胃出口閉塞用 AXIOS™ 胃腸瘻 IDE
切除不能な悪性疾患による胃出口閉塞に対する内腔近接金属ステントを用いた内視鏡的超音波ガイド下胃腸瘻造設術の多施設シングルアーム前向き研究
To investigate the safety and technical success of EUS-guided gastroenterostomy (EUS-GE) using the AXIOSTM lumen-apposing Metal Stent for the management of symptoms associated with gastric outlet obstruction from malignant unresectable neoplasm.
調査の概要
詳細な説明
The study is a prospective multi-center, single -arm study with treatment of up to 67 subjects at up to 10 clinical centers. Subjects who meet all eligibility criteria will receive the AXIOS stent and up to 12 months follow-up.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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Massachusetts
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Boston、Massachusetts、アメリカ、02115
- Brigham and Women's Hospital
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Minnesota
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Rochester、Minnesota、アメリカ、55905
- Mayo Clinic
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New York
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New York、New York、アメリカ、10065
- New York Presbyterian/ Weill Cornell Medical Center
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Pennsylvania
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Pittsburgh、Pennsylvania、アメリカ、15213
- University of Pittsburg Medical Center
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Washington
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Seattle、Washington、アメリカ、98101
- Virginia Mason Medical Center
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Hyderabad、インド
- Asian Institute of Gastroenterology
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Montreal、カナダ、H3Z 2E9
- McGill University Health Care
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São Paulo、ブラジル、01246-092
- Instituto do Cancer do Estado de Sao Paulo
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Leuven、ベルギー
- UZ Leuven
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Shanghai Municipality
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Shanghai、Shanghai Municipality、中国、200433
- Shanghai Changhai Hospital
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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
説明
Inclusion Criteria:
- Gastric outlet obstruction from unresectable malignant neoplasm
- Eligible for endoscopic intervention
- GOOS of 0 or 1 0 - no oral intake 1 - liquids only 2 - soft solids only 3 - low-residue or full diet
- 18 years of age or older
- Willing and able to comply with the study procedures or legally authorized representative (LAR) must provide written informed consent form (ICF) to participate in the study
- The distance between the gastric lumen and jejunal lumen must be no more than 1.0 cm
Exclusion Criteria:
- Patients with baseline ECOG > 2 and/or Karnofsky Performance score < 30
- Gastric cancer or any malignant infiltration precluding a cancer free puncture site of the AXIOSTM stent
- Abnormal coagulation INR > 1.5 and not correctable (per the discretion of the physician) or who require continuous complete anticoagulation, and/or any underlying condition associated with high risk of bleeding
- Altered anatomy of the upper gastrointestinal tract due to surgery of esophagus, stomach and duodenum that might preclude endoscopic gastroenterostomy
- Multiple-level bowel obstruction downstream from the intended location of the EUS-guided bypass confirmed by radiography such as small bowel series or computed tomography
- Presence of intraperitoneal fat between the gastric lumen and jejunal lumen estimated to be larger than 1.0 cm at the proposed site of AXIOSTM stent insertion
- Gastric varices located within a two-centimeter radius of the device insertion location on the gastric wall
- Ascites Grade ≥ 2 confirmed by cross-sectional imaging
- Vessels located within a two-centimeter radius of the device insertion location
- History of multiple abdominal surgeries and/or evidence of small bowel adhesions
- Allergic to any of the device materials
- Contraindications to use of electrical devices
- Pregnancy
- Prisoners and other vulnerable populations
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
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：AXIOS(TM) Stent and Electrocautery Enhanced Delivery System
Patients who meet all the inclusion criteria and none of the exclusion criteria will have a EUS-guided gastroenterostomy (EUS-GE) using the AXIOS(TM) lumen-apposing Metal Stent for the management of symptoms associated with gastric outlet obstruction from malignant unresectable neoplasm |
Patients who meet all the inclusion criteria and none of the exclusion criteria will have a EUS-guided gastroenterostomy (EUS-GE) using the AXIOS(TM) lumen-apposing Metal Stent for the management of symptoms associated with gastric outlet obstruction from malignant unresectable neoplasm |
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 |
|---|---|---|
|
Serious Adverse Events
時間枠：Through study completion, an average of 1 year
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The proportion of subjects with one or more AXIOS stent related or AXIOS endoscopic and/or study procedure related serious adverse events through 30 days post stent placement. |
Through study completion, an average of 1 year
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Technical Success
時間枠：During the procedure
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The proportion of subjects that demonstrate technical Successful stent placement, defined as transmural placement of the AXIOS stent with confirmed stent patency by visualization of the contralateral wall of the small bowel through the AXIOS stent lumen. Visualization of blue dye in the gastric lumen or injection of contrast to confirm continuity of the gastroenteric lumen, may be used to provide supplemental confirmation of intended stent placement. Note: Visualization of blue dye in the gastric lumen or injection of contrast to confirm continuity of the gastroenteric lumen, may be used to provide supplemental confirmation of intended stent placement. |
During the procedure
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Primary Effectiveness Endpoint
時間枠：through 14 days after procedure
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Clinical Success defined as improvement of Gastric Outlet Obstruction Score (GOOS)by 1 point from baseline to any point during 14 days after AXIOS stent placement and GOOS remaining at 1 or more without the need for reintervention due to loss of stent function at 30 days post-index procedure or death, whichever comes first. |
through 14 days after procedure
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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ステント留置後、経口摂取を再開するまでの時間。
時間枠：手続き直後
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手続き直後
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AXIOSTM ステント留置後の化学療法を開始または再開する時間（該当する場合）
時間枠：手続き直後
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手続き直後
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ベースラインから 30 日、3 か月、6 か月、および 12 か月後の生活の質スコア (SF-12 アンケート) の変化
時間枠：学習完了までに平均1年
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学習完了までに平均1年
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Clinical success over time defined as improvement of GOOS by 1 point from baseline at any time during 14 days after AXIOS stent placement and GOOS remaining at 1 or more. This endpoint will be evaluated at 3 months, 6 months, and 12 months
時間枠：Through study completion, an average of 1 year
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A patient undergoing reintervention for GOO is considered a failure of clinical success |
Through study completion, an average of 1 year
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Incidence of Device Deficiencies
時間枠：Immediately after the procedure
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Including but not limited to stent migration/misplacement, stent occlusion, leakage at site of stent placement. |
Immediately after the procedure
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Incidence of Reintervention for GOO
時間枠：Immediately after the procedure
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defined as need for repeat treatment for persistent or recurrent GOO symptoms |
Immediately after the procedure
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協力者と研究者
捜査官
- 主任研究者：Shayan Irani, MBBS, MD、Virginia Mason Medical Center
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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
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。