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

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

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 Overview

• Status: Unknown
• Conditions: Klatskin Tumor; Jaundice, Obstructive
• Intervention / Treatment: Procedure: PTBD group; Procedure: ENBD group; Procedure: EBS group

• Study Type: Interventional
• Enrollment (Anticipated): 564
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2018
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: April 23, 2018
• First Submitted That Met QC Criteria: May 4, 2018
• First Posted (Actual): May 17, 2018

Study Record Updates

• Last Update Posted (Actual): June 6, 2018
• Last Update Submitted That Met QC Criteria: June 1, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Skin Manifestations; Hyperbilirubinemia; Cholangiocarcinoma; Klatskin Tumor; Jaundice; Jaundice, Obstructive
• Other Study ID Numbers: 2018ZSLC24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No