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

Pancreatic Ductal Adenocarcinoma Clinical Trial

— EUS-RFA  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03444948
• Other study ID #: CE 17.215
• Status: Suspended
• Phase: N/A
• Start date: February 14, 2019
• Est. completion date: May 1, 2028

Study information

• Verified date: October 2023
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Other known NCT identifiers

• NCT03065985

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 108
• Est. completion date: May 1, 2028
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Ductal Adenocarcinoma

Intervention

Device:
• EUS-RFA using Habib Tm as a probe
3 EUS-RFA interventions at 1-month interval

Procedure:
• EUS
Standard intervention

Locations

Country	Name	City	State
Canada	Centre de recherche du Centre hospitalier de l'université de Montréal	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	Duration of survival	1 month
Primary	Survival	Duration of survival	at time of death on average 10months
Secondary	Quality of life (HEALTH, SOCIAL INTERACTIONS, DAILY ACTIVITIES)	Quality of life questionnaire DDQ15	1 month
Secondary	Quality of life (HEALTH, SOCIAL INTERACTIONS, DAILY ACTIVITIES)	Quality of life questionnaire DDQ15	Time of death on average 10 months
Secondary	Pain reduction	Likert Scale	1 month
Secondary	Pain reduction	Likert Scale	Time of death on average 10months
Secondary	Tumour Size	Measures during follow-upEUS	4 months
Secondary	Monitoring of Adverse reactions	Number of participants with treatment-related adverse events will be recorded	At time of death on average 10months