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Resection of Colorectal Liver Metastases With or Without Routine Hilar Lymphadenectomy

NCT ID: NCT01073358

Last Updated: 2017-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-09

Study Completion Date

2021-12-31

Brief Summary

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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

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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.

Conditions

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Hepatic Metastases Colorectal Cancer

Keywords

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resectable hepatic metastases of colorectal cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Group A: No routine hilar lymphadenectomy

Resection of colorectal liver metastases without routine hilar lymphadenectomy

Group Type NO_INTERVENTION

No interventions assigned to this group

Group B: Routine hilar lymphadenectomy

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

Group Type EXPERIMENTAL

Routine hilar lymphadenectomy

Intervention Type PROCEDURE

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

Interventions

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Routine hilar lymphadenectomy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heidelberg University

OTHER

Sponsor Role lead

Responsible Party

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Nuh Rahbari

PD MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jürgen Weitz, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Department of Gastrointestinal, Thoracic and Vascular Surgery Dresden

Locations

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Department of Gastrointestinal, Thoracic and Vascular Surgery

Dresden, , Germany

Site Status

Countries

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Germany

Other Identifiers

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NNR-5

Identifier Type: -

Identifier Source: org_study_id