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

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)

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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