便免疫化学検査陽性群における従来の結腸内視鏡検査と 3D 結腸内視鏡検査のパフォーマンスの比較
Comparison of the Performance Between Conventional Colonoscopy and 3D Colonoscopy in Positive Fecal Immunochemical Test Group: A Multi-center, Randomized Controlled Trial
Background:
Adenoma detection rate is one of the most quality indicator: an accumulating body of evidence has shown that detection and resection of pre-cancerous adenoma by colonoscopy could effectively prevent colorectal cancer (CRC) and its related mortality1,2. Among various colonoscopy quality indicators, such as cecal intubation rate, withdrawal time, and adenoma detection rate (ADR), ADR is the most important one and most closely associated with the subsequent risk of CRC3,4. A recent study further demonstrated the improvement of ADR could reduce subsequent risk of CRC5.
Equipment and technique to improve ADR: To be noted, among all colorectal neoplasm, non-polypoid lesions, such as flat or depressed lesions, carries higher likelihood to be overlooked during conventional colonoscopy and these overlooked lesions were the main etiology of post-colonoscopy colorectal cancer (PCCRC)6. Nowadays, several colonoscopy technologies had been developed to enhance the detection of colorectal adenoma such as using digital or dye-spray chromoendoscopy7 or add-on device such as Cap/Endocuff/third eye/FUSE-assisted endoscopy8. Among them, some had showed the potential to enhance the detection of non-polypoid lesion, for example, the next-generation NBI9 or iSCAN10.
Application of 3D endoscopy on GI disease: 3D endoscopy is a new technology that using image processing technique to offer more information on tissue depth in comparison with conventional 2D endoscopy. The utility of 3D endoscopy on GI tract was mainly from upper GI tract and it was proved to enhance the diagnostic accuracy on superficial gastric tumors11 and shortened the procedure time during performing gastric endoscopic submucosal dissection (ESD)12. However, few is known that whether 3D colonoscopy could enhance the ADR, especially for non-polypoid lesion detection, during colonoscopy examination.
Positive fecal immunochemical test(FIT) group Among subjects who receive colonoscopy examination, higher advanced adenoma or invasive caners were found in FIT positive group. However, still about half of positive FIT subjects who received colonoscopy exam, have negative colonoscopy result. Non polypoid lesions could be overlooked during the colonoscopy. Therefore, we tried to use this prospective, multicenter, randomized control study to demonstrate the efficacy of 3D colonoscopy on adenoma detection in comparison with conventional 2D colonoscopy in this kind of high risk group.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Hsuan-Ho Lin, MD
- 電話番号：886-9-72-654-359
- メール：tostart21@gmail.com
研究場所
-
-
-
Hsinchu、台湾
- 募集
- National Taiwan University Hospital, Hsinchu Branch
-
コンタクト：
- Hsuan-Ho Lin
- 電話番号：886-9-72-654-359
- メール：tostart21@gmail.com
-
主任研究者：
- Hsuan-Ho Lin, MD
-
Taipei、台湾
- 募集
- National Taiwan University Hospital
-
コンタクト：
- Li-Chun Chang, MD. PhD.
- 電話番号：886-9-72-651-258
- メール：lichunchang@ntu.edu.tw
-
Taipei、台湾
- 募集
- National Taiwan University Cancer Center
-
コンタクト：
- Hao-Che Chang, MD
- 電話番号：886-2-23123456
- メール：andrewhcchang@gmail.com
-
-
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:
- Subjects who are 40 years of older
- Subjects who have positive fecal immunochemical test
Exclusion Criteria:
- Contraindication for colonoscopy
- Subjects with familiar or hereditary polyposis
- Subjects with history of colectomy
- Inadequate bowel cleansing level
- Subjects with inflammatory bowel disease
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：診断
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：3D colonoscopy
Use 3D machine to generate the 3D image |
Use 3D machine to generate the 3D image |
|
介入なし：2D colonoscopy
Traditional colonoscopy |
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 |
時間枠 |
|---|---|
|
腺腫の検出率
時間枠：30分
|
30分
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
ポリープ検出率
時間枠：30分
|
30分
|
|
|
結腸内視鏡検査ごとの腺腫数、
時間枠：30分
|
30分
|
|
|
結腸内視鏡検査ごとのポリープ数、
時間枠：30分
|
30分
|
|
|
Flat-ADR
時間枠：30 minutes
|
detection rate of flat adenoma |
30 minutes
|
|
Proximal ADR
時間枠：30 minutes
|
detection rate of adenoma at proximal colon |
30 minutes
|
|
SSLDR
時間枠：30 minutes
|
detection rate of sessile serrated lesion |
30 minutes
|
|
AADR
時間枠：30 minutes
|
detection rate of advanced adenoma |
30 minutes
|
協力者と研究者
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。