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临床试验/NCT01913275
NCT01913275撤回不适用

Comparison Between Endoscopic Stenting and Cholecystojejunostomy for PreoperativeDrainage Before Pancreaticoduodenectomy

All India Institute of Medical Sciences, New Delhi2 个研究点 分布在 1 个国家开始时间: 2006年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
2
主要终点
Technical success

研究概览

简要总结

Periampullary carcinoma and carcinoma head of pancreas are common causes of obstruction at the lower end of the common bile duct. Whenever possible, surgical resection in the form of Whipple Pancreaticoduodenectomy (WPD) is the treatment of choice. However, this operation is associated with a substantial postoperative morbidity and mortality. With advances in surgical techniques and postoperative care there has been a decrease in the operative mortality. However, the postoperative morbidity remains high varying between 5%-64%. Of the various risk factors, the degree of jaundice as indicated by the serum bilirubin levels has been associated with an increased risk of complications. Preoperative biliary drainage has been tried to decrease the serum bilirubin levels and consequently decrease postoperative morbidity and mortality. Internal biliary drainage can be achieved by surgical cholecystojejunostomy or endoscopic bile duct stenting. Endoscopic stenting can be done as a day care procedure under conscious sedation, but involves insertion of a foreign body (stent), which results in introduction of bacteria into the bile and problems of postoperative infection. Also, endoscopic stenting before surgery may result in difficulty in dissecting around the common bile duct during the surgical procedure. While the surgical bilioenteric bypass has the advantage that no foreign body is inserted into the biliary tree and hence the likelihood of sepsis is low, it requires anesthesia and involves a surgical incision.

There is no study comparing the outcomes of preoperative endoscopic and surgical drainage in patients undergoing pancraticoduodenectomy. We plan to compare the outcomes of preoperative endoscopic biliary drainage with surgical drainage in patients undergoing pancreaticoduodenectomy.

详细描述

Hypothesis preoperative biliary decompression by Cholecystojejunostomy will reduce infective complication by 23% as compared to endocopic stenting INTRODUCTION Pancreaticoduodenectomy has been associated with a substantial postoperative morbidity and mortality. Advances in surgical techniques and postoperative care have led to a decrease in the operative mortality. However, the postoperative morbidity has remained high varying between 5%-64%.1 Of the various risk factors, analyzed in the retrospective studies, the degree of jaundice as indicated by the serum bilirubin levels has been associated with an increased risk of complications.2-5 Preoperative biliary drainage has been tried to decrease the serum bilirubin levels and consequently decrease postoperative morbidity and mortality. However, its role remains controversial.

External biliary drainage using percutaneous transhepatic insertion of a catheter has been used.6,7 The disadvantages of external bleary drainage include the risk of spontaneous catheter dislodgement, inflammation and pain at the puncture site, leak of ascitic fluid and bile around the catheter, and loss of fluid and electrolytes. Moreover, bile has an antibacterial action and its loss has been associated with sepsis and renal failure. Hence, internal biliary drainage is considered more appropriate.

Internal biliary drainage can be achieved by surgical cholecystojejunostomy or endoscopic bile duct stenting. The internal drainage provides a more physiological route for drainage of bile into duodenum or jejunum, which prevents any loss of electrolytes and bile salts, and reduces the risk of endotoxemia. Two studies using endoscopic bilary drainage have shown benefit in terms of reduced postoperative morbidity and mortality.7,8 However, it involves the insertion of a foreign body (stent), which results in occurrence of bacteria in bile with its attendant problems of postoperative sepsis.

Prior to the availability of the endoscopic and percutaneous methods, surgical bilioenteric bypass was the only method for preoperative biliary decompression. The disadvantage of this method is that it requires anesthesia and involves a surgical incision. However, its advantages are that no foreign body is inserted into the biliary tree and hence the likelihood of sepsis is low. Also, endoscopic stenting before pancreaticoduodenectomy may result in difficulty while dissecting the common bile duct. Historically, Whipple conceived pancreaticoduodenectomy as a two staged procedure. The first stage was surgical decompression of biliary tract to reduce the level of the hyperbilirubinemia to minimize mortality and morbidity after extirepative surgery and the second stage was a definitive surgical resection.

There is no study comparing the outcomes of preoperative endoscopic and surgical drainage in patients undergoing pancraticoduodenectomy. We plan to carry out a randomized trial comparing the outcomes of preoperative endoscopic biliary drainage with surgical drainage in patients undergoing pancraticoduodenectomy.

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
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with periampullary carcinoma and carcinoma of the head of pancreas.
  • Patients with serum bilirubin >15mg/dl

排除标准

  • Patients with gastric outlet obstruction.
  • Patients with unresectable tumour assessed by imaging techniques.
  • Patients with a history of cholecystectomy and Billroth II gastrectomy.
  • Patients stented outside

结局指标

主要结局

Technical success

时间窗: 2 minutes

Passage of a stent across the stricture, along with flow of bile through the stent

Successful drainage

时间窗: 5 days

A decrease in bilirubin of at least 20% of the pretreatment value within 5 days after procedure

Intraoperative assessment

时间窗: 0 hour

The operative difficulty, amount of blood loss, number of transfusions required and operative time during definitive surgery.

Procedure-related complication: was defined complications directly related to stent insertion/CJ

时间窗: 30 days

次要结局

  • a. Wound infection(30 days)
  • c. Postoperative haemorrhage(30 days)
  • b. Intra-abdominal abscess(30 days)
  • 1. Procedure-related mortality(30 days)
  • 2. Duration of hospital stay(30 days)
  • 3. Postoperative complication:(30 days)
  • d. Pancreaticojejunal leak(30 days)
  • e. Bile leak(30 days)

研究者

发起方
All India Institute of Medical Sciences, New Delhi
申办方类型
Other
责任方
Principal Investigator
主要研究者

Peush Sahni

Professor

All India Institute of Medical Sciences, New Delhi

研究点 (2)

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