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

Centre hospitalier de l'Université de Montréal (CHUM)

Status: Suspended

Conditions: Pancreatic Ductal Adenocarcinoma

Treatments: Procedure: EUS; Device: EUS-RFA using Habib Tm as a probe

Study type: Interventional

Funder types: Other

Identifiers

NCT03444948

CE 17.215

Details and patient eligibility

About

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.

Full 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).

Enrollment: 108 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 2 patient groups

3 radiofrequency ablation procedures

Experimental group

Description:

Subject will undergo 3 radiofrequency ablation procedures at 1 month intervals (EUS-RFA using Habib Tm as a probe)

Treatment:

Device: EUS-RFA using Habib Tm as a probe

standard medical care

Active Comparator group

Description:

Subject will receive standard medical care, including pain relief drugs

Treatment:

Procedure: EUS