跳至主要内容
临床试验/NCT03358095
NCT03358095撤回不适用

Cancer of the Head of the Pancreas: Early Surgery or Preoperative Biliary Drainage? A Prospective Study

Helsinki University Central Hospital2 个研究点 分布在 1 个国家开始时间: 2017年11月26日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Emerged complications related to surgery or preoperative endoscopy within 120 days of surgery

研究概览

简要总结

Surgical resection is the only option for cure for patients with a resectable tumor located at the head of the pancreas. At the time of diagnosis, these patients often suffer from jaundice. Studies have suggested, that jaundice might increase the risk of developing a serious postoperative complication. Preoperative biliary drainage is widely used, because it is considered to improve the surgical outcome and reduce the amount of postoperative complications. There are also studies that suggest the opposite. In these studies the overall complication rate with patients who underwent preoperative biliary drainage was higher than in the patients who were operated right away. A significant amount of these complications were related to the biliary drainage process itself. However, preoperative biliary decompression is widely used in many centers as many surgical centers don't possess the needed resources to arrange early surgery. The benefits and risks of this procedure remain unclear. This multicenter trial aims to compare the surgical outcome and the rate of serious complications in patients who proceed directly to early surgery and patients who have preoperative biliary drainage.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients in this study must have a resectable tumor of the head of the pancreas, and no evidence of distant metastasis or local vascular involvement. At the beginning of the study it's not necessary to have an accurate histologic diagnosis, the tumor might be malignant or benign. The patients also have jaundice with a total serum bilirubin level of 40-250µmol/l, and are fit enough to be considered for an early surgery.

排除标准

  • Patients with ongoing cholangitis, neoadjuvant treatments or previous biliary drainage with stenting by means of ERCP or PTC (Percutaneous Transhepatic Cholangiogram) are excluded.

结局指标

主要结局

Emerged complications related to surgery or preoperative endoscopy within 120 days of surgery

时间窗: 120 days after surgery

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Leena Kylanpaa

Head of department

Helsinki University Central Hospital

研究点 (2)

Loading locations...

相似试验