Resection of Colorectal Liver Metastases With or Without Routine Hilar Lymphadenectomy

NCT01073358 | Unknown DMC

• 1 other identifier: NNR-5
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatic Metastases; Colorectal Cancer

Keywords

resectable hepatic metastases of colorectal cancer

Outcome Measures

Primary Outcomes (1)

• rate of disease recurrence

  2 years after surgery

Study Arms (2)

Group A: No routine hilar lymphadenectomy

NO INTERVENTION

Resection of colorectal liver metastases without routine hilar lymphadenectomy

Group B: Routine hilar lymphadenectomy

EXPERIMENTAL

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

Procedure: Routine hilar lymphadenectomy

Interventions

Routine hilar lymphadenectomy PROCEDURE

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

Group B: Routine hilar lymphadenectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Heidelberg University: lead

Study Sites (1)

Department of Gastrointestinal, Thoracic and Vascular Surgery

Dresden, 01307, Germany

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Jürgen Weitz, MD, MSc

  Department of Gastrointestinal, Thoracic and Vascular Surgery Dresden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD MD

Study Record Dates

• First Submitted: February 22, 2010
• First Posted: February 23, 2010
• Study Start: March 9, 2010
• Primary Completion: July 1, 2019
• Study Completion: December 1, 2021
• Last Updated: October 27, 2017

Record last verified: 2017-10

Locations

DE (1)