NCT03358095

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

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Helsinki University Central Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Pancreatic Cancer
• Biliary Stasis

Interventions

Type	Name	Description
DEVICE	Tannenbaum Fr 10 stent or WallFlex stent	A plastic or metallic endoprosthesis is placed to the biliary ducts.

Timeline

• Start date: 2017-11-26
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2017-11-30
• Last updated: 2021-05-20

Locations

1 site across 1 country: Finland