Prospective Randomized Clinical Study for Timing of Laparoscopic Cholecystectomy After Endoscopic Retrograde Cholangiography for Acute Biliary Pancreatitis
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- measurement of peritoneal fibrinolytic response following endoscopic retrograde cholangiography
研究概览
简要总结
Timing of laparoscopic cholecystectomy following after endoscopic retrograde cholangiography for acute biliary pancreatitis is a controversial issue. There are still many confounding findings offering either early laparoscopic cholecystectomy within 72 hours following endoscopic sphincterotomy or delayed surgery after 6 weeks. Peritoneal plasmin system is known to be an important factor in peritoneal healing and adhesion formation. Measurement of tissue concentrations of tissue-type plasminogen activator and its specific activity, urokinase-type plasminogen activator, and plasminogen activator inhibitor type 1 are thought to be helpful to show peritoneal adhesions after endoscopic sphincterotomy.
详细描述
Peritoneal fibrinolysis is crucial in peritoneal healing processes and subsequent adhesion formation. It is expected that endoscopic retrograde cholangiography is a trauma causing adhesions around the hepatobiliary area. Such adhesions may cause some difficulty for consequent gallbladder surgery. For that reason, tissue measurements of factors indicating degree of peritoneal healing and adhesion is helpful for timing of such surgical interventions.
Patients are going to be randomized to early and delayed surgery groups. Sampling of peritoneum around the gallbladder during laparoscopic cholecystectomy in patients after endoscopic retrograde cholangiography is performed. Tissue concentrations of tissue-type plasminogen activator and its specific activity, urokinase-type plasminogen activator, and plasminogen activator inhibitor type 1 are going to be studied by using commercial assays.
Peritoneal fibrinolytic activity and surgical outcomes are going to be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •cholelithiasis following endoscopic retrograde cholangiography for acute biliary pancreatitis
排除标准
- •contraindication to laparoscopy
- •unsuccessful endoscopic retrograde cholangiography
- •complicated acute biliary pancreatitis
结局指标
主要结局
measurement of peritoneal fibrinolytic response following endoscopic retrograde cholangiography
时间窗: six months
measurement of tissue concentrations of tissue-type plasminogen activator and its specific activity, urokinase-type plasminogen activator , and plasminogen activator inhibitor type 1
次要结局
- surgical outcomes of laparoscopic cholecystectomy following endoscopic retrograde cholangiography(six months)
研究者
Mustafa Hasbahceci
MD, general surgeon
Bezmialem Vakif University