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临床试验/NCT02350166
NCT02350166Unknown3 期

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

West China Hospital2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2013年11月最近更新:
适应症

试验速览

阶段
3 期
入组人数
40
试验地点
2
主要终点
30-day complications

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Right colon cancer and transverse colon cancer
  • Pregnant or lactating women
  • A history of malignant tumor within 5 years
  • There was contraindication for operation
  • Discovery of metastasis in other organs in the operation
  • With mental disorder

结局指标

主要结局

30-day complications

时间窗: Postoperative 30 days

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

次要结局

  • Pain score(Postoperative 7 days)
  • Hospital time(an expected average of 7 days)
  • C-reactive protein(Postoperative 5 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ziqiang Wang,MD

Professor of the West China Hospital, Sichuan University

West China Hospital

研究点 (2)

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