Narrow Band Imaging Colon Polyp Study
A Multicenter, Prospective, Randomized Controlled Trial for the Detection of Colon Polyps and Predicting Histology
In this study the investigators hypothesize that High Definition White Light colonoscopy and narrow band imaging (NBI) will detect a higher number of adenomas compared to standard definition white light colonoscopy. NBI will have a higher accuracy in predicting polyp histology compared to high definition colonoscopy and standard colonoscopy.
Specific Aim 1 - To compare the prevalence of adenomas detected by standard colonoscopy, high-definition white light colonoscopy and NBI.
Specific Aim 2 - To compare the number of adenoma detected per subject by standard colonoscopy, high-definition white light colonoscopy and NBI.
Specific Aim 3 - To compare the accuracy of predicting polyp histology between standard colonoscopy, high-definition white light colonoscopy and NBI by evaluating the surface mucosal and vascular patterns during the procedure.
Specific Aim 4 - To determine the inter-observer agreement between investigators for the recognition of various polyp patterns
調査の概要
状態
詳細な説明
This study is a multi-center randomized controlled trial that will be conducted at the Kansas City VA Medical Center, Kansas City, MO and The Barnes Jewish Hospital, St Louis, MO. Patients referred for screening and surveillance colonoscopy will be enrolled. They will be randomized to one of the following three groups: standard white light colonoscopy, high-definition white light colonoscopy or NBI.
All colonoscopies will be performed at the Kansas City VA Medical Center and The Barnes Jewish Hospital, St Louis, MO. Moderate sedation will be administered for the procedure with intravenous midazolam, demerol or fentanyl and Propofol. In patients randomized to the NBI arm, the colonoscope will be inserted to the cecum under white light and will switch to NBI mode at the time of withdrawal. After cecal intubation, the colonic mucosa will be carefully visualized during withdrawal of the scope with one of the three imaging modalities to which the patient has been randomized. No effort will be made to look for polyps during the insertion of the colonoscope. All polyps detected will be documented for their size, morphology (Polypoid: sessile, pedunculated or Non polypoid: superficially elevated, completely flat, depressed), and location. The surface of the polyp will be assessed during the procedure and the histology will be predicted real time by evaluating the surface mucosal and vascular patterns. The patterns would be classified into one of the four patterns described in our pilot study (tubular and gyrus patterns will be combined to tubulogyrus pattern). Any other patterns detected would be described and kept in the miscellaneous category. If a pattern is not identified on a polyp with either white light or NBI, it will be recorded as such and no attempts will be made to predict histology. Photo documentation of the surface patterns of the polyps will be performed. Polyps will then be removed either with a biopsy forcep or snare and sent for histopathological evaluation. Each polyp removed will have one or more corresponding picture of its surface patterns and these will be labeled accordingly. The total time spent in inspecting the colonic mucosa (excluding the time spent in removal of polyps or clearing the colon of liquid and solid debris) will be measured with a stop watch. Representative images of the various polyp patterns will be reviewed, discussed and standardized amongst all the investigators at both sites. In addition, images of all the polyp patterns will be printed and posted in the endoscopy suites at both hospitals.
The bowel preparation will be evaluated and graded as follow:
Excellent (score=1) - >90% mucosa seen, mostly liquid colonic contents, minimal suctioning needed for adequate visualization.
Good (score=2) - >90% of mucosa seen, mostly liquid colonic contents, significant suctioning needed for adequate visualization Fair (score=3) - > 90% mucosa seen, mixture of liquid and semisolid colonic contents, could be suctioned and/or washed Inadequate (score=4) - <90% mucosa seen, mixture of semisolid ands solid colonic contents, which could not be suctioned or washed
Patients with "Inadequate" (score = 4) bowel prep will be excluded.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Missouri
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Kansas City、Missouri、アメリカ、64128
- Kansas City VA Medical Center
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St. Louis、Missouri、アメリカ、63110
- Barnes Jewish Hospital
-
-
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:
- referral for screening or surveillance colonoscopy
- the ability to provide informed consent
Exclusion criteria:
- prior surgical resection of any portion of colon
- prior history of colon cancer
- history of inflammatory bowel disease
- use of anti-platelet agents or anticoagulants that precludes removal of polyps during the procedure
- poor general condition or any other reason to avoid prolonged procedure time
- history of polyposis syndrome or HNPCC
- inability to give informed consent.
- Inadequate bowel preparation
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: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:1
Standard White Light Colonoscopy
|
Standard White Light Colonoscopy one exam per patient High Definition White Light Colonoscopy one exam per patient |
実験的:2
High Definition White Light Colonoscopy
|
Standard White Light Colonoscopy one exam per patient High Definition White Light Colonoscopy one exam per patient |
実験的:3
Narrow Band Imaging Colonoscopy
|
Narrow Band Imaging Colonoscopy one exam per patient |
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 |
---|---|---|
The prevalence of adenomas in the three arms of the study.
時間枠:2 years
|
Number of subjects with adenomas in the three arms of the study
|
2 years
|
二次結果の測定
結果測定 |
時間枠 |
---|---|
Secondary outcome will be number of adenomas detected per subject in the three arms, the sensitivity, specificity, and accuracy of predicting polyp histology real time by the three imaging modalities.
時間枠:2 years
|
2 years
|
協力者と研究者
捜査官
- 主任研究者:Amit Rastogi, MD、Kansas City VA Medical Center
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
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