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Hypothesis of the study: Neoadjuvant chemotherapy with Bevacizumab impairs postoperative outcome after resection of colorectal liver metastases.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| with bevacizumab | Neoadjuvant chemotherapy with bevacizumab |
| |
| without Bevacizumab | Neoadjuvant chemotherapy without Bevacizumab |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bevacizumab | Drug | Neoadjuvant chemotherapy with bevacizumab |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall complications | postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| specific complications such as liver insufficiency, length of hospital stay | postoperative |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Stefan Breitenstein, MD | Departement of Visceral and Transplantation Surgery of University hospital of Zurich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de Chirurgie Viscérale et de Transplantation, Hautepierre Hospital | Strasbourg | Strasbourg | France | |||
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Division of hepato-biliary-pancreatic surgery. Department of surgery, "Josep Tureta" Hospital |
| Girona |
| Girona |
| Spain |
| University Hospital of Zurich | Zurich | Canton of Zurich | 8091 | Switzerland |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |