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Completed

NCT Number: NCT02649712

Unilateral Stenting Versus Bilateral Stenting for 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.

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Key information

Conditions

Cholangiocarcinoma Adenocarcinoma Biliary Tract Diseases Biliary Tract Neoplasms Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Gallbladder Carcinoma Gallbladder Diseases Gallbladder Neoplasms Hepatocellular Carcinoma Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xuzhou Central Hospital

Xuzhou, Jiangsu, 221009, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Malignant hilar biliary obstruction;
  • Unresectable cases

Exclusion criteria

  • Bismuth I patients;
  • inability to obtain informed consent;
  • Eastern Cooperative Oncology Group performance status of 4;
  • severe dysfunction in other organs.

Treatment and study plan

biliary stent

Device

Self-expandable biliary nitinol alloys stent

Primary outcomes

  1. Stent patency (Stent dysfunction is suspected when the patient experiences recurrence of jaundice)

    Time frame: 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 outcomes

  1. Overall survival

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Xuzhou Central Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 7, 2016
Registry last updated
Nov 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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