NCT03104582

Brief Summary

To investigate the biliary drainage-related cholangitis and other complications of percutaneous transhepatic biliary drainage (PTBD) in the management of Klatskin tumor (KT) compared with endoscopic biliary drainage (EBD).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2011

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

November 1, 2011

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

March 25, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 7, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 14, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 14, 2017

Completed
Last Updated

July 11, 2019

Status Verified

July 1, 2019

Enrollment Period

5.7 years

First QC Date

March 25, 2017

Last Update Submit

July 10, 2019

Conditions

Cholangitis

Keywords

ERCPPTBDEBDCholangitisComplicationKlatskin tumor

Outcome Measures

Primary Outcomes (1)

  • Acute cholangitis

    Acute cholangitis is defined if patients experienced abdominal pain, high fever, or chill after procedure in 2 weeks

    2 weeks

Secondary Outcomes (3)

  • Abdominal pain

    2 weeks

  • Length of hospital stay

    6 months

  • Overall procedure related complication rate

    6 months

Study Arms (2)

Biliary drainage 1

EXPERIMENTAL

Patients with advanced hilar cholangiocarcinoma need biliary drainage performed Endoscopic Retrograde Cholangiopancreatography (ERCP) drainage

Procedure: ERCP Drainage

Biliary drainage 2

ACTIVE COMPARATOR

Patients with advanced hilar cholangiocarcinoma need biliary drainage performed percutaneous transhepatic biliary drainage(PTBD) drainage

Procedure: PTBD Drainage

Interventions

ERCP DrainagePROCEDURE

When advanced Klatskin Tumor patients need biliary drainage, they choose to perform endoscopic drainage after informed consent.

Biliary drainage 1
PTBD DrainagePROCEDURE

When advanced Klatskin Tumor patients need biliary drainage, they choose to perform percutaneous transhepatic biliary drainage after informed consent.

Biliary drainage 2

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type II、III、IV Klatskin tumor patients;
  • years old

You may not qualify if:

  • Unwillingness or inability to consent for the study;
  • Coagulation dysfunction (INR\> 1.3) and low peripheral blood platelet count(\<50×109 / L) or using anti-coagulation drugs;
  • Previous endoscopic sphincterectomy (EST) or endoscopic papillary balloon dilatation (EPBD);
  • Any type of GI reconstruction;
  • Combined with Mirizzi syndrome and intrahepatic bile duct stones;
  • Preoperative coexistent diseases: acute pancreatitis, GI tract hemorrhage, severe liver disease, primary sclerosing cholangitis (PSC), septic shock;
  • Biliary-duodenal fistula;
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hepatopancreatobiliary Surgery Institute of Gansu Province

Lanzhou, Gansu, 730000, China

Location

Related Publications (1)

  • Ba Y, Yue P, Leung JW, Wang H, Lin Y, Bai B, Zhu X, Zhang L, Zhu K, Wang W, Meng W, Zhou W, Liu Y, Li X. Percutaneous transhepatic biliary drainage may be the preferred preoperative drainage method in hilar cholangiocarcinoma. Endosc Int Open. 2020 Feb;8(2):E203-E210. doi: 10.1055/a-0990-9114. Epub 2020 Jan 22.

    PMID: 32010755DERIVED

MeSH Terms

Conditions

CholangitisKlatskin Tumor

Condition Hierarchy (Ancestors)

Bile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesCholangiocarcinomaAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Xun Li, M.D., Ph. D.

    Hepatopancreatobiliary Surgery Institute of Gansu Province

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Ph. D,

Study Record Dates

First Submitted

March 25, 2017

First Posted

April 7, 2017

Study Start

November 1, 2011

Primary Completion

July 14, 2017

Study Completion

July 14, 2017

Last Updated

July 11, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)