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The Pancreatic Enzymes After Gastrectomy Trial

RecruitingPhase 3Ages 18 Years - anyAllUniversity of Leipzig
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In plain words

What the trial is, and whether it could suit you

This trial evaluates the effects (e.g. on quality of life, weight) of NORTASE® compared to standard care of patients who have undergone gastrectomy.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Gastrectomy (total and partial distal); at least \> 50 % of the stomach must be resected 2. Age 18 or older 3. Written informed consent Exclusion Criteria: 1. Indication for pancreas enzyme therapy 2. Gastrectomy with palliative intention 3. UICC (Union for International Cancer Control) Stage IV gastric malignancy 4. Malnutrition of other aetiology 5. Life expectancy \< 12 months 6. Known lactose intolerance 7. Known hereditary galactose intolerance 8. Patients on alpha-glucosidase inhibitors (AGIs) 9. Acute pancreatitis 10. Acute episode of chronic pancreatitis 11. Known hypersensitivity to moulds (mould allergy) or any other ingredient of NORTASE® 12. Participation in competing interventional trials may be allowed under circumstances 13. Patients under legal supervision or guardianship 14. Patients who are dependent on the investigator or the medical staff of the trial team or the coordinating investigator or the sponsor 15. 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 16. Pregnant or nursing women 17. Suspected lack of compliance 18. Patients who were already enrolled in the trial
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What it tests

  • NORTASE®
  • Placebo
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Where

12 sites
Sana Kliniken Leipziger Land GmbH, Klinik für Allgemein-, Viszeral-, MIC- und Gefäßchirurgie / Thoraxchirurgie
Borna, Germany
Carl-Thiem-Klinikum Cottbus gGmbH; 4. Medizinische Klinik
Cottbus, Germany
KEM | Evang. Kliniken Essen-Mitte gGmbH, Klinik für Internistische Onkologie
Essen, Germany
UNIVERSITÄTSKLINIKUM FREIBURG Klinik für Allgemein- und Viszeralchirurgie Department Chirurgie
Freiburg im Breisgau, Germany
Klinik für Allgemein-, Viszeral- und Thoraxchirurgie; Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
Chirurgische Universitätsklinik, Universitätsklinikum Heidelberg
Heidelberg, Germany
Universitätsklinikum Jena, Allgemein-, Viszeral- und Gefäßchirurgie
Jena, Germany
Klinik und Poliklinik für Onkologie, Gastroenterologie, Hepatologie und Pneumologie Universitätsklinikum Leipzig
Leipzig, Germany

…and 4 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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