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Impact of Linked Color Imaging on Sessile Serrated Lesion Miss Rate

ConditionColorectal Sessile Serrated Lesion
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45+
SponsorNanfang Hospital, Southern Medical University

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Subjects aged ≥45 years, regardless of gender;

Subjects undergoing screening colonoscopy;

Subjects with no prior colonoscopy;

Voluntarily provide written informed consent.

Disqualifiers

Subjects unable to cooperate with or tolerate colonoscopy;

Subjects with inflammatory bowel disease;

Known or highly suspected colorectal obstruction;

History of colorectal surgery;

Trial design

Design model

Crossover

Treatments tested in this trial

  • WLI Then LCI Withdrawal

    Procedure/Surgery

    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.

  • LCI Then WLI Withdrawal

    Procedure/Surgery

    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.

Treatment groups

2,072 Participants
are divided into 2 treatment groups
Group A: WLI Then LCI Withdrawal GroupExperimental treatment 1 intervention
Group B: LCI Then WLI Withdrawal GroupActive comparator 1 intervention

Trial outcomes

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.

Time frame
One day

Secondary outcomes

1

adenoma miss rate (AMR)

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

Time frame
One day
2

advanced adenomas miss rate (AAMR)

the number of advanced adenomas detected in the second-pass examination/total number of advanced adenomas detected in the two pass.

Time frame
One day
3

polyps miss rate (PMR)

the number of polyps detected in the second-pass examination/total number of polyps detected in the two pass.

Time frame
One day
4

sessile serrated lesions detection rate (SSLDR)

the number of patients with at least one sessile serrated lesion detected by linked color imaging or white light imaging, divided by the total number of patients.

Time frame
One day

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nanfang Hospital, Southern Medical University

Lead sponsor

Shunde First People's Hospital of Foshan

Collaborator

ZhuHai Hospital

Collaborator

Jiangmen Central Hospital

Collaborator

Yangjiang People's Hospital

Collaborator

Zhongshan Guzhen People's Hospital

Collaborator

Sihui Wanlong Hospital

Collaborator

The Third People's Hospital of Huizhou

Collaborator

Longgang District People's Hospital of Shenzhen

Collaborator

Suixi People's Hospital of Zhanjiang

Collaborator

Source ClinicalTrials.gov

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