Texture and Colour Enhancement Imaging in Improving Detection and Miss Rate of Premalignant Lesions

Impact of Texture and Color Enhancement Imaging on Detection and Miss Rate of Premalignant Lesions: A Multicentre, Randomized, Tandem Trial

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06515977

Enrollment

2964

Registered

2024-07-23

Start date

2024-08-01

Completion date

2025-08-01

Last updated

2024-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenoma, Sessile Serrated Adenoma

Keywords

texture and color enhancement imaging, colonoscopy, adenoma detection rate, sessile serrated lesion detection rate, adenoma miss rate, sessile serrated lesion miss rate

Brief summary

Texture and Color Enhancement Imaging (TXI) is a newly developed image-enhancing endoscopy technology that has show potential in improving detection of colorectal lesions. This multicenter, randomized, tandem trial is aimed at evaluating whether TXI is superior to WLI endoscopy in terms of diagnosis of premalignant lesions.

Interventions

PROCEDURETXI (Group A)

Patients in Group A will undergo colonoscopy with TXI.

PROCEDURETXI followed by WLI (Group B)

Patients in group B will first undergo colonoscopy with TXI and every polyp found should be removed. Then switch to WLI for a second withdrawal to detect lesions that were not observed the first time.

PROCEDUREWLI (Group C)

Patients in Group C will undergo colonoscopy with WLI.

PROCEDUREWLI followed by TXI (Group D)

Patients in group D will first undergo colonoscopy with WLI and every polyp found should be removed. Then switch to TXI for a second withdrawal to detect lesions that were not observed the first time.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

45 Years to 85 Years

Healthy volunteers

Inclusion criteria

patients aged 45-85 years and scheduled for screening colonoscopy who provided written informed consent

Exclusion criteria

Surveillance, diagnostic or therapeutic colonoscopy Patients with an already known or suspected colorectal tumour Patients with alarming symptoms and signs, including haematochezia, melena, weight loss or anaemia without specific causes, an abdominal mass and positive digital rectal examination Pregnant or lactating women Patients with gastrointestinal tract obstruction Patients with inflammatory bowel diseases, hereditary CRC syndromes or serrated polyposis syndrome Patients with abnormal blood coagulation or taking antiplatelets or anticoagulants within 7 days before colonoscopy Patients with failed cecal intubation Patients with poor bowel preparation quality that necessitated a second bowel preparation Patients with a history of colonic resection

Design outcomes

Primary

Measure	Time frame	Description
adenoma detection rate	1 years	the number of patients with one or more adenomas detected and removed divided by the total number of patient
sessile serrated lesion detection rate	1 years	the number of patients with one or more sessile serrated lesions detected and removed divided by the total number of patients

Secondary

Measure	Time frame	Description
adenoma miss rate	1 years	the number of adenomas detected during the second examination divided by the total number of adenomas detected during the first and second colonoscopy
sessile serrated lesion miss rate	1 years	the number of sessile serrated lesions detected during the second examination divided by the total number of sessile serrated lesions detected during the first and second colonoscopy

Contacts

Primary ContactZhaoshen Li, MD

li.zhaoshen@hotmail.com86-021-31161365

Backup ContactYu Bai, MD

baiyu1998@hotmail.com86-021-31161335

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026