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| ID | Type | Description | Link |
|---|---|---|---|
| A41707-36 | Other Identifier | french ANSM |
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Main reason: negative echo in the literature after the first publications.
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The aim of this study is evaluate the feasibility of early two-stage hepatectomy in patients with liver metastasis from colorectal cancer.
In France, each year around 36,000 new cases of colorectal cancers are registered responsible in 16,000 deaths because of liver metastasis.
In case of bilobar metastasis, classic two-stage hepatectomy with portal embolization could be performed.
An alternative to the classic surgery, early two stage hepatectomy, could be proposed to simplify the patient's management and to improve the resectability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| two stage hepatectomy | Experimental | the two stage hepatectomy is defined as a two step procedure: first step: hepatotomy with ligature of the right branch of the portal vein second step (one week after the first step): right hepatectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| two stage hepatectomy | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| number of complete surgical procedure | the number of complete surgical procedure is defined as the number of patients in whom the two stage hepatectomy is complete. | postoperative week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| overall mortality | the overall mortality is defined as the number of patients who are dead at one year after the surgery | one year after the two stage hepatectomy |
| number of patient with hepatocellular insufficiency |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| jean marc regimbeau, MD, PhD | Amiens University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amiens University Hospital | Amiens | 80054 | France |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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the hepatocellular insufficiency is defined by a prothrombin rate below 50%
| postoperative day 30 |
| overall morbidity | the overall morbidity is classified according to the Dindo Clavien classification | postoperative day 30 |
| preoperative liver volumetry | the remnant liver volume is evaluated with the Myrian Software and calculated by the radiologist | one week prior to the surgery |
| quality of life | the quality of life is evaluated thanks to the EORTC QLQ C30 LMC 21 form the day before the first stage surgery and the day before the second stage surgery. | the day before the first stage surgery and the day before the second stage surgery |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |