The Pancreatic Enzymes After Gastrectomy Trial
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Gastrectomy
In brief
This trial evaluates the effects (e.g. on quality of life, weight) of NORTASE® compared to standard care of patients who have undergone gastrectomy.
Key facts
- Study ID
- NCT06058442
- Run by
- University of Leipzig
- People needed
- 188
- Starts
- 2024-01-24
- Expected to finish
- 2027-06-01
- Last updated by the study team
- 2026-01-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Gastrectomy (total and partial); at least > 50 % of the stomach must be resected
- Age 18 or older
- Written informed consent
You may not qualify if…
- 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
Where it is running
- Klinik für Allgemein- und Viszeralchirurgie, Universitätsklinikum Ulm — Ulm, Germany (enrolling)
- Carl-Thiem-Klinikum Cottbus gGmbH; 4. Medizinische Klinik — Cottbus, Germany (enrolling)
- Klinikum St. Georg, Abteilung für Allgemein-, Viszeral- und Onkologische Chirurgie — Leipzig, Germany (enrolling)
- Helios Kliniken Schwerin; Klinik für Allgemein- und Viszeralchirurgie — Schwerin, Germany (enrolling)
- UNIVERSITÄTSKLINIKUM FREIBURG Klinik für Allgemein- und Viszeralchirurgie Department Chirurgie — Freiburg im Breisgau, Germany (enrolling)
- Universitätsklinikum Jena, Allgemein-, Viszeral- und Gefäßchirurgie — Jena, Germany (enrolling)
- Klinik und Poliklinik für Onkologie, Gastroenterologie, Hepatologie und Pneumologie Universitätsklinikum Leipzig — Leipzig, Germany (enrolling)
- KEM | Evang. Kliniken Essen-Mitte gGmbH, Klinik für Internistische Onkologie — Essen, Germany
- Sana Kliniken Leipziger Land GmbH, Klinik für Allgemein-, Viszeral-, MIC- und Gefäßchirurgie / Thoraxchirurgie — Borna, Germany
Full record on ClinicalTrials.gov
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