The Pancreatic Enzymes After Gastrectomy Trial

Phase 3

Recruiting

• Conditions: Gastrectomy
• Interventions: Drug: NORTASE®; Drug: Placebo

• Registration Number: NCT06058442
• Lead Sponsor: University of Leipzig

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-08
• Study First Submitted QC: 2023-09-21
• Study First Posted: 2023-09-28
• Study Start: 2024-01-24
• Status Verified: 2024-03
• Last Update Submitted: 2024-10-28
• Last Update Posted: 2024-10-30
• Primary Completion: 2026-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 188

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NORTASE®	NORTASE®	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Disease specific quality of life (QOL)	6 months	This is the physical sub-score from the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC-QLQ-C30) and ranges from 0 (lowest physical functioning) to 100 (highest physical functioning).

Secondary Outcome Measures

Name	Time	Method
HbA1c	6 months	Concentration of HbA1c
Vitamin B12	6 months	Concentration of vitamin B12
Albumin	6 months	Concentration of albumin
Glucose	6 months	Concentration of glucose
Serum haemoglobin	6 months	Concentration of serum haemoglobin
Cholesterol	6 months	Concentration of cholesterol
Nutritional supplementation or weight loss	6 months	Proportion of patients who receive supplemental nutrition after the run-in period of 3 weeks or have \> 10% weight loss at six months
Weight	6 months	Percent weight-change at six months (weight in kilograms)
Vitamin A	6 months	Concentration of vitamin A
Vitamin D	6 months	Concentration of vitamin D
Vitamin E	6 months	Concentration of vitamin E
Total protein	6 months	Concentration of total protein
Vitamin K	6 months	Concentration of vitamin K

Trial Locations

Locations (6)

UNIVERSITÄTSKLINIKUM FREIBURG Klinik für Allgemein- und Viszeralchirurgie Department Chirurgie; 🇩🇪 Freiburg, Germany

Klinikum St. Georg, Abteilung für Allgemein-, Viszeral- und Onkologische Chirurgie; 🇩🇪 Leipzig, Germany

Carl-Thiem-Klinikum Cottbus gGmbH; 4. Medizinische Klinik; 🇩🇪 Cottbus, Germany

Klinik und Poliklinik für Viszeral-, Thorax- und Gefäßchirurgie Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden; 🇩🇪 Dresden, Germany

Universitätsklinikum Jena, Allgemein-, Viszeral- und Gefäßchirurgie; 🇩🇪 Jena, Germany

Klinik und Poliklinik für Onkologie, Gastroenterologie, Hepatologie und Pneumologie Universitätsklinikum Leipzig; 🇩🇪 Leipzig, Germany