Impact of Acetic Acid-Indigo Carmine Chromocolonoscopy on Proximal Sessile Serrated Lesions

Официальное название

Impact of Acetic Acid-Indigo Carmine Chromocolonoscopy on Proximal Sessile Serrated Lesions: a Multicenter Randomized Trial

Обзор

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.

Вмешательства

• Процедура 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 After successful cecal intubation and randomization, the colonoscope is withdrawn and a spray catheter is used to apply an opaque acetic acid-indigo carmine solution from the cecum to the splenic flexure.
• Процедура Brilliant Blue Chromocolonoscopy Sham-Control Group
  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.

Первичные конечные точки

• Proximal SSL Detection Rate [Срок оценки: 60 minutes]

Вторичные конечные точки (2)

• Colorectal precancerous lesions detection rate [Срок оценки: 60 minutes]
• Adenoma Detection Rate [Срок оценки: 60 minutes]

Критерии участия

Критерии включения

• Patients whose age are between 45-85
• Patients who have indications for screening
• Patients who have signed inform consent form.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Диагностика

Центры проведения

Китай · 1 центр

• China, Shanghai Changhai Hospital, Second Military Medical University — Шанхай

Публикации

• 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. PMID 31323292
• 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):287 PMID 40079452
• 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 PMID 36002247

Идентификаторы

NCT: NCT07601217 · CHSSLDR202602

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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