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

Pancreatic Carcinoma Clinical Trial

— HIFU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03962478
• Other study ID #: 20190522-021
• Status: Completed
• Phase: N/A
• Start date: May 31, 2019
• Est. completion date: September 28, 2020

Study information

• Verified date: September 2020
• Source: Xuzhou Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: September 28, 2020
• Est. primary completion date: February 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Biliary Obstruction
• Carcinoma
• Pancreatic Carcinoma
• Pancreatic Neoplasms

Intervention

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
• biliary stent
Self-expandable biliary nitinol alloys stent

Locations

Country	Name	City	State
China	Xuzhou Central Hospital	Xuzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Xuzhou Central Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6-month survival rate	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	Stent patency	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
Secondary	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.	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.