Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-25 @ 9:01 PM
Study NCT ID:
NCT03772756
Status:
COMPLETED
Last Update Posted:
2021-08-30
First Post:
2018-12-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
EUS-RFA for Unresectable Pancreatic Ductal Adenocarcinoma
Sponsor:
First People's Hospital of Hangzhou
Organization:
Study Overview
Official Title:
Endoscopic Ultrasound Guided Radiofrequency Ablation (EUS-RFA) for Unresectable Pancreatic Adenocarcinoma - a Randomised Controlled Trial
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 .
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: