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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

564 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-31

Study Completion Date

2022-07-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Jaundice, Obstructive Klatskin Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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PTBD group

Percutaneous Transhepatic Biliary Drainage

Group Type EXPERIMENTAL

PTBD group

Intervention Type PROCEDURE

Percutaneous Transhepatic Biliary Drainage, a kind of Preoperative Biliary Drainage methods for hilar cholangiocarcinoma patients

ENBD group

Endoscopic Nasobiliary Biliary Drainage

Group Type EXPERIMENTAL

ENBD group

Intervention Type PROCEDURE

Endoscopic Nasobiliary Drainage, a kind of Preoperative Biliary Drainage methods for hilar cholangiocarcinoma patients

EBS group

Endoscopic Biliary Stenting

Group Type EXPERIMENTAL

EBS group

Intervention Type PROCEDURE

Endoscopic Biliary Stenting, a kind of Preoperative Biliary Drainage methods for hilar cholangiocarcinoma patients

Without PBD group

receive surgery without PBD

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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PTBD group

Percutaneous Transhepatic Biliary Drainage, a kind of Preoperative Biliary Drainage methods for hilar cholangiocarcinoma patients

Intervention Type PROCEDURE

ENBD group

Endoscopic Nasobiliary Drainage, a kind of Preoperative Biliary Drainage methods for hilar cholangiocarcinoma patients

Intervention Type PROCEDURE

EBS group

Endoscopic Biliary Stenting, a kind of Preoperative Biliary Drainage methods for hilar cholangiocarcinoma patients

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No