Preoperative Biliary Drainage in Malignant Biliary Obstruction

Study Overview
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Brief Summary
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The first alarming symptom of a malignancy of the pancreas or periampullary tumor can be obstructive jaundice (OJ). Pancreato-duodenectomy (PD) combined with oncological treatment can provide long disease-free survival in resectable cases. The literature regarding the preoperative biliary drainage is controversial. The aim of this multicenter, prospective observational cohort study is to investigate the role of preoperative drainage, and to compare it with surgery alone.

Official Title
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Preoperative Biliary Drainage in Malignant Biliary Obstruction - an Observational Cohort Study

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Procedure: Preoperative drainage and pancreatoduodenectomy
* Procedure: Pancreatoduodenectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ≥ 18 years OJ of malignant origin (pancreatic head or periampullary tumor) Total bilirubin level ≥ 40 μmol per liter Signed written informed consent Exclusion Criteria: Proved metastasis Irresectable tumor Neo-adjuvant chemotherapy Co-existing malignancy Pregnancy Patients not fit for resection

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Preoperative biliary drainage and pancreatoduodenectomy<br>Patients receiving preoperative biliary drainage before the removal of the tumor. | Procedure: Preoperative drainage and pancreatoduodenectomy<br>* Preoperative biliary drainage before surgical removal of the tumor<br>|
| Pancreatoduodenectomy only<br>Patients undergoing only surgical intervention, without preoperative drainage. | Procedure: Pancreatoduodenectomy<br>* Pancreatic tumor resection without previous preoperative biliary drainage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of serious complications | rate of serious complications after preoperative biliary drainage and surgery Pancreatitis New onset of cholecystitis Cholangitis Perforation Hemorrhage after endoscopic retrograde cholangiopancreatography (ERCP) Related to stent Occlusion Need for exchange Related to surgery Pancreas anastomosis leakage | 120 days | 
| rate of serious complications | rate of serious complications after preoperative biliary drainage and surgery defined as: Pancreatitis New onset of cholecystitis Cholangitis Perforation Hemorrhage after endoscopic retrograde cholangiopancreatography (ERCP) Related to stent Occlusion Need for exchange Related to surgery Pancreas anastomosis leakage | 120 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospitalization | Length of hospitalization after biliary drainage and surgery | 120 days | 
| Mortality | Rate of mortality among groups | 30 days | 
| Mortality | Rate of mortality among the groups | 120 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pancreatic cancer, biliary drainage, pancreato-duodenectomy