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

Jaundice, Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03527875
• Other study ID #: 2018ZSLC24
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2018
• Est. completion date: July 2022

Study information

• Verified date: June 2018
• Source: Shanghai Zhongshan Hospital
• Contact: Houbao Liu, PHD
• Phone: 13818971698
• Email: houbaoliu[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 564
• Est. completion date: July 2022
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients who meet the following four criteria are included into the study:

1. Preoperative clinical diagnosis of hilar cholangiocarcinoma, distal bile duct cancer, periampullary cancer without distant metastasis or peripheral vascular invasion, and plan for radical surgery;

2. Serum total bilirubin is higher than 51 umol/l;

3. Age is older than 18 and younger than 80 years old;

4. 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.

1. Incorporate severe mental illness, severe heart, lungs and kidneys disease, etc., and be unable to tolerate surgery;

2. Malignant obstructive jaundice caused by metastatic tumors;

3. Pregnancy or lactation women.

Related Conditions & MeSH terms

• Jaundice
• Jaundice, Obstructive
• Klatskin Tumor

Intervention

Procedure:
• PTBD group
Percutaneous Transhepatic Biliary Drainage, a kind of Preoperative Biliary Drainage methods for hilar cholangiocarcinoma patients
• ENBD group
Endoscopic Nasobiliary Drainage, a kind of Preoperative Biliary Drainage methods for hilar cholangiocarcinoma patients
• EBS group
Endoscopic Biliary Stenting, a kind of Preoperative Biliary Drainage methods for hilar cholangiocarcinoma patients

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Complication rate after radical surgery	Complication rate after radical surgery	1 month post operatively
Primary	Success rate of PBD	Success rate of different methods of PBD	Day 1
Secondary	operative time	duration of radical surgery	Day 1
Secondary	Hepatoduodenal edema	Degree of hepatoduodenal edema (including no edema, mild edema, moderate edema, and severe edema)	at time of radical surgery
Secondary	Perioperative mortality	Mortality between PBD and 4 weeks after surgery	from PBD to 4 weeks after surgery, an average of 2 month
Secondary	implantation metastasis	Rate of implantation metastasis	Day 1
Secondary	Rate of change in Total bilirubin	Recovery efficiency of liver function	2 weeks after PBD
Secondary	Rate of change in alanine aminotransferase	Recovery efficiency of liver function	2 weeks after PBD
Secondary	Rate of change in aspartate aminotransferase	Recovery efficiency of liver function	2 weeks after PBD