Process Optimization of Preoperative Biliary Drainage in Patients With Malignant Obstructive Jaundice

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and effectiveness of different methods of preoperative biliary drainage in patients with extrahepatic bile duct neoplasms with obstructive jaundice (hilar cholangiocarcinoma, distal bile duct cancer, and periampullary carcinoma), including PTBD (Percutaneous Transhepatic Biliary Drainage), ENBD (Endoscopic Nasobiliary Drainage) and EBS (Endoscopic Biliary Stenting).

Official Title
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Process Optimization of Preoperative Biliary Drainage in Patients With Malignant Obstructive Jaundice of Extrahepatic Bile Duct: A Multi-center, Prospective, Open-labeled, Real World Study Based on Electronic Data Capture System

Conditions
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Jaundice, Obstructive, Klatskin Tumor

Intervention / Treatment
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* Procedure: PTBD group
* Procedure: ENBD group
* Procedure: EBS group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who meet the following four criteria are included into the study: Preoperative clinical diagnosis of hilar cholangiocarcinoma, distal bile duct cancer, periampullary cancer without distant metastasis or peripheral vascular invasion, and plan for radical surgery; Serum total bilirubin is higher than 51 umol/l; Age is older than 18 and younger than 80 years old; Sign in informed consent to receive preoperative PTBD, ENBD, EBS or without PBD. Exclusion Criteria: If any of the following items are met, the subject cannot enter the study. Incorporate severe mental illness, severe heart, lungs and kidneys disease, etc., and be unable to tolerate surgery; Malignant obstructive jaundice caused by metastatic tumors; Pregnancy or lactation women.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PTBD group<br>Percutaneous Transhepatic Biliary Drainage | Procedure: PTBD group<br>* Percutaneous Transhepatic Biliary Drainage, a kind of Preoperative Biliary Drainage methods for hilar cholangiocarcinoma patients<br>|
| Experimental: ENBD group<br>Endoscopic Nasobiliary Biliary Drainage | Procedure: ENBD group<br>* Endoscopic Nasobiliary Drainage, a kind of Preoperative Biliary Drainage methods for hilar cholangiocarcinoma patients<br>|
| Experimental: EBS group<br>Endoscopic Biliary Stenting | Procedure: EBS group<br>* Endoscopic Biliary Stenting, a kind of Preoperative Biliary Drainage methods for hilar cholangiocarcinoma patients<br>|
| No Intervention: Without PBD group<br>receive surgery without PBD | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rate after drainage | Complication rate between PBD (preoperative biliary drainage) and radical surgery | From PBD to completion of radical surgery, an average of 1 month | 
| Complication rate after radical surgery | Complication rate after radical surgery | 1 month post operatively | 
| Success rate of PBD | Success rate of different methods of PBD | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operative time | duration of radical surgery | Day 1 | 
| Hepatoduodenal edema | Degree of hepatoduodenal edema (including no edema, mild edema, moderate edema, and severe edema) | at time of radical surgery | 
| Perioperative mortality | Mortality between PBD and 4 weeks after surgery | from PBD to 4 weeks after surgery, an average of 2 month | 
| implantation metastasis | Rate of implantation metastasis | Day 1 | 
| Rate of change in Total bilirubin | Recovery efficiency of liver function | 2 weeks after PBD | 
| Rate of change in alanine aminotransferase | Recovery efficiency of liver function | 2 weeks after PBD | 
| Rate of change in aspartate aminotransferase | Recovery efficiency of liver function | 2 weeks after PBD |