A Clinical Study of EUS-RFA for Inoperable Pancreatic Ductal Adenocarcinoma

Not Applicable

Suspended

• Conditions: Pancreatic Ductal Adenocarcinoma

• Registration Number: NCT03444948
• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Brief Summary

To assess if endoscopic ultrasound-guided radiofrequency ablation application in patients with inoperable pancreatic cancer confers survival benefit when compared to patients receiving standard medical care.

Detailed Description

The five-year survival for pancreatic ductal adenocarcinoma (PDAC) is less than 5% in spite of the advances in management of cancers in the last few decades. Endobiliary application of radiofrequency (RF) has been developed and used in patients with inoperable bile duct and pancreatic head adenocarcinomas presenting with biliary obstruction. (1, 2) Endoscopic ultrasound (EUS) radiofrequency ablation (RFA) of pancreatic neoplasms has been proven to be well tolerated and safe, inducing a significant reduction in tumour size (3). Various techniques of EUS-guided tumour ablation have been described, including RF ablation, photodynamic therapy, laser ablation, and ethanol injection (4). Kahaleh et al. have demonstrated that Endoscopic ultrasound guided RF ablation (EUS-RFA) of the pancreatic head using Habib EUS-RFA catheter (EMcision Ltd, UK) through a 19-gauge needle was well tolerated in 5 Yucatan pigs and with minimum amount of pancreatitis (5). In a pilot clinical study, Pai et al showed either a complete response or at least a 50% reduction in tumours following application of radiofrequency ablation with the Habib™ EUS-RFA device in a group of eight patients with pancreatic cancers (3).

Study Timeline

• Study First Submitted: 2017-10-27
• Study First Submitted QC: 2018-02-19
• Study First Posted: 2018-02-26
• Study Start: 2019-02-14
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-18
• Last Update Posted: 2024-06-20
• Primary Completion: 2028-06-30
• Study Completion: 2028-12-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

• Patients above 18 years of age.
• A cytological / histological diagnosis of inoperable PDAC based on multidisciplinary review of cross-sectional imaging and cytology / histology results.
• Patients ought to be fit enough to be considered for the study (ECOG (Eastern Cooperative Oncology Group) performance status 0, 1 or 2)
• Patients who have commenced chemotherapy are not excluded from the study
• Patients capable of giving informed consent
• Negative blood pregnancy test for women of childbearing potential
• Willingness and ability to comply with all protocol requirements including scheduled visits, treatment plans, laboratory tests and other study procedures.

Exclusion Criteria

• ECOG performance status 3 or 4
• Life expectancy less than 3 months (including liver metastases, carcinomatosis)
• Prior investigational drugs within the last 30 days
• Known infection with human immunodeficiency virus (HIV)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Survival	at time of death on average 10months	Duration of survival

Secondary Outcome Measures

Name	Time	Method
Tumour Size	4 months	Measures during follow-upEUS
Monitoring of Adverse reactions	At time of death on average 10months	Number of participants with treatment-related adverse events will be recorded
Quality of life (HEALTH, SOCIAL INTERACTIONS, DAILY ACTIVITIES)	Time of death on average 10 months	Quality of life questionnaire DDQ15
Pain reduction	Time of death on average 10months	Likert Scale

Trial Locations

Locations (1)

Centre de recherche du Centre hospitalier de l'université de Montréal; 🇨🇦 Montréal, Quebec, Canada