Application of Endoscopic Scissors Cutting ENBD Tube in the Treatment of Malignant Hilar Biliary Strictures

Naval Military Medical University

Status: Withdrawn

Conditions: Klatskin Tumor; Endoscopic Retrograde Cholangiopancreatography

Treatments: Device: Biliary stent; Device: Endoscopic scissors

Study type: Interventional

Funder types: Other

Identifiers

NCT03353181

ENBD-01

Details and patient eligibility

About

The purpose of this study is to evaluate application value of the endoscopic cutting technique in the treatment of malignant hilar biliary strictures.

Full description

The management unresectable malignant hilar biliary strictures is still very difficult in spite of the rapid development of new endoscopic devices.The application of stent (plastic or metallic) has allowed us to achieve successful drainage. However,there are many complications related to the placement of stents,such as cholangitis,high rate of re-intervention,and so on. The application of endoscopic cutting technique is considered to reduce these complication.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients age over 18 and able to tolerate ERCP.
2. Pathologically confirmed inoperable malignant hilar biliary strictures of Bismuth type II to IV.
3. No history of biliary tract surgery and first attempt at endoscopic or percutaneous drainage.
4. No acute cholangitis before ERCP.
5. Informed consent.

Exclusion criteria

1. The patient is very ill(Septic shock, sepsis,coagulation disorders and so on) and cannot tolerate endoscopic treatment.
2. Previous biliary drainage procedure.
3. Inability to provide informed consent.
4. Participating in other clinical trials.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Endoscopic scissors

Experimental group

Description:

Endoscopic nasobiliary drainage for malignant hilar biliary strictures at first， and application of endoscopic cutting technique followed.

Treatment:

Device: Endoscopic scissors

Stent

Active Comparator group

Description:

Standard placement of biliary stent for malignant hilar biliary strictures.

Treatment:

Device: Biliary stent