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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:
Information provided by:
University of Heidelberg
ClinicalTrials.gov Identifier:
NCT01073358
First received: February 22, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Heidelberg:

Primary Outcome Measures:
  • rate of disease recurrence [ Time Frame: 2 years after surgery ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 166
Study Start Date: February 2010
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: September 2013 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01073358

Locations
Germany
Department of General, Visceral and Transplantation Surgery, University hospital Heidelberg
Heidelberg, Germany, 69120
Sponsors and Collaborators
University of Heidelberg
Investigators
Principal Investigator: Jürgen Weitz, MD, MSc Department of General, Visceral and Transplantation Surgery, University Hospital Heidelberg
  More Information

No publications provided

Responsible Party: Prof. Dr. Jürgen Weitz, Department of General, Visceral and Transplantation Surgery, University Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT01073358     History of Changes
Other Study ID Numbers: NNR-5
Study First Received: February 22, 2010
Last Updated: February 22, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by University of Heidelberg:
resectable hepatic metastases of colorectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
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

ClinicalTrials.gov processed this record on May 23, 2013