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

2026年5月30日 更新者：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.

調査の概要

状態

募集

条件

研究の種類

観察的

入学 (推定)

50

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • アメリカ
    • West Virginia
      • Morgantown、West Virginia、アメリカ、26505
        • 募集
        • West Virginia University

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

なし

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change From Baseline to 1 Month in Target Lesion Size
時間枠：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
時間枠：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
時間枠：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
時間枠：Baseline to 12 months
Change in tumor size (cm) from baseline to 12 months, assessed by imaging.
Baseline to 12 months
Overall Survival
時間枠：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
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Change From Baseline to 1 Month in Serum CA 19-9 Concentration
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

West Virginia University

捜査官

  • 主任研究者：Shailendra Singh, MD、West Virginia University

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年3月10日

一次修了 (推定)

2028年3月1日

研究の完了 (推定)

2028年3月1日

試験登録日

最初に提出

2026年4月2日

QC基準を満たした最初の提出物

2026年5月30日

最初の投稿 (実際)

2026年6月4日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月4日

QC基準を満たした最後の更新が送信されました

2026年5月30日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • STUDY00000041

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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