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出境医 / 临床实验 / Combined Stent Insertion and HIFU Ablation for Pancreatic Carcinoma With Biliary Obstruction (HIFU)

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

Study Description
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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 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
Actual Primary Completion Date : February 8, 2020
Actual Study Completion Date : September 28, 2020
Arms and Interventions
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
Outcome Measures
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.


Eligibility Criteria
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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.
Contacts and Locations

Locations
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China, Jiangsu
Xuzhou Central Hospital
Xuzhou, Jiangsu, China, 221009
Sponsors and Collaborators
Xuzhou Central Hospital
Investigators
Layout table for investigator information
Principal Investigator: Chi Cao, MD Xuzhou Central Hospital
Tracking Information
First Submitted Date  ICMJE May 22, 2019
First Posted Date  ICMJE May 24, 2019
Last Update Posted Date September 30, 2020
Actual Study Start Date  ICMJE May 31, 2019
Actual Primary Completion Date February 8, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2019) 		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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2019)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combined Stent Insertion and HIFU Ablation for Pancreatic Carcinoma With Biliary Obstruction
Official Title  ICMJE Combined Stent Insertion and High-intensity Focused Ultrasound Ablation for Pancreatic Carcinoma With Biliary Obstruction
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pancreatic Carcinoma
  • Biliary Obstruction
Intervention  ICMJE
  • 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
  • Device: biliary stent
    Self-expandable biliary nitinol alloys stent
Study Arms  ICMJE
  • Experimental: Stent with high-intensity focused ultrasound ablation
    Patients undergo stent insertion with high-intensity focused ultrasound ablation on day 1.
    Intervention: Device: biliary stent and high-intensity focused ultrasound ablation system
  • Active Comparator: Stent without high-intensity focused ultrasound ablation
    Patients undergo stent insertion on day 1.
    Intervention: Device: biliary stent
Publications *
  • Niu S, Cheng L, Qiao Y, Fu YF, Cao C. Combined Stent Insertion and High-intensity Focused Ultrasound Ablation for Patients With Malignant Obstructive Jaundice. Surg Laparosc Endosc Percutan Tech. 2016 Dec;26(6):488-492.
  • Zhang FQ, Li L, Huang PC, Xia FF, Zhu L, Cao C. Stent Insertion With High Intensity-Focused Ultrasound Ablation for Biliary Obstruction Caused by Pancreatic Carcinoma: A Randomized Controlled Trial. Surg Laparosc Endosc Percutan Tech. 2021 Feb 17;31(3):298-303. doi: 10.1097/SLE.0000000000000918.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 28, 2020) 		92
Original Estimated Enrollment  ICMJE
 (submitted: May 22, 2019) 		90
Actual Study Completion Date  ICMJE September 28, 2020
Actual Primary Completion Date February 8, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03962478
Other Study ID Numbers  ICMJE 20190522-021
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: There is not a plan to make individual participant data available.
Responsible Party Xuzhou Central Hospital
Study Sponsor  ICMJE Xuzhou Central Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chi Cao, MD Xuzhou Central Hospital
PRS Account Xuzhou Central Hospital
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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