Impact of Acetic Acid-Indigo Carmine Chromocolonoscopy on Proximal Sessile Serrated Lesions (ACID-SSL)
2026年5月17日 更新者:Zhaoshen Li、Changhai Hospital
Impact of Acetic Acid-Indigo Carmine Chromocolonoscopy on Proximal Sessile Serrated Lesions: a Multicenter Randomized Trial
Chromocolonoscopy with acetic acid and indigo carmine has shown promise for improving the detection of sessile serrated lesions (SSLs), the precursor lesions responsible for a substantial proportion of interval colorectal cancers.
Previous studies have demonstrated its potential to enhance visualization of both adenomatous and non-adenomatous polyps, particularly the subtle SSLs that are frequently missed during conventional white-light colonoscopy.
However, high-quality randomized controlled trials comparing chromocolonoscopy with standard white-light imaging to provide definitive evidence on its efficacy for SSL detection are lacking.
We therefore conducted a multicenter, prospective, randomized controlled trial to evaluate the diagnostic yield of acetic acid-indigo carmine chromocolonoscopy versus standard colonoscopy for SSL detection.
研究概览
地位
尚未招聘
条件
研究类型
介入性
注册 (估计的)
2689
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Zhaoshen Li, MD
- 电话号码:86-021-31161365
- 邮箱:li.zhaoshen@hotmail.com
研究联系人备份
- 姓名:Yu Bai, MD
- 电话号码:86-021-31161335
- 邮箱:baiyu1998@hotmail.com
学习地点
-
-
Shanghai Municipality
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Shanghai、Shanghai Municipality、中国、200433
- China, Shanghai Changhai Hospital, Second Military Medical University
-
接触:
- Zhaoshen Li, MD
- 电话号码:86-021-31161365
- 邮箱:li.zhaoshen@hotmail.com
-
接触:
- Yu Bai, MD
- 电话号码:86-021-31161335
- 邮箱:baiyu1998@hotmail.com
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Patients whose age are between 45-85
- Patients who have indications for screening
- Patients who have signed inform consent form.
Exclusion Criteria:
- Patients undergoing surveillance colonoscopy after polypectomy or therapeutic colonoscopy for known polyps
- Patients with a history of colonoscopy within the past 5 years
- Patients with highly suspected or confirmed colorectal cancer
- Patients with alarming signs or symptoms: hematochezia, melena, unexplained anemia, weight loss, abdominal mass, positive digital rectal examination
- Pregnant or breastfeeding women
- Patients with gastrointestinal obstruction
- Patients with inflammatory bowel disease, colonic polyposis, or melanosis coli
- Patients with coagulation disorders or who have taken antiplatelets or anticoagulants (e.g., aspirin, warfarin) within 7 days before colonoscopy
- Patients currently participating in another clinical trial or who have participated in another clinical trial within the preceding 60 days
- Patients with failed cecal intubation for any reason (e.g., obstructing lesion, intolerance of the procedure)
- Patients with an Aronchick bowel preparation score >3 at colonoscope insertion, indicating inadequate preparation requiring a repeat bowel preparation
- Patients who have used bowel preparation agents not recommended by guidelines, such as oral sodium phosphate or senna
- Patients with known allergy to acetic acid-indigo carmine, brilliant blue dye, or medications related to colonoscopy
- Patients with missing essential information in the case report form prior to enrollment
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:诊断
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Acetic Acid-Indigo Carmine Chromocolonoscopy Group
|
Participants undergo colonoscopy with acetic acid-indigo carmine chromoendoscopy.
After successful cecal intubation and randomization, the colonoscope is withdrawn and a spray catheter is used to apply an opaque acetic acid-indigo carmine solution from the cecum to the splenic flexure.
|
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假比较器:Brilliant Blue Chromocolonoscopy Sham-Control Group
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Participants undergo colonoscopy with brilliant blue dye application as a sham chromoendoscopy control to maintain participant blinding.
After cecal intubation and randomization, an opaque brilliant blue solution is sprayed from the cecum to the splenic flexure using a spray catheter, with suctioning of any excess dye.
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无干预:Conventional White-Light Colonoscopy Group
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Proximal SSL Detection Rate
大体时间:60 minutes
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The proportion of participants with at least one histologically confirmed sessile serrated lesion detected in the proximal colon (cecum, ascending colon, hepatic flexure, transverse colon, and splenic flexure) during withdrawal examination.
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60 minutes
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Colorectal precancerous lesions detection rate
大体时间:60 minutes
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The proportion of participants with at least one histologically confirmed precancerous lesion (adenoma, or SSL) detected during withdrawal examination.
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60 minutes
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Adenoma Detection Rate
大体时间:60 minutes
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The proportion of participants with at least one histologically confirmed adenoma (tubular, villous, or tubulovillous) detected during withdrawal examination, compared across all three study groups.
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60 minutes
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员:Zhaoshen Li, MD、Changhai Hospital
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Crockett SD, Nagtegaal ID. Terminology, Molecular Features, Epidemiology, and Management of Serrated Colorectal Neoplasia. Gastroenterology. 2019 Oct;157(4):949-966.e4. doi: 10.1053/j.gastro.2019.06.041. Epub 2019 Jul 16.
- Kinugasa H, Hiraoka S, Kobayashi S, Matsubara M, Nagahara T, Higashi R, Takei K, Ohmori M, Nakamura T, Tsuzuki T, Tanaka S, Hirai R, Toyosawa J, Aoyama Y, Yamasaki Y, Inokuchi T, Takahara M, Tanaka T, Mitsuhashi T, Otsuka M; cAIM Study Group. Acetic Acid-Indigo Carmine Chromocolonoscopy for Proximal Serrated Lesions: A Randomized, 3-Arm Colonoscopy Study. Am J Gastroenterol. 2025 Dec 1;120(12):2877-2888. doi: 10.14309/ajg.0000000000003411. Epub 2025 Mar 13.
- Sung JJY, Chiu HM, Lieberman D, Kuipers EJ, Rutter MD, Macrae F, Yeoh KG, Ang TL, Chong VH, John S, Li J, Wu K, Ng SSM, Makharia GK, Abdullah M, Kobayashi N, Sekiguchi M, Byeon JS, Kim HS, Parry S, Cabral-Prodigalidad PAI, Wu DC, Khomvilai S, Lui RN, Wong S, Lin YM, Dekker E. Third Asia-Pacific consensus recommendations on colorectal cancer screening and postpolypectomy surveillance. Gut. 2022 Nov;71(11):2152-2166. doi: 10.1136/gutjnl-2022-327377. Epub 2022 Aug 24.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年6月15日
初级完成 (估计的)
2028年11月15日
研究完成 (估计的)
2028年11月15日
研究注册日期
首次提交
2026年5月17日
首先提交符合 QC 标准的
2026年5月17日
首次发布 (实际的)
2026年5月22日
研究记录更新
最后更新发布 (实际的)
2026年5月22日
上次提交的符合 QC 标准的更新
2026年5月17日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
其他研究编号
- CHSSLDR202602
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不
研究美国 FDA 监管的设备产品
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