Randomized Multicentre Double-blind Clinical Trial Comparing ERCP vs ERCP and Transmural Gall Bladder Drainage in Non-surgical Patients With Symptomatic Choledocholithiasis
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
- Number of paticipants readmitted due to biliary pathology
研究概览
简要总结
Cholelithiasis occurs in 10-20% of the general population. Up to 18% of these subjects will present symptoms. In patients with symptomatic choledocholithiasis who are not candidates for surgery with indication for ERCP, transmural drainage of the gallbladder reduces the risk of recurrence.
The investigators propose a multicentric double-blind randomized trial. Our primary objective is to assess whether ERCP associated with transmural gallbladder drainage is able to reduce biliary disease income compared with ERCP in patients not candidates for surgery with symptomatic choledocholithiasis and cholelithiasis during one year of follow-up. Also the investigators will analyze the proportion of technical success and complications.
The study population includes all patients older than 75 years with symptomatic choledocholithiasis. An estimated 75 subjects per group (ERCP alone and ERCP and transmural drainage) are needed.
详细描述
- Introduction Cholelithiasis occurs in 10-20% of the general population (1). Up to 18% of these subjects will present symptoms and, of these, 1.5% will present an episode of pancreatitis, cholecystitis or acute cholangitis (2). In this way, the pathology associated with biliary lithiasis is the first digestive cause of hospital admission (3).
The treatment of the pathology associated with biliary lithiasis therefore deals with two problems, controlling the acute process and preventing new episodes. In general, laparoscopic cholecystectomy is the recommended method to reduce the risk of recurrence. 2. Hypothesis
Conceptual hypothesis:
In patients with symptomatic choledocholithiasis who are not candidates for surgery with indication for ERCP, transmural drainage of the gallbladder reduces the risk of recurrence.
Operational hypothesis:
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, Care Provider, Outcomes Assessor)
盲法说明
The patient and the physician responsible for the follow-up will be blinded as to the procedure performed (it will not be specified if transmural drainage was performed in the endoscopic report, nor will images of the drainage be included in the discharge report available in the electronic medical record until after the completion of the study or if complications are suspected).
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic choledocholithiasis (choledocholithiasis demonstrated radiologically or highly suspected by clinical data (acute cholangitis or obstructive jaundice), analytical and imaging according to the criteria of high probability of choledocholithiasis established in the clinical guidelines (ASGE Guide).
- •Discarded for surgical treatment due to age, comorbidity or refusal of the patient.
- •Age>75 years
排除标准
- •Charlson comorbidity scale adjusted to age <
- •Hepatobiliary surgery or previous superior digestive tract.
- •Inability to tolerate sedation of endoscopy, perforation of the digestive tract or other contraindication to endoscopy.
- •Coagulopathy with INR (international normalized ratio) > 1.5 not correctable or thrombocytopenia <50000 / mm3 not correctable.
- •Other diagnoses at admission (acute cholecystitis, acute pancreatitis, biliopancreatic neoplasia).
- •Hemodynamic instability.
- •Urgent procedure performed after hours
- •No availability of expert material / endoscopist in drainage.
- •Anatomical impossibility of performing biliary drainage (absence of vesicular distension, contact between gallbladder and stomach or duodenum, contact area <10 mm).
- •Baseline ECOG (Easthern Cooperative Oncology Group) > = 4
- •Expectancy of survival <6 months.
- •Refusal to participate.
- •Distance between the gallbladder and upper digestive tract> 1cm, scleroatrophic vesicle, lack of stable acoustic window for drainage
- •ERCP failed (inhability to dain common bile duct)
研究组 & 干预措施
ERCP with sphincterotomy + gall bladder drainage with LAMS
An ERCP with biliary sphincterotomy will be performed. The performance of other techniques (balloon extraction, dilation, placement of biliary prosthesis ...) is at the expense of the endoscopist. After this, transmural drainage of the gallbladder will be performed by placing a LAMS Axios (Boston Scientific) usually 15x10 mm or 10x10 mm to allow direct cholecystoscopy with a conventional gastroscope or transnasal gastroscope. The placement of the drainage will be performed in the same endoscopic act, by means of an Olympus® sectorial echoendoscope, assisted with X-rays, which allows puncturing the vesicle from the gastric antrum or the duodenal bulb to generate a cholecysto-gastrostomy or cholecysto-duodenostomy respectively. After the puncture of the vesicle from the most optimal anatomical point, it will be tutored with guidance and a Hot Axios® PAL will be placed on it to generate the anastomosis between the aforementioned structures.
干预措施: Gall bladder transmural drainage with LAMS (Procedure)
ERCP with sphincterotomy
An ERCP with biliary sphincterotomy will be performed. The performance of other techniques (balloon extraction, dilation, placement of biliary prosthesis ...) is at the expense of the endoscopist.
干预措施: Gall bladder transmural drainage with LAMS (Procedure)
结局指标
主要结局
Number of paticipants readmitted due to biliary pathology
时间窗: 1 year
Rate of participants readmitted due to biliary pathology (cholecystitis, cholangitis, pancreatitis, hepatic abscess...) in each group
次要结局
- Number of dead participants(1 year)
- Number of participants with technical success(1 day)
- Hospital costs (euros)(1 year)
研究者
Marina de Benito Sanz
Principal investigator
Hospital del Rio Hortega