跳至主要内容
临床试验/NCT05116735
NCT05116735已完成不适用

Biliary Fistula and Late Recurrence of Liver Hydatid Cyst: Role of Cysto-biliary Communication - A Prospective Multicenter Study.

Zagazig University0 个研究点目标入组 244 人开始时间: 2010年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
244
主要终点
recurrence

研究概览

简要总结

Purpose : The primary goals of this study were to determine the prevalence and risk factors of occult CBC and recurrence, as well as the relationship between occult cysto-biliary communications manifested as postoperative biliary leakage and recurrence. The secondary goal was to use chemical analysis of hydatid cyst fluid to assess excessive bilirubin and alkaline phosphatase levels as predictors of fistula and recurrence.

Methods: This prospective multi-center experimental and follow-up study of six years duration was conducted at the hepato-biliary pancreatic units of our universities hospitals from September 2010 to September 2016. Initially, 292 patients were included, but only 244 patients enrolled in the final study.

详细描述

Hydatid cyst disease (HCD) is a zoonotic illness caused by Echinococcus Granulosus that infects humans via ingestion of eggs and primarily affects the liver (50-70%), followed by the lungs, brain, and other viscera . To facilitate consistent diagnosis, treatment, and follow-up, the World Health Organization Informal Working Group on Echinococcosis (WHO-IWGE) arranged a standardized ultrasonography staging based on the cyst's active-transitional-inactive stage .

Various therapy options for hydatid cyst management range from medical treatment alone, which has been shown to be ineffective in curing the condition , to surgical treatment, which is considered the primary therapeutic option [6]. For hydatid cysts, laparoscopic surgery is both safe and successful. Laparoscopic procedures range from conservative procedures such as laparoscopic partial cystectomy and omentoplasty to obliterate the residual cavity to radical procedures such as pericystectomy or hepatic resection . The type of surgery to be performed is determined by the location, size, and presence of cyst complications .

Cysto-biliary communication (CBC) is a common complication after hepatic HCD surgery that occurs when a cyst bursts into the biliary system , with a reported incidence of 13%-37% and can manifest as frank or occult (silent) CBC . Cyst fluid, scolices, small daughter cysts, and minor fragments of the endocyst membranes migrate into the biliary tract in occult or silent CBC, but neither clinically nor radiologically can be detected . Postoperative biliary leakage will occur if Occult CBC is overlooked during surgery, and will manifest as biliary drainage, biliary peritonitis, and biliary abscess. . Another issue is recurrence after hydatid cyst surgery, which has a range of (0-22 percent) .

Aim of the study, gap statement, and study strength:

Although several studies have looked at the results of laparoscopic partial cystectomy with omentoplasty in terms of postoperative biliary fistula and recurrence, no investigations into the link between occult cysto-biliary communication and late recurrence have been published. Furthermore, no studies have looked into the value of cystic fluid analysis in detecting occult cysto-biliary communication, which can lead to biliary leakage and recurrence after surgery. The primary goals of this study were to determine the prevalence and risk factors of occult CBC and recurrence, as well as the relationship between occult cysto-biliary communications manifested as postoperative biliary leakage and recurrence. The secondary goal was to use chemical analysis of hydatid cyst fluid to assess excessive bilirubin and alkaline phosphatase levels as predictors of fistula and recurrence.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Stages CE2
  • CE3b According to the WHO-IWGE classification
  • symptomatic or asymptomatic
  • superficial cyst
  • cases not suited for hepatic resection as the cyst wall abutting critical vascular and biliary structures as hepatic resection is harmful or excessive loss of hepatic tissue

排除标准

  • stages CL, CE1, CE3a, CE4, CE5 according to WHO-IWGE classification of the hydatid cyst
  • preoperative total bilirubin level greater than 2.0 mg/dl and direct bilirubin level greater than 1.5 mg/dl
  • common bile duct dilatation greater than 10 mm , or CT, or MRI, previous percutaneous treatment
  • recurrent cases after any type of surgery, cases with associated extrahepatic or extra-abdominal hydatid cyst
  • cysts affecting an entire lobe or the main pedicles
  • stages Cysts that are complicated (ruptured or diseased cysts), deep cysts .Patients who refuse intervention, have a surgical contraindication, are pregnant, have hydatid cysts in both lobes of the liver, previous liver surgery, liver abscess, frank CBC, cases lost during follow-up, cases who refused to take albendazole, or cases who developed albendazole-related issues (disturbed liver function).

结局指标

主要结局

recurrence

时间窗: 5 years

detection of recurrence by CT and sonar abdomen

biliary leakage

时间窗: 30 days postoperatively

incidence of biliary leakage detected clinically, sonar or CT

次要结局

  • biochemical analysis of hydatid cyst fluid(intraoperative)

研究者

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

Tamer.A.A.M.Habeeb

assistant professour of general and laparoscopic surgery

Zagazig University

相似试验