Trials / Unknown
UnknownNCT02758977
Associating Liver Partition With Portal Vein Ligation for Staged Hepatectomy (ALPPS) vs. Two-Stage Hepatectomy (TSH) for Marginally Resectable Colorectal Liver Metastases (CRLM)
Associating Liver Partition With Portal Vein Ligation for Staged Hepatectomy (ALPPS) vs. Conventional Two-Stage Hepatectomy (TSH) for Surgical Treatment of Marginally Resectable Colorectal Liver Metastases (CRLM) - A Multicentric, Randomized Controlled Trial
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 214 (estimated)
- Sponsor
- University of Zurich · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2016-05-01
- Primary completion
- 2019-04-01
- First posted
- 2016-05-03
- Last updated
- 2016-05-03
Locations
1 site across 1 country: Switzerland
Source: ClinicalTrials.gov record NCT02758977. Inclusion in this directory is not an endorsement.