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

Not Applicable

• Conditions: Klatskin Tumor; Jaundice, Obstructive
• Interventions: Procedure: PTBD group; Procedure: ENBD group; Procedure: EBS group

• Registration Number: NCT03527875
• Lead Sponsor: Shanghai Zhongshan Hospital

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-23
• Study First Submitted QC: 2018-05-04
• Study First Posted: 2018-05-17
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-01
• Last Update Posted: 2018-06-06
• Study Start: 2018-08
• Primary Completion: 2019-12
• Study Completion: 2022-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 564

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PTBD group	PTBD group	Percutaneous Transhepatic Biliary Drainage
ENBD group	ENBD group	Endoscopic Nasobiliary Biliary Drainage
EBS group	EBS group	Endoscopic Biliary Stenting

Primary Outcome Measures

Name	Time	Method
Complication rate after drainage	From PBD to completion of radical surgery, an average of 1 month	Complication rate between PBD (preoperative biliary drainage) and radical surgery
Success rate of PBD	Day 1	Success rate of different methods of PBD
Complication rate after radical surgery	1 month post operatively	Complication rate after radical surgery

Secondary Outcome Measures

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