Short-term Effects of LASI Surgery Versus Conventional Laparotomy for Colorectal Liver Metastasis

Sponsor

West China Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02350166

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Procedure: laparoscopic surgery	Phase 3

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Short-term Effects of Laparoscopic-assisted Small-incision Surgery Versus Conventional Laparotomy in Treatment of Resectable Colorectal Liver Metastasis

Study Start Date :

Nov 1, 2013

Anticipated Primary Completion Date :

Nov 1, 2016

Anticipated Study Completion Date :

Nov 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Laparoscopic group Laparoscopic group, laparoscopic surgery or laparoscopic-assisted small-incision for resection of laparoscopic colorectal tumor combined with synchronously small-incision open resection of liver metastasis	Procedure: laparoscopic surgery laparoscopic-assisted small-incision surgery
No Intervention: Conventional group Conventional group, conventional laparotomy for simultaneously resection of both primary colorectal tumor and liver metastasis

Arm

Intervention/Treatment

Experimental: Laparoscopic group

Laparoscopic group, laparoscopic surgery or laparoscopic-assisted small-incision for resection of laparoscopic colorectal tumor combined with synchronously small-incision open resection of liver metastasis

Procedure: laparoscopic surgery

laparoscopic-assisted small-incision surgery

No Intervention: Conventional group

Conventional group, conventional laparotomy for simultaneously resection of both primary colorectal tumor and liver metastasis

Outcome Measures

Primary Outcome Measures

30-day complications [Postoperative 30 days]
Postoperative 30-day complications including anastomotic leakage, infection, and bile leakage

Secondary Outcome Measures

Pain score [Postoperative 7 days]
Postoperative pain assessment
Hospital time [an expected average of 7 days]
Postoperative stay in hospital
C-reactive protein [Postoperative 5 days]
serum C-reactive protein level after operation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Pathologically confirmed resectable upper rectal cancer, sigmoid cancer, and left colon cancer
MRI/CT confirmed resectable liver metastasis after muti-disciplinary team assessment
No evidence of other metastasis
Organs function well to tolerance simultaneous surgery, especially liver function
No special treatment before surgery
Informed consent was written