Endosonography-guided Gallbladder Drainage vs Non-endoscopic Treatment in Patients With Inoperable Acute Cholecystitis: a Multicenter Randomized Clinical Trial (EUS-DRAIN)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Cumulative rate of biliopancreatic events development at one year of follow-up
研究概览
简要总结
In this project the investigators propose to carry out a clinical trial that compares non-endoscopic treatment of cholecystitis with antibiotics versus endoscopic drainage in non-operable acute cholecystitism (AC), especially focused on the rate of subsequent EBP and recurrence of AC, as well as the impact on the quality of life, also exploring the costs.
The ultimate goal of this project is to generate knowledge and scientific evidence that makes it easier for health professionals to choose the most appropriate strategy for non-operable patients with lithiasic AC.
Ourworking hypothesis is that endoscopic treatment (EUS-GBD) will significantly reduce the number of EBP compared to non-endoscopic treatment in patients with non-operable lithiasic AC.
详细描述
Design
- Randomized, open-label, low-intervention, superiority clinical trial with parallel groups for the two treatment strategies.
- Cost study Patients who meet the inclusion criteria and do not meet any exclusion criteria will be invited to participate in the study. Between the formalization of the request and the endoscopic examination, the informed consent will be completed in accordance with Law 41/2002 on patient autonomy without altering the relationship with your doctor or causing any damage to your health.
Patients will be randomized in non-endoscopic group or in endoscopic drainage group.
Antibiotic treatment will start from the moment of diagnosis in both arms of the study. Following the recommendations of the Clinical Practice Guideline for the Management of Acute Cholecystitis of Tokyo 2018.
The duration of antibiotic treatment in undrained patients will be 10 to 14 days as long as the cholecystitis has been cured and it will be 4-7 days after gallbladder drainage (EUS-GBD or PC) as long as the cure has been achieved of cholecystitis.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient older than 18 years.
- •Definitive diagnosis of acute lithiasic cholecystitis according to the GP Tokyo 2018 criteria.
- •Surgical decision of inoperable patient (if one or more of the following criteria is met: age ≥80 years, American Society of Anesthesiology (ASA) III or more, Charlson Comorbidity Index > 5 and/or Karnofsky < 50 or decision of the patient not to have surgery.
- •Signature of the informed consent of the study
排除标准
- •Operable acute cholecystitis.
- •Refusal of the patient to participate in the study.
- •Anatomy of the GI tract altered by previous hepatobiliary or upper GI surgery.
- •Inability to tolerate endoscopy sedation, perforation of the digestive tract, or other contraindication to endoscopy.
- •Patients with decompensated cirrhosis, portal hypertension and/or gastric varices
- •Coagulopathy with uncorrectable INR>1.5 or thrombocytopenia <50,000/mm3 uncorrectable.
- •Other diagnoses on admission (choledocholithiasis, liver abscesses, acute pancreatitis or biliopancreatic neoplasia).
- •Hemodynamic instability.
- •Baseline ECOG >=4
- •Survival expectancy < 6 months
结局指标
主要结局
Cumulative rate of biliopancreatic events development at one year of follow-up
时间窗: 2 years
Biliopancreatic event (BPE): event related to biliary pathology such as acute cholecystitis, acute cholangitis, symptomatic choledocholithiasis, acute pancreatitis mild-moderate, severe acute pancreatitis, biliary colic (complicated or uncomplicated), liver abscess
次要结局
- Evaluate the duration of antibiotic treatment(2 years)
- Evaluate the duration of the index admission(2 years)
- Evaluate the need for percutaneous cholecystostomy(2 years)
- Evaluate healing and time to healing of acute cholecystitis(2 years)
- Evaluate the costs of the two treatment strategies: hospital costs of the index admission and the costs generated during the follow-up period related to the biliopancreatic pathology(2 years)
- Evaluate mortality during admission and follow-up in the two treatment groups(2 years)
- Evaluate the digestive symptoms and quality of life of the patients during follow-up(2 years)
- Proportion of technical success of EUS-GBD and the complications(2 years)
研究者
Jesus Maria Urman Fernandez
Head of Pancreas Unit
Fundacion Miguel Servet