Evaluation of Endoscopic Ultrasound-Guided Radiofrequency Ablation for the Management of Pancreatic Tumors, ERASE Study (ERASE)
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ClinicalTrials.gov Identifier: NCT05961982 |
Recruitment Status :
Recruiting
First Posted : July 27, 2023
Last Update Posted : July 27, 2023
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Condition or disease | Intervention/treatment | Phase |
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Pancreatic Neoplasm | Procedure: Chemical Ablation Procedure: Computed Tomography Other: Electronic Health Record Review Procedure: Endoscopic Ultrasound-Guided Fine-Needle Aspiration Procedure: Endoscopic Ultrasound-Guided Radiofrequency Ablation Procedure: Magnetic Resonance Cholangiopancreatography Procedure: Magnetic Resonance Imaging | Not Applicable |
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 (MRI)/magnetic 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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 32 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Endoscopic Ultrasound-Guided Radiofrequency Ablation of Pancreatic Cysts - A Safety and Efficacy Trial (ERASE Study) |
Actual Study Start Date : | April 24, 2023 |
Estimated Primary Completion Date : | December 31, 2024 |
Estimated Study Completion Date : | December 31, 2025 |
Arm | Intervention/treatment |
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Experimental: Treatment (EUS-RFA)
Patients undergo standard of care EUS-FNA followed by EUS-RFA on study and may undergo repeat EUS-RFA or EUS-guided chemoablation during surveillance. Patients undergo MRI/MRCP, CT, or EUS-FNA at baseline and at follow-up timepoints.
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Procedure: Chemical Ablation
Undergo EUS-guided chemoablation
Other Name: ABLATION, CHEMICAL Procedure: Computed Tomography Undergo CT
Other Names:
Other: Electronic Health Record Review Ancillary studies Procedure: Endoscopic Ultrasound-Guided Fine-Needle Aspiration Undergo EUS-FNA
Other Names:
Procedure: Endoscopic Ultrasound-Guided Radiofrequency Ablation Undergo EUS-RFA
Other Name: EUS-RFA Procedure: Magnetic Resonance Cholangiopancreatography Undergo MRI/MRCP
Other Name: MRCP Procedure: Magnetic Resonance Imaging Undergo MRI/MRCP
Other Names:
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- Efficacy of endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) [ Time Frame: At 1 years after EUS-RFA ]Defined as at least a 50% decrease in the cyst diameter. Other markers of response to EUS-RFA will be evaluated by cross-sectional imaging and EUS: change in the diameter, morphology of cyst - fibrosis, septations, loculations, wall thickness, intracystic or mural nodules; cyst fluid aspiration (biopsy if there is fibrosis): next generation sequencing (NGS) - persistence or absence of mutations (molecular markers), cytology - results can include either: mucin, atypical/suspicious cells, necrotic material, or inflammatory debris, experimental: flow cytometry for immunological markers of antineoplastic response; serological changes: chromogranin A (for cystic-neuroendocrine tumor), and serum cancer antigen (CA) 19-9 (if elevated prior to intervention).
- Long-term response to EUS-RFA [ Time Frame: At 2 and 3 years after EUS-RFA ]Defined as at least a 50% decrease in the cyst diameter. Durable response: Continued response with further decrease in cyst diameter beyond the first calendar year. The response will be evaluated by cross-sectional imaging and EUS: change in the diameter, morphology of cyst - fibrosis, septations, loculations, wall thickness, intracystic or mural nodules; cyst fluid aspiration (biopsy if there is fibrosis): NGS - persistence or absence of mutations (molecular markers), cytology - results can include either: mucin, atypical/suspicious cells, necrotic material, or inflammatory debris, experimental: flow cytometry for immunological markers of antineoplastic response; serological changes: chromogranin A (for cystic-neuroendocrine tumor), and serum CA 19-9 (if elevated prior to intervention).
- Safety of EUS-guided RFA of pancreatic cystic neoplasms post procedure [ Time Frame: Post-procedure (after EUS-RFA) ]Documented using the adverse events in gastrointestinal endoscopy classification for adverse events in gastrointestinal advanced endoscopy. Only grade II or higher degree of complications will be documented since patients are electively admitted after EUS-RFA for overnight observation. If patient has post-procedure acute pancreatitis, document severity based on Revised Atlanta Classification.
- Safety of EUS-guided RFA of pancreatic cystic neoplasms at one year [ Time Frame: at one year after EUS-RFA ]Documented using the adverse events in gastrointestinal endoscopy classification for adverse events in gastrointestinal advanced endoscopy. Only grade II or higher degree of complications will be documented since patients are electively admitted after EUS-RFA for overnight observation. If patient has post-procedure acute pancreatitis, document severity based on Revised Atlanta Classification.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age > 18 years
- A diagnosis of a PCN confirmed by EUS-FNA including cyst fluid next generation sequencing (NGS) and/or EUS-guided needle-based confocal laser endomicroscopy (nCLE) and/or EUS- guided through-the-needle biopsy (TTNB)
- The pancreatic cystic lesion (PCL) measures at least 2 cm in diameter on either CT or MRI/MRCP or EUS and demonstrates concerning worrisome and/or high-risk features as defined by International Consensus Guidelines (2017 revised Fukuoka Guidelines)
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The patient is not a surgical candidate. Common clinical scenarios include -
- Cirrhosis of the liver (common clinical scenario)
- Advanced ( >= 75 years) age (common clinical scenario)
- Morbid obesity
- Significant cardiorespiratory comorbidity
- Patient's choice (patient elects for non-surgical management)
- Other significant comorbid conditions that impose prohibitive surgical risks
- Estimated life expectancy of at least 1 year
- Capable of giving written informed consent
- Women of childbearing potential must have a negative pregnancy test (serum/urine) on the day of treatment. Pregnancy testing is the routine standard of care practice in the endoscopy laboratory for all patients undergoing endoscopy and sedation for endoscopy
- The patient prefers non-surgical management after consultation with hepato-pancreato-biliary (HPB) surgery
- The patient is not a surgical candidate and has had prior attempts at ablation of the PCN by EUS-guided injection of chemotherapy (Ohio State University [OSU] Institutional Review Board [IRB] protocol 2020C0198)
Exclusion Criteria:
- A diagnosis of a benign or non-neoplastic PCL such as a pseudocyst confirmed by EUS-FNA including cyst fluid NGS and/or EUS-nCLE and/or EUS-TTNB
- A diagnosis of a malignant PCN confirmed by evidence of adenocarcinoma and/or invasive carcinoma and/or distant metastases
- Cysts or neuroendocrine tumors (NETS) involving or in close proximity to blood vessels, the biliary tree, or the main pancreatic duct where the zone of ablation is likely to compromise these structures
- Acute pancreatitis in the preceding 4 weeks prior to date of EUS-RFA
- Any evidence of severe or uncontrolled systemic diseases or laboratory finding that in the view of the investigator makes it unsafe for the patient to participate in the study
- Any psychiatric disorder making reliable informed consent impossible
- Pregnancy or breast-feeding
- Eastern Cooperative Oncology Group (ECOG) performance status 4
- Contraindication to general anesthesia after review by OSU Preoperative Assessment Clinic (OPAC)
- Cardiac implantable electrical devices
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05961982
Contact: The Ohio State University Comprehensive Cancer Center | 800-293-5066 | OSUCCCClinicaltrials@osumc.edu |
United States, Ohio | |
Ohio State University Comprehensive Cancer Center | Recruiting |
Columbus, Ohio, United States, 43210 | |
Contact: Somashekar G. Krishna, MD 614-293-6255 Somashekar.Krishna@osumc.edu | |
Principal Investigator: Somashekar G. Krishna, MD |
Principal Investigator: | Somashekar G Krishna, MD | Ohio State University Comprehensive Cancer Center |
Responsible Party: | Somashekar Krishna, Principal Investigator, Ohio State University Comprehensive Cancer Center |
ClinicalTrials.gov Identifier: | NCT05961982 |
Other Study ID Numbers: |
OSU-22277 NCI-2023-04688 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) |
First Posted: | July 27, 2023 Key Record Dates |
Last Update Posted: | July 27, 2023 |
Last Verified: | July 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases |