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Recruiting NCT07625189

EUS-Guided Ablation (RFA and MWA) for Pancreatic and Other Gastrointestinal Lesions Registry

— Observational RFA Microwave Ablation Pancreatic Lesion Gastrointestinal Lesions

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: RFA, Microwave Ablation, Pancreatic Lesion, Gastrointestinal Lesions. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Prospective Observational Registry of EUS-Guided Ablation (RFA and MWA) for Pancreatic and Other Gastrointestinal Lesions

Overview

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.

Primary outcome measures

  • Change From Baseline to 1 Month in Target Lesion Size [Time frame: Baseline to 1 month]
  • Change From Baseline to 3 Months in Target Lesion Size [Time frame: Baseline to 3 months]
  • Change From Baseline to 6 Months in Target Lesion Size [Time frame: Baseline to 6 months]
  • Change From Baseline to 12 Months in Target Lesion Size [Time frame: Baseline to 12 months]
  • Overall Survival [Time frame: From ablation to death or last follow-up, assessed up to 1 year]
  • Overall Survival [Time frame: From ablation to death or last follow-up, assessed up to 3 year]
Secondary outcome measures (12)
  • Change From Baseline to 1 Month in Serum CA 19-9 Concentration [Time frame: Baseline to 1 month]
  • Change From Baseline to 3 Month in Serum CA 19-9 Concentration [Time frame: Baseline to 3 month]
  • Change From Baseline to 6 Month in Serum CA 19-9 Concentration [Time frame: Baseline to 6 month]
  • Change From Baseline to 12 Month in Serum CA 19-9 Concentration [Time frame: Baseline to 12 month]
  • Change From Baseline to 1 Month in Serum CEA Concentration [Time frame: Baseline to 1 month]
  • Change From Baseline to 3 Month in Serum CEA Concentration [Time frame: Baseline to 3 month]
  • Change From Baseline to 6 Month in Serum CEA Concentration [Time frame: Baseline to 6 month]
  • Change From Baseline to 12 Month in Serum CEA Concentration [Time frame: Baseline to 12 month]
  • Change From Baseline to 1 Month in Size of Non-Target Lesions [Time frame: Baseline to 1 month]
  • Change From Baseline to 3 Months in Size of Non-Target Lesions [Time frame: Baseline to 3 months]
  • Change From Baseline to 6 Months in Size of Non-Target Lesions [Time frame: Baseline to 6 months]
  • Change From Baseline to 12 Months in Size of Non-Target Lesions [Time frame: Baseline to 12 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • West Virginia University — Morgantown

Publications

  • 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. PMID 35146230
  • 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. PMID 38729313
  • 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 PMID 40680897
  • 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. PMID 40429384
  • 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. PMID 35398344
  • 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. PMID 40787569
  • 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. PMID 40787544
  • 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. PMID 37174050

Identifiers

NCT: NCT07625189 · STUDY00000041

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗