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Resection of Colorectal Liver Metastases With or Without Routine Hilar Lymphadenectomy (RELY)

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01073358
First Posted: February 23, 2010
Last Update Posted: October 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nuh Rahbari, University Hospital Carl Gustav Carus
  Purpose

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 Intervention
Hepatic Metastases Colorectal Cancer Procedure: Routine hilar lymphadenectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Resection of Colorectal Liver Metastases With or Without Routine Hilar Lymphadenectomy - A Randomized Controlled Trial

Further study details as provided by Nuh Rahbari, University Hospital Carl Gustav Carus:

Primary Outcome Measures:
  • rate of disease recurrence [ Time Frame: 2 years after surgery ]

Estimated Enrollment: 166
Actual Study Start Date: March 9, 2010
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: July 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Germany
Department of Gastrointestinal, Thoracic and Vascular Surgery
Dresden, Germany, 01307
Sponsors and Collaborators
Heidelberg University
Investigators
Principal Investigator: Jürgen Weitz, MD, MSc Department of Gastrointestinal, Thoracic and Vascular Surgery Dresden
  More Information

Responsible Party: Nuh Rahbari, PD MD, University Hospital Carl Gustav Carus
ClinicalTrials.gov Identifier: NCT01073358     History of Changes
Other Study ID Numbers: NNR-5
First Submitted: February 22, 2010
First Posted: February 23, 2010
Last Update Posted: October 27, 2017
Last Verified: October 2017

Keywords provided by Nuh Rahbari, University Hospital Carl Gustav Carus:
resectable hepatic metastases of colorectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Liver Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Liver Diseases