Back to resultsProcess Optimization of Preoperative Biliary Drainage in Patients With Malignant Obstructive Jaundice
Primary Purpose
Jaundice, Obstructive, Klatskin Tumor
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PTBD group
ENBD group
EBS group
Sponsored by
About this trial
This is an interventional prevention trial for Jaundice, Obstructive
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
No Intervention
Arm Label
PTBD group
ENBD group
EBS group
Without PBD group
Arm Description
Percutaneous Transhepatic Biliary Drainage
Endoscopic Nasobiliary Biliary Drainage
Endoscopic Biliary Stenting
receive surgery without PBD
Outcomes
Primary Outcome Measures
Complication rate after drainage
Complication rate between PBD (preoperative biliary drainage) and radical surgery
Complication rate after radical surgery
Complication rate after radical surgery
Success rate of PBD
Success rate of different methods of PBD
Secondary Outcome Measures
operative time
duration of radical surgery
Hepatoduodenal edema
Degree of hepatoduodenal edema (including no edema, mild edema, moderate edema, and severe edema)
Perioperative mortality
Mortality between PBD and 4 weeks after surgery
implantation metastasis
Rate of implantation metastasis
Rate of change in Total bilirubin
Recovery efficiency of liver function
Rate of change in alanine aminotransferase
Recovery efficiency of liver function
Rate of change in aspartate aminotransferase
Recovery efficiency of liver function
Full Information
NCT ID
NCT03527875
First Posted
April 23, 2018
Last Updated
June 1, 2018
Sponsor
Shanghai Zhongshan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03527875
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 2018 (Anticipated)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
July 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Zhongshan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Jaundice, Obstructive, Klatskin Tumor
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
564 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PTBD group
Arm Type
Experimental
Arm Description
Percutaneous Transhepatic Biliary Drainage
Arm Title
ENBD group
Arm Type
Experimental
Arm Description
Endoscopic Nasobiliary Biliary Drainage
Arm Title
EBS group
Arm Type
Experimental
Arm Description
Endoscopic Biliary Stenting
Arm Title
Without PBD group
Arm Type
No Intervention
Arm Description
receive surgery without PBD
Intervention Type
Procedure
Intervention Name(s)
PTBD group
Intervention Description
Percutaneous Transhepatic Biliary Drainage, a kind of Preoperative Biliary Drainage methods for hilar cholangiocarcinoma patients
Intervention Type
Procedure
Intervention Name(s)
ENBD group
Intervention Description
Endoscopic Nasobiliary Drainage, a kind of Preoperative Biliary Drainage methods for hilar cholangiocarcinoma patients
Intervention Type
Procedure
Intervention Name(s)
EBS group
Intervention Description
Endoscopic Biliary Stenting, a kind of Preoperative Biliary Drainage methods for hilar cholangiocarcinoma patients
Primary Outcome Measure Information:
Title
Complication rate after drainage
Description
Complication rate between PBD (preoperative biliary drainage) and radical surgery
Time Frame
From PBD to completion of radical surgery, an average of 1 month
Title
Complication rate after radical surgery
Description
Complication rate after radical surgery
Time Frame
1 month post operatively
Title
Success rate of PBD
Description
Success rate of different methods of PBD
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
operative time
Description
duration of radical surgery
Time Frame
Day 1
Title
Hepatoduodenal edema
Description
Degree of hepatoduodenal edema (including no edema, mild edema, moderate edema, and severe edema)
Time Frame
at time of radical surgery
Title
Perioperative mortality
Description
Mortality between PBD and 4 weeks after surgery
Time Frame
from PBD to 4 weeks after surgery, an average of 2 month
Title
implantation metastasis
Description
Rate of implantation metastasis
Time Frame
Day 1
Title
Rate of change in Total bilirubin
Description
Recovery efficiency of liver function
Time Frame
2 weeks after PBD
Title
Rate of change in alanine aminotransferase
Description
Recovery efficiency of liver function
Time Frame
2 weeks after PBD
Title
Rate of change in aspartate aminotransferase
Description
Recovery efficiency of liver function
Time Frame
2 weeks after PBD
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Houbao Liu, PHD
Phone
13818971698
Email
houbaoliu@aliyun.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Process Optimization of Preoperative Biliary Drainage in Patients With Malignant Obstructive Jaundice
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