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

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

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.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer; Hepatic Metastases
• Intervention / Treatment: Procedure: Routine hilar lymphadenectomy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 166
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Dresden, Germany, 01307
    • Department of Gastrointestinal, Thoracic and Vascular Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
rate of disease recurrence	2 years after surgery

Collaborators and Investigators

• Sponsor: Heidelberg University
• Investigators: Principal Investigator: Jürgen Weitz, MD, MSc, Department of Gastrointestinal, Thoracic and Vascular Surgery Dresden

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2010
• Primary Completion (Anticipated): July 1, 2019
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: February 22, 2010
• First Submitted That Met QC Criteria: February 22, 2010
• First Posted (Estimate): February 23, 2010

Study Record Updates

• Last Update Posted (Actual): October 27, 2017
• Last Update Submitted That Met QC Criteria: October 26, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: resectable hepatic metastases of colorectal cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplastic Processes; Colorectal Neoplasms; Neoplasm Metastasis
• Other Study ID Numbers: NNR-5