Laparoscopic Split-PVE vs. PVE alone for Generation of Hypertrophy Before Major Liver Resection - A randomized controlled trial

Laparoscopic Split-PVE vs. PVE alone for Generation of Hypertrophy Before Major Liver Resection - A randomized controlled trial - LAS VEGAS

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00021607

Enrollment

Registered

2020-04-29

Start date

2020-07-27

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

C22

Interventions

Group 1: Split-PVE: Patients randomized to the experimental group will undergo laparoscopic partial in-situ split in a standardized approach. Partial transection of the parenchyma (~50-60%) will be ca

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Indication for major hepatectomy confirmed by multi-disciplinary tumor conference 2) Insufficient future liver remnant of total liver volume, defined as: - < 30% in patients with healthy liver parenchyma - < 40% in patients with diseased liver parenchyma (e.g. chemotherapy-associated steatohepatitis, non-alcoholic steatohepatitis, Child-A liver cirrhosis) 3) Age equal to or greater than 18 years 4) WHO/ECOG 0-2 5) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Child B or C liver cirrhosis 2) Portal vein thrombosis with complete luminal obstruction affecting the main trunk 3) Impaired mental state or language problems 4) Expected lack of compliance

Design outcomes

Primary

Measure	Time frame
The degree of contralateral hypertrophy at 10 days following PVE is the primary endpoint. The FLR volume will be calculated in percentage as following: FLR (ml) / total liver volume (ml) x 100 = FLR (%). The degree of contralateral liver lobe hypertrophy (DH) is defined as the relative increase in volume of the FLR after PVE in both study groups calculated as following: FLRpost-PVE – FLRpre- PVE.	—

Measure

Time frame

The degree of contralateral hypertrophy at 10 days following PVE is the primary endpoint. The FLR volume will be calculated in percentage as following: FLR (ml) / total liver volume (ml) x 100 = FLR (%). The degree of contralateral liver lobe hypertrophy (DH) is defined as the relative increase in volume of the FLR after PVE in both study groups calculated as following: FLRpost-PVE – FLRpre- PVE.

—

Secondary

Measure	Time frame
- Resectability rate - Postoperative morbidity and mortality - Timing of completion hepatic resection and delayed hepatic resection (days/weeks) - Disease-free and overall survival at 24 months - Differences in circulating biomarkers - Differences in tissue-related biomarkers - Patient-reported outcome	—

Countries

Germany

Contacts

Public ContactNuh N.;Emrullah Rahbari;Birgin

Universität Heidelberg, Medizinische Fakultät Mannheim, Chirurgische Klinik;Universität Heidelberg, Medizinische Fakultät Mannheim, Chirurgische Klinik

nuh.rahbari@umm.de;Emrullah.birgin@umm.de+49 621 383 3591;+49 621 383 2225

Outcome results

None listed

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