Clinical trial NCT01073358: Resection of Colorectal Liver Metastases With or Without Routine Hilar Lymphadenectomy
Official title: Resection of Colorectal Liver Metastases With or Without Routine Hilar Lymphadenectomy - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatic Metastases
Colorectal Cancer
Keywords: resectable hepatic metastases of colorectal cancer
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2010-02-23
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: rate of disease recurrence
timeFrame: 2 years after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Department of Gastrointestinal, Thoracic and Vascular Surgery
Study officials:
affiliation: Department of Gastrointestinal, Thoracic and Vascular Surgery Dresden
name: Jürgen Weitz, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: