Clinical trial NCT03962478: Combined Stent Insertion and HIFU Ablation for Pancreatic Carcinoma With Biliary Obstruction
Official title: Combined Stent Insertion and High-intensity Focused Ultrasound Ablation for Pancreatic Carcinoma With Biliary Obstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Carcinoma
Biliary Obstruction
Lead sponsor: Xuzhou Central Hospital
Sponsor class: OTHER
First posted: 2019-05-24
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: 6-month survival rate
timeFrame: From the date of randomization until the date of first documented death from any cause, assessed up to 12 months
Secondary outcomes:
measure: Stent patency
timeFrame: From the date of randomization until the date of first documented stent dysfunction, assessed up to 10 months
measure: Stent dysfunction free survival
timeFrame: 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.
Other outcomes:
Locations:
city: Xuzhou
country: China
facility: Xuzhou Central Hospital
state: Jiangsu
Study officials:
affiliation: Xuzhou Central Hospital
name: Chi Cao, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.