Radio Frequency Ablation in the Management of Pancreatico-biliary Disorders: A Multicenter Registry.
Bile duct cancer and pancreatic cancer are cancers that cannot be surgically removed. As the cancer grows, it blocks the drainage of the bile ducts that carry digestive juices from the gallbladder and pancreas to the small intestine. ERCP (endoscopic retrograde cholangiopancreatography) is often prescribed during which a tube with a tiny camera attached is inserted through the subject's mouth and advanced to a place in the small intestine where the bile duct empties. Through this scope the doctor enlarges the ducts with tiny balloons and places plastic or metal stents (straws) that help keep the bile ducts open so they can drain properly. However, due to the cancer, the stents are blocked eventually.
The purpose of this registry is to record information and evaluate the impact of endoscopic radiofrequency ablation (RFA) probes in improving the management of bile duct cancer or pancreatic cancer by ablating the tissue in the bile duct(s) before the stent(s) are implanted. By using radiofrequency (RF) energy to heat the tissue in the duct(s) prior to stent(s) insertion, the surrounding tissue becomes coagulated and this may delay tumor growth and the time before the stent lumen becomes blocked. Thereby, allowing increased periods between the need for intervention and further stent implantation(s). The registry will evaluate the efficacy and safety of RFA procedures conducted for pancreatico-biliary disorders
調査の概要
詳細な説明
Background
Bile duct cancer and pancreatic cancer are cancers that cannot be surgically removed. As the cancer grows, it blocks the drainage of the bile ducts that carry digestive juices from the gallbladder and pancreas to the small intestine. ERCP (endoscopic retrograde cholangiopancreatography) is often prescribed during which a tube with a tiny camera attached is inserted through the subject's mouth and advanced to a place in the small intestine where the bile duct empties. Through this scope the doctor enlarges the ducts with tiny balloons and places plastic or metal stents (straws) that help keep the bile ducts open so they can drain properly. However, due to the cancer, the stents are blocked eventually.
The purpose of this registry is to record information and evaluate the impact of endoscopic radiofrequency ablation (RFA) probes in improving the management of bile duct cancer or pancreatic cancer by ablating the tissue in the bile duct(s) before the stent(s) are implanted. By using radiofrequency (RF) energy to heat the tissue in the duct(s) prior to stent(s) insertion, the surrounding tissue becomes coagulated and this may delay tumor growth and the time before the stent lumen becomes blocked. Thereby, allowing increased periods between the need for intervention and further stent implantation(s). The registry will evaluate the efficacy and safety of RFA procedures conducted for pancreatico-biliary disorders
Objectives:
The safety and efficacy of various radio frequency ablation probes have been assessed in a series of studies. This multi-center registry has been initiated since June 2011 and is ongoing until June 2017:
- To document the immediate and post procedure clinical performance of radio frequency ablation in a "real world" patient population requiring stent implantation for pancreatico-biliary disorders.
- To assess the immediate and 6 months post procedure adverse event rate in patients.
- To assess the impact of RFA on the life expectancy of patients suffering from pancreatico-biliary malignancies.
Study Design at Coordinating Center - Weill Cornell Medical College Primary site (WCMC):
This study entails review of data from a database protocol [IRB # 1104011642 : collected for non-research related purposes]. The purpose of this protocol is to establish a database that captures all Endoscopic Retrograde Cholangiopancreatography, Endoscopic Ultrasound and Interventional endoscopy cases. Its objective is to assess prospectively the efficacy and safety of these routine procedures to permit identification of technical details about the procedures or other factors, which might be associated with outcome or results. Assessment of these details would help us with problem identification and recommendations to improve health outcomes and quality of life in these patients
The registry will review and document:
- All patients who have had Interventional Endoscopy procedures done which involved radio frequency ablations for pancreatico-biliary disorders since June 2011 and extending forward through June 2017.
- Data will be reviewed and collected from database protocol IRB # 1104011642.
- No subject intervention is involved in this study. Subject contact is not needed for database review.
Study Design at Secondary sites:
The registry will review and document:
- All patients who have had Interventional Endoscopy procedures done which involved radio frequency ablations for pancreatico-biliary disorders.
- No subject intervention is involved in this study. Subject contact is not needed for retrospective review.
- These sites would have IRB approved protocols to collect and send radio frequency ablation procedure data to the primary site (WCMC). Additionally, the secondary study sites would mention WCMC as an entity that could receive PHI in their prospective protocols and consent/HIPAA forms.
- All secondary study sites' IRB approvals will be sent to the primary/coordinating study center at WCMC. The primary center will then forward these IRB approvals to WCMC IRB as soon as they are received from the secondary study sites.
- Relevant IRB documentation will be maintained at both primary and secondary sites.
Registry Hosting:
The coordinating center and primary site (WCMC) will host the registry on the local servers.
A secure Data management or Electronic Data Capture (EDC) system will be used for data entry, compilation and querying.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
Texas
-
Dallas、Texas、アメリカ、75203
- Methodist Dallas Medical Center
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- All patients who have had Interventional Endoscopy procedures done which involved radio frequency ablations and stent insertion(s) for pancreatico-biliary disorders.
- Above 18 years of age.
Exclusion Criteria:
- Any patient who has not undergone interventional endoscopy with RFA and stent insertion(s).
- Below 18 years of age
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
---|---|
Interventional Endoscopy procedures
All patients who have had Interventional Endoscopy procedures done which involved radio frequency ablations for pancreatico-biliary disorders since June 2011 and extending forward through June 2023.
|
• All patients who have had Interventional Endoscopy procedures done which involved radio frequency ablations and stent insertion(s) for pancreatico-biliary disorders.
|
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 |
---|---|---|
Measurement of Bile Duct Stricture Diameter
時間枠:June 2011 through June 2021
|
Change from Baseline in Bile Duct Stricture Diameter
|
June 2011 through June 2021
|
Adverse Events
時間枠:June 2011 through June 2021
|
Number of Participants with Adverse Events, Type of adverse events, frequency and intensity
|
June 2011 through June 2021
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
survival duration
時間枠:June 2011 through June 2023
|
Documentation of response rates and overall survival duration
|
June 2011 through June 2023
|
stent occlusion-free duration
時間枠:June 2011 through June 2023
|
Documentation of overall stent occlusion-free duration
|
June 2011 through June 2023
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Prashant Kedia, MD、Methodist Dallas Medical Center
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 003.GID.2016.D
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
- Data will be collected and entered at/submitted to the primary site (WCMC).
- A secure Access Database or an alternative secure Electronic Data Capture (EDC) system hosted on the WCMC server will be used for data entry, compilation and reporting.
IPD 共有時間枠
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。
胆管がんの臨床試験
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Interventional Endoscopy proceduresの臨床試験
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Baylor College of MedicineAlliance for Academic Internal Medicine完了
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Johns Hopkins University積極的、募集していない
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Baylor College of Medicine積極的、募集していない
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University Hospital, Clermont-FerrandFondation Apicilわからない