The Pancreatic Enzymes After Gastrectomy Trial

Launched by UNIVERSITY OF LEIPZIG · Sep 21, 2023

Keywords

ClinConnect Summary

The Pancreatic Enzymes After Gastrectomy Trial is a study looking at how a medication called NORTASE® affects patients who have had part or all of their stomach removed, a procedure known as gastrectomy. The researchers want to see if NORTASE® can improve quality of life and help with weight management compared to the usual care these patients receive. The trial is currently recruiting participants aged 18 and older, who have had a gastrectomy. However, certain individuals will not be eligible, such as those with specific pancreatic issues or severe nutritional problems.

If you join this study, you will be asked to take NORTASE® for a certain period while the researchers monitor your health and wellbeing. You'll also need to provide written consent to participate. This trial aims to gather important information that could help improve care for patients after gastrectomy, so your involvement could make a difference for others in the future.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. Gastrectomy (total and partial)
• • 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