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Associating Liver Partition With Portal Vein Ligation for Staged Hepatectomy (ALPPS) vs. Two-Stage Hepatectomy (TSH) for Marginally Resectable Colorectal Liver Metastases (CRLM)

NCT02758977 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2016-05-03

No results posted yet for this study

Summary

Surgical resection has offered the best option for prolonged survival in patients with colorectal liver metastases. Limiting factor for major liver resections is the size of the future liver remnant (FLR). In case of normal liver function, 30% of the total liver volume is considered to be sufficient to maintain adequate liver function after resection. In an attempt to further increase "resectability" criteria for patients with too small FLR surgical and interventional maneuvers such as portal vein embolization and portal vein ligation in two-stage hepatectomies have been implemented, but they need an interval of 4-8 weeks to achieve sufficient hypertrophy. In order to obtain adequate but rapid parenchymal hypertrophy a new surgical two-step technique, ALPPS, was introduced for oncological patients requiring extended hepatic resection with limited functional reserve. Both procedures can be performed with acceptable morbidity and mortality.

The investigators conclude that it is time to perform a randomized study comparing the two surgical approaches in regard to oncological outcome.

Conditions

  • Colon Cancer Liver Metastases
  • Liver Neoplasms
  • Liver Diseases
  • Secondary Malignant Neoplasm of Liver
  • Malignant Neoplasm of Large Intestine Metastatic to Liver
  • Hepatectomy
  • Surgery

Interventions

PROCEDURE

ALPPS

For detailed information please refer to description of experimental arm

PROCEDURE

TWO STAGE HEPATECTOMY

For detailed information please refer to description of active comparator arm

Sponsors & Collaborators

  • University of Zurich

    lead OTHER

Principal Investigators

  • Pierre-Alain Clavien, MD, PhD · University of Zurich

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2019-04-30

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02758977 on ClinicalTrials.gov