Colorectal Cancer Clinical Trial
Official title:
Short-term Effects of Laparoscopic-assisted Small-incision Surgery Versus Conventional Laparotomy in Treatment of Resectable Colorectal Liver Metastasis
Surgical resection is still recommended as the optional treatment for colorectal liver metastasis (CLM) patients. There are two main concerns for resectable colorectal liver metastasis which remain controversial: surgical time and surgical type. As for the former, synchronous resection of primary colorectal tumor and liver metastasis, with the reason of fare overall survival rate and absence of a second surgery, has gained wide population from gastrointestinal surgeons who believe it will bring benefits to CLM patients. With regard to surgical type, Open liver resection is the optimum choice for CLM patients no matter what the metastasis profile is. And for management of primary tumor, laparoscopic procedure is mature in surgical skill and has been evidenced equivalent overall survival rate compared with open resection. So, primary colorectal tumor resection could be either open or laparoscopic procedure. Therefore, the investigators team conducted the controlled trial to compare two surgical procedures in treatment of resectable colorectal liver metastasis. Patients will be randomly assigned into conventional laparotomy group for simultaneously resection of both primary colorectal tumor and liver metastasis, or laparoscopic-assisted small-incision group for resection of laparoscopic colorectal tumor combined with synchronously small-incision open resection of liver metastasis. The aim of this trial is to observing short-term operative effects after surgeries.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | November 2016 |
Est. primary completion date | November 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: 1. Pathologically confirmed resectable upper rectal cancer, sigmoid cancer, and left colon cancer 2. MRI/CT confirmed resectable liver metastasis after muti-disciplinary team assessment 3. No evidence of other metastasis 4. Organs function well to tolerance simultaneous surgery, especially liver function 5. No special treatment before surgery 6. Informed consent was written Exclusion Criteria: 1. Right colon cancer and transverse colon cancer 2. Pregnant or lactating women 3. A history of malignant tumor within 5 years 4. There was contraindication for operation 5. Discovery of metastasis in other organs in the operation 6. With mental disorder |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | West China Hospital | Chengdu | Sichuan |
China | West China hospital, Sichuan University | Chengdu | Sichuan |
Lead Sponsor | Collaborator |
---|---|
West China Hospital |
China,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 30-day complications | Postoperative 30-day complications including anastomotic leakage, infection, and bile leakage | Postoperative 30 days | No |
Secondary | Pain score | Postoperative pain assessment | Postoperative 7 days | No |
Secondary | Hospital time | Postoperative stay in hospital | an expected average of 7 days | No |
Secondary | C-reactive protein | serum C-reactive protein level after operation | Postoperative 5 days | No |
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