NCT03772756

EUS-RFA for Unresectable Pancreatic Ductal Adenocarcinoma

Endoscopic Ultrasound Guided Radiofrequency Ablation (EUS-RFA) for Unresectable Pancreatic Adenocarcinoma - a Randomised Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: First People's Hospital of Hangzhou · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Accepted

Summary

the study evaluate the efficacy and safety of EUS-RFA using Habib EUS-RFA catheter with a prospective randomised trial in patients with inoperable PDAC.

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 ablation (RFA) has been developed in our unit and used in patients with unresectable bile duct and pancreatic head adenocarcinomas presenting with biliary obstruction. Various techniques of EUS-guided tumour ablation have been described, including RF ablation, photodynamic therapy, laser ablation, and ethanol injection. Endoscopic ultrasound guided RFA (EUS-RFA) of the pancreatic head using Habib EUS-RFA catheter through a 19-gauge needle was well tolerated in 5 Yucatan pigs and with minimum amount of pancreatitis .

Conditions

• Pancreatic Adenocarcinoma Non-resectable

Interventions

Type	Name	Description
PROCEDURE	Endoscopic ultrasound guided radiofrequency ablation	Endoscopic ultrasound guided radiofrequency ablation （EUS-RFA） will be done in 3 different sessions with 2 weeks interval between each session on Day 1, Day 15 and Day 30. Each session will involve multiple applications of EUS-RFA (up to 10) with RF setting of 25 Watts over 90 seconds for each application.
RADIATION	chemoradiotherapy	Receive chemoradiotherapy

Timeline

• Start date: 2018-12-20
• Primary completion: 2021-08-16
• Completion: 2021-08-16
• First posted: 2018-12-11
• Last updated: 2021-08-30

Locations

2 sites across 1 country: China