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

Brief Title

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

Official Title

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

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.
    


Study Type

Interventional


Primary Outcome

occurrence of acute cholangitis

Secondary Outcome

 Clinical success

Condition

Endoscopic Retrograde Cholangiopancreatography

Intervention

Endoscopic scissors

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

242

Start Date

November 30, 2017

Completion Date

March 25, 2019

Primary Completion Date

September 25, 2018

Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Zhaoshen Li, M.D, 8613816758802, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT03353181

Organization ID

ENBD-01


Responsible Party

Principal Investigator

Study Sponsor

Changhai Hospital

Collaborators

 First People's Hospital of Hangzhou

Study Sponsor

Zhaoshen Li, M.D, Principal Investigator, Changhai Hospital


Verification Date

November 2017