- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07443761
Patients Undergoing Pancreatic Surgery at the Antwerp University Hospital. (PANREG)
Pancreatic Surgery Registry (PANREG)
Study Overview
Status
Detailed Description
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.
There 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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
Antwerp
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Edegem, Antwerp, Belgium, 2650
- University Hospital Antwerp
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- benign indications for pancreatic surgery, including chronic pancreatitis, cystic lesions and IPMN
- malignant indications for pancreatic surgery, including PDAC, duodenal carcinoma, pancreatic neuro-endocrine tumours, distal cholangiocarcinoma.
Exclusion criteria:
- indications for pancreatic resection caused by acute pancreatitis
- pancreatic resection after abdominal trauma
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
90-day mortality
Time Frame: 25 years
|
90-day mortality
|
25 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Establishment of a registry for patients undergoing pancreatic surgery - secondary outcome measures
Time Frame: 25 years
|
|
25 years
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Ho CK, Kleeff J, Friess H, Buchler MW. Complications of pancreatic surgery. HPB (Oxford). 2005;7(2):99-108. doi: 10.1080/13651820510028936.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Pathologic Processes
- Neoplasms by Site
- Neoplasms
- Chronic Disease
- Disease Attributes
- Digestive System Neoplasms
- Digestive System Diseases
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Pathological Conditions, Signs and Symptoms
- Pancreatitis
- Pancreatic Neoplasms
- Pancreatitis, Chronic
Other Study ID Numbers
- 004516
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Full access to the dataset will be limited to the PI, co-PI and study coordinator.
Site 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.
IPD Sharing Time Frame
IPD Sharing Access Criteria
Full access to the dataset will be limited to the PI, co-PI and study coordinator.
Site 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.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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