Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03962478
Recruitment Status : Recruiting
First Posted : May 24, 2019
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Xuzhou Central Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pancreatic Carcinoma Biliary Obstruction Device: biliary stent and high-intensity focused ultrasound ablation system Device: biliary stent Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combined Stent Insertion and High-intensity Focused Ultrasound Ablation for Pancreatic Carcinoma With Biliary Obstruction
Actual Study Start Date : May 31, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03962478


Contacts
Layout table for location contacts
Contact: Chi Cao, MD -86-18952171065 xzcaochi@126.com
Contact: Yu-Fei Fu, MD +8618112000304 fuyufei1985@163.com

Locations
Layout table for location information
China, Jiangsu
Xuzhou Central Hospital Recruiting
Xuzhou, Jiangsu, China, 221009
Contact: Chi Cao, MD    +8618952171195    xzcaochi@126.com   
Sponsors and Collaborators
Xuzhou Central Hospital
Investigators
Layout table for investigator information
Principal Investigator: Chi Cao, MD Xuzhou Central Hospital

Publications:
Layout table for additonal information
Responsible Party: Xuzhou Central Hospital
ClinicalTrials.gov Identifier: NCT03962478     History of Changes
Other Study ID Numbers: 20190522-021
First Posted: May 24, 2019    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan to make individual participant data available.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Pancreatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases