Clinical trial NCT00875147: Impact of Pre-operative Bevacizumab on Complications After Resection of Colorectal Liver Metastases
Official title: Impact of Pre-operative Bevacizumab on Complications After Resection of Colorectal Liver Metastases A Case Matched Control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Liver Metastases
Keywords: neoadjuvant chemotherapy
bevacizumab
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2009-04-03
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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

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.

Eligibility criteria: Inclusion Criteria:

* Patients with neoadjuvant chemotherapy prior to liver resection

Exclusion Criteria:

* Patients without neoadjuvant chemotherapy

Primary outcomes:
measure: Overall complications
timeFrame: postoperative
Secondary outcomes:
measure: specific complications such as liver insufficiency, length of hospital stay
timeFrame: postoperative
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Centre de Chirurgie Viscérale et de Transplantation, Hautepierre Hospital
city: Girona
country: Spain
facility: Division of hepato-biliary-pancreatic surgery. Department of surgery, "Josep Tureta" Hospital
city: Zurich
country: Switzerland
facility: University Hospital of Zurich
Study officials:
affiliation: Departement of Visceral and Transplantation Surgery of University hospital of Zurich
name: Stefan Breitenstein, MD
role: PRINCIPAL_INVESTIGATOR
References: