Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06058442

The Pancreatic Enzymes After Gastrectomy Trial

Led by University of Leipzig · Updated on 2026-01-22

188

Participants Needed

9

Research Sites

174 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

The Pancreatic Enzymes After Gastrectomy Trial

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Gastrectomy (total or partial) with at least > 50% of the stomach removed
  • Age 18 years or older
  • Written informed consent provided
Not Eligible

You will not qualify if you...

  • Indication for pancreas enzyme therapy
  • Gastrectomy performed with palliative intent
  • UICC Stage IV gastric cancer
  • Malnutrition from other causes
  • Life expectancy less than 12 months
  • Known lactose intolerance
  • Known hereditary galactose intolerance
  • Use of alpha-glucosidase inhibitors
  • Acute pancreatitis or acute episode of chronic pancreatitis
  • Known allergy to molds or any ingredient of NORTASE4
  • Participation in competing interventional trials under certain conditions
  • Under legal supervision or guardianship
  • Dependency on trial investigators or staff
  • Fertile women within two years of last menstruation without appropriate contraception
  • Pregnant or nursing women
  • Suspected non-compliance
  • Previous enrollment in this trial

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 9 locations

1

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

Borna, Germany

Not Yet Recruiting

2

Carl-Thiem-Klinikum Cottbus gGmbH; 4. Medizinische Klinik

Cottbus, Germany, 03048

Actively Recruiting

3

KEM | Evang. Kliniken Essen-Mitte gGmbH, Klinik für Internistische Onkologie

Essen, Germany

Not Yet Recruiting

4

UNIVERSITÄTSKLINIKUM FREIBURG Klinik für Allgemein- und Viszeralchirurgie Department Chirurgie

Freiburg im Breisgau, Germany, 79106

Actively Recruiting

5

Universitätsklinikum Jena, Allgemein-, Viszeral- und Gefäßchirurgie

Jena, Germany, 07740

Actively Recruiting

6

Klinik und Poliklinik für Onkologie, Gastroenterologie, Hepatologie und Pneumologie Universitätsklinikum Leipzig

Leipzig, Germany, 04103

Actively Recruiting

7

Klinikum St. Georg, Abteilung für Allgemein-, Viszeral- und Onkologische Chirurgie

Leipzig, Germany

Actively Recruiting

8

Helios Kliniken Schwerin; Klinik für Allgemein- und Viszeralchirurgie

Schwerin, Germany, 19055

Actively Recruiting

9

Klinik für Allgemein- und Viszeralchirurgie, Universitätsklinikum Ulm

Ulm, Germany

Actively Recruiting

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Research Team

A

Albrecht Hoffmeister, Prof. Dr.

CONTACT

A

Anett Schmiedeknecht, Dr.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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