Endoscopic Stenting Versus Surgical Bypass for Low Bile Duct Obstruction by Cancer of the Pancreatic Head (STENTBY)

Heidelberg University

Status: Terminated

Conditions: Pancreatic Cancer

Treatments: Procedure: Endoscopic stenting; Procedure: Surgical bypass

Study type: Interventional

Funder types: Other

Identifiers

NCT00753441

NNR-02

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age equal or greater than 18 years
• Diagnosis of unresectable cancer of the pancreatic head (after clinical, laboratory, radiological assessment) requiring palliative treatment for biliary obstruction. In unclear cases an exploratory laparotomy will be performed and resectability will be evaluated intraoperatively
• Operability certified by anesthesiologist
• Written informed consent

Exclusion criteria

• Intervention technically/medically not feasible
• Expected lack of compliance
• One treatment option considered to be clearly in favor of the patient

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

A

Experimental group

Description:

Surgical bypass (choledochojejunostomy, in combination with gastroenterostomy if necessary)

Treatment:

Procedure: Surgical bypass

B

Active Comparator group

Description:

Endoscopic biliary stenting using metal stent (completed by duodenal stent, if necessary)

Treatment:

Procedure: Endoscopic stenting