Phase 2/3 Study of Use of Streptokinase for Enhancement of Percutaneous Drainage of Pancreatic Necrosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Sepsis reversal
研究概览
简要总结
Around 20 per cent of patients with acute pancreatitis develop pancreatic or peripancreatic necrosis with or without peripancreatic collection.
Percutaneous catheter drainage successfully drains the liquefied component of pancreatic necrosis while the solid component still remains undrained. This infected solid component of pancreatic necrosis is probably responsible for failure of percutaneous catheter drainage which demands surgical debridement.
Streptokinase is a protein secreted by several species of streptococci which can bind and activate human plasminogen.
In the present study investigators plan to instill streptokinase locally in to the collections of patients with severe acute pancreatitis via pigtail catheter inorder to liquefy the solid necrotic component and analyze whether it hastens the drainage and thereby delays or obviates the need for necrosectomy.
详细描述
Around 20 per cent of patients with acute pancreatitis develop pancreatic or peripancreatic necrosis with or without peripancreatic collections. Sterile necrosis can generally be managed conservatively and the mortality rate is relatively low (12 per cent). Approximately 30 (range 14-62) per cent of patients with necrotizing pancreatitis, however, develop secondary infections of peripancreatic fluid collection which is associated with sepsis and organ failure and is an indication for intervention1.
Until recently, the first-choice intervention in patients with infected necrotizing pancreatitis or sterile necrosis with clinical deterioration (multiple organ failure) has been open surgical necrosectomy. This approach is associated with considerable morbidity (34-95 per cent) and mortality (11-39 per cent). In 1998, Freeny and colleagues10 first described a consecutive series of patients with infected pancreatic necrosis who were treated primarily with imaging-guided percutaneous catheter drainage (PCD), as an alternative to primary surgical necrosectomy. The rationale for PCD was to drain the infected fluid under tension and gain time to improve organ function of these critically ill patients and thereby delay or avoid surgical necrosectomy. In their retrospective cohort study, PCD was successful in postponing surgical intervention for a median of 4 weeks and even obviated the need for surgical necrosectomy in almost half of the patients. In addition, PCD seems technically feasible in the vast majority of patients with necrotizing pancreatitis.
In clinical experience, investigators have found that PCD successfully drains the liquefied component of pancreatic necrosis while the solid component still remains undrained. This infected solid component of pancreatic necrosis is probably responsible for failure of PCD which demands surgical debridement.
Streptokinase is a protein secreted by several species of streptococci which can bind and activate human plasminogen. It is primarily used in clinical practice intravenously as an effective thrombolytic agent in cases of myocardial infarction and pulmonary thromboembolism.
The earliest reports on intracavitatory use of Streptokinase and other fibrinolytics were for empyemas. Later because of beneficial results, their intracavitatory use was extended to other conditions like liver, retroperitoneal and peritoneal abscesses.
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 (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with severe acute pancreatitis managed by percutaneous catheter drainage
排除标准
- •An acute intra abdominal event (perforation of hollow viscus, bleeding, or abdominal compartment syndrome) before or after PCD insertion.
- •Previous drainage or surgical necrosectomy for infected pancreatic necrosis (ERCP with or without papillotomy is allowed.)
- •Previous exploratory laparotomy for acute abdomen and diagnosis of pancreatitis during laparotomy
- •Patients who are allergic to streptokinase.
- •Patients with deranged coagulation profile.
- •Patients with recent history of cerebrovascular accident [< 2 months], intracranial or intraspinal surgery, uncontrolled hypertension, intracranial neoplasm.
研究组 & 干预措施
Group B [streptokinase]
50000U of injection streptokinase dissolved in 100ml of normal saline instilled in to the pancreatic and/or peripancreatic collections via the percutaneous catheters and clamped for 2 hours. After release of clamp, cavity will be irrigated with 100-500ml of normal saline. This procedure will be done thrice daily for five days
干预措施: streptokinase (Drug)
Group A [placebo]
100 ml of normal saline will be instilled through percutaneous catheters in the pancreatic and/or peripancreatic collections and clamped for 2 hours. After release of clamp, cavity will be irrigated with 100-500ml of saline. This procedure will be performed thrice daily for five days
干预措施: Saline irrigation (Other)
结局指标
主要结局
Sepsis reversal
时间窗: From date of randomization until the date of necrosectomy, discharge or death from any cause, whichever came first, assessed upto 1 month
Mortality
时间窗: From the date of randomization until last follow up after discharge, assessed up to 1 month
次要结局
- Length of intensive care unit (ICU) and hospital stay(From date of randomization until the date of discharge or death from any cause, whichever came first, assessed upto 1 month)
- Proportion of patients requiring surgical necrosectomy(From date of randomization until the date of discharge or death from any cause, whichever came first, assessed upto 1 month)
- Number and size of catheters required(From date of first pigtail insertion until the date of necrosectomy, discharge or death from any cause, whichever came first, assessed upto 1 month)
- Number of interventions required(From date of first pigtail insertion until the date of necrosectomy, discharge or death from any cause, whichever came first, assessed upto 1 month)
- Catheter-related complications(From date of first pigtail insertion until the date of necrosectomy, discharge or death from any cause, whichever came first, assessed upto 1 month)
- Streptokinase related complications(From date of randomization until the date of necrosectomy, discharge or death from any cause, whichever came first, assessed upto 1 month)
研究者
Rajesh Gupta
Additional Professor, Division of Surgical Gastroenterology, Department of General Surgery
Post Graduate Institute of Medical Education and Research, Chandigarh