Sessile Serrated Lesion
Conditions
Keywords
Sessile Serrated Lesion, Sessile Serrated Lesion Detection Rate, Chromocolonoscopy, Acetic Acid and Indigo Carmine
Brief summary
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.
Interventions
PROCEDUREAcetic 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 After successful cecal intubation and randomization, the colonoscope is withdrawn and a spray catheter is used to apply an opaque acetic acid-indigo carmine solution from the cecum to the splenic flexure.
PROCEDUREBrilliant 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.
Sponsors
Changhai Hospital
Heilongjiang Provicial Hospital
Ankang Central Hospital
Huadong Hospital Affiliated with Fudan University, Shanghai
The First Affiliated Hospital of Nanchang University
Yan'an People's Hospital
The Second Hospital of Hebei Medical University
Chongqing General Hospital
Guangzhou Medical University Affiliated Qingyuan Hospital (Qingyuan People's Hospital)
Shanxi Provincial People's Hospital
Shanghai Sixth Hospital
People's Hospital of Leshan, Sichuan Province
The Third People's Hospital of Chengdu
The Third People's Hospital of Jingdezhen
Ningbo Hospital of Integrated Traditional Chinese and Western Medicine
Shandong Provincial Second People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proximal SSL Detection Rate | 60 minutes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Colorectal precancerous lesions detection rate | 60 minutes | The proportion of participants with at least one histologically confirmed precancerous lesion (adenoma, or SSL) detected during withdrawal examination. |
| Adenoma Detection Rate | 60 minutes | 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. |
Countries
China
Contacts
CONTACTZhaoshen Li, MD
CONTACTYu Bai, MD
PRINCIPAL_INVESTIGATORZhaoshen Li, MD
Changhai Hospital
Outcome results
None listed