PancreatectomyHYPPONCT06126601
Incidence and Clinical Impact of Serum Hyperamylasemia (POH) After Pancreatectomy on Postoperative Outcome and Patient Safety
An observational study of Pancreatectomy and Hyperamylasemia, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
Recent evidence suggests that postoperative hyperamylasemia (POH) is a predictor of morbidity after pancreatectomy. This is based on the assumption that pancreatitis after pancreatectomy (PPAP) is a major trigger for the development of complications and is indicated by hyperamylasemia. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pancreatectomy, Hyperamylasemia, Pancreatitis, Acute
- What is being tested?
- Pancreatectomy
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- 18 Jul 2023to Mar 2027
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients undergoing a pancreatic resection
Who may be able to join
- All patients undergoing pancreatic resection for malignant and benign disease with or without pancreatic anastomosis
- Patients aged 18-85 years
- Willingness to participate as demonstrated by giving a written informed consent.
Who cannot join
- Necrosectomy (endoscopic or open) for primary acute pancreatitis or within laparotomy
- Age less than 18 years
- Surgical drainage procedures without pancreatic resection (cystojejunostomy for pancreatic pseudocysts)
- One-stage total pancreatectomy
- Missing written consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Dresden, Dept. Visceral, Thoracic and Vascular Surgery
Dresden, 01307
Olga Radulova-Mauersberger, Dr. med., studienzentrum-vtg@ukdd.de
About this study
Recent evidence suggests that postoperative hyperamylasemia (POH) is a predictor of morbidity after pancreatectomy. This is based on the assumption that pancreatitis after pancreatectomy (PPAP) is a major trigger for the development of complications and is indicated by hyperamylasemia. Standardized prospective analysis and correlation with other laboratory parameters, hasn't been performed to date.
Therefore the overall study aims are:
- To prospectively evaluate the incidence and assess the clinical value of biochemical changes for the postoperative course.
- To confirm and improve the definition and classification of postpancreatectomy acute pancreatitis (PPAP) of the International Study Group of Pancreatic Surgery (ISGPS) and to provide knowledge for effective early management of complications.
- Conditions
- Pancreatectomy, Hyperamylasemia, Pancreatitis, Acute
- Being tested
- Pancreatectomy
- Medical subject headings
- Hyperamylasemia, Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PancreatectomyOther
Patients who underwent pancreatectomy will be enrolled. Serum amylase and lipase will be measured preoperatively. During surgery, blood samples will be taken after completing the pancreatic anastomosis and at the end of the operation during skin suture. Patients will be followed up during hospital stay, 3 and 6 months after discharge. The clinical outcome (complications, rescue pancreatectomy) will be recorded and analysed.
Postoperative blood samples, according to clinical standard, will be taken at the 1, 2, 3, 5 and 7 day postoperatively. In addition to amylase several more parameters will be examined intra- and postoperatively: leucocytes, lipase, CRP, bilirubin, transaminases, AP, GGT, creatinine, interleukin-6, PCT. Intraoperative 1-2ml of pancreas juice will be taken for the evaluation of amylase and lipase levels.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of PPAP (Postpancreatectomy Acute Pancreatitis)
Incidence after pancreasresection (pancreatoduodenectomy and distal pancreas resection) according to the definition of ISGPS (International Study Group on Pancreatic Surgery)
Measured: 90 days after surgery
Significance of biochemical changes (postoperative hyperamylasemia and hyperlipasemia)
Correlation with postoperative complications according to the Clavien-Dindo classification and Comprehensive Complication Index ( CCI)
Measured: 90 days after surgery
Secondary outcomes (3)
Correlation between hyperamylasemia and rescue pancreatectomy after pancreatoduodenectomy
Incidence of rescue pancreatectomy after pancreatoduodenectomy with postoperative hyperamylasemia
Measured: 90 days after surgery
Correlation between hyperamylasemia and radiological findings for pancreatitis
Incidence of pancreatitis according to the CT scan postoperatively
Measured: 90 days after surgery
Incidence of postoperative mortality
Postoperative death after complications
Measured: 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start18 Jul 2023
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PancreatectomyStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marius Distler, Prof. Dr., Principal investigator, University Hospital Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06126601
- Sponsor's protocol ID
- VTG-14
- Other IDs
- DRKS00031860
- Acronym
- HYPPO
- Status last verified
- Aug 2026
- First submitted
- 7 Aug 2023
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Clinical Impact of Serum Hyperamylasemia (POH) After Pancreatectomy on Postoperative Outcome and Patient Safety
- ClinicalTrials.gov ID
- NCT06126601
- Acronym / sponsor ID
- HYPPO / VTG-14
- Conditions
- Pancreatectomy, Hyperamylasemia, Pancreatitis, Acute
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- 18 Jul 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 13 Nov 2023 (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.
Recent evidence suggests that postoperative hyperamylasemia (POH) is a predictor of morbidity after pancreatectomy. This is based on the assumption that pancreatitis after pancreatectomy (PPAP) is a major trigger for the development of complications and is indicated by hyperamylasemia. Standardized prospective analysis and correlation with other laboratory parameters, hasn't been performed to date.
Therefore the overall study aims are:
- To prospectively evaluate the incidence and assess the clinical value of biochemical changes for the postoperative course.
- To confirm and improve the definition and classification of postpancreatectomy acute pancreatitis (PPAP) of the International Study Group of Pancreatic Surgery (ISGPS) and to provide knowledge for effective early management of complications.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing a pancreatic resection
Key inclusion criteria (3 listed)
- All patients undergoing pancreatic resection for malignant and benign disease with or without pancreatic anastomosis
- Patients aged 18-85 years
- Willingness to participate as demonstrated by giving a written informed consent.
Key exclusion criteria (5 listed)
- Necrosectomy (endoscopic or open) for primary acute pancreatitis or within laparotomy
- Age less than 18 years
- Surgical drainage procedures without pancreatic resection (cystojejunostomy for pancreatic pseudocysts)
- One-stage total pancreatectomy
- Missing written consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PancreatectomyPatients who underwent pancreatectomy will be enrolled. Serum amylase and lipase will be measured preoperatively. During surgery, blood samples will be taken after completing the pancreatic anastomosis and at the end of the operation during skin suture. Patients will be followed up during hospital stay, 3 and 6 months after discharge. The clinical outcome (complications, rescue pancreatectomy) will be recorded and analysed. Postoperative blood samples, according to clinical standard, will be taken at the 1, 2, 3, 5 and 7 day postoperatively. In addition to amylase several more parameters will be examined intra- and postoperatively: leucocytes, lipase, CRP, bilirubin, transaminases, AP, GGT, creatinine, interleukin-6, PCT. Intraoperative 1-2ml of pancreas juice will be taken for the evaluation of amylase and lipase levels. | Other | – |
Primary outcome
Incidence of PPAP (Postpancreatectomy Acute Pancreatitis)
Time frame: 90 days after surgery
Incidence after pancreasresection (pancreatoduodenectomy and distal pancreas resection) according to the definition of ISGPS (International Study Group on Pancreatic Surgery)
Significance of biochemical changes (postoperative hyperamylasemia and hyperlipasemia)
Time frame: 90 days after surgery
Correlation with postoperative complications according to the Clavien-Dindo classification and Comprehensive Complication Index ( CCI)
3 secondary outcomes
Correlation between hyperamylasemia and rescue pancreatectomy after pancreatoduodenectomy
Time frame: 90 days after surgery
Correlation between hyperamylasemia and radiological findings for pancreatitis
Time frame: 90 days after surgery
Incidence of postoperative mortality
Time frame: 90 days after surgery
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 27 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Marius Distler, Prof. Dr. principal investigator
University Hospital Dresden
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 Pancreatectomy and Hyperamylasemia, run by Technische Universität Dresden at 1 site in Germany.
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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 27 Aug 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 Germany. 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?
Contact Olga Radulova-Mauersberger, Dr. med. (+49 351 458-0, studienzentrum-vtg@ukdd.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of PPAP (Postpancreatectomy Acute Pancreatitis) (time frame: 90 days after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Aug 2026.