NCT03527875

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of different methods of preoperative biliary drainage in patients with extrahepatic bile duct neoplasms with obstructive jaundice (hilar cholangiocarcinoma, distal bile duct cancer, and periampullary carcinoma), including PTBD (Percutaneous Transhepatic Biliary Drainage), ENBD (Endoscopic Nasobiliary Drainage) and EBS (Endoscopic Biliary Stenting).

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
564

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2018

Longer than P75 for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

April 23, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

May 17, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

June 6, 2018

Status Verified

June 1, 2018

Enrollment Period

1.3 years

First QC Date

April 23, 2018

Last Update Submit

June 1, 2018

Conditions

Jaundice, ObstructiveKlatskin Tumor

Outcome Measures

Primary Outcomes (3)

  • Complication rate after drainage

    Complication rate between PBD (preoperative biliary drainage) and radical surgery

    From PBD to completion of radical surgery, an average of 1 month

  • Complication rate after radical surgery

    Complication rate after radical surgery

    1 month post operatively

  • Success rate of PBD

    Success rate of different methods of PBD

    Day 1

Secondary Outcomes (7)

  • operative time

    Day 1

  • Hepatoduodenal edema

    at time of radical surgery

  • Perioperative mortality

    from PBD to 4 weeks after surgery, an average of 2 month

  • implantation metastasis

    Day 1

  • Rate of change in Total bilirubin

    2 weeks after PBD

  • +2 more secondary outcomes

Study Arms (4)

PTBD group

EXPERIMENTAL

Percutaneous Transhepatic Biliary Drainage

Procedure: PTBD group

ENBD group

EXPERIMENTAL

Endoscopic Nasobiliary Biliary Drainage

Procedure: ENBD group

EBS group

EXPERIMENTAL

Endoscopic Biliary Stenting

Procedure: EBS group

Without PBD group

NO INTERVENTION

receive surgery without PBD

Interventions

PTBD groupPROCEDURE

Percutaneous Transhepatic Biliary Drainage, a kind of Preoperative Biliary Drainage methods for hilar cholangiocarcinoma patients

PTBD group
ENBD groupPROCEDURE

Endoscopic Nasobiliary Drainage, a kind of Preoperative Biliary Drainage methods for hilar cholangiocarcinoma patients

ENBD group
EBS groupPROCEDURE

Endoscopic Biliary Stenting, a kind of Preoperative Biliary Drainage methods for hilar cholangiocarcinoma patients

EBS group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who meet the following four criteria are included into the study:
  • Preoperative clinical diagnosis of hilar cholangiocarcinoma, distal bile duct cancer, periampullary cancer without distant metastasis or peripheral vascular invasion, and plan for radical surgery;
  • Serum total bilirubin is higher than 51 umol/l;
  • Age is older than 18 and younger than 80 years old;
  • Sign in informed consent to receive preoperative PTBD, ENBD, EBS or without PBD.

You may not qualify if:

  • If any of the following items are met, the subject cannot enter the study.
  • Incorporate severe mental illness, severe heart, lungs and kidneys disease, etc., and be unable to tolerate surgery;
  • Malignant obstructive jaundice caused by metastatic tumors;
  • Pregnancy or lactation women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Jaundice, ObstructiveKlatskin Tumor

Condition Hierarchy (Ancestors)

JaundiceHyperbilirubinemiaPathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and SymptomsCholangiocarcinomaAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Central Study Contacts

Houbao Liu, PHD

CONTACT

13818971698houbaoliu@aliyun.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2018

First Posted

May 17, 2018

Study Start

August 1, 2018

Primary Completion

December 1, 2019

Study Completion

July 1, 2022

Last Updated

June 6, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share