Modification of liver function and liver structure caused by parenteral nutritio

• Conditions: K91.2; Postsurgical malabsorption, not elsewhere classified

• Registration Number: DRKS00010993
• Lead Sponsor: Charité - Universitätsmedizin Berlin Chirurgische Klinik Campus Charité Mitte l Campus Virchow-Klinikum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-17
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Patients with intestinal failure receiving total parenteral nutrition
2. patients' age between 18 and 100 years
3. written informed consent

Exclusion Criteria

1. Patients with previous liver surgery (excluding cholecystectomy)
2. Patients with active cancer
3. Patients with underlying liver disease or systemic disease not related to PN with significant impact on liver function
4. Patients receiving medical treatment with significant impact on liver function (e.g. chemotherapy)

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary endpoint is to identify protective and adverse predictors of liver function by liver function assessment (LiMAx, ICG, FibroScan), nutritional status assessment (indirect calorimeter, BIA) and quality of life assessment (SF-36, SBS-QoL) based on one study visit in the cross-section and four study visits (inclusion, 6 months, 12 months, 24 months) in the longitudinal section.

Secondary Outcome Measures

Name	Time	Method
Establishment and validation of noninvasive liver function tests (LiMAx, ICG, FibroScan).