Resection of Colorectal Liver Metastases With or Without Routine Hilar Lymphadenectomy (RELY)

Heidelberg University

Status: Unknown

Conditions: Hepatic Metastases; Colorectal Cancer

Treatments: Procedure: Routine hilar lymphadenectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01073358

NNR-5

Details and patient eligibility

About

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.

Full 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.

Enrollment: 166 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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166 participants in 2 patient groups

Group A: No routine hilar lymphadenectomy

No Intervention group

Description:

Resection of colorectal liver metastases without routine hilar lymphadenectomy

Group B: Routine hilar lymphadenectomy

Experimental group

Description:

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

Treatment:

Procedure: Routine hilar lymphadenectomy