Early Postoperative Liver Function Parameters as Predictors of Posthepatectomy Liver Failure

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00037463

Enrollment

400

Registered

2025-07-17

Start date

2025-05-20

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

K72

Interventions

Group 1: PHLF according to the ISGLS definition—i.e., clinically relevant changes in bilirubin and INR from POD 5 onwards—after elective liver resection were included. Changes in early postoperative l

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Elective liver resection

Exclusion criteria

Exclusion criteria: Emergency liver resections Multivisceral resections

Design outcomes

Primary

Measure	Time frame
The primary endpoint of the study is the occurrence of PHLF as defined by the International Study Group of Liver Surgery (ISGLS). PHLF is defined as a postoperative deterioration in the liver’s synthetic function, reflected by an increase in serum bilirubin and/or INR from postoperative day (POD) 5 onward, compared to previous postoperative values, and considered clinically relevant—i.e., associated with a change in clinical management (e.g., intensified monitoring, pharmacological treatment, or invasive interventions). The ISGLS further classifies PHLF into three grades: Grade A: PHLF without impact on clinical management Grade B: PHLF requiring deviation from the standard postoperative course but manageable without invasive treatment Grade C: PHLF requiring invasive treatment or intensive care management	—

Measure

Time frame

The primary endpoint of the study is the occurrence of PHLF as defined by the International Study Group of Liver Surgery (ISGLS). PHLF is defined as a postoperative deterioration in the liver’s synthetic function, reflected by an increase in serum bilirubin and/or INR from postoperative day (POD) 5 onward, compared to previous postoperative values, and considered clinically relevant—i.e., associated with a change in clinical management (e.g., intensified monitoring, pharmacological treatment, or invasive interventions). The ISGLS further classifies PHLF into three grades: Grade A: PHLF without impact on clinical management Grade B: PHLF requiring deviation from the standard postoperative course but manageable without invasive treatment Grade C: PHLF requiring invasive treatment or intensive care management

—

Secondary

Measure	Time frame
The following secondary endpoints were evaluated: 1. Predictive accuracy (AUC) of bilirubin, INR, AST, and ALT on POD 1–5 for the occurrence of PHLF 2. Optimal cut-off values for AST, ALT, bilirubin, and INR on POD 3 to predict PHLF 3. Trajectory analysis of transaminase levels (AST and ALT) and their association with PHLF 4. Comparison of AST vs. ALT in terms of predictive performance 5. Postoperative length of hospital stay 6. 90-day morbidity and mortality, defined according to Clavien-Dindo and standard definitions 7. Intraoperative blood loss (mL) 8. Operative time (minutes)	—

Measure

Time frame

The following secondary endpoints were evaluated: 1. Predictive accuracy (AUC) of bilirubin, INR, AST, and ALT on POD 1–5 for the occurrence of PHLF 2. Optimal cut-off values for AST, ALT, bilirubin, and INR on POD 3 to predict PHLF 3. Trajectory analysis of transaminase levels (AST and ALT) and their association with PHLF 4. Comparison of AST vs. ALT in terms of predictive performance 5. Postoperative length of hospital stay 6. 90-day morbidity and mortality, defined according to Clavien-Dindo and standard definitions 7. Intraoperative blood loss (mL) 8. Operative time (minutes)

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Countries

Germany

Contacts

Public ContactSchaima Abdelhadi

Medizinische Fakultät Mannheim, Universität Heidelberg, Universitätsmedizin Mannheim

schaima.abdelhadi@umm.de486213832225

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026