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.
Nowadays, colorectal liver metastasis (CLM) is gaining wide population from
multi-disciplinary doctors including gastroenterologists, oncologists, and hepatic doctors
for its increasing incidence and poor prognosis. Nearly, 15%-25% of colorectal cancer
patients present with simultaneous liver metastasis at the time of diagnosis and 20%-35%
patients are evaluated with primary tumor and liver metastasis resectable synchronously.
Although the use of chemotherapy regimen has been certified favorable outcomes, surgical
resection is still recommended as the optional treatment for CLM patients. However, there
are two main concerns for resectable colorectal liver metastasis which remain controversial:
surgical time and surgical type. As for the former, a latest evidence shows synchronous
resection of primary colorectal tumor and liver metastasis, with the reason of fare overall
survival rate and absence of a second surgery. Moreover, an increasing number of surgeons
favor synchronous resection from their initial experience and they believe it will bring
benefits to CLM patients.
With regard to surgical type, although laparoscopic liver resection has been proven
feasible, safe and efficient in management of liver metastasis, this procedure is limited in
selected patients such as tumor size less than 10 centimeters or located in left liver. In
addition, laparoscopic liver resection is technically difficult which is applied in most
medical centers. So open liver resection may be the optimum choice for CLM patients no
matter what the metastasis profile is. In the management of primary tumor, laparoscopic
procedure is mature in surgical skill and has been evidenced equivalent overall survival
rate compared with open resection. A research conducted by Arezzo also confirms lower 30-day
morbidity of laparoscopic colorectal cancer resection. Unlike liver metastasis resection,
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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