Surgical vs Endoscopic Treatments as ImmunoModulating Interventions in High-Risk Acute Calculous Cholecystitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- The primary objective of the study is to find if TUGD with LAMSs, compared to LC, has a lower inflammatory and immunologic impact on high-risk patients with ACC.
研究概览
简要总结
Randomized controlled trial on high-risk patients with ACC. Consecutive patients with a diagnosis of ACC, if they meet the inclusion and exclusion criteria, will be randomized to receive Laparoscopic cholecystectomy (LC) or transmural ultrasound-guided gallbladder drainage (TUGD) with lumen-apposing self-expandable metal stents (LAMSs) within 10 days from onset of symptoms. Blood cultures will be performed at the time of admission, just before the procedure, 24 ± 3h after procedure, 72 ± 3h after procedure. Bile samples will be taken during the procedure for microbiological exam and culture. Blood samples will collected from all patients at the time of admission, just before the procedure, 24 ± 3h after procedure, 72 ± 3h after procedure.
The follow-up will be performed after 30 days and after 6 months from intervention with an outpatient medical examination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •have a diagnosis of ACC as defined by 2018 Tokyo Guidelines criteria
- •be ≥ 18 years old
- •have a POSSUM PS ≥ 25
- •onset of symptoms <= 7 days before Emergency Department (ED) admission
- •provide signed and dated informed consent form
- •willing to comply with all study procedures and be available for the duration of the study
- •have an Israelian Score (IS) (Table 3) for the risk of main bile duct stones <2 or an IS =2 and an EUS or a MRCP negative for main bile duct stones
排除标准
- •Pregnancy
- •Patients unwilling to undergo follow-up assessments
- •Patients diagnosed with concomitant pancreatitis
- •Acute cholecystitis not related to a gallstone etiology
- •Onset of symptoms >7 days before ED admission
- •Altered anatomy of the upper gastrointestinal tract due to surgery of the esophagus, stomach and duodenum
- •Previous drainage of the gallbladder
- •Biliary peritonitis
结局指标
主要结局
The primary objective of the study is to find if TUGD with LAMSs, compared to LC, has a lower inflammatory and immunologic impact on high-risk patients with ACC.
时间窗: baseline, pre-surgery, day 3
Difference between the plasma elastase concentration before surgery and on the third postoperative day
次要结局
- difference between the plasma concentration biochemical and immunological parameters(baseline, pre-surgery, day 1, day 3)
- 30-day postoperative complication rate according to Clavien-Dindo(day 30)
- 30-day postoperative biliary complication rate(day 30)
- 30-day postoperative mortality rate(day 30)
- Intraoperative complication rate(day 0)
- Failure rate of performing the procedure(day 0)
- Operative times(through study completion, an average of 2 years)
- Postoperative length of stay (PO-LOS)(through study completion, an average of 2 years)
- Total length of stay (T-LOS)(through study completion, an average of 2 years)
- Total readmission rate within 6 months(6 Months after procedure)
- Readmission rate within 6 months due to Gallstones Relates Events (GRE)(6 Months after procedure)
- Outcomes of blood and bile cultures (to define the infectious state of the patient)(Baseline, pre-surgery, during the surgery, day 1, day 3)
- Post-operative pain(through study completion, an average of 2 years)
研究者
Luca Ansaloni
MD
Fondazione IRCCS Policlinico San Matteo di Pavia