NCT07745842

Brief Summary

This prospective, multicenter randomized controlled trial aimed to investigate whether linked color imaging (LCI) could reduce the miss rate of sessile serrated lesions (SSLs) during tandem colonoscopy compared with conventional white-light imaging (WLI).

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,072

participants targeted

Target at P75+ for not_applicable

Timeline
31mo left

Started Aug 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Aug 2026Feb 2029

First Submitted

Initial submission to the registry

July 30, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 4, 2026

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2029

Last Updated

August 4, 2026

Status Verified

July 1, 2026

Enrollment Period

2.3 years

First QC Date

July 30, 2026

Last Update Submit

July 30, 2026

Conditions

Colorectal Sessile Serrated Lesion

Outcome Measures

Primary Outcomes (1)

  • sessile serrated lesions miss rate(SSLMR)

    The number of SSL detected in the second-pass examination/total number of SSL detected in both two pass.

    One day

Secondary Outcomes (7)

  • adenoma miss rate (AMR)

    One day

  • advanced adenomas miss rate (AAMR)

    One day

  • polyps miss rate (PMR)

    One day

  • sessile serrated lesions detection rate (SSLDR)

    One day

  • adenomas detection rate (ADR)

    One day

  • +2 more secondary outcomes

Study Arms (2)

WLI Then LCI Withdrawal Group

EXPERIMENTAL

Tandem colonoscopy of the entire colorectum was performed, with initial observation using conventional white-light imaging, followed by linked color imaging.

Procedure: WLI Then LCI Withdrawal

LCI Then WLI Withdrawal Group

ACTIVE COMPARATOR

Tandem colonoscopy of the entire colorectum was performed, with initial observation using linked color imaging, followed by conventional white-light imaging.

Procedure: LCI Then WLI Withdrawal

Interventions

WLI Then LCI WithdrawalPROCEDURE

Patients in the WLI then LCI withdrawal group first underwent careful endoscopic inspection with white-light imaging (WLI). The endoscopic setting was then switched to linked color imaging (LCI) for the second withdrawal. All polyps detected during both inspection passes were resected, and the number of lesions missed on the first withdrawal was subsequently calculated.

WLI Then LCI Withdrawal Group
LCI Then WLI WithdrawalPROCEDURE

Patients in the LCI then WLI withdrawal group first underwent careful endoscopic inspection with linked color imaging (LCI). The endoscopic setting was then switched to white-light imaging (WLI) for the second withdrawal. All polyps detected during both inspection passes were resected, and the number of lesions missed on the first withdrawal was subsequently calculated.

LCI Then WLI Withdrawal Group

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects aged ≥45 years, regardless of gender;
  • Subjects undergoing screening colonoscopy;
  • Subjects with no prior colonoscopy;
  • Voluntarily provide written informed consent.

You may not qualify if:

  • Subjects unable to cooperate with or tolerate colonoscopy;
  • Subjects with inflammatory bowel disease;
  • Known or highly suspected colorectal obstruction;
  • History of colorectal surgery;
  • Chronic recurrent constipation;
  • Failure to discontinue anticoagulants or antiplatelet agents for at least 1 week before the procedure;
  • Poor bowel preparation with an inadequate Aronchick scale score during colonoscopy;
  • Failed cecal intubation;
  • High-risk conditions including severe cardiovascular and cerebrovascular diseases, uncorrected severe anemia or active infection;
  • Pregnant or breastfeeding women;
  • Subjects deemed ineligible for participation in this trial at the investigator's discretion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Zelong Han, MD

CONTACT

+86 20-6278-7385hanzelong2025@163.com

Bitao Lin, MD

CONTACT

+86 137-2532-1385linbitao1996@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2026

First Posted

August 4, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

February 1, 2029

Last Updated

August 4, 2026

Record last verified: 2026-07