Resection of Colorectal Liver Metastases With or Without Routine Hilar Lymphadenectomy

Not Applicable

• Conditions: Hepatic Metastases; Colorectal Cancer
• Interventions: Procedure: Routine hilar lymphadenectomy

• Registration Number: NCT01073358
• Lead Sponsor: Heidelberg University

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.

Study Timeline

• Study First Submitted: 2010-02-22
• Study First Submitted QC: 2010-02-22
• Study First Posted: 2010-02-23
• Study Start: 2010-03-09
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-26
• Last Update Posted: 2017-10-27
• Primary Completion: 2019-07
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 166

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B: Routine hilar lymphadenectomy	Routine hilar lymphadenectomy	Hilar lymphadenectomy is performed before actual resection of the colorectal liver metastases.

Primary Outcome Measures

Name	Time	Method
rate of disease recurrence	2 years after surgery

Trial Locations

Locations (1)

Department of Gastrointestinal, Thoracic and Vascular Surgery; 🇩🇪 Dresden, Germany