Status:
RECRUITING
The Pancreatic Enzymes After Gastrectomy Trial
Lead Sponsor:
University of Leipzig
Conditions:
Gastrectomy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This trial evaluates the effects (e.g. on quality of life, weight) of NORTASE® compared to standard care of patients who have undergone gastrectomy.
Eligibility Criteria
Inclusion
- Gastrectomy (total and partial)
- Age 18 or older
- Written informed consent
Exclusion
- Indication for pancreas enzyme therapy
- Gastrectomy with palliative intention
- UICC (Union for International Cancer Control) Stage IV gastric malignancy
- Malnutrition of other aetiology
- Life expectancy \< 12 months
- Known lactose intolerance
- Known hereditary galactose intolerance
- Patients on alpha-glucosidase inhibitors (AGIs)
- Acute pancreatitis
- Acute episode of chronic pancreatitis
- Known hypersensitivity to moulds (mould allergy) or any other ingredient of NORTASE®
- Participation in competing interventional trials may be allowed under circumstances
- Patients under legal supervision or guardianship
- Patients who are dependent on the investigator or the medical staff of the trial team or the coordinating investigator or the sponsor
- Fertile women (within two years of their last menstruation) without appropriate contraceptive measures (implanon, injections, oral contraceptives, intrauterine devices, partner with vasectomy) while participating in the trial
- Pregnant or nursing women
- Suspected lack of compliance
- Patients who were already enrolled in the trial
Key Trial Info
Start Date :
January 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT06058442
Start Date
January 24 2024
End Date
April 1 2026
Last Update
May 31 2025
Active Locations (7)
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1
Carl-Thiem-Klinikum Cottbus gGmbH; 4. Medizinische Klinik
Cottbus, Germany, 03048
2
Klinik und Poliklinik für Viszeral-, Thorax- und Gefäßchirurgie Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
Dresden, Germany, 01307
3
UNIVERSITÄTSKLINIKUM FREIBURG Klinik für Allgemein- und Viszeralchirurgie Department Chirurgie
Freiburg im Breisgau, Germany, 79106
4
Universitätsklinikum Jena, Allgemein-, Viszeral- und Gefäßchirurgie
Jena, Germany, 07740