Impact of Pre-operative Bevacizumab on Complications After Resection of Colorectal Liver Metastases

October 24, 2016 updated by: Ksenija Slankamenac, University of Zurich

Impact of Pre-operative Bevacizumab on Complications After Resection of Colorectal Liver Metastases A Case Matched Control Study

Hypothesis of the study: Neoadjuvant chemotherapy with Bevacizumab impairs postoperative outcome after resection of colorectal liver metastases.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Bevacizumab is a humanized monoclonal antibody against vascular endothelial growth factor (VEGF) increasingly added to other drugs in the treatment of colorectal cancer. Bev is typically used in combination with other chemotherapeutic agents such as oxaliplatin, irinotecan, leucovorin and 5-fluorouracil (5-FU) for treatment of patients with CRLM. The objective of this study was to assess the impact of neoadjuvant bevacizumab on clinical outcome after hepatectomy of colorectal liver metastases (CRLM).

Patients, who underwent liver resection due to colorectal liver metastases after neoadjuvant chemotherapy, operated between 2005 and 2007 will be evaluated retrospectively. The patients will be distributed in two groups, either with or without bevacicumab. Outcome parameters are mortality, complications, hospital stay and ICU stay. To increase the power of the study the total number of patients will be increased by adding patients from other centers. Results will be adjusted for the propensity of developing complications.

Study Type

Observational

Enrollment (Actual)

163

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Strasbourg, France
        • Centre de Chirurgie Viscérale et de Transplantation, Hautepierre Hospital
  • Spain
      • Girona, Spain
        • Division of hepato-biliary-pancreatic surgery. Department of surgery, "Josep Tureta" Hospital
  • Switzerland
      • Zurich, Switzerland, 8091
        • University Hospital of Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients, who underwent liver resection due to CRLM between 2005 and 2007, were retrospectively assessed for eligibility. Patients with chemotherapy containing Bev prior to surgery are identified consequtively. This group of patient with preoperative Bev is matched to patients without Bev. Consecutive patients with neoadjuvant application of Bevacizumab will be matched to patients without Bevacizumab. Results are statistically adjusted according to potential confounders.

Description

Inclusion Criteria:

  • Patients with neoadjuvant chemotherapy prior to liver resection

Exclusion Criteria:

  • Patients without neoadjuvant chemotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
with bevacizumab
Neoadjuvant chemotherapy with bevacizumab
Drug: bevacizumab
Neoadjuvant chemotherapy with bevacizumab
without Bevacizumab
Neoadjuvant chemotherapy without Bevacizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall complications
Time Frame: postoperative
postoperative

Secondary Outcome Measures

Outcome Measure
Time Frame
specific complications such as liver insufficiency, length of hospital stay
Time Frame: postoperative
postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

  • Principal Investigator: Stefan Breitenstein, MD, Departement of Visceral and Transplantation Surgery of University hospital of Zurich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

April 2, 2009

First Submitted That Met QC Criteria

April 2, 2009

First Posted (Estimate)

April 3, 2009

Study Record Updates

Last Update Posted (Estimate)

October 25, 2016

Last Update Submitted That Met QC Criteria

October 24, 2016

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • StV 12-2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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