Incidence and Clinical Impact of Serum Hyperamylasemia (POH) After Pancreatectomy on Postoperative Outcome and Patient Safety (HYPPO)

February 2, 2026 updated by: Technische Universität Dresden

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Dresden, Germany, 01307
        • Recruiting
        • University Hospital Dresden, Dept. Visceral, Thoracic and Vascular Surgery
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

All patients undergoing a pancreatic resection

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
90 days after 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)
90 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between hyperamylasemia and rescue pancreatectomy after pancreatoduodenectomy
Time Frame: 90 days after surgery
Incidence of rescue pancreatectomy after pancreatoduodenectomy with postoperative hyperamylasemia
90 days after surgery
Correlation between hyperamylasemia and radiological findings for pancreatitis
Time Frame: 90 days after surgery
Incidence of pancreatitis according to the CT scan postoperatively
90 days after surgery
Incidence of postoperative mortality
Time Frame: 90 days after surgery
Postoperative death after complications
90 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technische Universität Dresden

Investigators

  • Principal Investigator: Marius Distler, Prof. Dr., University Hospital Dresden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 18, 2023

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

August 7, 2023

First Submitted That Met QC Criteria

November 8, 2023

First Posted (Actual)

November 13, 2023

Study Record Updates

Last Update Posted (Actual)

February 3, 2026

Last Update Submitted That Met QC Criteria

February 2, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VTG-14
  • DRKS00031860 (Other Identifier: German Clinical Trials Register)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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