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Recruiting

NCT Number: NCT06058442

The Pancreatic Enzymes After Gastrectomy Trial

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

Recruiting

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sana Kliniken Leipziger Land GmbH, Klinik für Allgemein-, Viszeral-, MIC- und Gefäßchirurgie / Thoraxchirurgie, Borna, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

NORTASE®

Drug

10-15 capsules of NORTASE® per day - over 6 months

Placebo

Drug

10-15 capsules of placebo per day - over 6 months

Primary outcomes

  1. Disease specific quality of life (QOL)

    Time frame: 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 outcomes

  1. Nutritional supplementation or weight loss

    Time frame: 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

  2. Weight

    Time frame: 6 months

    Percent weight-change at six months (weight in kilograms)

  3. Serum haemoglobin

    Time frame: 6 months

    Concentration of serum haemoglobin

  4. Total protein

    Time frame: 6 months

    Concentration of total protein

  5. Albumin

    Time frame: 6 months

    Concentration of albumin

  6. Glucose

    Time frame: 6 months

    Concentration of glucose

  7. HbA1c

    Time frame: 6 months

    Concentration of HbA1c

  8. Cholesterol

    Time frame: 6 months

    Concentration of cholesterol

  9. Vitamin A

    Time frame: 6 months

    Concentration of vitamin A

  10. Vitamin B12

    Time frame: 6 months

    Concentration of vitamin B12

  11. Vitamin D

    Time frame: 6 months

    Concentration of vitamin D

  12. Vitamin E

    Time frame: 6 months

    Concentration of vitamin E

  13. Vitamin K

    Time frame: 6 months

    Concentration of vitamin K

Other outcomes

  1. Faecal elastase-1

    Time frame: 6 months

    Concentration of faecal elastase-1

Study contacts

Contact information is provided by the study sponsor or research team.

Albrecht Hoffmeister, Prof. Dr.

CONTACT

[email protected]

+4934197 ext. 12240

Anett Schmiedeknecht, Dr.

CONTACT

[email protected]

+49 34197 ext. 16256

Sponsors and collaborators

Lead sponsor

University of Leipzig

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Sep 28, 2023
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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