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Completed

NCT Number: NCT03962478

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

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.

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Key information

Conditions

Pancreatic Carcinoma Biliary Obstruction Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xuzhou Central Hospital

Xuzhou, Jiangsu, 221009, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

biliary stent and high-intensity focused ultrasound ablation system

Device

Self-expandable biliary nitinol alloys stent and YDME FEP-BY02 high-intensity focused ultrasound equipment

biliary stent

Device

Self-expandable biliary nitinol alloys stent

Primary outcomes

  1. 6-month survival rate

    Time frame: 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 outcomes

  1. Stent patency

    Time frame: 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.

  2. Stent dysfunction free survival

    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.

    From the date of randomization until the date of first documented stent dysfunction or the date of death from any cause, whichever came first.

Sponsors and collaborators

Lead sponsor

Xuzhou Central Hospital

Other

Registry information

Official study title

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

Acronym: HIFU

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 24, 2019
Registry last updated
Sep 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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