward under the supervision of the Digestive and General Surgery Department or the Gastroenterology Department. Symptomatic treatment is administered, and abdominal ultrasound is performed to assess the cause of pancreatic inflammation. The remaining 20% fulfill the severity criteria from its onset onwards and require intensive care support.\n\nWe will conduct a multicenter randomized controlled clinical trial to compare two different approaches to mild non-alcoholic acute pancreatitis: hospital admission and outpatient management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'INCLUSION CRITERIA\n\nPatients diagnosed with mild acute pancreatitis based on at least two of the three following criteria:\n\n* Abdominal pain\n* Amylase or lipase 3x ULN (in blood/urine)\n* Imaging tests (Ultrasound/CT scan) suggestive of acute pancreatitis.\n\nAge ≥18 years and \\<80 years\n\nAbsence of potential pancreatitis-related severity criteria:\n\n* No evidence of SIRS in the emergency room\n* C-Reactive Protein levels \\<150mg/dL\n* Marked increase in the White Blood Cell Count\n* Absence of coagulopathy (INR \\<1.4)\n* Hematocrit \\< 44%\n* Creatinine \\< 170 µmol/L\n* BISAP score ≤2 at the time of randomization.\n\nPatients with good pain response to 12-hour supportive care in the ER (VAS \\<4) or adequate oral feeding tolerability.\n\nAbsence of local or systemic complications of acute pancreatitis on imaging tests.\n\nAdequate cognitive capacity and without any previous diagnose of psychiatric disease.\n\nPatients who meet each participating hospital home care criteria. Patients who give their written informed consent to participate.\n\nEXCLUSION CRITERIA\n\nPast medical history of pancreatic disease:\n\n* Known or newly diagnosed chronic pancreatitis (Wirsung dilation or pancreatic calcifications in previous imaging tests)\n* Patients with recurrent acute pancreatitis (\\>3 episodes/year) or an episode of acute pancreatitis \\<1 month ago.\n* Acute pancreatitis after endoscopic retrograde cholangiography.\n* Hyperbilirubinemia \\>3x ULN\n\nComorbidities that required previous hospitalization (myocardial infarction, liver cirrhosis, chronic kidney disease, or chronic lung disease).\n\nBMI ≥35 Kg/m2 Patients who refuse to participate in the study.'}, 'identificationModule': {'nctId': 'NCT05473260', 'acronym': 'RHINO', 'briefTitle': 'Home Monitoring Vs. Hospitalization for Mild Acute Pancreatitis', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitari de Bellvitge'}, 'officialTitle': 'Home Monitoring Vs. Hospitalization for Mild Acute Pancreatitis. A Pilot Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'RHINO-TRIAL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'HOSPI Group', 'description': 'Patients with mild acute pancreatitis randomized to in-hospital care.', 'interventionNames': ['Other: Control']}, {'type': 'EXPERIMENTAL', 'label': 'HOME Group', 'description': 'Patients with mild acute pancreatitis randomized to early discharge and outpatient clinic follow-up.', 'interventionNames': ['Other: Experimental']}], 'interventions': [{'name': 'Control', 'type': 'OTHER', 'otherNames': ['HOSPIT'], 'description': 'In-patient care.', 'armGroupLabels': ['HOSPI Group']}, {'name': 'Experimental', 'type': 'OTHER', 'otherNames': ['HOME'], 'description': 'Early discharge and outpatient follow-up.', 'armGroupLabels': ['HOME Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08907', 'city': "L'Hospitalet de Llobregat", 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Maria Sorribas, MD', 'role': 'CONTACT', 'email': 'sorribasgrifell@gmail.com'}], 'facility': 'Hospital Universitari de Bellvitge', 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}], 'centralContacts': [{'name': 'Juli Busquets, PhD', 'role': 'CONTACT', 'email': 'jbusquets@bellvitgehospital.cat', 'phone': '93 260 75 00'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitari de Bellvitge', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Digestive and General Surgeon', 'investigatorFullName': 'BUSQUETS, JULI', 'investigatorAffiliation': 'Hospital Universitari de Bellvitge'}}}}