Evaluation of Preoperative Biliary Drainage Before Pancreatoduodenectomy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of preoperative biliary drainage (PBD) which is performed prior to pancreatoduodenectomy candidates with obstructive jaundice by observing the prevalence of drainage and surgery related complications, hospital stay, medical cost and life quality compared to surgery alone. It is anticipated that PBD can reduce the prevalence of complications and improve the outcome of pancreatoduodenectomy.

Detailed Description
-----------------
Obstructive jaundice is a common symptom in patients with pancreatic head cancer or peri-ampullary cancer. It is regarded that proper surgical resection is the only possible way of radical cure for those patients without evidence of metastasis. Since high preoperative bilirubin level is suggested to be a risk factor for pancreatoduodenectomy, preoperative biliary drainage has been applied to clinical practice to improve the outcome of surgery. However, results from previous studies have inconsistent results showing that PBD may have adverse effect on patients by elevating the prevalence of complications. Since PBD is widely performed worldwide, its value needs to be clarified. Thus the present study is designed to systematically evaluate the value of PBD via recruiting participants who may most likely benefit from PBD. It is anticipated that results from this study can present an instructive conclusion on whether PBD should be performed prior to pancreatoduodenectomy as well as reveal the preferable type of PBD.

Official Title
-----------------
Evaluation of Preoperative Biliary Drainage on Outcome of Pancreatoduodenectomy: A Multicenter Randomized Controlled Study

Conditions
-----------------
Pancreatic Cancer, Periampullary Carcinoma

Intervention / Treatment
-----------------
* Procedure: Pancreatoduodenectomy
* Procedure: ENBD and Pancreatoduodenectomy
* Procedure: EBD and Pancreatoduodenectomy
* Procedure: PTCD and Pancreatoduodenectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 to 70 years old CT (Computed Tomography), CTA (Computed Tomographic Angiography), MRI (Magnetic Resonance Imaging) or ultrasonic test suggested pancreatic head carcinoma or periampullary carcinoma with obstructive jaundice First routine test of serum bilirubin above 250μmol per liter Exclusion Criteria: Distant metastasis in liver, lung or other sites Invasion of local blood vessels (e.g. aorta, portal vein, postcava) Poor physical condition, unable to tolerate anesthesia and surgery (e.g. severe cardio-pulmonary diseases, blood coagulation disorders) With cholangitis, active hepatitis or other diseases which should be excluded from study according to the investigators

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pancreatoduodenectomy<br>Instant pancreatoduodenectomy within one week after diagnosis including: Evaluate the resectability; Remove pancreas head, gastric pyloric antrum, duodenum, distal common bile duct and regional lymph nodes; Reconstruct digestive tract. | Procedure: Pancreatoduodenectomy<br> <br> |
| Experimental: ENBD and Pancreatoduodenectomy<br>Consistent ENBD (Endoscopic Nasobiliary Drainage) for 3 weeks or drainage until bilirubin level decreases to 200μmol per liter or below then perform pancreatoduodenectomy including: Evaluate the resectability; Remove pancreas head, gastric pyloric antrum, duodenum, distal common bile duct and regional lymph nodes; Reconstruct digestive tract. | Procedure: ENBD and Pancreatoduodenectomy<br> <br> |
| Experimental: EBD and Pancreatoduodenectomy<br>Consistent EBD (Endoscopic Biliary Drainage) for 3 weeks or drainage until bilirubin level decreases to 200μmol per liter or below then perform pancreatoduodenectomy including: Evaluate the resectability; Remove pancreas head, gastric pyloric antrum, duodenum, distal common bile duct and regional lymph nodes; Reconstruct digestive tract. | Procedure: EBD and Pancreatoduodenectomy<br> <br> |
| Experimental: PTCD and Pancreatoduodenectomy<br>Consistent PTCD (Percutaneous Transhepatic Cholangial Drainage) for 3 weeks or drainage until bilirubin level decreases to 200μmol per liter or below then perform pancreatoduodenectomy including: Evaluate the resectability; Remove pancreas head, gastric pyloric antrum, duodenum, distal common bile duct and regional lymph nodes; Reconstruct digestive tract. | Procedure: PTCD and Pancreatoduodenectomy<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Infectious Complications |  | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Hemorrhagic Complications |  | up to 6 months | 
| Liver Function Evaluation |  | up to 6 months | 
| Incidence of Bile Leakage |  | up to 6 months | 
| Incidence of Pancreatic Leakage |  | up to 6 months | 
| Life Quality Score |  | up to 12 months | 
| Digestive Function Recovery |  | up to 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obstructive Jaundice, Preoperative Biliary Drainage, Pancreatoduodenectomy