Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 3:22 AM
Study NCT ID:
NCT07443761
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-03-02
First Post:
2026-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patients Undergoing Pancreatic Surgery at the Antwerp University Hospital.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D050500', 'term': 'Pancreatitis, Chronic'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D010195', 'term': 'Pancreatitis'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-11-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2050-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-26', 'studyFirstSubmitDate': '2026-01-15', 'studyFirstSubmitQcDate': '2026-02-26', 'lastUpdatePostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2050-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '90-day mortality', 'timeFrame': '25 years', 'description': '90-day mortality'}], 'secondaryOutcomes': [{'measure': 'Establishment of a registry for patients undergoing pancreatic surgery - secondary outcome measures', 'timeFrame': '25 years', 'description': '* 30-day mortality\n* morbidity, expressed as specific postpancreatectomy complications ( = defined by the ISPGS (International Study Group for Pancreatic Surgery), i.e. POPF (postoperative pancreatic fistula), chyle leak, PPH (postpancreatectomy haemorrhage), bile leak and delayed gastric emptying), postoperative complications defined by the Clavien Dindo scoring and the CCI (comprehensive complication index)\n* duration of hospital stay\n* need for postoperative transfusion\n* development of exocrine- or endocrine insufficiency (through systematic postoperative function testing)\n* overall survival\n* disease free survival'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['004516', 'benign pancreas tumor', 'malignant pancreatic neoplasm', 'pancreaticoduodenectomy', 'distal pancreatectomy', 'total pancreatectomy', 'central pancreatectomy', 'chronic pancreatitis'], 'conditions': ['Benign Pancreas Tumor', 'Malignant Pancreatic Neoplasm']}, 'referencesModule': {'references': [{'pmid': '39766142', 'type': 'BACKGROUND', 'citation': 'Hartman V, Bracke B, Chapelle T, Hendrikx B, Liekens E, Roeyen G. Robotic Pancreaticoduodenectomy for Pancreatic Head Tumour: A Single-Centre Analysis. Cancers (Basel). 2024 Dec 20;16(24):4243. doi: 10.3390/cancers16244243.'}, {'pmid': '18333171', 'type': 'BACKGROUND', 'citation': 'Ho CK, Kleeff J, Friess H, Buchler MW. Complications of pancreatic surgery. HPB (Oxford). 2005;7(2):99-108. doi: 10.1080/13651820510028936.'}, {'pmid': '38743040', 'type': 'BACKGROUND', 'citation': 'PancreasGroup.org Collaborative. Pancreatic surgery outcomes: multicentre prospective snapshot study in 67 countries. Br J Surg. 2024 Jan 3;111(1):znad330. doi: 10.1093/bjs/znad330.'}]}, 'descriptionModule': {'briefSummary': 'There is a need for a structured registry to collect real-world data on patient characteristics, surgical strategies, perioperative outcomes, and long-term results. Such a registry will provide insights into quality of care, support benchmarking, and form the basis for clinical and translational research.', 'detailedDescription': 'The objective of this study is to collect and register all clinical data on patients undergoing pancreatic surgery at Antwerp University Hospital. Data collection will include demographic information, medical history, preoperative workup, surgical details, postoperative outcomes, lab results, pathology results and long-term follow-up.\n\nThere is no intervention in this study; patient care will be done according to the current standard of care. The data will be used to further improve patient outcomes, identify risk factors for complications (both patient-specific and procedure-specific), investigate oncological outcomes and long-term patient survival, help predict exocrine and endocrine insufficiency, and identify patient populations in which specific screening for this is indicated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing pancreatic surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* benign indications for pancreatic surgery, including chronic pancreatitis, cystic lesions and IPMN\n* malignant indications for pancreatic surgery, including PDAC, duodenal carcinoma, pancreatic neuro-endocrine tumours, distal cholangiocarcinoma.\n\nExclusion criteria:\n\n* indications for pancreatic resection caused by acute pancreatitis\n* pancreatic resection after abdominal trauma'}, 'identificationModule': {'nctId': 'NCT07443761', 'acronym': 'PANREG', 'briefTitle': 'Patients Undergoing Pancreatic Surgery at the Antwerp University Hospital.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Antwerp'}, 'officialTitle': 'Pancreatic Surgery Registry (PANREG)', 'orgStudyIdInfo': {'id': '004516'}}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Edegem', 'state': 'Antwerp', 'country': 'Belgium', 'facility': 'University Hospital Antwerp', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'IPD would be available depending on the study...', 'ipdSharing': 'YES', 'description': 'Full access to the dataset will be limited to the PI, co-PI and study coordinator.\n\nSite investigators may access the full dataset upon formal request, subject to approval by the steering group. Requests must include a description of their research plans for consideration.', 'accessCriteria': 'Full access to the dataset will be limited to the PI, co-PI and study coordinator.\n\nSite investigators may access the full dataset upon formal request, subject to approval by the steering group. Requests must include a description of their research plans for consideration.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Antwerp', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}