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Unilateral Stenting Versus Bilateral Stenting for Malignant Hilar Biliary Obstruction

Sponsor
Xuzhou Central Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02649712
Collaborator
(none)
72
Enrollment
1
Location
2
Arms
33.3
Actual Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the clinical effectiveness and long-term outcomes between patients with malignant hilar biliary obstruction who are treated by unilateral or bilateral stenting.

Condition or Disease Intervention/Treatment Phase
  • Device: biliary stent
 N/A

Detailed Description

Malignant hilar biliary obstruction is a common clinical manifestation and it can be caused by cholangiocarcinoma, gallbladder carcinoma, liver cancer, or other metastatic carcinoma. Most patients with malignant hilar biliary obstruction are unresectable at diagnosis. Biliary stenting has been widely used in palliative treatment of malignant hilar biliary obstruction.

Hilar biliary obstruction usually involves the bifurcation of the biliary tract. Some researchers recommended unilateral stenting for malignant hilar biliary obstruction because drainage of 25% of entire liver can achieve the clinical success of biliary drainage. However, some researchers recommended bilateral stenting for malignant hilar biliary obstruction because some researches demonstrated that bilateral stenting can achieve a longer stent patency.In addition, there was no significant difference in post stenting survival between patients who were treated by unilateral or bilateral stenting. Therefore, it remains under debate whether unilateral or bilateral stenting is better in the treatment of malignant hilar biliary obstruction.

The purpose of this study is to compare the clinical effectiveness and long-term outcomes between patients with malignant hilar biliary obstruction who are treated by unilateral or bilateral stenting.

Study Design

Study Type:
Interventional
Actual Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Unilateral Stenting Versus Bilateral Stenting for Malignant Hilar Biliary Obstruction
Actual Study Start Date :
Jan 20, 2016
Actual Primary Completion Date :
Oct 31, 2018
Actual Study Completion Date :
Oct 31, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Unilateral stent

Patients undergo placement of unilateral biliary stent on day 1.

Device: biliary stent
Self-expandable biliary nitinol alloys stent
Active Comparator: Bilateral stents

Patients undergo placement of bilateral biliary stents on day 1.

Device: biliary stent
Self-expandable biliary nitinol alloys stent

Outcome Measures

Primary Outcome Measures

  1. Stent patency (Stent dysfunction is suspected when the patient experiences recurrence of jaundice) [From the date of randomization until the date of first documented stent dysfunction, assessed up to 10 months]

    Stent dysfunction is suspected when the patient experiences recurrence of jaundice.

Secondary Outcome Measures

  1. Overall survival [From the date of randomization until the date of first documented death from any cause, assessed up to 12 months]

    From the date of randomization until the date of first documented death from any cause.

  2. Stent dysfunction free-patient survival [From the date of randomization until the date of first documented stent dysfunction or the date of death from any cause, whichever came first, assessed up to 10 months.]

    From the date of randomization until the date of first documented stent dysfunction or the date of death from any cause, whichever came first.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Malignant hilar biliary obstruction;

  2. Unresectable cases

Exclusion Criteria:

  1. Bismuth I patients;

  2. inability to obtain informed consent;

  3. Eastern Cooperative Oncology Group performance status of 4;

  4. severe dysfunction in other organs.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Xuzhou Central Hospital Xuzhou Jiangsu China 221009

Sponsors and Collaborators

  • Xuzhou Central Hospital

Investigators

  • Principal Investigator: Chi Cao, MD, Xuzhou Central Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Xuzhou Central Hospital
ClinicalTrials.gov Identifier:
NCT02649712
Other Study ID Numbers:
  • xzxy20160106
First Posted:
Jan 7, 2016
Last Update Posted:
Nov 20, 2018
Last Verified:
Nov 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Carcinoma
Cholangiocarcinoma

Study Results

No Results Posted as of Nov 20, 2018