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临床试验/NCT03252379
NCT03252379Unknown不适用

Endoscopic Access Loop With Bilio-enteric Anastomosis: A Prospective Randomized Comparison Between Gastric and Subcutaneous Accesses

Assiut University0 个研究点目标入组 30 人开始时间: 2017年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
30
主要终点
endoscopic access

研究概览

简要总结

Roux-en-Y hepaticojejunostomy is the standard procedure used by most hepatobiliary surgeons for biliary reconstruction following iatrogenic bile duct injury, benign and malignant CBD strictures, choledochal cysts and biliary tract tumors management. The incidence of anastomotic stricture following hepaticojejunostomy in experienced centers ranges between 5%-22%. Hepaticojejunostomy stricture is a serious complication of biliary surgery, if untreated, can lead to repeated cholangitis, intrahepatic stones formation, biliary cirrhosis, hepatic failure and eventually death.

Revision of hepaticojejunostomy is a complex procedure, the surgical procedure being made difficult by the sequelae of long-standing unrelieved biliary obstruction like portal hypertension due to secondary biliary cirrhosis, atrophy of liver lobes and presence of cholangiolytic liver abscess.

Endoscopic management is not only the least invasive but also very effective via either balloon dilatation or stenting of the stricture. In patients with "Roux-en-Y" hepaticojejunostomy, the endoscopic access to the anastomosis is hampered by the distance traveled by the jejunal loop until reaching the angle of the enteral anastomosis.

Many modifications of hepaticojejunostomy to provide permanent endoscopic access have been described in the literature including duodenal, gastric and subcutaneous access loops.

Gastric access loop was first described by Sitaram et al. Ten patients had undergone gastric access loop. Access loop was entered easily with the gastroscope in five patients in whom it was attempted. In a series with 16 cases, Hamad MA and El-Amin H assessed different construction of gastric access loop in the form of bilioenterogastrostomy the overall success rate of endoscopic access to the HJ through the three types of BEG was 87.5%, while it was 100% for BEG type III, which is a construction similar to the previous series (BEG) type.

Subcutaneous loop access was described by Chen et al. and by Huston et al. In Hutson's series of 7 patients, recurrent strictures were treated with repeated balloon dilations. The stone extractions were all successful. In most series, the subcutaneous loop was used for management os HJ stricture and intrahepatic stones by radiologic intervention. Recently the subcutaneous loop can be used as an endoscopic biliary access.

详细描述

This study is a prospective randomized controlled study; which will include all patients who will undergo Roux-en-Y hepaticojejunostomy reconstruction during the period from 9-2017 to 12-2019.

* Methodology:

Patients will be randomized into three groups according to the surgical procedure performed as follows:

  • Group A: Patients undergoing modified hepaticojejunostomy with gastric access loop

  • Group B: Patients undergoing modified hepaticojejunostomy with subcutaneous access loop

  • Group C: Patients undergoing standard hepaticojejunostomy with no endoscopic access loop

  • Pre-operative preparation:

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
Single (Participant)

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
否

入选标准

  • •All patients who will undergo roux-en-Y hepaticojejunostomy reconstruction at General surgery department - Assiut University.

排除标准

  • •Patients with malignant disease necessitating roux-en-Y hepaticojejunostomy (Cholangiocarcinoma or inoperable pancreatic cancer) will be excluded from this study.

研究组 & 干预措施

Group A

Experimental

Patients undergoing modified hepaticojejunostomy with gastric access loop

干预措施: modified hepaticojejunostomy with gastric access loop (Procedure)

Group B:

Experimental

Patients undergoing modified hepaticojejunostomy with subcutaneous access loop

干预措施: modified hepaticojejunostomy with subcutaneous access loop (Procedure)

Group C:

Experimental

Group C: Patients undergoing standard hepaticojejunostomy with no endoscopic access loop

干预措施: hepaticojejunostomy (Procedure)

结局指标

主要结局

endoscopic access

时间窗: first trial after 2 months (8 weeks) and second trial one year postoperatively

two trial of endoscopic entry for assessment of hepaticojejunostomy after 2 months (8 weeks) and one year postoperatively

次要结局

  • mortality rate(up to 3 months postoperative for each case)
  • bilio-enteric fistula(1 month post-operative for each case, data will be available)
  • hepaticojejunostomy stricture(6 months after the last case)

研究者

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

Mohamad Raafat

Assistant lecturer at General surgery department

Assiut University

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