Clinical trial NCT06058442: The Pancreatic Enzymes After Gastrectomy Trial
Official title: The Pancreatic Enzymes After Gastrectomy Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Gastrectomy
Keywords: enzyme supplementation
lipase
elastase
gastrointestinal
quality of life
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Disease specific quality of life (QOL)
timeFrame: 6 months
Secondary outcomes:
measure: Nutritional supplementation or weight loss
timeFrame: 6 months
measure: Weight
timeFrame: 6 months
measure: Serum haemoglobin
timeFrame: 6 months
measure: Total protein
timeFrame: 6 months
measure: Albumin
timeFrame: 6 months
measure: Glucose
timeFrame: 6 months
measure: HbA1c
timeFrame: 6 months
measure: Cholesterol
timeFrame: 6 months
measure: Vitamin A
timeFrame: 6 months
measure: Vitamin B12
timeFrame: 6 months
measure: Vitamin D
timeFrame: 6 months
measure: Vitamin E
timeFrame: 6 months
measure: Vitamin K
timeFrame: 6 months
Other outcomes:
measure: Faecal elastase-1
timeFrame: 6 months
Locations:
city: Cottbus
country: Germany
facility: Carl-Thiem-Klinikum Cottbus gGmbH; 4. Medizinische Klinik
city: Dresden
country: Germany
facility: Klinik und Poliklinik für Viszeral-, Thorax- und Gefäßchirurgie Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
city: Freiburg
country: Germany
facility: UNIVERSITÄTSKLINIKUM FREIBURG Klinik für Allgemein- und Viszeralchirurgie Department Chirurgie
city: Jena
country: Germany
facility: Universitätsklinikum Jena, Allgemein-, Viszeral- und Gefäßchirurgie
city: Leipzig
country: Germany
facility: Klinik und Poliklinik für Onkologie, Gastroenterologie, Hepatologie und Pneumologie Universitätsklinikum Leipzig
city: Leipzig
country: Germany
facility: Klinikum St. Georg, Abteilung für Allgemein-, Viszeral- und Onkologische Chirurgie
city: Schwerin
country: Germany
facility: Helios Kliniken Schwerin; Klinik für Allgemein- und Viszeralchirurgie
Study officials:
affiliation: Universität Leipzig
name: Albrecht Hoffmeister, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: