Minimally Invasive Liver Surgery for Metastases From Colo... | NCT01356706

Studies
Minimally Invasive Liver Surgery for Metastases From Colorectal Cancer: Oncologic Outcome and Prognostic Factors

NCT01356706

Sponsor

University Hospital, Gasthuisberg

Status

Completed

Last Update Posted

Jul 3, 2012Estimated

Enrollment

274Actual

Phase

Not provided

Conditions

Long-term Oncologic Outcome of MILS in Patients With CRLM and Prognostic Indicators

Interventions

Not provided

Countries

Belgium

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

Jul 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2002

Primary Completion Date

Dec 2008Actual

Completion Date

Jul 2012Actual

First Submitted Date

May 17, 2011

First Submission Date that Met QC Criteria

May 17, 2011

First Posted Date

May 19, 2011Estimated

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

Jul 1, 2012

Last Update Posted Date

Jul 3, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Baki Topal, Professor of Surgery, University Hospital, GasthuisbergPrincipal Investigator

Lead Sponsor

University Hospital, GasthuisbergOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

Only few reports exist on long-term survival after minimally invasive liver surgery (MILS for colorectal liver metastases. No data are available assessing prognostic factors in the era of current modern treatment strategies. The aim of the current study is to analyze the long-term oncologic outcome after MILS for metastases from colorectal cancer and determine prognostic indicators.

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

274Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CRLM		patients with colorectal liver metastases (CRLM) who undergo their primary surgery at UZ. Leuven (single-center academic study)

Interventions

Not provided

Measure	Description	Time Frame
overall survival		5 years

Measure	Description	Time Frame
prognostic variables		5 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with CRLM
Surgery: resection and/or ablation
preoperative chemotherapy and/or biological agents are allowed
postoperative chemotherapy and/or biological agents are allowed
simultaneous colorectal resection is allowed

Exclusion Criteria:

primary liver cancer
benign liver tumors
pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Consecutive patients sufering from colorectal liever metastases (CRLM) who undergo minimally invasive liver surgery (MILS) or open liver surgery (OLS)

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospitals Leuven KUL		Leuven	Vlaams-Brabant	3000	Belgium

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

Browse Leaves

Not provided

Browse Branches

Not provided