Resection of Colorectal Liver Metastases With or Without... | NCT01073358

Studies
Resection of Colorectal Liver Metastases With or Without Routine Hilar Lymphadenectomy

NCT01073358

Sponsor

Heidelberg University

Status

Unknown status

Last Update Posted

Oct 27, 2017Actual

Enrollment

166Estimated

Phase

Not Applicable

Conditions

Hepatic Metastases
Colorectal Cancer

Interventions

Routine hilar lymphadenectomy

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 9, 2010Actual

Primary Completion Date

Jul 2019Estimated

Completion Date

Dec 2021Estimated

First Submitted Date

Feb 22, 2010

First Submission Date that Met QC Criteria

Feb 22, 2010

First Posted Date

Feb 23, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 26, 2017

Last Update Posted Date

Oct 27, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

166Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Routine hilar lymphadenectomy	Procedure	Hilar lymphadenectomy is performed before actual resection of the colorectal liver metastases	Group B: Routine hilar lymphadenectomy

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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jürgen Weitz, MD, MSc	Department of Gastrointestinal, Thoracic and Vascular Surgery Dresden	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Gastrointestinal, Thoracic and Vascular Surgery		Dresden		01307	Germany

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

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