Resection of Colorectal Liver Metastases With or Without Routine Hilar Lymphadenectomy (RELY)
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|ClinicalTrials.gov Identifier: NCT01073358|
Recruitment Status : Enrolling by invitation
First Posted : February 23, 2010
Last Update Posted : October 27, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Hepatic Metastases Colorectal Cancer||Procedure: Routine hilar lymphadenectomy||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||166 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Resection of Colorectal Liver Metastases With or Without Routine Hilar Lymphadenectomy - A Randomized Controlled Trial|
|Actual Study Start Date :||March 9, 2010|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||December 2021|
No Intervention: Group A: No routine hilar lymphadenectomy
Resection of colorectal liver metastases without routine hilar lymphadenectomy
Experimental: Group B: Routine hilar lymphadenectomy
Hilar lymphadenectomy is performed before actual resection of the colorectal liver metastases.
Procedure: Routine hilar lymphadenectomy
Hilar lymphadenectomy is performed before actual resection of the colorectal liver metastases
- rate of disease recurrence [ Time Frame: 2 years after surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01073358
|Department of Gastrointestinal, Thoracic and Vascular Surgery|
|Dresden, Germany, 01307|
|Principal Investigator:||Jürgen Weitz, MD, MSc||Department of Gastrointestinal, Thoracic and Vascular Surgery Dresden|