NCT03444948

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.

Trial Health

53
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
31mo left

Started Feb 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Feb 2019Dec 2028

First Submitted

Initial submission to the registry

October 27, 2017

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 26, 2018

Completed
12 months until next milestone

Study Start

First participant enrolled

February 14, 2019

Completed
9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

9.4 years

First QC Date

October 27, 2017

Last Update Submit

April 20, 2026

Conditions

Pancreatic Ductal Adenocarcinoma

Outcome Measures

Primary Outcomes (2)

  • Survival

    Duration of survival

    1 month

  • Survival

    Duration of survival

    at time of death on average 10months

Secondary Outcomes (6)

  • Quality of life (HEALTH, SOCIAL INTERACTIONS, DAILY ACTIVITIES)

    1 month

  • Quality of life (HEALTH, SOCIAL INTERACTIONS, DAILY ACTIVITIES)

    Time of death on average 10 months

  • Pain reduction

    1 month

  • Pain reduction

    Time of death on average 10months

  • Tumour Size

    4 months

  • +1 more secondary outcomes

Study Arms (2)

3 radiofrequency ablation procedures

EXPERIMENTAL

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

standard medical care

ACTIVE COMPARATOR

Subject will receive standard medical care, including pain relief drugs

Procedure: EUS

Interventions

EUS-RFA using Habib Tm as a probeDEVICE

3 EUS-RFA interventions at 1-month interval

3 radiofrequency ablation procedures
EUSPROCEDURE

Standard intervention

standard medical care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de recherche du Centre hospitalier de l'université de Montréal

Montreal, Quebec, H2X 0A9, Canada

Location

Study Officials

  • ANAND V SAHAI, MD

    Centre de Recherche du Centre Hospitalier de l'Université de Montréal

    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

October 27, 2017

First Posted

February 26, 2018

Study Start

February 14, 2019

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

April 23, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)