Impact of Linked Color Imaging on Sessile Serrated Lesion Miss Rate
30. juli 2026 opdateret af: Nanfang Hospital, Southern Medical University
Impact of Linked Color Imaging on Sessile Serrated Lesion Miss Rate: a Multicenter Tandem Rondomized Controlled 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).
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
2072
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Bitao Lin, MD
- Telefonnummer: +86 137-2532-1385
- E-mail: linbitao1996@163.com
Undersøgelse Kontakt Backup
- Navn: Zelong Han, MD
- Telefonnummer: +86 20-6278-7385
- E-mail: hanzelong2025@163.com
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Beskrivelse
Inclusion Criteria:
- Subjects aged ≥45 years, regardless of gender;
- Subjects undergoing screening colonoscopy;
- Subjects with no prior colonoscopy;
- Voluntarily provide written informed consent.
Exclusion Criteria:
- 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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: WLI Then LCI Withdrawal Group
Tandem colonoscopy of the entire colorectum was performed, with initial observation using conventional white-light imaging, followed by linked color imaging.
|
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.
|
|
Aktiv komparator: LCI Then WLI Withdrawal Group
Tandem colonoscopy of the entire colorectum was performed, with initial observation using linked color imaging, followed by conventional white-light imaging.
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
sessile serrated lesions miss rate(SSLMR)
Tidsramme: One day
|
The number of SSL detected in the second-pass examination/total number of SSL detected in both two pass.
|
One day
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
adenoma miss rate (AMR)
Tidsramme: One day
|
The number of adenomas detected in the second-pass examination/total number of adenomas detected in the two pass.
|
One day
|
|
advanced adenomas miss rate (AAMR)
Tidsramme: One day
|
the number of advanced adenomas detected in the second-pass examination/total number of advanced adenomas detected in the two pass.
|
One day
|
|
polyps miss rate (PMR)
Tidsramme: One day
|
the number of polyps detected in the second-pass examination/total number of polyps detected in the two pass.
|
One day
|
|
sessile serrated lesions detection rate (SSLDR)
Tidsramme: One day
|
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.
|
One day
|
|
adenomas detection rate (ADR)
Tidsramme: One day
|
the number of patients with at least one adenoma detected by linked color imaging or white light imaging, divided by the total number of patients.
|
One day
|
|
advanced adenomas detection rate (AADR)
Tidsramme: One day
|
the number of patients with at least one advanced adenoma detected by linked color imaging or white light imaging, divided by the total number of patients.
|
One day
|
|
polyps detection rate (PDR)
Tidsramme: One day
|
the number of patients with at least one polyp detected by linked color imaging or white light imaging, divided by the total number of patients.
|
One day
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. august 2026
Primær færdiggørelse (Anslået)
1. november 2028
Studieafslutning (Anslået)
1. februar 2029
Datoer for studieregistrering
Først indsendt
30. juli 2026
Først indsendt, der opfyldte QC-kriterier
30. juli 2026
Først opslået (Faktiske)
4. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
4. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- NFEC-2026-304
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