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

Primary Purpose

Hepatic Metastases, Colorectal Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Routine hilar lymphadenectomy
Sponsored by
Heidelberg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatic Metastases focused on measuring resectable hepatic metastases of colorectal cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Gastrointestinal, Thoracic and Vascular Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Group A: No routine hilar lymphadenectomy

Group B: Routine hilar lymphadenectomy

Arm Description

Resection of colorectal liver metastases without routine hilar lymphadenectomy

Hilar lymphadenectomy is performed before actual resection of the colorectal liver metastases.

Outcomes

Primary Outcome Measures

rate of disease recurrence

Secondary Outcome Measures

Full Information

First Posted
February 22, 2010
Last Updated
October 26, 2017
Sponsor
Heidelberg University
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1. Study Identification

Unique Protocol Identification Number
NCT01073358
Brief Title
Resection of Colorectal Liver Metastases With or Without Routine Hilar Lymphadenectomy
Acronym
RELY
Official Title
Resection of Colorectal Liver Metastases With or Without Routine Hilar Lymphadenectomy - A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 9, 2010 (Actual)
Primary Completion Date
July 2019 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Heidelberg University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Metastases, Colorectal Cancer
Keywords
resectable hepatic metastases of colorectal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
166 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A: No routine hilar lymphadenectomy
Arm Type
No Intervention
Arm Description
Resection of colorectal liver metastases without routine hilar lymphadenectomy
Arm Title
Group B: Routine hilar lymphadenectomy
Arm Type
Experimental
Arm Description
Hilar lymphadenectomy is performed before actual resection of the colorectal liver metastases.
Intervention Type
Procedure
Intervention Name(s)
Routine hilar lymphadenectomy
Intervention Description
Hilar lymphadenectomy is performed before actual resection of the colorectal liver metastases
Primary Outcome Measure Information:
Title
rate of disease recurrence
Time Frame
2 years after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jürgen Weitz, MD, MSc
Organizational Affiliation
Department of Gastrointestinal, Thoracic and Vascular Surgery Dresden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Gastrointestinal, Thoracic and Vascular Surgery
City
Dresden
ZIP/Postal Code
01307
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

Resection of Colorectal Liver Metastases With or Without Routine Hilar Lymphadenectomy

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