The prognosis of patients with unresectable pancreatic cancer is dismal. Hence, palliation of tumor-associated symptoms, in particular jaundice due to low bile duct obstruction and gastric outlet obstruction, is the primary aim of these patients' care. Endoscopic stenting and surgical bypass are currently the two competing treatment options. There is currently no randomized trial comparing the recently developed metal stents to surgical bypass. Furthermore, there is very limited data on quality of life of these patients receiving either therapy. While endoscopic stenting represents the less invasive treatment, surgery may provide better long-term control requiring one-time treatment. Due to the incomplete evidence the present randomized controlled trial is designed to compare quality of life of patients undergoing endoscopic stenting on demand or surgical bypass for palliation of symptoms caused by cancer of the pancreatic head requiring with low bile duct obstruction.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Surgical bypass (choledochojejunostomy, in combination with gastroenterostomy if necessary)
Placement of a biliary metal stent (in combination with a duodenal metal stent in case of gastric outlet obstruction if necessary)
Universityhospital Heidelberg
Heidelberg, Germany
Quality of life
Time frame: 12 months
Serum bilirubin
Time frame: 12 months
Procedure-related complications
Time frame: 12 months
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