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

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

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Key information

Conditions

Colorectal Liver Metastases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre de Chirurgie Viscérale et de Transplantation, Hautepierre Hospital, Strasbourg, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with neoadjuvant chemotherapy prior to liver resection

Exclusion criteria

Patients without neoadjuvant chemotherapy

Treatment and study plan

Bevacizumab

Drug

Neoadjuvant chemotherapy with bevacizumab

Primary outcomes

Overall complications

Time frame: postoperative

Secondary outcomes

specific complications such as liver insufficiency, length of hospital stay

Time frame: postoperative

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2009
First posted: Apr 3, 2009
Registry last updated: Oct 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed