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

Not Applicable

Completed

• Conditions: Pancreatic Carcinoma; Biliary Obstruction
• Interventions: Device: biliary stent; Device: biliary stent and high-intensity focused ultrasound ablation system

• Registration Number: NCT03962478
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2019-05-22
• Study First Submitted QC: 2019-05-22
• Study First Posted: 2019-05-24
• Study Start: 2019-05-31
• Primary Completion: 2020-02-08
• Status Verified: 2020-09
• Study Completion: 2020-09-28
• Last Update Submitted: 2020-09-28
• Last Update Posted: 2020-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stent without high-intensity focused ultrasound ablation	biliary stent	Patients undergo stent insertion on day 1.
Stent with high-intensity focused ultrasound ablation	biliary stent and high-intensity focused ultrasound ablation system	Patients undergo stent insertion with high-intensity focused ultrasound ablation on day 1.

Primary Outcome Measures

Name	Time	Method
6-month survival rate	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

Name	Time	Method
Stent patency	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	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.

Trial Locations

Locations (1)

Xuzhou Central Hospital; 🇨🇳 Xuzhou, Jiangsu, China