Resection of Colorectal Liver Metastases With or Without Routine Hilar Lymphadenectomy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hepatic Metastases, Colorectal Cancer

Intervention / Treatment
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* Procedure: Routine hilar lymphadenectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Group A: No routine hilar lymphadenectomy<br>Resection of colorectal liver metastases without routine hilar lymphadenectomy | |
| Experimental: Group B: Routine hilar lymphadenectomy<br>Hilar lymphadenectomy is performed before actual resection of the colorectal liver metastases. | Procedure: Routine hilar lymphadenectomy<br>* Hilar lymphadenectomy is performed before actual resection of the colorectal liver metastases<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of disease recurrence |  | 2 years after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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resectable hepatic metastases of colorectal cancer