Ignite Creation Date:
2024-05-06 @ 7:17 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05961982
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2023-07-11
Brief Title:
Evaluation of Endoscopic Ultrasound-Guided Radiofrequency Ablation for the Management of Pancreatic Tumors ERASE Study
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
Ohio State University Comprehensive Cancer Center
Study Overview
Official Title:
Endoscopic Ultrasound-Guided Radiofrequency Ablation of Pancreatic Cysts - A Safety and Efficacy Trial ERASE Study
Status:
RECRUITING
Status Verified Date:
2024-06
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:
ERASE
Brief Summary:
This clinical trial evaluates the safety and effectiveness of endoscopic ultrasound-guided radiofrequency ablation EUS-RFA for the management of patients with pancreatic tumors including cysts performed during recommended surveillance endoscopic ultrasound examinations Pancreatic tumors cysts can progress to pancreatic cancer at rate of more than 25 per year risk Pancreatic cancer is a fatal disease that is difficult to diagnose at an early stage and the five-year survival rate is currently less than 10 It is projected to be the second leading cause of cancer-related mortality by the year 2030 A procedure known as radiofrequency ablation may help Radiofrequency ablation is an established way to treat benign and cancerous tumors in the human body In the last 5 years radiofrequency ablation has been applied to treat precancerous tumors including cysts in the pancreas This procedure implements a medical technology that destroys tumors in a much less invasive way compared to traditional surgical removal By delivering a high-frequency alternating current radiofrequency ablation uses electrical energy and heat to destroy cancer cells Radiofrequency ablation is being recognized as a management option in patients with high-risk pancreatic tumors cysts but are not deemed surgical candidates While surgical removal offers a chance of cure pancreatic surgeries have 20-40 morbidity rate short and long-term complication and a 1-2 mortality rate in patients who are surgical candidates Furthermore radiofrequency ablation can potentially decrease the need for frequent imagingsurveillance of the pancreatic tumor cyst In patients with immediate prohibitive but reversible risks for surgery radiofrequency ablation of a high-risk tumors cysts can potentially prevent further progression of the lesion and bridge the time before the need for surgical resection
Detailed Description:
PRIMARY OBJECTIVE
I To assess the efficacy of EUS-RFA of pancreatic cystic neoplasms PCNs
SECONDARY OBJECTIVES
I To assess the safety of EUS-guided RFA of PCNs II To assess the long-term response to EUS-RFA
OUTLINE
Patients undergo standard of care EUS-fine-needle aspiration FNA followed by EUS-RFA on study and may undergo repeat EUS-RFA or EUS-guided chemoablation during surveillance Patients undergo magnetic resonance imaging MRImagnetic resonance cholangiopancreatography MRCP computed tomography CT or EUS-FNA at baseline and at follow-up timepoints
After completion of study treatment patients are followed up every 3-6 months for cysts 3 cm or every 6-12 months for cysts 3 cm for up to 3 years
I To assess the efficacy of EUS-RFA of pancreatic cystic neoplasms PCNs
SECONDARY OBJECTIVES
I To assess the safety of EUS-guided RFA of PCNs II To assess the long-term response to EUS-RFA
OUTLINE
Patients undergo standard of care EUS-fine-needle aspiration FNA followed by EUS-RFA on study and may undergo repeat EUS-RFA or EUS-guided chemoablation during surveillance Patients undergo magnetic resonance imaging MRImagnetic resonance cholangiopancreatography MRCP computed tomography CT or EUS-FNA at baseline and at follow-up timepoints
After completion of study treatment patients are followed up every 3-6 months for cysts 3 cm or every 6-12 months for cysts 3 cm for up to 3 years
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2023-04688 | REGISTRY | CTRP Clinical Trial Reporting Program | None |