NCT03812250

Brief Summary

Purpose of the study: To compare efficacy, stent patency, re-intervention rate, cost, quality of life, survival time, and adverse events between EUS-guide biliary drainage (EUS-BD) and ERCP assisted trans-papillary drainage for malignant biliary obstruction. Subjects of the study: Patients who have malignant biliary obstruction. Methods of the study:

  • Prospective randomized controlled study
  • Patients were randomly divided into two groups, EUS-BD group or ERCP group
  • Patients will get assigned procedure (EUS-BD or ERCP assisted trans-papillary drainage)for decompression of malignant biliary obstruction
  • After the procedure, regular follow up, blood test, and imaging test will be done to check sufficient biliary decompression, stent patency, re-intervention rate, cost, quality of life, survival time, and adverse events rate. Statistical methods: SPSS 23.0 statistical software was used. The measurement data was expressed as x± s, and t-test or non-parametric test was used. Chi-square test was used for count data.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 23, 2019

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2023

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2023

Completed
Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

4.1 years

First QC Date

January 15, 2019

Last Update Submit

February 18, 2023

Conditions

Malignant Biliary Obstruction

Outcome Measures

Primary Outcomes (2)

  • Clinical success rates

    The number of patients with total bilirubin drop more than 50 % compared with baseline after successful endoscopic procedures.

    one month after the procedures.

  • Adverse events rates

    The number of patients who developed adverse events, included biliary leakage, hemorrhage, perforation, cholangitis as defined and graded according to the consensus guideline.

    within 6-9 months after the procedures

Secondary Outcomes (3)

  • Re-intervention rates

    within 6-9 months from the procedures

  • Evaluation of the cost of the procedure and hospitalization.

    Up to 30 days after the intervention.

  • overall survival

    within 6-9 months from the procedures

Study Arms (2)

ERCP assisted trans-papillary drainage

ACTIVE COMPARATOR

ERCP assisted trans-papillary drainage for malignant biliary obstruction

Procedure: ERCP assisted trans-papillary drainage for malignant biliary obstruction

EUS-guide biliary drainage

ACTIVE COMPARATOR

EUS-guide biliary drainage for malignant biliary obstruction

Procedure: EUS-guide biliary drainage for malignant biliary obstruction

Interventions

ERCP assisted trans-papillary drainage for malignant biliary obstructionPROCEDURE

ERCP assisted trans-papillary drainage for malignant biliary obstruction

ERCP assisted trans-papillary drainage
EUS-guide biliary drainage for malignant biliary obstructionPROCEDURE

EUS-guide biliary drainage for malignant biliary obstruction

EUS-guide biliary drainage

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age: 18 - 85 years
  • a patients who had malignant biliary obstruction confirmed by imaging examinations and Pathological examination
  • Hyperbilirubinemia (total bilirubin \>= 1.5 mg/dl)
  • inoperable state
  • patients who agree to join this study

You may not qualify if:

  • a patients who cannot endure sedation or therapeutic endoscopic procedure
  • a patients with bleeding tendency (PT \> 1.5 INR, PLT \< 50,000)
  • patients underwent biliary drainage by surgery, ERCP or percutaneous transhepatic biliary drainage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hangzhou First People's Hospital

Hangzhou, China

Location

Related Publications (1)

  • Park JK, Woo YS, Noh DH, Yang JI, Bae SY, Yun HS, Lee JK, Lee KT, Lee KH. Efficacy of EUS-guided and ERCP-guided biliary drainage for malignant biliary obstruction: prospective randomized controlled study. Gastrointest Endosc. 2018 Aug;88(2):277-282. doi: 10.1016/j.gie.2018.03.015. Epub 2018 Mar 30.

    PMID: 29605722RESULT

Study Officials

  • Xiaofeng Zhang, M.D.

    First People's Hospital of Hangzhou

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Hangzhou First People's Hospital

Study Record Dates

First Submitted

January 15, 2019

First Posted

January 23, 2019

Study Start

January 1, 2019

Primary Completion

February 10, 2023

Study Completion

February 15, 2023

Last Updated

February 21, 2023

Record last verified: 2023-02

Locations

CN(1)