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

Primary Purpose

Endoscopic Retrograde Cholangiopancreatography, Klatskin Tumor

Status
Withdrawn
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Endoscopic scissors
Biliary stent
Sponsored by
Changhai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endoscopic Retrograde Cholangiopancreatography focused on measuring Endoscopic Retrograde Cholangiopancreatography, endoscopic drainage, endoscopic nasobiliary drainage, stent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Department of Gastroenterology, Changhai Hospital, Second Military Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Endoscopic scissors

Stent

Arm Description

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

Standard placement of biliary stent for malignant hilar biliary strictures.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Clinical success
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
Re-intervention was defined as any type of endoscopic or percutaneous procedure necessary to improve biliary drainage for jaundice or cholangitis after successful placement.

Full Information

First Posted
November 21, 2017
Last Updated
August 22, 2022
Sponsor
Changhai Hospital
Collaborators
First People's Hospital of Hangzhou, First Affiliated Hospital Xi'an Jiaotong University, Fuzhou General Hospital, LanZhou University, Zhejiang University, Chengdu PLA General Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, General Hospital of Beijing PLA Military Region, Dongfang Hospital Beijing University of Chinese Medicine, Peking Union Medical College Hospital, ShuGuang Hospital, Eastern Hepatobiliary Surgery Hospital, Xijing Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03353181
Brief Title
Application of Endoscopic Scissors Cutting ENBD Tube in the Treatment of Malignant Hilar Biliary Strictures
Acronym
ENBD
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Failure to recruit patients
Study Start Date
November 30, 2017 (Actual)
Primary Completion Date
September 25, 2019 (Actual)
Study Completion Date
December 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changhai Hospital
Collaborators
First People's Hospital of Hangzhou, First Affiliated Hospital Xi'an Jiaotong University, Fuzhou General Hospital, LanZhou University, Zhejiang University, Chengdu PLA General Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, General Hospital of Beijing PLA Military Region, Dongfang Hospital Beijing University of Chinese Medicine, Peking Union Medical College Hospital, ShuGuang Hospital, Eastern Hepatobiliary Surgery Hospital, Xijing Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endoscopic Retrograde Cholangiopancreatography, Klatskin Tumor
Keywords
Endoscopic Retrograde Cholangiopancreatography, endoscopic drainage, endoscopic nasobiliary drainage, stent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Endoscopic scissors
Arm Type
Experimental
Arm Description
Endoscopic nasobiliary drainage for malignant hilar biliary strictures at first， and application of endoscopic cutting technique followed.
Arm Title
Stent
Arm Type
Active Comparator
Arm Description
Standard placement of biliary stent for malignant hilar biliary strictures.
Intervention Type
Device
Intervention Name(s)
Endoscopic scissors
Intervention Description
Application of endoscopic cutting technique following endoscopic nasobiliary drainage in the treatment of malignant hilar biliary strictures.
Intervention Type
Device
Intervention Name(s)
Biliary stent
Intervention Description
Standard placement of biliary stent
Primary Outcome Measure Information:
Title
occurrence of acute cholangitis
Description
Acute cholangitis is defined as cholangitis that occurred within 30 days after endoscopic retrograde cholangiopancreatography(ERCP).
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Clinical success
Description
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.
Time Frame
30 days
Title
Re-intervention
Description
Re-intervention was defined as any type of endoscopic or percutaneous procedure necessary to improve biliary drainage for jaundice or cholangitis after successful placement.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
early adverse
Description
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.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients age over 18 and able to tolerate ERCP. Pathologically confirmed inoperable malignant hilar biliary strictures of Bismuth type II to IV. No history of biliary tract surgery and first attempt at endoscopic or percutaneous drainage. No acute cholangitis before ERCP. Informed consent. Exclusion Criteria: The patient is very ill(Septic shock, sepsis,coagulation disorders and so on) and cannot tolerate endoscopic treatment. Previous biliary drainage procedure. Inability to provide informed consent. Participating in other clinical trials.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhaoshen Li, M.D
Organizational Affiliation
Changhai Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Gastroenterology, Changhai Hospital, Second Military Medical University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11822021
Citation
Uchida N, Ezaki T, Fukuma H, Tsutsui K, Kobara H, Bang MH, Ogawa M, Watanabe K, Ono M, Morishita A, Ogi T, Kamata H, Masaki T, Watanabe S, Kuriyama S. Conversion of endoscopic nasobiliary drainage to internal drainage by means of endoscopic scissor forceps. Endoscopy. 2002 Feb;34(2):180. doi: 10.1055/s-2002-19841. No abstract available.
Results Reference
background
PubMed Identifier
22895398
Citation
Kawashima H, Itoh A, Ohno E, Itoh Y, Ebata T, Nagino M, Goto H, Hirooka Y. Preoperative endoscopic nasobiliary drainage in 164 consecutive patients with suspected perihilar cholangiocarcinoma: a retrospective study of efficacy and risk factors related to complications. Ann Surg. 2013 Jan;257(1):121-7. doi: 10.1097/SLA.0b013e318262b2e9.
Results Reference
background
PubMed Identifier
11808135
Citation
Asanuma Y, Andoh H, Tanaka J, Koyama K. [Biliary tract cancer]. Nihon Rinsho. 2001 Nov;59 Suppl 7:301-6. No abstract available. Japanese.
Results Reference
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Application of Endoscopic Scissors Cutting ENBD Tube in the Treatment of Malignant Hilar Biliary Strictures

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