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利用者名:
UMIN ID:

試験進捗状況 試験終了/Completed
UMIN試験ID UMIN000013560
受付番号 R000015560
科学的試験名 非切除悪性中下部胆道閉塞に対するFully Covered Metallic Stentの外径別臨床成績の多施設共同無作為化比較試験
一般公開日(本登録希望日) 2014/05/01
最終更新日 2019/04/03

※ 本ページ収載の情報は、臨床試験に関する情報公開を目的として、UMINが開設しているUMIN臨床試験登録システムに提供された臨床試験情報です。
※ 特定の医薬品や治療法等については、医療関係者や一般の方に向けて広告することは目的としていません。


基本情報/Basic information
一般向け試験名/Public title 非切除悪性中下部胆道閉塞に対するFully Covered Metallic Stentの外径別臨床成績の多施設共同無作為化比較試験 A Multicenter Prospective Randomized Study of 8mm versus 10mm Fully Covered Metallic Stent in Patients with Distal Malignant biliary Obstruction
一般向け試験名略称/Acronym 名古屋胆管ステント研究(NABIS study) Nagoya Biliary Stent Study (NABIS study)
科学的試験名/Scientific Title 非切除悪性中下部胆道閉塞に対するFully Covered Metallic Stentの外径別臨床成績の多施設共同無作為化比較試験 A Multicenter Prospective Randomized Study of 8mm versus 10mm Fully Covered Metallic Stent in Patients with Distal Malignant biliary Obstruction
科学的試験名略称/Scientific Title:Acronym 名古屋胆管ステント研究(NABIS study) Nagoya Biliary Stent Study (NABIS study)
試験実施地域/Region
日本/Japan

対象疾患/Condition
対象疾患名/Condition 非切除中下部悪性胆道狭窄症例 case of unresectable malignant distal biliary obstruction
疾患区分1/Classification by specialty
消化器内科学(肝・胆・膵)/Hepato-biliary-pancreatic medicine
疾患区分2/Classification by malignancy 悪性腫瘍/Malignancy
ゲノム情報の取扱い/Genomic information いいえ/NO

目的/Objectives
目的1/Narrative objectives1 Fully Covered Metalic Stentの8mm径、10mm径それぞれの特長を比較評価すること To compare clinical efficacy of 8mm Fully Covered Metalic Stent with 10mm Fully Covered Metalic Stent
目的2/Basic objectives2 有効性/Efficacy
目的2 -その他詳細/Basic objectives -Others

試験の性質1/Trial characteristics_1 検証的/Confirmatory
試験の性質2/Trial characteristics_2 実務的/Pragmatic
試験のフェーズ/Developmental phase 該当せず/Not applicable

評価/Assessment
主要アウトカム評価項目/Primary outcomes ステント有効期間 patency period of stent
副次アウトカム評価項目/Key secondary outcomes 全生存期間、合併症の頻度とその種類、死亡時ステント開存率、 Overall survival, frequency of adverse event, kinds of adeverse event, stent patency rate at patients' death

基本事項/Base
試験の種類/Study type 介入/Interventional

試験デザイン/Study design
基本デザイン/Basic design 並行群間比較/Parallel
ランダム化/Randomization ランダム化/Randomized
ランダム化の単位/Randomization unit 個別/Individual
ブラインド化/Blinding オープン/Open -no one is blinded
コントロール/Control 用量対照/Dose comparison
層別化/Stratification はい/YES
動的割付/Dynamic allocation はい/YES
試験実施施設の考慮/Institution consideration 動的割付けの際に施設を調整因子としている/Institution is considered as adjustment factor in dynamic allocation.
ブロック化/Blocking いいえ/NO
割付コードを知る方法/Concealment 中央登録/Central registration

介入/Intervention
群数/No. of arms 2
介入の目的/Purpose of intervention 治療・ケア/Treatment
介入の種類/Type of intervention
医療器具・機器/Device,equipment
介入1/Interventions/Control_1 8mm Fully Covered Metalic Stent 8mm Fully Covered Metalic Stent
介入2/Interventions/Control_2 10mm Fully Covered Metalic Stent 10mm Fully Covered Metalic Stent
介入3/Interventions/Control_3

介入4/Interventions/Control_4

介入5/Interventions/Control_5

介入6/Interventions/Control_6

介入7/Interventions/Control_7

介入8/Interventions/Control_8

介入9/Interventions/Control_9

介入10/Interventions/Control_10


適格性/Eligibility
年齢(下限)/Age-lower limit
20 歳/years-old 以上/<=
年齢(上限)/Age-upper limit

適用なし/Not applicable
性別/Gender 男女両方/Male and Female
選択基準/Key inclusion criteria 非切除中下部悪性胆管閉塞症例
転移所見など臨床的に悪性診断が確定的あるいは、病理学的に悪性の確定診断が得られたもの(細胞診によるか、組織診によるかは問わない。)。
Case of unresectable malignant distal biliary obstruction
Patients with accurate diagnosis of malignancy
除外基準/Key exclusion criteria Performance status 4の症例
他臓器に重篤な合併症を有する症例
生命予後が3ヶ月未満と判断される場合
重症の精神障害がある症例。
その他、研究責任(分担)医師が被験者として不適切と判断した患者
Performance status 4
Estimated life expectancy less than 3 months
Severe neurologic
impairment or mental disorder and
目標参加者数/Target sample size 200

責任研究者/Research contact person
責任研究者/Name of lead principal investigator
芳樹
ミドルネーム
廣岡
Yoshiki
ミドルネーム
Hirooka
所属組織/Organization 名古屋大学医学部附属病院 Nagoya University Hospital
所属部署/Division name 光学医療診療部 Department of Endoscopy
郵便番号/Zip code 466-8550
住所/Address 名古屋市昭和区鶴舞町65 65 Tsuruma-cho, Showa-ku, Nagoya, Japan
電話/TEL +81-52-744-2602
Email/Email hirooka@med.nagoya-u.ac.jp

試験問い合わせ窓口/Public contact
試験問い合わせ窓口担当者/Name of contact person
啓揮
ミドルネーム
川嶋
Hiroki
ミドルネーム
Kawashima
組織名/Organization 名古屋大学医学部 Nagoya University Graduate School of Medicine
部署名/Division name 消化器内科 Gastroenterology and Hepatology
郵便番号/Zip code 466-8550
住所/Address 名古屋市昭和区鶴舞町65 65 Tsuruma-cho, Showa-ku, Nagoya, Japan
電話/TEL +81-52-744-2602
試験のホームページURL/Homepage URL
Email/Email h-kawa@med.nagoya-u.ac.jp

実施責任組織/Sponsor
機関名/Institute その他 Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine
機関名/Institute
(機関選択不可の場合)
名古屋大学医学部消化器内科学
部署名/Department

研究費提供組織/Funding Source
機関名/Organization その他 Boston Scientific Japan
機関名/Organization
(機関選択不可の場合)
Boston Scientific Japan
組織名/Division
組織の区分/Category of Funding Organization 営利企業/Profit organization
研究費拠出国/Nationality of Funding Organization


その他の関連組織/Other related organizations
共同実施組織/Co-sponsor 愛知県がんセンター中央病院消化器内科
藤田保健衛生大学肝胆膵内科     
小牧市民病院消化器科   
東海病院消化器内科         
大垣市民病院消化器科        
 岡崎市民病院消化器内科      
名古屋第一赤十字病院第二消化器内科 大同病院消化器科           
豊橋市民病院消化器内科        
一宮市立市民病院消化器内科     
江南厚生病院消化器内科 
安城更生病院消化器内科        
山下病院消化器内科         
豊田厚生病院消化器科         
総合上飯田第一病院消化器内科    
八千代病院消化器内科       
公立陶生病院消化器内科       
名鉄病院消化器内科       

その他の研究費提供組織/Name of secondary funder(s)


IRB等連絡先(公開)/IRB Contact (For public release)
組織名/Organization 名古屋大学医学部附属病院 生命倫理委員会 Institutional Review Boards of Nagoya University Hospital
住所/Address 名古屋市昭和区鶴舞町65 65 Tsuruma-cho, Showa-ku, Nagoya, Japan
電話/Tel 052-744-2061
Email/Email iga-shinsa@adm.nagoya-u.ac.jp

他機関から発行された試験ID/Secondary IDs
他機関から発行された試験ID/Secondary IDs いいえ/NO
試験ID1/Study ID_1
ID発行機関1/Org. issuing International ID_1

試験ID2/Study ID_2
ID発行機関2/Org. issuing International ID_2

治験届/IND to MHLW

試験実施施設/Institutions
試験実施施設名称/Institutions 名古屋大学医学部附属病院(愛知県)

その他の管理情報/Other administrative information
一般公開日(本登録希望日)/Date of disclosure of the study information
2014 05 01

関連情報/Related information
プロトコル掲載URL/URL releasing protocol https://onlinelibrary.wiley.com/journal/14431661
試験結果の公開状況/Publication of results 最終結果が公表されている/Published

結果/Result
結果掲載URL/URL related to results and publications https://onlinelibrary.wiley.com/journal/14431661
組み入れ参加者数/Number of participants that the trial has enrolled 202
主な結果/Results Median TRBOs did not differ significantly between the 8-mm (n=102) and 10-mm (n=100) groups (275 vs. 293 days, P=0.971). The hazard ratio of the 8-mm to 10-mm groups was 0.90 (80% confidence interval 0.77-1.04, upper limit lower than the acceptable hazard ratio (1.33) of the null hypothesis). Based on these findings, the 8-mm diameter stent was determined to be non-inferior to the 10-mm diameter stent. Median TRBOs did not differ significantly between the 8-mm (n=102) and 10-mm (n=100) groups (275 vs. 293 days, P=0.971). The hazard ratio of the 8-mm to 10-mm groups was 0.90 (80% confidence interval 0.77-1.04, upper limit lower than the acceptable hazard ratio (1.33) of the null hypothesis). Based on these findings, the 8-mm diameter stent was determined to be non-inferior to the 10-mm diameter stent.
主な結果入力日/Results date posted
2019 04 03
結果掲載遅延/Results Delayed
結果遅延理由/Results Delay Reason

最初の試験結果の出版日/Date of the first journal publication of results
参加者背景/Baseline Characteristics A total of 202 eligible patients were enrolled, with 102 and 100 patients allocated to the 10-mm and 8-mm groups, respectively. A total of 202 eligible patients were enrolled, with 102 and 100 patients allocated to the 10-mm and 8-mm groups, respectively.
参加者の流れ/Participant flow The median TRBO was 293 days in the 10-mm group and 275 days in the 8-mm group, with no significant difference between the groups (P=0.971, log-rank test) (Figure 2). The HR of the 8-mm to 10-mm group in the Cox proportional hazard model was 0.90. The 80% CI using the Wald method corresponding to a one-sided significance level of 10% was 0.77-1.04, in which the upper limit of the 80% CI was smaller than the acceptable HR (1.33) of the null hypothesis. Based on this, the 8-mm diameter FCSEMS was judged to be non-inferior to the 10-mm diameter FCSEMS with regard to TRBO. The median TRBO was 293 days in the 10-mm group and 275 days in the 8-mm group, with no significant difference between the groups (P=0.971, log-rank test) (Figure 2). The HR of the 8-mm to 10-mm group in the Cox proportional hazard model was 0.90. The 80% CI using the Wald method corresponding to a one-sided significance level of 10% was 0.77-1.04, in which the upper limit of the 80% CI was smaller than the acceptable HR (1.33) of the null hypothesis. Based on this, the 8-mm diameter FCSEMS was judged to be non-inferior to the 10-mm diameter FCSEMS with regard to TRBO.
有害事象/Adverse events Cholecystitis developed in 16 (8.1%) of the 198 patients, including 10 (10.2%) in the 10-mm group and 6 (6%) in the 8-mm group (P=0.278, Table 2). Cholecystitis developed within one week, suggesting a direct influence of stent placement, in 4 (4.1%) and 1 (1%) patients in the 10-mm and 8-mm groups, respectively, with no significant difference between the groups (P=0.167). Cholecystitis was improved by conservative treatment in 4 patients, but percutaneous drainage was needed in 12 patients. The median onset period was 10.5 days after stent placement (range: 2-363 days, showing wide variation). Pancreatitis developed in 14 (7.1%) of 198 patients, including 4 (4.1%) in the 10-mm group and 10 (10%) in the 8-mm group. The difference was not significant (P=0.104, Table 2). Pancreatitis was severe in one patient with distal bile duct carcinoma in the 10-mm group and moderate in one patient with pancreatic carcinoma in the 8-mm group, but mild in the other 12 patients, and was conservatively improved in all patients. Pain at stent insertion occurred in 28 patients, including 17 (17.3%) in the 10-mm group and 11 (11%) in the 8-mm group, with no significant difference between the groups (P= 0.200, Table 2). Other adverse events included perforation during insertion in one patient in the 8-mm group and hemorrhage from a duodenal ulcer on the opposite side of the papilla in one patient in the 10-mm group. Cholecystitis developed in 16 (8.1%) of the 198 patients, including 10 (10.2%) in the 10-mm group and 6 (6%) in the 8-mm group (P=0.278, Table 2). Cholecystitis developed within one week, suggesting a direct influence of stent placement, in 4 (4.1%) and 1 (1%) patients in the 10-mm and 8-mm groups, respectively, with no significant difference between the groups (P=0.167). Cholecystitis was improved by conservative treatment in 4 patients, but percutaneous drainage was needed in 12 patients. The median onset period was 10.5 days after stent placement (range: 2-363 days, showing wide variation). Pancreatitis developed in 14 (7.1%) of 198 patients, including 4 (4.1%) in the 10-mm group and 10 (10%) in the 8-mm group. The difference was not significant (P=0.104, Table 2). Pancreatitis was severe in one patient with distal bile duct carcinoma in the 10-mm group and moderate in one patient with pancreatic carcinoma in the 8-mm group, but mild in the other 12 patients, and was conservatively improved in all patients. Pain at stent insertion occurred in 28 patients, including 17 (17.3%) in the 10-mm group and 11 (11%) in the 8-mm group, with no significant difference between the groups (P= 0.200, Table 2). Other adverse events included perforation during insertion in one patient in the 8-mm group and hemorrhage from a duodenal ulcer on the opposite side of the papilla in one patient in the 10-mm group.
評価項目/Outcome measures In conclusion, a prospective randomized multicenter study using the WallFlex Biliary RX Fully Covered Stent showed that an 8-mm diameter FCSEMS was not inferior to a 10-mm diameter FCSEMS for TRBO or the incidence of adverse events. These findings may be important in further development of SEMS.

In conclusion, a prospective randomized multicenter study using the WallFlex Biliary RX Fully Covered Stent showed that an 8-mm diameter FCSEMS was not inferior to a 10-mm diameter FCSEMS for TRBO or the incidence of adverse events. These findings may be important in further development of SEMS.

個別症例データ共有計画/Plan to share IPD

個別症例データ共有計画の詳細/IPD sharing Plan description


試験進捗状況/Progress
試験進捗状況/Recruitment status 試験終了/Completed
プロトコル確定日/Date of protocol fixation
2014 04 20
倫理委員会による承認日/Date of IRB
2014 06 09
登録・組入れ開始(予定)日/Anticipated trial start date
2014 06 09
フォロー終了(予定)日/Last follow-up date
2017 06 30
入力終了(予定)日/Date of closure to data entry
2017 06 30
データ固定(予定)日/Date trial data considered complete
2017 07 31
解析終了(予定)日/Date analysis concluded
2017 08 31

その他/Other
その他関連情報/Other related information


管理情報/Management information
登録日時/Registered date
2014 03 30
最終更新日/Last modified on
2019 04 03


閲覧ページへのリンク/Link to view the page
URL(日本語) https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000015560
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015560

研究計画書
登録日時 ファイル名

研究症例データ仕様書
登録日時 ファイル名

研究症例データ
登録日時 ファイル名


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