Combined Stent Insertion and HIFU Ablation for Pancreatic Carcinoma With Biliary Obstruction (HIFU)

September 28, 2020 updated by: Xuzhou Central Hospital

Combined Stent Insertion and High-intensity Focused Ultrasound Ablation for Pancreatic Carcinoma With Biliary Obstruction

The purpose of this study is to compare the clinical effectiveness and long-term outcomes between patients with pancreatic carcinoma and biliary obstruction who are treated by stent insertion with or without high-intensity focused ultrasound ablation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Distal malignant biliary obstruction is a common problem in patients with pancreatic carcinoma. In unresectable pancreatic carcinomas, percutaneous stent placement has been pivotal in providing relief from obstructive jaundice, improving the quality of life, and allowing the maintenance of anticancer treatment.

Venous chemotherapy, transcatheter arterial chemoembolization, or radiotherapy have been used to prolong stent patency and survival after stent insertion for patients with pancreatic carcinoma and biliary obstruction. High-intensity focused ultrasound ablation is a noninvasive and atoxic treatment of malignant tumor using focused ultrasound energy from an extracorporeal source that is targeted within the body resulting in thermally induced necrosis and apoptosis.

The purpose of this study is to compare the clinical effectiveness and long-term outcomes between patients with pancreatic carcinoma and biliary obstruction who are treated by stent insertion with or without high-intensity focused ultrasound ablation.

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Xuzhou, Jiangsu, China, 221009
        • Xuzhou Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. malignant distal biliary obstruction;
  2. pathologically diagnosed pancreatic carcinoma;
  3. unresectable cases.

Exclusion Criteria:

  1. inability to obtain informed consent;
  2. Eastern Cooperative Oncology Group performance status of 4;
  3. life expectancy of 3 months or less;
  4. biliary obstruction that was not directly caused by pancreatic carcinoma.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stent with high-intensity focused ultrasound ablation
Patients undergo stent insertion with high-intensity focused ultrasound ablation on day 1.
Device: biliary stent and high-intensity focused ultrasound ablation system
Self-expandable biliary nitinol alloys stent and YDME FEP-BY02 high-intensity focused ultrasound equipment
Active Comparator: Stent without high-intensity focused ultrasound ablation
Patients undergo stent insertion on day 1.
Device: biliary stent
Self-expandable biliary nitinol alloys stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6-month survival rate
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.
From the date of randomization until the date of first documented death from any cause, assessed up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stent patency
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.
From the date of randomization until the date of first documented stent dysfunction, assessed up to 10 months
Stent dysfunction free 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xuzhou Central Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2019

Primary Completion (Actual)

February 8, 2020

Study Completion (Actual)

September 28, 2020

Study Registration Dates

First Submitted

May 22, 2019

First Submitted That Met QC Criteria

May 22, 2019

First Posted (Actual)

May 24, 2019

Study Record Updates

Last Update Posted (Actual)

September 30, 2020

Last Update Submitted That Met QC Criteria

September 28, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20190522-021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make individual participant data available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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