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临床试验/NCT01459965
NCT01459965已完成不适用

Endoscopic Palliation of Malignant Biliary Tract Obstruction: Emphasis on Improvement in Quality of Life

Indiana University0 个研究点目标入组 164 人开始时间: 1993年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
164
主要终点
Documented change in Quality Of Life

研究概览

简要总结

Endoscopic stent insertion is considered the method of choice for palliation of malignant bile duct obstruction (MBDO). However, it can cause complications and requires periodic stent exchanges. While endoscopic stenting is clearly indicated for relief of cholangitis or refractory pruritus, its role in patients with jaundice alone is less clear. Endoscopic stenting for this relative indication might be justified, if there is a significant improvement in quality of life (QOL) of such patients. The aim of the investigators study was to determine whether endoscopic stenting for MBDO results in improved QOL.

详细描述

Most malignant tumors causing bile duct obstruction, such as pancreatic adenocarcinoma, gallbladder carcinoma or cholangiocarcinoma, have an extremely poor prognosis. At the time of diagnosis the majority of these tumors will be unresectable with a median survival of 4-6 months. Palliation is the goal for those patients with unresectable tumors and limited survival and for those at high risk for attempts at curative resection.

Endoscopic retrograde cholangiopancreatography (ERCP) with endoscopic stent insertion is considered the method of choice for palliative treatment of malignant bile duct obstruction (MBDO). However, it can cause complications, such as pancreatitis, bleeding, perforation, cholangitis and stent migration in a significant proportion of treated patients. Clogging of plastic stents is a predictable consequence and requires periodic stent exchanges with attendant risks and costs. While endoscopic stenting is clearly indicated for relief of cholangitis or refractory pruritus, the role of stenting in patients with jaundice alone, abdominal pain, or failure to thrive due to malignancy is less clear. Given the risk for complications and costs, endoscopic therapy might be justified in these clinical scenarios if quality of life (QOL) is significantly improved. A few available studies have demonstrated improved QOL in stented patients. However, these studies include a small number of patients and/or are retrospective in design. Therefore, more evidence to support routine palliative biliary drainage in patients with MBDO is desired.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with suspected or proven malignant biliary obstruction who were unresectable or inoperable and were undergoing ERCP and biliary stenting for biliary depression.

排除标准

  • Had previously undergone biliary stenting
  • Surgery was planned
  • A guidewire could not be passed through the stricture
  • Suspected survival of < 3 months
  • Impending duodenal obstruction

结局指标

主要结局

Documented change in Quality Of Life

时间窗: 180 days after stent insertion

Documented change in QOL over the first month and over six months after successful biliary drainage compared with that before the procedure. The FACT-G questionnaire administered at baseline, at 1 month after stent insertion and at 180 days after stent insertion was used to assess this outcome. Change from baseline was analyzed at each of these time points separately.

次要结局

  • Documented change in symptoms and concerns specific for patients with MBDO(180 days after stent placement)

研究者

申办方类型
Other
责任方
Sponsor

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