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Exocrine Pancreatic Insufficiency after pancreatic surgery - evaluation of pancreatic enzyme replacement therapy

Exocrine Pancreatic Insufficiency after pancreatic surgery - evaluation of pancreatic enzyme replacement therapy - EPI

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00025409
Enrollment
50
Registered
2021-06-08
Start date
2021-04-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

K90.3

Interventions

Group 1: All patients undergoing a partial pancreatectomy will be screened for an EPI to determine the postoperativ EPI-incidence. Group 2: In a second group of patients, already receiving PERT, the

Sponsors

Klinik für Allgemein-, Viszeral- und Thoraxchirurgie Universitätsklinikum Hamburg-Eppendorf 20246 Hamburg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - surgical procedure: partial pancreatectomy - status EPI preoperative: no EPI - individual patient characteristics: sufficient patient adherence to follow-up

Exclusion criteria

Exclusion criteria: Complicated post-operative course (prolonged stay in the intensive care unit and necessity of reoperation).

Design outcomes

Primary

MeasureTime frame
1. Incidence of newly developed postoperative organic EPI based on the quantitative determination of fecal elastase (pre- and postoperative determination of fecal elastase) 2. Incidence of newly developed postoperative functional EPI based on cardinal symptoms and further diagnostics (standardized questionnaire for assessment of symptoms)

Secondary

MeasureTime frame
1. Reduction in quality of life due to pancreatic enzymes replacement therapy (standardized questionnaire to assess willingness to pay) 2. Monetary cost of pancreatic enzyme replacement therapy (questionnaire to assess average daily doses of pancreatic enzymes, known cost of pancreatic enzyme capsules) 3. Monetary cost of EPI-screening (laboratory cost and postage price)

Countries

Germany

Contacts

Public ContactLouisa Stern

Klinik und Poliklinik für Allgemein-, Viszeral- und ThoraxchirurgieUniversitätsklinikum Hamburg-Eppendorf

l.stern@uke.de015222827349

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026