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

Recruiting

• Conditions: K90.3; Pancreatic steatorrhoea

• Registration Number: DRKS00025409
• Lead Sponsor: Klinik für Allgemein-, Viszeral- und Thoraxchirurgie Universitätsklinikum Hamburg-Eppendorf 20246 Hamburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-08
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Incidence of newly developed postoperative organic EPI based on the quantitative determination of fecal elastase (pre- and postoperative determination of fecal elastase)<br>2. Incidence of newly developed postoperative functional EPI based on cardinal symptoms and further diagnostics (standardized questionnaire for assessment of symptoms)

Secondary Outcome Measures

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