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

Brief Title

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

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

Brief 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).
    



Study Type

Interventional


Primary Outcome

Complication rate after drainage

Secondary Outcome

 operative time

Condition

Jaundice, Obstructive

Intervention

PTBD group

Study Arms / Comparison Groups

 PTBD group
Description:  Percutaneous Transhepatic Biliary Drainage

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

564

Start Date

August 2018

Completion Date

July 2022

Primary Completion Date

December 2019

Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

, 13818971698, [email protected]



Administrative Informations


NCT ID

NCT03527875

Organization ID

2018ZSLC24


Responsible Party

Sponsor

Study Sponsor

Shanghai Zhongshan Hospital


Study Sponsor

, , 


Verification Date

June 2018