NCT03444948

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

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

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Pancreatic Ductal Adenocarcinoma

Interventions

Type	Name	Description
DEVICE	EUS-RFA using Habib Tm as a probe	3 EUS-RFA interventions at 1-month interval
PROCEDURE	EUS	Standard intervention

Timeline

• Start date: 2019-02-14
• Primary completion: 2028-06-30
• Completion: 2028-12-01
• First posted: 2018-02-26
• Last updated: 2024-06-20

Locations

1 site across 1 country: Canada