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

Primary Purpose

Pancreatic Carcinoma, Biliary Obstruction

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
biliary stent and high-intensity focused ultrasound ablation system
biliary stent
Sponsored by
Xuzhou Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Carcinoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Xuzhou Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Stent with high-intensity focused ultrasound ablation

Stent without high-intensity focused ultrasound ablation

Arm Description

Patients undergo stent insertion with high-intensity focused ultrasound ablation on day 1.

Patients undergo stent insertion on day 1.

Outcomes

Primary Outcome Measures

6-month survival rate
From the date of randomization until the date of first documented death from any cause.

Secondary Outcome Measures

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

Full Information

First Posted
May 22, 2019
Last Updated
September 28, 2020
Sponsor
Xuzhou Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03962478
Brief Title
Combined Stent Insertion and HIFU Ablation for Pancreatic Carcinoma With Biliary Obstruction
Acronym
HIFU
Official Title
Combined Stent Insertion and High-intensity Focused Ultrasound Ablation for Pancreatic Carcinoma With Biliary Obstruction
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
May 31, 2019 (Actual)
Primary Completion Date
February 8, 2020 (Actual)
Study Completion Date
September 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xuzhou Central Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Carcinoma, Biliary Obstruction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stent with high-intensity focused ultrasound ablation
Arm Type
Experimental
Arm Description
Patients undergo stent insertion with high-intensity focused ultrasound ablation on day 1.
Arm Title
Stent without high-intensity focused ultrasound ablation
Arm Type
Active Comparator
Arm Description
Patients undergo stent insertion on day 1.
Intervention Type
Device
Intervention Name(s)
biliary stent and high-intensity focused ultrasound ablation system
Intervention Description
Self-expandable biliary nitinol alloys stent and YDME FEP-BY02 high-intensity focused ultrasound equipment
Intervention Type
Device
Intervention Name(s)
biliary stent
Intervention Description
Self-expandable biliary nitinol alloys stent
Primary Outcome Measure Information:
Title
6-month survival rate
Description
From the date of randomization until the date of first documented death from any cause.
Time Frame
From the date of randomization until the date of first documented death from any cause, assessed up to 12 months
Secondary Outcome Measure Information:
Title
Stent patency
Description
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
Title
Stent dysfunction free survival
Description
From the date of randomization until the date of first documented stent dysfunction or the date of death from any cause, whichever came first.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: malignant distal biliary obstruction; pathologically diagnosed pancreatic carcinoma; unresectable cases. Exclusion Criteria: inability to obtain informed consent; Eastern Cooperative Oncology Group performance status of 4; life expectancy of 3 months or less; biliary obstruction that was not directly caused by pancreatic carcinoma.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chi Cao, MD
Organizational Affiliation
Xuzhou Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xuzhou Central Hospital
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221009
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan to make individual participant data available.
Citations:
PubMed Identifier
27783026
Citation
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. doi: 10.1097/SLE.0000000000000327.
Results Reference
background
PubMed Identifier
33605677
Citation
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.
Results Reference
derived

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

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