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

Study Overview
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Brief Summary
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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.

Official Title
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Endoscopic Biliary Stenting on Demand Versus Surgical Biliary Bypass for Palliation of Patients With Advanced Cancer of the Pancreatic Head: STENTBY - A Randomized Controlled Trial

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Procedure: Surgical bypass
* Procedure: Endoscopic stenting


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Surgical bypass (choledochojejunostomy, in combination with gastroenterostomy if necessary) | Procedure: Surgical bypass<br>* Surgical bypass (choledochojejunostomy, in combination with gastroenterostomy if necessary)<br>|
| Active Comparator: B<br>Endoscopic biliary stenting using metal stent (completed by duodenal stent, if necessary) | Procedure: Endoscopic stenting<br>* Placement of a biliary metal stent (in combination with a duodenal metal stent in case of gastric outlet obstruction if necessary)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  | 12 months | 
| Serum bilirubin |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure-related complications |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stent, Pancreatic cancer, Bile duct obstruction, Bypass