Benign Pancreas TumorPANREGNCT07443761
Patients Undergoing Pancreatic Surgery at the Antwerp University Hospital.
An observational study of Benign Pancreas Tumor and Malignant Pancreatic Neoplasm, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Benign Pancreas Tumor, Malignant Pancreatic Neoplasm
- How many people
- 2,000 participants
- Where
- 1 siteBelgium
- Study dates
- 19 Nov 2025to 1 Jan 2050
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing pancreatic surgery
Who may be able to join
- 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.
Who cannot join
- indications for pancreatic resection caused by acute pancreatitis
- pancreatic resection after abdominal trauma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pancreatic Surgery Registry (PANREG)
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.
Read the 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.
- Keywords
- 004516, benign pancreas tumor, malignant pancreatic neoplasm, pancreaticoduodenectomy, distal pancreatectomy, total pancreatectomy, central pancreatectomy, chronic pancreatitis
- Medical subject headings
- Pancreatic Neoplasms, Pancreatitis, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
90-day mortality
90-day mortality
Measured: 25 years
Secondary outcomes (1)
Establishment of a registry for patients undergoing pancreatic surgery - secondary outcome measures
- 30-day mortality
- 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)
- duration of hospital stay
- need for postoperative transfusion
- development of exocrine- or endocrine insufficiency (through systematic postoperative function testing)
- overall survival
- disease free survival
Measured: 25 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start19 Nov 2025
- Primary completion1 Jan 2050 (estimated)
- Study completion1 Jan 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Benign Pancreas TumorStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07443761
- Sponsor's protocol ID
- 004516
- Acronym
- PANREG
- Status last verified
- Jan 2026
- First submitted
- 15 Jan 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 39766142Ho CK, Kleeff J, Friess H, Buchler MW. Complications of pancreatic surgery. HPB (Oxford). 2005;7(2):99-108. doi: 10.1080/13651820510028936.
PubMed 18333171PancreasGroup.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.
PubMed 38743040
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pancreatic Surgery Registry (PANREG)
- ClinicalTrials.gov ID
- NCT07443761
- Acronym / sponsor ID
- PANREG / 004516
- Keywords
- 004516, benign pancreas tumor, malignant pancreatic neoplasm, pancreaticoduodenectomy, distal pancreatectomy, total pancreatectomy, central pancreatectomy, chronic pancreatitis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- 19 Nov 2025 (actual)
- Primary completion
- 1 Jan 2050 (estimated)
- Study completion
- 1 Jan 2050 (estimated)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing pancreatic surgery
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- indications for pancreatic resection caused by acute pancreatitis
- pancreatic resection after abdominal trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
90-day mortality
Time frame: 25 years
90-day mortality
1 secondary outcome
Establishment of a registry for patients undergoing pancreatic surgery - secondary outcome measures
Time frame: 25 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Background: PubMed 39766142Hartman 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.
- Background: PubMed 18333171Ho CK, Kleeff J, Friess H, Buchler MW. Complications of pancreatic surgery. HPB (Oxford). 2005;7(2):99-108. doi: 10.1080/13651820510028936.
- Background: PubMed 38743040PancreasGroup.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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Pancreas Tumor and Malignant Pancreatic Neoplasm, run by University Hospital, Antwerp at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
90-day mortality (time frame: 25 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07443761, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.