Recruiting NCT06058442

The Pancreatic Enzymes After Gastrectomy Trial

Phase III Interventional Gastrectomy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: NORTASE®, Placebo.
Who it may be relevant to: Registry conditions: Gastrectomy. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Germany
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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

Secondary outcome measures (12)

Gastrectomy (total and partial); at least > 50 % of the stomach must be resected
Age 18 or older
Written informed consent

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Germany · 9 centers

Sana Kliniken Leipziger Land GmbH, Klinik für Allgemein-, Viszeral-, MIC- und Gefäßchirurg — Borna
Carl-Thiem-Klinikum Cottbus gGmbH; 4. Medizinische Klinik — Cottbus
KEM | Evang. Kliniken Essen-Mitte gGmbH, Klinik für Internistische Onkologie — Essen
UNIVERSITÄTSKLINIKUM FREIBURG Klinik für Allgemein- und Viszeralchirurgie Department Chiru — Freiburg im Breisgau
Universitätsklinikum Jena, Allgemein-, Viszeral- und Gefäßchirurgie — Jena
Klinik und Poliklinik für Onkologie, Gastroenterologie, Hepatologie und Pneumologie Univer — Leipzig
Klinikum St. Georg, Abteilung für Allgemein-, Viszeral- und Onkologische Chirurgie — Leipzig
Helios Kliniken Schwerin; Klinik für Allgemein- und Viszeralchirurgie — Schwerin
… and 1 more center

NCT: NCT06058442 · PANEM