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

A Phase II Prospective Randomised Clinical Study of Endoscopic Ultrasound Guided Radiofrequency Ablation (EUS-RFA) for Inoperable Pancreatic Ductal Adenocarcinoma

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.

Study Overview

• Status: Suspended
• Conditions: Pancreatic Ductal Adenocarcinoma
• Intervention / Treatment: Device: EUS-RFA using Habib Tm as a probe; Procedure: EUS

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 Type: Interventional
• Enrollment (Estimated): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H2X 0A9
      • Centre de Recherche du Centre Hospitalier de l'Universite de Montreal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3 radiofrequency ablation procedures; Subject will undergo 3 radiofrequency ablation procedures at 1 month intervals (EUS-RFA using Habib Tm as a probe)	Device: EUS-RFA using Habib Tm as a probe; 3 EUS-RFA interventions at 1-month interval
Active Comparator: standard medical care; Subject will receive standard medical care, including pain relief drugs	Procedure: EUS; Standard intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival	Duration of survival	1 month
Survival	Duration of survival	at time of death on average 10months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life (HEALTH, SOCIAL INTERACTIONS, DAILY ACTIVITIES)	Quality of life questionnaire DDQ15	1 month
Quality of life (HEALTH, SOCIAL INTERACTIONS, DAILY ACTIVITIES)	Quality of life questionnaire DDQ15	Time of death on average 10 months
Pain reduction	Likert Scale	1 month
Pain reduction	Likert Scale	Time of death on average 10months
Monitoring of Adverse reactions	Number of participants with treatment-related adverse events will be recorded	At time of death on average 10months
Tumour Size	Measures during follow-up EUS	4 months

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Investigators: Principal Investigator: ANAND V SAHAI, MD, Centre de Recherche du Centre Hospitalier de l'Universite de Montreal

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2019
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: October 27, 2017
• First Submitted That Met QC Criteria: February 19, 2018
• First Posted (Actual): February 26, 2018

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma
• Other Study ID Numbers: CE 17.215

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No