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

Xuzhou Central Hospital (Xuzhou Fourth People's Hospital)

Status: Completed

Conditions: Biliary Obstruction; Pancreatic Carcinoma

Treatments: Device: biliary stent and high-intensity focused ultrasound ablation system; Device: biliary stent

Study type: Interventional

Funder types: Other

Identifiers

NCT03962478

20190522-021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 92 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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92 participants in 2 patient groups

Stent with high-intensity focused ultrasound ablation

Experimental group

Description:

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

Treatment:

Device: biliary stent and high-intensity focused ultrasound ablation system

Stent without high-intensity focused ultrasound ablation

Active Comparator group

Description:

Patients undergo stent insertion on day 1.

Treatment:

Device: biliary stent