Resection of Colorectal Liver Metastases With or Without Routine Hilar Lymphadenectomy

Resection of Colorectal Liver Metastases With or Without Routine Hilar Lymphadenectomy - A Randomized Controlled Trial

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01073358

Acronym

RELY

Enrollment

166

Registered

2010-02-23

Start date

2010-03-09

Completion date

2021-12-31

Last updated

2017-10-27

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

Conditions

Colorectal Cancer, Hepatic Metastases

Keywords

resectable hepatic metastases of colorectal cancer

Brief summary

It is uncertain, whether hilar lymphadenectomy should be performed routinely in patients undergoing resection of colorectal liver metastases. For this reason it is the aim of the present prospective randomized trial to evaluate, if routine lymphadenectomy reduces recurrent disease in patients undergoing resection of colorectal liver metastases.

Detailed description

Routine lymphadenectomy in patients undergoing hepatic resection for colorectal liver metastases may improve outcome of further patients due to the presence of micrometastases that have been shown to be of prognostic relevance. While previous studies highlight the clinical significance of perihepatic lymph node metastases, the outcome of patients with and without hilar lymphadenectomy has not yet been compared and thus no clear conclusion about the clinical value of routine hilar lymphadenectomy in CRC patients undergoing resection of liver metastases can be drawn from present data. As disease recurrence occurs frequently and may affect up to 75 % of patients, further strategies are required to improve postoperative outcome. Routine hilar lymphadenectomy may offer an effective approach to remove residual disease and by this to reduce disease recurrence with little additional morbidity. For this reason it is the aim of the present prospective randomized trial to evaluate, if routine lymphadenectomy reduces recurrent disease in patients undergoing resection of colorectal liver metastases.

Interventions

PROCEDURERoutine hilar lymphadenectomy

Hilar lymphadenectomy is performed before actual resection of the colorectal liver metastases

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients scheduled for curative (R0) resection * No evidence of extrahepatic disease * No history of previous hepatic lymphadenectomy * Age equal or greater than 18 years * Written Informed consent

Exclusion criteria

* Expected lack of compliance * Impaired mental state or language problems * History of another primary cancer, except: * Curatively treated in situ cervical cancer or curatively resected non-melanoma skin cancer * Other primary solid tumour curatively treated with no known active disease present and no treatment administered for ≥ 5 years prior to randomisation

Design outcomes

Primary

Measure	Time frame
rate of disease recurrence	2 years after surgery

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026