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临床试验/NCT03012243
NCT03012243尚未招募不适用

Randomized Controlled Trial of Bile Aspiration vs Drain in Acute Cholecystitis

Karolinska Institutet2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
40
试验地点
2
主要终点
Amount of morphine administrated

研究概览

简要总结

In order to compare percutaneous cholecystostomy and leaving a drain in situ with percutaneous gallbladder aspiration we plan to undertake a double-blind randomized controlled trial.

详细描述

Percutaneous cholecystostomy is a minimally invasive technique for treatment of cholecystitis. The cholecystostomy can be inserted transhepatically or transabdominally. The transhepatic route is preferred due to lower risk for bile leakage. The drainage decompresses the gallbladder and drains the bile. This decompression reduces the inflammatory process in the gallbladder. Percutaneous cholecystostomy is often applied in patients not fit for emergency surgery who are in need of intervention due to deterioration of their clinical status. However, even though cholecystostomy is widely practised, it is not fully evaluated.

Percutaneous cholecystostomy has a high success rate, a low procedure-related mortality but a 30 day mortality of 15%. Furthermore, recurrence rates within one year after a cholecystostomy are reported to range between 4 to 22%.

The time duration of the drainage differ between different studies and range from three to six weeks. Optimal timing for drainage has not been studied. Two weeks seem to be sufficient for a maturation of the tract for the transhepatic route and 3 weeks for the transabdominal route. It has been suggested that a prolonged drainage duration is associated with increased risk for recurrence of inflammation due to local irritation of the gallbladder mucosa by the drain.

Percutaneous cholecystostomy is often considered as a bridge to surgery. However, less than half of patients treated with PC are treated with cholecystectomy. This suggests that this treatment is often chosen in a group not fit for surgery and often turns out to be a definitive treatment.

Percutaneous gallbladder aspiration is a technique used for purposes similar to percutaneous cholecystostomy. This technique is an alternative that may be more convenient than percutaneous cholecystostomy. The aspiration is performed with a small gauge needle under ultrasound guidance without leaving a drain. The aspiration leads to a decompression of the gallbladder, which facilitates recovery. However, it has only been described in a few studies and need more evaluation.

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
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Acute cholecystitis, not warranting acute cholecystectomy

排除标准

  • Indication for acute cholecystectomy, i.e. history < 5 days and no contraindication to surgery
  • Liver cirrhosis
  • Emphysematous cholecystitis
  • Gallbladder perforation
  • Suspected malignant condition
  • Portal Hypertension
  • Biliary pancreatitis
  • Common bile duct stones

结局指标

主要结局

Amount of morphine administrated

时间窗: 24 hours

The total amount of morphine required to relieve the pain the first 24 hours

次要结局

  • Pain(5 days)
  • Nausea(5 days)
  • Body temperature(5 days)
  • CRP(5 days)
  • Complications(30 days)
  • LPK(5 days)
  • Re-intervention(5 days)
  • Time to discharge(30 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gabriel Sandblom

Associate Professor

Karolinska Institutet

研究点 (2)

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