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临床试验/NCT04758923
NCT04758923尚未招募不适用

Single-stage Versus Two-staged Management for Concomitant Gallstones and Common Bile Duct Stones

Assiut University0 个研究点目标入组 64 人开始时间: 2024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
状态
尚未招募
入组人数
64
主要终点
Surgical successful rates

研究概览

简要总结

Choledocholithiasis is identified in approximately 3-10 % of patients with cholelithiasis. (1-3) While laparoscopic cholecystectomy (LC) is considered the treatment of choice in patients with gall bladder stones, there is a debate about the management of common bile duct (CBD) stones, (4) and this has led to a range of therapeutic strategies for the management of concomitant gallstones and CBD stones patients. Two-stage endoscopic management using endoscopic retrograde cholangiopancreatography (ERCP) followed by laparoscopic cholecystectomy is a common approach, although single-stage management by laparoscopic cholecystectomy with surgical exploration of the CBD is an alternative, with the single-stage approach more common in the open surgery era. Currently, it is unclear whether two-stage management is better than or at least equivalent to the single-stage surgical approach to choledocholithiasis. To address this, we undertook this study to compare these two approaches. The aim of this prospective randomized trial was to determine the best technique for the management of patients with concomitant gallstones and common bile duct stones, by comparing the success rate, complication rates, and longer-term follow-up outcomes.

详细描述

Single stage approach Under General anaesthesia a5 trocar method will be used to access the abdominal cavity. Aconventional approach to laparoscopic cholecystectomy will be first udertaken with dissection of calot's triangle. The cystic duct will be pulled laterally to facilitate exposure of the anterior wall of the CBDand the CBD will be opened longitudinally for adistance of approximately 1to1.5 cm using laparoscopic scissors. A5mm flexible choledoscope will be used to identify the CBD stone(s) which will be removed by flushing sterile saline, passingastone basket, or electrohydraulic lithotrpsy as necessary to clear the CBD. A T-tube will be inserted into the CBD via the choledochotomy which will be closed by interrupted resorbable sutures, before completing the cholecystectomy. Cholangiography throuh T-tube be performed 14 14 days later and the T-tube will be removed immediately after Cholangiography if no residual CBD stones is identified. If residual stones are found then will be removed through the T-tube track using A choledoscope Two-stage approach The treatment process commenced with intial endoscopic treatment phase. This will be udertaken Under General anaesthesia and entailed ERCP and endoscopic sphincterectomy. The CBD stones will be removed using a basket or ballon, with lithotrpsy added if necessary. An endoscopic nasobiliary drainge will be inserted and kept in place until after laparoscopic cholecystectomy which perfermed 2 to 5 days later depending on the patients 's condition.. Surgery will be delsyed if urine amylase is elevated or significant abdominal pain is present. 2 to 5 days after the operation, Cholangiography will be performed via endoscopic nasobiliary drainge tube. And the endoscopic nasobiliary drainge tube wii be removed if no residual CBD stones are seen.

研究设计

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

入排标准

年龄范围
16 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age 16 to 70 years; Clinical presentation with biliary colic with or without jaundice; Serum elevation of at least one of the following enzymes: aspartate aminotransferase, alanine aminotransferase, glutamyl transpeptidase, alkaline phosphatase, and total bilirubin; Radiological findings suggestive of gallstones and concomitant common bile duct stones, with abdominal ultrasound showing possible CBD stones or a dilated CBD >8 mm in diameter.
  • •only patients with MRCP evidence of a CBD stone(s) were eligible after meeting all the previous criteria.

排除标准

  • •active acute pancreatitis, pregnancy, septic shock, intrahepatic gallstones, malignant pancreatic or biliary tumors, prior sphincterotomy, unfit for anesthesia and surgery, contraindications to MRCP and ERCP, liver cirrhosis, previous history of abdominal surgery (e.g., gastrectomy), and inability to give informed consent.

研究组 & 干预措施

Two-Stage

Active Comparator

Two-stage approach The treatment process commenced with an intial treatment phase. This will be udertaken Under General anaesthesia and entailed ERCP and endoscopic sphincterectomy

干预措施: Cholecystectomy (Procedure)

Single stage

Active Comparator

Single stage approach Under General anaesthesia a5 trocar method will be used to access the abdominal cavity. Aconventional approach to laparoscopic cholecystectomy will be first udertaken with dissection of calot's triangle. The cystic duct will be pulled laterally to facilitate exposure of the anterior wall of the CBD, and the CBD will be opened longitudinally for a distance of approximately 1 to 1.5 cm using laparoscopic scissors. A5 mm flexible choledoscope will be used to identify the cbd stone which will be removed by flushing with sterile saline, passing a stone basket or electrohydroulic lithotripsy as neccesary to clear the CBD. A T-tube will be inserted into the CBD via the choledochotomy which will be closed by interrupted resorbable sutures before completing the cholecystectomy.

干预措施: Cholecystectomy (Procedure)

结局指标

主要结局

Surgical successful rates

时间窗: 2 weeks

The prospective clinical trial aims to determine the best technigue for the management of the patient with concomitant GB and CBD stones by comparing success rate and complication rates

次要结局

未报告次要终点

研究者

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

Hossam Mahmoud Ibrahim

Resident

Assiut University

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