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

NCT07625189 | Recruiting

• 1 other identifier: STUDY00000041
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

RFA; Microwave Ablation; Pancreatic Lesion; Gastrointestinal Lesions; Ablation Techniques

Outcome Measures

Primary Outcomes (6)

• 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

Secondary Outcomes (20)

• Change From Baseline to 1 Month in Serum CA 19-9 Concentration

  Baseline to 1 month

• Change From Baseline to 3 Month in Serum CA 19-9 Concentration

  Baseline to 3 month

• Change From Baseline to 6 Month in Serum CA 19-9 Concentration

  Baseline to 6 month

• Change From Baseline to 12 Month in Serum CA 19-9 Concentration

  Baseline to 12 month

• Change From Baseline to 1 Month in Serum CEA Concentration

  Baseline to 1 month

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• The individual is expected to be unable to complete routine clinical follow-up.

Sponsors & Collaborators

• West Virginia University: lead

Study Sites (1)

West Virginia University

Morgantown, West Virginia, 26505, United States

RECRUITING

Related Publications (10)

• 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 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.

  PMID: 38729313 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.

  PMID: 40680897 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.

  PMID: 40429384 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.

  PMID: 35398344 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.

  PMID: 40787569 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.

  PMID: 40787544 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.

  PMID: 37174050 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.

  PMID: 40245290 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.

  PMID: 34547082 BACKGROUND

Study Officials

• Shailendra Singh, MD

  West Virginia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zim Warda Hasan

CONTACT

364-203-1900; zh00027@mix.wvu.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Advanced Endoscopy, Director of Bariatric Endoscopy, Associate Professor of Medicine

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: June 4, 2026
• Study Start: March 10, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: June 4, 2026

Record last verified: 2026-05

Locations

US (1)