Randomized Controlled Trial Of Endoscopic Stenting Across the Papilla Versus the Leak Site to Treat Bile Leak
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Proportion of patients with resolution of bile leak by cholangiography
研究概览
简要总结
- Biliary duct injury are a relatively frequent complication of hepatobiliary surgery, most comonly laparoscopic cholecystecomy.
- Prior to the development of more sophisticated endoscopic interventions, repeat surgery was often necessary for the management of biliary leaks.
- Advances in technique and technology in gastroenterology endoscopy have largely replaced surgery as the first line intervention for biliary leak.
- Most practices utilize endoscopic plastic biliary stent placement alone and are efficacious and equivalent to the biliary stent placement with endoscopic biliary sphincterotomy.
- An area of variation is in whether biliary stent should cross the papilla ( with a shorter stent) versus the site of the bile leak (with a longer stent).
- Our objective is to assess whether placing a biliary stent across the leak versus across the papilla alone improves the treatment of biliary leaks.
详细描述
1.0 BACKGROUND 1.1) Biliary duct injuries are a relatively frequent complications of hepatobiliary surgery, most commonly laparoscopic cholecystectomy1. Such injuries can manifest clinically in a number of ways including biliary leakage, biliary stricture formation, or associated infectious complications. Biliary leakage is the most common of these postoperative complications and is estimated to be clinically significant in 0.8 to 1.1% of such surgeries.
Prior to the development of more sophisticated endoscopic interventions, repeat surgery was often necessary for management of biliary leaks. However, advances in technique and technology in gastrointestinal endoscopy have largely replaced surgery as a first line intervention for biliary leaks. The generally accepted goal in the endoscopic management of biliary leaks is to equalize the pressure between the biliary system and the duodenum, so as to allow bile to flow into the lower pressure small bowel and thereby affording the leak time to close.
How to best achieve this goal has been a topic of considerable interest. Randomized studies have shown that endoscopic plastic biliary stent placement alone is highly efficacious and equivalent to biliary stent placement with endoscopic biliary sphincterotomy. Thin (7 French[Fr]) and wide (10 French) diameter stents seem to have similar efficacy with regards to leak resolution. Beyond these well-validated techniques, there are other variations in clinical practice that are not supported by high-levels of evidence.
1.2) One area of variation is in whether the biliary stent should cross the papilla (with a shorter stent) versus the site of the leak (with a longer stent).
2.0 OBJECTIVES AND PURPOSE
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing ERCP for the treatment of suspected acute bile leaks will be eligible for inclusion (bile leaks felt to be complications of surgical intervention). A patient is suspected to have an acute bile leak if the patient is referred within two weeks following the original surgery.. Legally authorized representatives may serve as surrogates to consent for inclusion in this study.
- •Bile leaks are suspected based on the following:
- •A) Persistent, significant drainage of bilious fluid from post-surgical drains following hepatobiliary surgery or cholecystectomy,.
- •B) Compatible symptoms plus imaging findings on abdominal ultrasonography, computed tomography, HIDA scanning, or MRCP of an abnormal intra-abdominal fluid collection in the setting of recent hepatobiliary surgery.
排除标准
- •Patients with bile duct transection (in which the duct has been totally severed into 2 parts) will be excluded as these are known to not be amenable to endoscopic therapy. Further, suspected bile leaks of non-surgical etiology will be excluded from the study (malignancy, trauma, spontaneous perforation, and other rarer causes). Bile leaks suspected two weeks post surgery will also not be included. Additionally patients who are pregnant, imprisoned, under age 18, unable to give informed consent, or have undergone prior biliary diversion surgery will be excluded.
结局指标
主要结局
Proportion of patients with resolution of bile leak by cholangiography
时间窗: within 5 weeks
The primary outcome is the proportion of patients with resolution of bile leak determined by cholangiography at 5 weeks among the two groups.
次要结局
- Time to from ERCP to remove surgical drain(within 5 weeks)
- Proportion of patients who required surgery(within 10 weeks)
研究者
James Buxbaum
Associate Professor
University of Southern California