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

Application of Endoscopic Scissors Cutting Endoscopic Nasobiliary Drainage Tube in the Treatment of Malignant Hilar Biliary Strictures: a Multicenter, Prospective, Randomized Controlled Study

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03353181

Acronym

ENBD

Enrollment

Registered

2017-11-27

Start date

2017-11-30

Completion date

2019-12-25

Last updated

2022-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endoscopic Retrograde Cholangiopancreatography, Klatskin Tumor

Keywords

Endoscopic Retrograde Cholangiopancreatography, endoscopic drainage, endoscopic nasobiliary drainage, stent

Brief summary

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

Detailed 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.

Interventions

DEVICEEndoscopic scissors

Application of endoscopic cutting technique following endoscopic nasobiliary drainage in the treatment of malignant hilar biliary strictures.

DEVICEBiliary stent

Standard placement of biliary stent

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Parallel Assignment

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
occurrence of acute cholangitis	30 days	Acute cholangitis is defined as cholangitis that occurred within 30 days after endoscopic retrograde cholangiopancreatography(ERCP).

Secondary

Measure	Time frame	Description
Clinical success	30 days	Clinical success was defined as a decrease in the total bilirubin level to ≤50% of the pretreatment value within 1 week or to ≤75% within 4 weeks.
Re-intervention	6 months	Re-intervention was defined as any type of endoscopic or percutaneous procedure necessary to improve biliary drainage for jaundice or cholangitis after successful placement.

Other

Measure	Time frame	Description
early adverse	30 days	Early adverse event was defined as any ERCP-related adverse event within 4 weeks and a late event was defined as one that occurred after 4 weeks.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026