The Pancreatic Enzymes After Gastrectomy Trial

Gastrectomy Clinical Trial

Official title:

The Pancreatic Enzymes After Gastrectomy Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06058442
• Other study ID #: PANEM
• Status: Recruiting
• Phase: Phase 3
• Start date: January 24, 2024
• Est. completion date: April 2026

Study information

• Verified date: March 2024
• Source: University of Leipzig
• Contact: Albrecht Hoffmeister, Prof. Dr.
• Phone: 004934197
• Email: Albrecht.Hoffmeister[@]medizin.uni-leipzig.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 188
• Est. completion date: April 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastrectomy

Intervention

Drug:
• NORTASE®
10-15 capsules of NORTASE® per day - over 6 months
• Placebo
10-15 capsules of placebo per day - over 6 months

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
University of Leipzig

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Faecal elastase-1	Concentration of faecal elastase-1	6 months
Primary	Disease specific quality of life (QOL)	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).	6 months
Secondary	Nutritional supplementation or weight loss	Proportion of patients who receive supplemental nutrition after the run-in period of 3 weeks or have > 10% weight loss at six months	6 months
Secondary	Weight	Percent weight-change at six months (weight in kilograms)	6 months
Secondary	Serum haemoglobin	Concentration of serum haemoglobin	6 months
Secondary	Total protein	Concentration of total protein	6 months
Secondary	Albumin	Concentration of albumin	6 months
Secondary	Glucose	Concentration of glucose	6 months
Secondary	HbA1c	Concentration of HbA1c	6 months
Secondary	Cholesterol	Concentration of cholesterol	6 months
Secondary	Vitamin A	Concentration of vitamin A	6 months
Secondary	Vitamin B12	Concentration of vitamin B12	6 months
Secondary	Vitamin D	Concentration of vitamin D	6 months
Secondary	Vitamin E	Concentration of vitamin E	6 months
Secondary	Vitamin K	Concentration of vitamin K	6 months