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試験進捗状況 主たる結果の公表済み/Main results already published
UMIN試験ID UMIN000026262
受付番号 R000030056
科学的試験名 膵管内乳頭粘液性腫瘍(intraductal papillary mucnous neoplasm:IPMN)手術症例におけるIPMN併存癌、IPMN由来癌とMRCP所見の関連性の検討
一般公開日(本登録希望日) 2017/02/22
最終更新日 2020/06/08

※ 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 膵管内乳頭粘液性腫瘍(intraductal papillary mucnous neoplasm:IPMN)手術症例におけるIPMN併存癌、IPMN由来癌とMRCP所見の関連性の検討 Location of cystic lesion and the Incidence of Pancreatic Cancer Concomitant with Intraductal Papillary Mucinous Neoplasm(IPMN)
一般向け試験名略称/Acronym 嚢胞の部位とIPMN随伴癌の関連性の検討 Cyst location and pancreatic cancer with IPMN
科学的試験名/Scientific Title 膵管内乳頭粘液性腫瘍(intraductal papillary mucnous neoplasm:IPMN)手術症例におけるIPMN併存癌、IPMN由来癌とMRCP所見の関連性の検討 Location of cystic lesion and the Incidence of Pancreatic Cancer Concomitant with Intraductal Papillary Mucinous Neoplasm(IPMN)
科学的試験名略称/Scientific Title:Acronym 嚢胞の部位とIPMN随伴癌の関連性の検討 Cyst location and pancreatic cancer with IPMN
試験実施地域/Region
日本/Japan

対象疾患/Condition
対象疾患名/Condition 膵管内乳頭粘液性腫瘍 intraductal papillary mucnous neoplasm
疾患区分1/Classification by specialty
消化器内科学(肝・胆・膵)/Hepato-biliary-pancreatic medicine 消化器外科(肝・胆・膵)/Hepato-biliary-pancreatic surgery
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 IPMN随伴癌はIPMN由来浸潤癌よりも予後が悪いとされる。しかし、IPMN随伴癌のリスクファクターについてはIPMNガイドラインに記載がない。我々は嚢胞の部位とIPMN随伴癌の関連性について検討した。 Cancer-specific survival of PDAC with IPMN was significantly poorer compared with invasive IPMN. However, there was no description of the risk factors of PDAC concomitant with IPMN in The recent guideline for IPMNs. Therefore, we investigated the association of the location of cysts with the incidence of PDAC concomitant with IPMN.
目的2/Basic objectives2 その他/Others
目的2 -その他詳細/Basic objectives -Others 嚢胞性病変の部位とIPMN併存膵癌の関連性 The relationship between location of cystic lesion and the Incidence of Pancreatic Cancer Concomitant with IPMN
試験の性質1/Trial characteristics_1 検証的/Confirmatory
試験の性質2/Trial characteristics_2 その他/Others
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 IPMN併存膵癌とIPMNの個数・存在する領域との関連性の評価 The relationship between location of cystic lesion and the Incidence of Pancreatic Cancer Concomitant with IPMN
副次アウトカム評価項目/Key secondary outcomes IPMN由来浸潤癌、IPMN併存膵癌と膵癌家族歴有無、糖尿病の有無、飲酒状態、BMI、喫煙歴との関連性 The relationship between family history of pancreatic cancer, diabetes mellitus, alcohol consumption, BMI and smoking history, and the incidence of IPMN with an associated invasive carcinoma or pancreatic cancer concomitant with IPMN

基本事項/Base
試験の種類/Study type 観察/Observational

試験デザイン/Study design
基本デザイン/Basic design
ランダム化/Randomization
ランダム化の単位/Randomization unit
ブラインド化/Blinding
コントロール/Control
層別化/Stratification
動的割付/Dynamic allocation
試験実施施設の考慮/Institution consideration
ブロック化/Blocking
割付コードを知る方法/Concealment

介入/Intervention
群数/No. of arms
介入の目的/Purpose of intervention
介入の種類/Type of intervention
介入1/Interventions/Control_1

介入2/Interventions/Control_2

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
100 歳/years-old 以下/>=
性別/Gender 男女両方/Male and Female
選択基準/Key inclusion criteria 20歳以上のもの more than 20 years old
除外基準/Key exclusion criteria なし None
目標参加者数/Target sample size 164

責任研究者/Research contact person
責任研究者/Name of lead principal investigator
充弘
ミドルネーム
増田 
Atsuhiro
ミドルネーム
Masuda
所属組織/Organization 神戸大学医学部附属病院 Kobe University Hospital
所属部署/Division name 消化器内科 Dep. of Gastroenterology
郵便番号/Zip code 6500017
住所/Address 神戸市中央区楠町7-5-1 7-5-1 Kusunoki-cho Chuo-ku Kobe
電話/TEL 078-382-6305
Email/Email atmasuda@med.kobe-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
充弘
ミドルネーム
増田 
Atsuhiro
ミドルネーム
Masuda
組織名/Organization 神戸大学医学部附属病院 Kobe University Hospital
部署名/Division name 消化器内科 Dep. of Gastroenterology
郵便番号/Zip code 6500017
住所/Address 神戸市中央区楠町7-5-1 7-5-1 Kusunoki-cho Chuo-ku Kobe
電話/TEL 078-382-6305
試験のホームページURL/Homepage URL
Email/Email atmasuda@med.kobe-u.ac.jp

実施責任組織/Sponsor
機関名/Institute その他 Division of Gastroenterology, Department of Internal medicine, Kobe University Graduate School of Medicine
機関名/Institute
(機関選択不可の場合)
神戸大学消化器内科
部署名/Department

研究費提供組織/Funding Source
機関名/Organization その他 Division of Gastroenterology, Department of Internal medicine, Kobe University Graduate School of Medicine
機関名/Organization
(機関選択不可の場合)
神戸大学消化器内科
組織名/Division
組織の区分/Category of Funding Organization 自己調達/Self funding
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 なし None
その他の研究費提供組織/Name of secondary funder(s) なし None

IRB等連絡先(公開)/IRB Contact (For public release)
組織名/Organization 神戸大学臨床研究推進センター CTRC
住所/Address 神戸市中央区楠町7-5-1 7-5-1, Kusunoki-cho, Kobe
電話/Tel 078-382-6669
Email/Email rinri@med.kobe-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

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
2017 02 22

関連情報/Related information
プロトコル掲載URL/URL releasing protocol https://www.med.kobe-u.ac.jp/gi/pdf/study/ipmn-mrcp.pdf
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://pubmed.ncbi.nlm.nih.gov/29685673/?from_term=ikagawa+takuya&from_exact_term=ikegawa+takuya&fr
組み入れ参加者数/Number of participants that the trial has enrolled 141
主な結果/Results Multiple cyst-existing regions (two or more regions) correlated with the incidence of PDAC concomitant with IPMN (PDAC concomitant with IPMN in one region vs. two or more regions: 3/66 vs. 13/75, multivariable odds ratio [OR] = 4.11, 95% confidence interval [CI] = 1.22 to 18.8, P = 0.02). In contrast, multiple cyst-existing regions did not correlate with the incidence of IPMN (invasive IPMN in one region vs. two or more regions: 13/66 vs. 18/75, OR = 1.19, 95% CI = 0.52 to 2.76, P = 0.67). Multiple cyst-existing regions (two or more regions) correlated with the incidence of PDAC concomitant with IPMN (PDAC concomitant with IPMN in one region vs. two or more regions: 3/66 vs. 13/75, multivariable odds ratio [OR] = 4.11, 95% confidence interval [CI] = 1.22 to 18.8, P = 0.02). In contrast, multiple cyst-existing regions did not correlate with the incidence of IPMN (invasive IPMN in one region vs. two or more regions: 13/66 vs. 18/75, OR = 1.19, 95% CI = 0.52 to 2.76, P = 0.67).
主な結果入力日/Results date posted
2020 06 08
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 Subjects comprised 141 patients undergoing resection for IPMN (Non-invasive IPMN (IPMN with low-to high-grade dysplasia): N = 94, invasive IPMN: N = 31, and PDAC concomitant with IPMN: N = 16) between November 2000 and February 2017. Subjects comprised 141 patients undergoing resection for IPMN (Non-invasive IPMN (IPMN with low-to high-grade dysplasia): N = 94, invasive IPMN: N = 31, and PDAC concomitant with IPMN: N = 16) between November 2000 and February 2017.
参加者の流れ/Participant flow Subjects comprised 141 patients undergoing resection for IPMN (Non-invasive IPMN (IPMN with low-to high-grade dysplasia): N = 94, invasive IPMN: N = 31, and PDAC concomitant with IPMN: N = 16) between November 2000 and February 2017. Subjects comprised 141 patients undergoing resection for IPMN (Non-invasive IPMN (IPMN with low-to high-grade dysplasia): N = 94, invasive IPMN: N = 31, and PDAC concomitant with IPMN: N = 16) between November 2000 and February 2017.
有害事象/Adverse events なし none
評価項目/Outcome measures A logistic regression analysis was performed to assess the relationship between the number of cyst-existing regions (one region/two or more regions) and incidence of PDAC concomitant with IPMN, adjusted by clinical characteristics. Cyst-existing regions were defined by the number of anatomical parts of the pancreas: the head/body/tail of the pancreas. A logistic regression analysis was performed to assess the relationship between the number of cyst-existing regions (one region/two or more regions) and incidence of PDAC concomitant with IPMN, adjusted by clinical characteristics. Cyst-existing regions were defined by the number of anatomical parts of the pancreas: the head/body/tail of the pancreas.
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 主たる結果の公表済み/Main results already published
プロトコル確定日/Date of protocol fixation
2016 11 09
倫理委員会による承認日/Date of IRB
2016 11 05
登録・組入れ開始(予定)日/Anticipated trial start date
2016 11 09
フォロー終了(予定)日/Last follow-up date
2018 12 31
入力終了(予定)日/Date of closure to data entry
2018 12 31
データ固定(予定)日/Date trial data considered complete
2018 12 31
解析終了(予定)日/Date analysis concluded
2018 12 31

その他/Other
その他関連情報/Other related information 後ろ向き研究

症例(対象者)数:
2008年4月から2017年2月までにIPMNまたはIPMN随伴癌に対して神戸大学医学部附属病院で外科的切除を施行された患者164名

調査項目:
患者背景(年齢、BMI、性別、糖尿病の有無、膵癌家族歴、アルコール摂取量、喫煙歴)、IPMNの形態分類(主膵管型、分枝型、混合型)、組織亜型(胃型、腸型、膵胆道上皮型、好酸性/膨大細胞型)、主膵管径、壁在結節、嚢胞の部位
retrospective study

164 consecutive patients of IPMN (N=142) or PDAC concomitant with IPMN (N=22) who underwent surgical resection at Kobe University Hospital between April 2008 and February 2017 were collected.

Survey items
age, body mass index (BMI), sex, diabetes mellitus (present or absent), family history of pancreatic cancer (present or absent), alcohol consumption (> 50 g/day or < 50 g/day), history of smoking, macroscopic type of IPMN (main duct type, mixed type, or branch duct type), mucin phenotype(gastric, intestinal, pancreatobiliary, or oncocytic), diameter of main pancreatic duct, nodule in cyst, diameter of cyst and location of cystic lesion.

管理情報/Management information
登録日時/Registered date
2017 02 22
最終更新日/Last modified on
2020 06 08


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=R000030056
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030056

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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