Percutaneous or Endoscopic Gallbladder Drainage: The PEG Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Composite endpoint of 1) procedure-related adverse events, 2) reintervention for disease recurrence or procedure-related adverse events, and/or 3) readmission due to underlying disease or procedure-related adverse events
研究概览
简要总结
This is a randomized trial of patients with acute calculous cholecystitis who are never-surgery candidates. Patients will be randomized to one of two treatment groups, percutaneous cholecystostomy or endoscopic ultrasound-guided drainage. The aim of the study is to compare between these two treatment methods, the treatment outcomes and quality of life over a follow-up duration of 36 months.
详细描述
Acute calculous cholecystitis (ACC) is characterized by an inflammatory condition involving the gallbladder wall, most often caused by an obstruction at the infundibulum or cystic duct, with less than 10% of cases provoked by other causes.
Surgical cholecystectomy (SC), especially by laparoscopic assistance, is considered the gold standard approach for the treatment of ACC. However, some patients due to high frailty, multiple comorbidities, and clinically significant organ failure are considered suboptimal or "unfit" candidates for surgery. Therefore, less invasive approaches have been developed for this challenging population.
Percutaneous choleystostomy (PC) has been traditionally considered the first alternative in patients who are not considered for surgery, as it is a less invasive approach with lower rates of complications compared to SC. The procedure is considered technically easy for experienced interventional radiologists and is based on the insertion of a percutaneous catheter in the gallbladder under fluoroscopic assistance after an ultrasound-guided puncture with an 18-gauge needle. Nevertheless, like any other procedure, PC is not exempt from complications, such as bleeding, pneumothorax, peritonitis, injury to adjacent organs, pain at the site of insertion, catheter dislodgement, and risk for recurrent cholecystitis upon removal of the catheter.
Endoscopic ultrasound (EUS)-guided gallbladder drainage (EUS-GBD) has been described as another minimally invasive option for these patients. Under endoscopic ultrasound-guidance, a lumen-apposing metal stent is placed within the gallbladder lumen from the stomach or the duodenum (EUS-GBD), thus allowing internal drainage. EUS-GBD appears to have some benefits over PC, since the latter is typically associated with patient's discomfort and pain at the site of insertion, and carries inherent disadvantages associated with external drainage.
The management of ACC in patients who are not surgical candidates is complex. These patients carry a high risk of peri-cholecystectomy and post-cholecystectomy complications and a mortality rate of up to 19%. The initial management of patients who are not surgical candidates consists of antibiotic therapy and minimally invasive procedures for adequate gallbladder drainage. These procedures include PC and endoscopy-guided gallbladder drainage. Tokyo Guidelines-2018 (TG-18) recommend PC as the standard drainage method for surgically high-risk patients with AC. World Society of Emergency Surgery 2020 guidelines recommend considering endoscopic transpapillary gallbladder drainage (ET-GBD) or EUS-GBD as an alternative to PC in high-volume centers when performed by skilled endoscopists. There is a lumen-apposing metal stent (LAMS), which was recently approved by the Food and Drug Administration (FDA) for EUS-GBD in poor surgical candidates.
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)
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
- •Patients with suspected or confirmed acute calculous cholecystitis, diagnosed per Tokyo guidelines
- •Age ≥ 18 years
- •Patients due to severe comorbidity who are deemed to be never-surgery candidates by the multidisciplinary team or patients who refuse to undergo surgery.
- •Patients can undergo EUS-guided drainage and percutaneous cholecystostomy tube placement.
- •Written informed consent by the patient or guardian who can understand the nature and possible consequences of participation in the study.
排除标准
- •Pregnancy
- •Patients who are potential candidates for future cholecystectomy.
- •Patients unwilling to undergo follow-up assessments.
- •Patients with suspected gangrene or perforation of the gallbladder
- •Patients are diagnosed with concomitant liver abscess or necrotizing pancreatitis.
- •Altered anatomy of the upper gastrointestinal tract due to surgery of the esophagus, stomach and duodenum.
- •Indwelling percutaneous cholecystostomy tube.
- •Refractory/persistently significant ascites despite paracentesis.
- •Distance between the gallbladder and gastric/duodenal wall that cannot be bridged by the metal stent.
- •Abnormal coagulation parameters that cannot be correct: INR > 1.7 and/or platelets < 50.000/mm3
结局指标
主要结局
Composite endpoint of 1) procedure-related adverse events, 2) reintervention for disease recurrence or procedure-related adverse events, and/or 3) readmission due to underlying disease or procedure-related adverse events
时间窗: 36 months
A composite endpoint of 1) procedure-related adverse events, 2) reintervention for disease recurrence or procedure-related adverse events, and/or 3) readmission due to underlying disease or procedure-related adverse events, from index procedure to 36 months post-index intervention.
次要结局
- Mortality(30 days)
- Procedure-related adverse events(36 months)
- Disease-related adverse events(36 months)
- New onset single and multiple organ failure.(36 months)
- New onset systemic dysfunction.(36 months)
- Intraabdominal bleeding.(36 months)
- Leakage of bile from the gallbladder or the biliary tract.(36 months)
- Perforation of a visceral organ requiring interventional procedure.(36 months)
- Stent or percutaneous catheter-related complications(36 months)
- Disease recurrence(36 months)
- Need for reintervention(36 months)
- Total number of reinterventions performed(36 months)
- Length of hospitalization(36 months)
- Readmissions(36 months)
- New onset SIRS at 24, 48 and 72 hours, post-index intervention.(72 hours)
- Resolution and improvement of SIRS at 24, 48 and 72 hours, post-index intervention.(72 hours)
- Technical success(36 months)
- Clinical success(36 months)
- Health-related quality of life (HRQoL) scores(36 months)
- Overall treatment costs from index intervention until hospital discharge.(36 months)