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临床试验/NCT01643018
NCT01643018已完成不适用

Laparoscopic Versus Open Conservative Surgery for the Management of Cystic Echinococcosis of the Liver: Prospective, Randomized, and Controlled Clinical Trial of Efficacy and Safety

Medical Park Gaziantep Hospital8 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2006年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
350
试验地点
8
主要终点
cyst recurrence

研究概览

简要总结

Echinococcosis in humans is a parasitic tapeworm infection, caused by a larval stage (the metacestode) of Echinococcus species. The infection can be asymptomatic or severe, causing extensive organ damage and even death of the patient.

Echinococcosis is one of the most neglected parasitic diseases and the lack of the prospective randomised studies supports this idea. Development of new drugs and other treatment modalities receives very little attention, if any. In most developed countries, Cystic Echinococcosis (CE) is an imported disease of very low incidence and prevalence and is found almost exclusively in migrants from endemic regions. In endemic regions, predominantly settings with limited resources, patient numbers are high.

The aim of the hydatid cyst treatment is the death of the parasite and consequently the cure of the disease. It has to be done with a minimal risk and maximum comfort for the patient, and always paying attention to avoid complications, secondary hydatidosis, and relapses.

There are several treatment modalities. Of them the most preferred surgical method is traditional cyst management through a laparotomy incision. Same can be done with laparoscopy. In the past 15 years significant advances in laparoscopic surgical skills and techniques combined with explosive advances in laparoscopic technology have encouraged the application of laparoscopy to the evaluation and treatment of solid organs including the liver. There are many studies about the laparoscopic treatment of liver hydatid cyst published in the literature and the feasibility of this procedure has been demonstrated by them. While the majority of them are case reports or case series, there are some relatively large series comparing open versus laparoscopic surgery published in the last decade, which all are not randomized trial.

详细描述

This is a multicenter, balanced randomization, double blind, active-controlled, parallel-group, non-inferiority study conducted in Turkey (4 sites).

The objective of this trial is to show there is no difference in rate of recurrence 2 years after laparoscopic as compared to open management of cystic echinococcosis of the liver, by at least M (non-inferiority margin). If PLAP/POP: denotes the cure rate in the laparoscopy group (LAP) / open group (OP), then the following two-sided test problem is assessed:

H0: POP - PLAP >= M (Open Surgery is superior to Laparoscopic surgery) H1: POP - PLAP < M (Laparoscopic surgery is not inferior to open surgery)

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients eighteen year-old or older
  • patients diagnosed as cystic echinococcosis of the liver
  • cyst number less then 3
  • cyst size greater than 3 cm

排除标准

  • previous liver surgery
  • recurrent disease
  • hydatid cyst with multi-organ involvement
  • liver hydatid cyst complicated with infection
  • contraindication for general anesthesia
  • contraindication for laparoscopic surgery
  • patient younger than 18
  • allergy to albendazole

结局指标

主要结局

cyst recurrence

时间窗: 24 months

次要结局

  • mortality(24 months)
  • intraoperative complications(24 hours)
  • late complications(24 months)
  • pain score(Post opertaive 6th hour, 1, 2, and 7th days)
  • patient comfort/satisfaction(24 months)
  • hospital stay(10 days)
  • duration of the operation(240 minutes)
  • quality of life(first week, 1, 6, 12, and 24 month after operation)

研究者

发起方
Medical Park Gaziantep Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mehmet Kaplan

MKaplan

Medical Park Gaziantep Hospital

研究点 (8)

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