Resection of Colorectal Liver Metastases With or Without Routine Hilar Lymphadenectomy

Colorectal Cancer Clinical Trial

— RELY  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01073358
• Other study ID #: NNR-5
• Status: Enrolling by invitation
• Phase: N/A
• First received: February 22, 2010
• Last updated: October 26, 2017
• Start date: March 9, 2010
• Est. completion date: December 2021

Study information

• Verified date: October 2017
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 166
• Est. completion date: December 2021
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Hepatic Metastases
• Liver Neoplasms
• Neoplasm Metastasis
• Neoplasms, Second Primary

Intervention

Procedure:
• Routine hilar lymphadenectomy
Hilar lymphadenectomy is performed before actual resection of the colorectal liver metastases

Locations

Country	Name	City	State
Germany	Department of Gastrointestinal, Thoracic and Vascular Surgery	Dresden

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of disease recurrence		2 years after surgery