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This is a single-center, investigator-initiated, prospective observational registry that will collect longitudinal clinical data on adult patients (≥18 years) undergoing endoscopic ultrasound (EUS)-guided radiofrequency ablation (RFA) or microwave ablation (MWA) for pancreatic and other gastrointestinal/hepatobiliary lesions as part of routine clinical care. The registry will not alter standard-of-care management. Data will be abstracted from the medical record and routine clinical systems. Primary outcomes include change in target lesion size on clinically obtained imaging and overall survival following ablation. Secondary outcomes include changes in tumor biomarkers, adverse events, non-target lesion changes, and patient-reported symptoms.
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to 1 Month in Target Lesion Size | Change in tumor size (cm) from baseline to 1 month, assessed by imaging. | Baseline to 1 month |
| Change From Baseline to 3 Months in Target Lesion Size | Change in tumor size (cm) from baseline to 3 months, assessed by imaging. | Baseline to 3 months |
| Change From Baseline to 6 Months in Target Lesion Size | Change in tumor size (cm) from baseline to 6 months, assessed by imaging. | Baseline to 6 months |
| Change From Baseline to 12 Months in Target Lesion Size | Change in tumor size (cm) from baseline to 12 months, assessed by imaging. | Baseline to 12 months |
| Overall Survival | Overall survival defined as the time from ablation to death from any cause. Participants still alive will be censored at last known follow-up. | From ablation to death or last follow-up, assessed up to 1 year |
| Overall Survival | Overall survival defined as the time from ablation to death from any cause. Participants still alive will be censored at last known follow-up. | From ablation to death or last follow-up, assessed up to 3 year |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to 1 Month in Serum CA 19-9 Concentration | Change in serum CA 19-9 concentration from baseline to 1 month. | Baseline to 1 month |
| Change From Baseline to 3 Month in Serum CA 19-9 Concentration |
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Inclusion Criteria:
Exclusion Criteria:
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The purpose of this registry is to create a longitudinal clinical dataset describing patients who undergo EUS-guided RFA or MWA as part of routine care and to explore clinical outcomes and factors associated with those outcomes.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zim Warda Hasan | Contact | 364-203-1900 | zh00027@mix.wvu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Shailendra Singh, MD | West Virginia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Virginia University | Recruiting | Morgantown | West Virginia | 26505 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35146230 | Background | Robles-Medranda C, Arevalo-Mora M, Oleas R, Alcivar-Vasquez J, Del Valle R. Novel EUS-guided microwave ablation of an unresectable pancreatic neuroendocrine tumor. VideoGIE. 2022 Jan 19;7(2):74-76. doi: 10.1016/j.vgie.2021.10.009. eCollection 2022 Feb. | |
| 38729313 | Background | Wray CJ, O'Brien B, Cen P, Rowe JH, Faraoni EY, Bailey JM, Rubin E, Tammisetti VS, Thosani N. EUS-guided radiofrequency ablation for pancreatic adenocarcinoma. Gastrointest Endosc. 2024 Oct;100(4):759-766. doi: 10.1016/j.gie.2024.04.2926. Epub 2024 May 8. |
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Change in serum CA 19-9 concentration from baseline to 3 month.
| Baseline to 3 month |
| Change From Baseline to 6 Month in Serum CA 19-9 Concentration | Change in serum CA 19-9 concentration from baseline to 6 month. | Baseline to 6 month |
| Change From Baseline to 12 Month in Serum CA 19-9 Concentration | Change in serum CA 19-9 concentration from baseline to 12 month. | Baseline to 12 month |
| Change From Baseline to 1 Month in Serum CEA Concentration | Change in serum carcinoembryonic antigen (CEA) concentration from baseline to 1 month. | Baseline to 1 month |
| Change From Baseline to 3 Month in Serum CEA Concentration | Change in serum carcinoembryonic antigen (CEA) concentration from baseline to 3 month. | Baseline to 3 month |
| Change From Baseline to 6 Month in Serum CEA Concentration | Change in serum carcinoembryonic antigen (CEA) concentration from baseline to 6 month. | Baseline to 6 month |
| Change From Baseline to 12 Month in Serum CEA Concentration | Change in serum carcinoembryonic antigen (CEA) concentration from baseline to 12 month. | Baseline to 12 month |
| Change From Baseline to 1 Month in Size of Non-Target Lesions | Change in size (cm) of non-target lesions from baseline to 1 month, assessed by imaging. | Baseline to 1 month |
| Change From Baseline to 3 Months in Size of Non-Target Lesions | Change in size (cm) of non-target lesions from baseline to 3 months, assessed by imaging. | Baseline to 3 months |
| Change From Baseline to 6 Months in Size of Non-Target Lesions | Change in size (cm) of non-target lesions from baseline to 6 months, assessed by imaging. | Baseline to 6 months |
| Change From Baseline to 12 Months in Size of Non-Target Lesions | Change in size (cm) of non-target lesions from baseline to 12 months, assessed by imaging. | Baseline to 12 months |
| Number of Participants With Procedure-Related Adverse Events (1 Month) | Number of participants experiencing one or more procedure-related adverse events within 1 month after ablation. Adverse events will be assessed according to standard criteria. | Up to 1 month after ablation procedure |
| Number of Participants With Procedure-Related Adverse Events (3 Months) | Number of participants experiencing one or more procedure-related adverse events within 3 months after ablation. Adverse events will be assessed according to standard criteria. | Up to 3 months after ablation procedure |
| Number of Participants With Procedure-Related Adverse Events (6 Months) | Number of participants experiencing one or more procedure-related adverse events within 6 months after ablation. Adverse events will be assessed according to standard criteria. | Up to 6 months after ablation procedure |
| Number of Participants With Procedure-Related Adverse Events (12 Months) | Number of participants experiencing one or more procedure-related adverse events within 12 months after ablation. Adverse events will be assessed according to standard criteria. | Up to 12 months after ablation procedure |
| Change From Baseline to 1 Month in Quality of Life Score (EORTC QLQ-C30) | Change in overall quality of life score from baseline to 1 month as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Scores are calculated according to the instrument scoring manual, with higher scores indicating better quality of life. | Baseline to 1 month |
| Change From Baseline to 3 Month in Quality of Life Score (EORTC QLQ-C30) | Change in overall quality of life score from baseline to 3 month as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Scores are calculated according to the instrument scoring manual, with higher scores indicating better quality of life. | Baseline to 3 month |
| Change From Baseline to 6 Month in Quality of Life Score (EORTC QLQ-C30) | Change in overall quality of life score from baseline to 6 month as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Scores are calculated according to the instrument scoring manual, with higher scores indicating better quality of life. | Baseline to 6 month |
| Change From Baseline to 12 Month in Quality of Life Score (EORTC QLQ-C30) | Change in overall quality of life score from baseline to 12 month as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Scores are calculated according to the instrument scoring manual, with higher scores indicating better quality of life. | Baseline to 12 month |
| 40680897 | Background | Kongkam P, Tantitanawat K, Kerr S, Lopimpisuth C, Tiankanon K, Angsuwatcharakon P, Ridtitid W, Mekaroonkamol P, Teeyapun N, Tanasanvimon S, Treeprasertsuk S, Kullavanijaya P, Sriuranpong V, Rerknimitr R, Luangsukrerk T. One-year survival rate of unresectable pancreatic cancer size 4 cm or smaller treated with or without EUS-radiofrequency ablation. Gastrointest Endosc. 2025 Dec;102(6):883-887. doi: 10.1016/j.gie.2025.06.008. Epub 2025 Jul 17. |
| 40429384 | Background | Bidani K, Marinovic AG, Moond V, Harne P, Broder A, Thosani N. Treatment of Pancreatic Neuroendocrine Tumors: Beyond Traditional Surgery and Targeted Therapy. J Clin Med. 2025 May 13;14(10):3389. doi: 10.3390/jcm14103389. |
| 35398344 | Background | Wood LD, Canto MI, Jaffee EM, Simeone DM. Pancreatic Cancer: Pathogenesis, Screening, Diagnosis, and Treatment. Gastroenterology. 2022 Aug;163(2):386-402.e1. doi: 10.1053/j.gastro.2022.03.056. Epub 2022 Apr 7. |
| 40787569 | Background | Mohan A, Prasanth M, Saeed NA, Shehzadi T, Hasan ZW, Khan NN, Tanush D, Aminpoor H. Advancements in endoscopic closure techniques for gastrointestinal luminal defects comparative perspectives on OTSC, endo suturing, TTS clips, and X-Tack. Ann Med Surg (Lond). 2025 Jul 16;87(8):5077-5086. doi: 10.1097/MS9.0000000000003571. eCollection 2025 Aug. |
| 40787544 | Background | Hasan ZW, Shehzadi T, Mohan A, Rehman AU, Muskan F, Zia M, Lal PM, Aminpoor H, Karimi H, Kumar V, Tejwaney U, Kumar S. Percutaneous, transpapillary, and transmural drainage in acute cholecystitis: a comparative analysis of techniques, stent selection, and clinical. Ann Med Surg (Lond). 2025 Jul 30;87(8):5056-5061. doi: 10.1097/MS9.0000000000003527. eCollection 2025 Aug. |
| 37174050 | Background | Slodkowski M, Wronski M, Karkocha D, Kraj L, Smigielska K, Jachnis A. Current Approaches for the Curative-Intent Surgical Treatment of Pancreatic Ductal Adenocarcinoma. Cancers (Basel). 2023 Apr 30;15(9):2584. doi: 10.3390/cancers15092584. |
| 40245290 | Background | Rahib L, Coffin T, Kenner B. Factors Driving Pancreatic Cancer Survival Rates. Pancreas. 2025 Jul 1;54(6):e530-e536. doi: 10.1097/MPA.0000000000002489. |
| 34547082 | Background | Park W, Chawla A, O'Reilly EM. Pancreatic Cancer: A Review. JAMA. 2021 Sep 7;326(9):851-862. doi: 10.1001/jama.2021.13027. |