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RELY-Resection of colorectal liver metastases with or without routine hilar lymphadenectomy - A Randomized Controlled Trial

Effect of resection of colorectal liver metastases with or without routine hilar lymphadenectomy on disease recurrence within 2 years

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614001195640
Acronym
RELY study
Enrollment
180
Registered
2014-11-13
Start date
2014-09-16
Completion date
2018-03-14
Last updated
2026-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This trial is designed to show that routine hilar lymphadenectomy compared to no routine lymphadenectomy improves the rate of disease recurrence within 2 years after surgery in patients undergoing resection of CRC liver metastases

Interventions

Group A: Resection of colorectal liver metastases without routine hilar lymphadenectomy. However, patients with macroscopically enlarged lymph nodes undergo lymphadenectomy in accordance with current guidelines at the Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus Dresden. These patients will be analyzed in the intention-to-treat population. Group B: Routine hilar lymphadenectomy First, exploration of the abdomen and intraoperative ultrasound are p

Group A: Resection of colorectal liver metastases without routine hilar lymphadenectomy. However, patients with macroscopically enlarged lymph nodes undergo lymphadenectomy in accordance with current guidelines at the Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus Dresden. These patients will be analyzed in the intention-to-treat population. Group B: Routine hilar lymphadenectomy First, exploration of the abdomen and intraoperative ultrasound are performed to assess the extent of intrahepatic and potential extrahepatic disease and to confirm resectability. Hilar lymphadenectomy is performed before actual resection of the colorectal liver metastases. Following cholecystectomy in a fundus-first fashion, hilar lymphadenectomy is carried out including defined groups of lymph nodes (nomenclature of the lymph nodes according to the Japanese classification of gastric cancer). The groups of lymph nodes at the following sites will be resected : Common hepatic artery, Coeliac trunk, duodenal ligament, hepatic artery, Hepatoduodenal ligament, portal vein/bile duct. The duration of each procedure is approximately 200 minutes

Sponsors

Juergen Weitz, MD, MSc
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients scheduled for resection of colorectal cancer liver metastases. Patients undergoing simultanous resection of the primary tumor together with liver metastases may also be enrolled in the trial Patients scheduled for curative (R0) resection No evidence of extrahepatic disease No history of previous hilar 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 up to 5 years prior to randomisation

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026