preGallstep: One-step Laparoscopic Cholecystectomy, Common Bile Duct Exploration and Stone Extraction Versus Two-step Endoscopic Retrograde Cholangiography and Stone Extraction Plus Laparoscopic Cholecystectomy for Common Bile Duct Stones
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Postoperative complications
研究概览
简要总结
In Denmark, more than 7500 cholecystectomies are performed every year. Common bile duct gallstones (CBDS) are found in 3.4% to 18% of patients undergoing cholecystectomy. A two-step approach including endoscopic retrograde cholangiography (ERC) with stone extraction and papillotomy with subsequent laparoscopic cholecystectomy has become gold standard for treatment of CBDS in Denmark. However, ERC is associated with a high risk of complications and more than 50% of patients require multiple ERCs. Recent meta analyses find that a one-step approach might be superior in terms of safety, CBDS clearance rate, hospital stay, operative time, hospital cost and stone recurrence, but much more data is needed.
The preGallstep trial is an investigator-initiated multicentre randomised clinical pilot trial with blinded outcome assessment investigating a novel one-step laparoscopic cholecystectomy with common bile duct exploration and stone extraction versus conventional two-step endoscopic retrograde cholangiography with stone extraction plus a subsequent laparoscopic cholecystectomy for patients with CBDS. After enrolment, the participant will be randomised to one of the two treatment approaches. Adult patients with imaging confirmed CBDS are eligible for inclusion. Potential postoperative complications will be assessed within 90 days following the procedure.
The primary outcome is the proportion of serious adverse events (corresponding to a Clavien-Dindo score II or above) requiring re-intervention within 90 days of the initial procedure. This outcome will be used for a future sample size calculation. The sample size estimate, the inclusion rate and the estimated length of subsequent trial will be used to determine the feasibility of a large pragmatic and confirmatory trial.
We hypothesize that the one-step approach will significantly reduce the risk of complications and number of treatments needed thereby making a difference to hundreds of people in Denmark each year.
详细描述
Purpose The preGallstep pilot trial is a pilot randomised clinical trial investigating two different surgical methods in patients with common bile duct stones: one-step laparoscopic cholecystectomy with common bile duct exploration (experimental intervention) versus two-step endoscopic retrograde cholangiography with stone extraction plus subsequent laparoscopic cholecystectomy (control intervention) for the removal of common bile duct stones.
The investigators alternative hypothesis is that both patient safety, assessed by serious adverse events, as well as the number of procedures needed to obtain stone clearance are better in the one-step approach than in the control approach. However, based on updated systematic review of previously conducted randomised clinical trials (RCTs) the investigators are not able to say which procedure is preferable. Further analysis of these previous RTCs show they are very far from obtaining a confirmatory sample size, thus illustrating the need for larger multicenter trials.
Prior to conducting a large pragmatic and confirmatory trial, the investigators propose this multicenter preGallstep pilot trial.
The purpose of preGallstep is to assess the proportion of participants in the control group with complications in order to conduct more precise sample size estimation for a future pragmatic randomised clinical trial. Furthermore, the investigators want to assess the feasibility of implementing randomisation between different surgical techniques in a daily complex clinical setting.
Background In the Nordic countries, 80 to 200 surgical removals of the gallbladder (cholecystectomies) per 100000 inhabitants are performed annually making it one of the most common surgical procedures. In Denmark, over 7500 cholecystectomies are performed every year. Cholecystectomy is most often performed due to symptomatic gallstones in the gallbladder. However, common bile duct gallstones (CBDS) are found in 3.4% to 18% of patients undergoing cholecystectomy, with highest proportions during acute surgery. However, the most efficient and safest procedure to remove CBDS has yet to be identified.
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 (Outcomes Assessor)
盲法说明
The obvious advantages of a one-step procedure compared with a two-step procedure are the fewer surgical procedures required to clear CBDS and to remove the gallbladder. Due to the nature of the surgical interventions, blinding of patients or physicians is not possible for this trial. Most of the outcomes are dependent on the physician's clinical assessment. However, we will engage a blinded adjudication committee of 3 independent experts who will examine medical charts from randomisation to 90-day follow-up for outcome assessment. Photocopies of the medical charts will have intervention blinded. Also photocopies or print outs of medical charts will be changed so that follow up interventions will become blinded for initial intervention in both intervention groups.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Common bile duct stones identified by magnetic resonance cholangiopancreatography (MRCP).
- •Age 18 years or older.
- •Both interventions must be possible to perform within a clinically reasonable timeframe, as assessed by the investigator.
- •Informed consent.
排除标准
- •Patients with acute cholangitis corresponding to a grade III (elevated serum bilirubin, fever, and/or elevated white blood cell count and signs of severe organ failure) according to Tokyo guidelines 2018 including severe organ failure.
- •Common bile duct cysts shown by magnetic resonance cholangiopancreatography (MRCP), ultrasonography, computer tomography (CT), or cholangiography.
- •Pancreatic/biliary/hepatic malignancies.
- •Prior cholecystectomy or sphincterotomy.
- •Chronic pancreatitis.
- •If assessed by investigator that laparoscopic cholecystectomy is not possible, e.g. due to prior surgery or patient condition.
- •Gastric bypass.
- •Pregnancy confirmed by elevated choriogonadotropin (hCG) in women below 60 years.
- •No informed consent.
结局指标
主要结局
Postoperative complications
时间窗: 90 days
Proportion of participants with postoperative complications corresponding to a Clavien-Dindo score of 2-5
次要结局
- Stone size(Perioperatively)
- Stone clearance failure(perioperatively)
- Number of procedures(90 days after initial procedure)
- Lenght of hospital stay(90 days)
- Stone extraction pathway(perioperatively)
- Number of stones(perioperatively)
- Stone extraction method(perioperatively)
- Cholangiography(perioperatively)
- Procedure time(From start of initial procedure until 90 days follow-up)
- Conversion to open surgery(From start of initial procedure until 90 days follow-up)
研究者
Lars Tue Sorensen
Head of Surgical Department
Bispebjerg Hospital