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临床试验/NCT02166840
NCT02166840已完成2 期

Self Expanding Metal Stents (SEMS) or Plastic Stents to Relieve Obstruction of Obstructive Jaundice Prior to Resection of Periampullary Tumors.

Karolinska University Hospital2 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2007年3月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
92
试验地点
2
主要终点
Degree and amount of bile bacterial contamination at the time of resection

研究概览

简要总结

Patients with obstructive jaundice due to periampullary tumor can temporarily be relieved of their jaundice with transpapillary stenting at endoscopic retrograde cholangio-pancreatography (ERCP) prior to operation. Usually plastic stents are used.

Hypothesis: Self expanding metallic stents offer a be a better alternative for preoperative stenting in patients with obstructive jaundice due to periampullary tumour obstruction.

详细描述

Patients who present with obstructive jaundice and have a periampullary tumor and where the patient seems to be in good condition for surgical resection are offered the opportunity to become randomized to either endoscopic drainage with self expanding metallic or plastic stents. Before randomization they are informed about the study details and have to give their consent to participate. The metallic as well as plastic stents are standard commercially available stents. Within four weeks after stent placement the patient will be operated and the following parameters will be evaluated: quality of life, clinical symptoms and lab tests. At the operation the surgeon will make an evaluation of the inflammatory reaction in the area of the bile ducts. A culture from the bile is sampled close to the area where the anastomosis will be sutured. A tissue sample is also taken from the bile ducts to evaluate inflammation. A Lymph node is also sampled for the same reason. The surgeon also evaluates the difficulty with which the stent had to be removed. Postoperative complications are monitored in line with the regular routines at the clinic.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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

入选标准

  • Obstructive jaundice in periampullary tumor.

排除标准

  • Not willing to participate.
  • Not a resectable tumor.

研究组 & 干预措施

Self expanding metal stent

Experimental

Patients with self expanding metal stent inserted into bile duct.

干预措施: Self Expanding Metal Stent (Procedure)

Plastic stent

Active Comparator

Patients with obstructive jaundice who got a plastic stent inserted into bile duct.

干预措施: Plastic stent (7-10Fr) (Procedure)

结局指标

主要结局

Degree and amount of bile bacterial contamination at the time of resection

时间窗: Time at the operation

次要结局

  • Degree of inflammation around the bile duct.(Time at the operative intervention)
  • Bacterial culture of lymph nodes in the hepatoduodenal ligament.(Time of operative intervention)
  • Postoperative hospital stay.(Time from intervention until day of discharge from hospital (on an average less than 90 days).)
  • General complication rates(Time from intervention until day of discharge from hospital (on an average less than 90 days).)

研究者

发起方
Karolinska University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lars Lundell

Professor

Karolinska University Hospital

研究点 (2)

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