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The purpose of this study is to investigate the safety and efficacy of simultaneous liver resections compared to staged hepatectomies of rectal cancer with liver metastasis and to compare the short and long-term survival between the two groups.
The optimal surgical strategy for treatment of patients with resectable synchronous rectal liver metastases remains controversial. To answer whether synchronous rectal cancer liver metastases (SLM) should be resected simultaneously with primary cancer or should be delayed, We conducted a randomized, controlled trial to compare the safety and efficacy of simultaneous versus delayed resection of the rectum and liver. Patients with rectal cancer and resectable SLM were randomly assigned to either simultaneous or delayed resection of the metastases. The primary outcome was the rate of major complications (Clavien-Dindo grade≥III) within 30 days following surgery. Secondary outcomes included disease-free and overall survival. A consecutive patients of rectal cancer with liver metastasis from ZhongShan hospital, Fudan university were enrolled and randomly assigned to simultaneous liver resections and staged hepatectomies. Post-operative complications, peri-operative mortality, long-term survival were compared.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | simultaneous resection of liver metastasis and the rectal primary tumor |
|
| 2 | Active Comparator | staged resection of the liver metastasis and the rectal primary tumor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| simultaneous resection of liver metastasis and the rectal primary tumor | Procedure | simultaneous resection of liver metastasis and the rectal primary tumor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Severe complication rate after resection of primary and metastatic lesions | Grade of III-V complication rate according to Clavien-Dindo | 30 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Disease free survival | Disease free survival after the last resection of primary and metastatic lesions | 3 years |
| Overall survival | Overall survival after the last resection of primary and metastatic lesions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| jianmin xu, MD, PHD | department of general surgery, zhongshan hospital, fudan university | Study Director |
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Rectal cancer patients with synchronous resectable liver metastasis were randomized to simultaneous resection of primary and metastatic lesions or staged resection
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| staged resection of liver metastasis and the rectal primary tumor | Procedure | Patients received resection of the rectal tumor. 1 months later received resection of liver metastasis |
|
| 3 years |
| Post-operative mortality | any death occured within 90 days after the last resection of primary and metastatic lesions | 90 days after surgery |
| Cost of hospitalization | any cost during the resection of primary and metastatic lesions | 2 months |
| Complication rate after resection of primary and metastatic lesions | All grade of complication rate according to Clavien-Dindo | 30 days after surgery |
| Postoperative hospital stay | The postoperative hospital stay is defined as the number of date from the first day after operation to discharge | 30 days after surgery |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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