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

NCT03962478 | Completed DMC

• 1 other identifier: 20190522-021
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Carcinoma; Biliary Obstruction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Stent patency

  From the date of randomization until the date of first documented stent dysfunction, assessed up to 10 months

• 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.

Study Arms (2)

Stent with high-intensity focused ultrasound ablation

EXPERIMENTAL

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

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

Stent without high-intensity focused ultrasound ablation

ACTIVE COMPARATOR

Patients undergo stent insertion on day 1.

Device: biliary stent

Interventions

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

Stent with high-intensity focused ultrasound ablation

biliary stent DEVICE

Self-expandable biliary nitinol alloys stent

Stent without high-intensity focused ultrasound ablation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• malignant distal biliary obstruction;
• pathologically diagnosed pancreatic carcinoma;
• unresectable cases.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xuzhou Central Hospital: lead

Study Sites (1)

Xuzhou Central Hospital

Xuzhou, Jiangsu, 221009, China

Location

Related Publications (2)

• 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.

  PMID: 27783026 BACKGROUND

• 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.

  PMID: 33605677 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Chi Cao, MD

  Xuzhou Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: May 24, 2019
• Study Start: May 31, 2019
• Primary Completion: February 8, 2020
• Study Completion: September 28, 2020
• Last Updated: September 30, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)