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

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Fudan University

Status

Unknown

Conditions

Klatskin Tumor
Jaundice, Obstructive

Treatments

Procedure: PTBD group
Procedure: ENBD group
Procedure: EBS group

Study type

Interventional

Funder types

Other

Identifiers

NCT03527875
2018ZSLC24

Details and patient eligibility

About

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).

Enrollment

564 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

564 participants in 4 patient groups

PTBD group
Experimental group
Description:
Percutaneous Transhepatic Biliary Drainage
Treatment:
Procedure: PTBD group
ENBD group
Experimental group
Description:
Endoscopic Nasobiliary Biliary Drainage
Treatment:
Procedure: ENBD group
EBS group
Experimental group
Description:
Endoscopic Biliary Stenting
Treatment:
Procedure: EBS group
Without PBD group
No Intervention group
Description:
receive surgery without PBD

Trial contacts and locations

0

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Central trial contact

Houbao Liu, PHD

Data sourced from clinicaltrials.gov

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