Evaluating NORTASE® for patients after stomach surgery
The Pancreatic Enzymes After Gastrectomy Trial
This study tests if taking NORTASE®, an enzyme supplement, can help improve the quality of life and weight for patients after stomach surgery compared to standard care.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 188 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Leipzig Academic / other |
| Locations | 9 sites (Borna and 8 other locations) |
| Trial ID | NCT06058442 on ClinicalTrials.gov |
What this trial studies
This trial assesses the impact of NORTASE®, an enzyme supplement, on the quality of life and weight of patients who have undergone gastrectomy, compared to standard care. It aims to determine whether enzyme supplementation can improve post-operative outcomes in this patient population. Participants will be randomly assigned to receive either NORTASE® or a placebo, and their progress will be monitored throughout the study.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older who have undergone total or partial gastrectomy.
Not a fit: Patients with indications for pancreatic enzyme therapy or those with severe complications related to their condition may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the quality of life for patients recovering from gastrectomy by improving their digestive health.
How similar studies have performed: Previous studies have shown promising results with enzyme supplementation in similar patient populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Gastrectomy (total and partial); 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
Where this trial is running
Borna and 8 other locations
- Sana Kliniken Leipziger Land GmbH, Klinik für Allgemein-, Viszeral-, MIC- und Gefäßchirurgie / Thoraxchirurgie — Borna, Germany (Not_yet_recruiting)
- Carl-Thiem-Klinikum Cottbus gGmbH; 4. Medizinische Klinik — Cottbus, Germany (Recruiting)
- KEM | Evang. Kliniken Essen-Mitte gGmbH, Klinik für Internistische Onkologie — Essen, Germany (Not_yet_recruiting)
- UNIVERSITÄTSKLINIKUM FREIBURG Klinik für Allgemein- und Viszeralchirurgie Department Chirurgie — Freiburg im Breisgau, Germany (Recruiting)
- Universitätsklinikum Jena, Allgemein-, Viszeral- und Gefäßchirurgie — Jena, Germany (Recruiting)
- Klinik und Poliklinik für Onkologie, Gastroenterologie, Hepatologie und Pneumologie Universitätsklinikum Leipzig — Leipzig, Germany (Recruiting)
- Klinikum St. Georg, Abteilung für Allgemein-, Viszeral- und Onkologische Chirurgie — Leipzig, Germany (Recruiting)
- Helios Kliniken Schwerin; Klinik für Allgemein- und Viszeralchirurgie — Schwerin, Germany (Recruiting)
- Klinik für Allgemein- und Viszeralchirurgie, Universitätsklinikum Ulm — Ulm, Germany (Recruiting)
Study contacts
- Principal investigator: Albrecht Hoffmeister, Prof. Dr. — Universität Leipzig
- Study coordinator: Albrecht Hoffmeister, Prof. Dr.
- Email: Albrecht.Hoffmeister@medizin.uni-leipzig.de
- Phone: +4934197
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.