EUS-Guided Ablation (RFA and MWA) for Pancreatic and Other Gastrointestinal Lesions Registry
30 maggio 2026 aggiornato da: Shailendra Singh, West Virginia University
Prospective Observational Registry of EUS-Guided Ablation (RFA and MWA) for Pancreatic and Other Gastrointestinal Lesions
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.
Panoramica dello studio
Stato
Reclutamento
Tipo di studio
Osservativo
Iscrizione (Stimato)
50
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Zim Warda Hasan
- Numero di telefono: 364-203-1900
- Email: zh00027@mix.wvu.edu
Luoghi di studio
-
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West Virginia
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Morgantown, West Virginia, Stati Uniti, 26505
- Reclutamento
- West Virginia University
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
N/A
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
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.
Descrizione
Inclusion Criteria:
- Adults ≥ 18 years of age.
- Diagnosis of a pancreatic premalignant lesion or malignancy, and other gastrointestinal or hepatobiliary lesion for which EUS-guided ablation is planned as part of standard clinical care.
- At least one clinically identified target lesion for which RFA or MWA is performed.
Exclusion Criteria:
- In the judgment of the treating clinician, inclusion in the registry would not be appropriate
- The individual is expected to be unable to complete routine clinical follow-up.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change From Baseline to 1 Month in Target Lesion Size
Lasso di tempo: Baseline to 1 month
|
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
Lasso di tempo: Baseline to 3 months
|
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
Lasso di tempo: Baseline to 6 months
|
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
Lasso di tempo: Baseline to 12 months
|
Change in tumor size (cm) from baseline to 12 months, assessed by imaging.
|
Baseline to 12 months
|
|
Overall Survival
Lasso di tempo: From ablation to death or last follow-up, assessed up to 1 year
|
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
Lasso di tempo: From ablation to death or last follow-up, assessed up to 3 year
|
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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change From Baseline to 1 Month in Serum CA 19-9 Concentration
Lasso di tempo: Baseline to 1 month
|
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
Lasso di tempo: Baseline to 3 month
|
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
Lasso di tempo: Baseline to 6 month
|
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
Lasso di tempo: Baseline to 12 month
|
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
Lasso di tempo: Baseline to 1 month
|
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
Lasso di tempo: Baseline to 3 month
|
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
Lasso di tempo: Baseline to 6 month
|
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
Lasso di tempo: Baseline to 12 month
|
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
Lasso di tempo: Baseline to 1 month
|
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
Lasso di tempo: Baseline to 3 months
|
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
Lasso di tempo: Baseline to 6 months
|
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
Lasso di tempo: Baseline to 12 months
|
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)
Lasso di tempo: Up to 1 month after ablation procedure
|
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)
Lasso di tempo: Up to 3 months after ablation procedure
|
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)
Lasso di tempo: Up to 6 months after ablation procedure
|
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)
Lasso di tempo: Up to 12 months after ablation procedure
|
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)
Lasso di tempo: Baseline to 1 month
|
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)
Lasso di tempo: Baseline to 3 month
|
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)
Lasso di tempo: Baseline to 6 month
|
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)
Lasso di tempo: Baseline to 12 month
|
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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Shailendra Singh, MD, West Virginia University
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
10 marzo 2026
Completamento primario (Stimato)
1 marzo 2028
Completamento dello studio (Stimato)
1 marzo 2028
Date di iscrizione allo studio
Primo inviato
2 aprile 2026
Primo inviato che soddisfa i criteri di controllo qualità
30 maggio 2026
Primo Inserito (Effettivo)
4 giugno 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
4 giugno 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
30 maggio 2026
Ultimo verificato
1 maggio 2026
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- STUDY00000041
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .