Sammenligning av ytelsen mellom konvensjonell koloskopi og 3D koloskopi i positiv fekal immunokjemisk testgruppe
Comparison of the Performance Between Conventional Colonoscopy and 3D Colonoscopy in Positive Fecal Immunochemical Test Group: A Multi-center, Randomized Controlled Trial
Background:
Adenoma detection rate is one of the most quality indicator: an accumulating body of evidence has shown that detection and resection of pre-cancerous adenoma by colonoscopy could effectively prevent colorectal cancer (CRC) and its related mortality1,2. Among various colonoscopy quality indicators, such as cecal intubation rate, withdrawal time, and adenoma detection rate (ADR), ADR is the most important one and most closely associated with the subsequent risk of CRC3,4. A recent study further demonstrated the improvement of ADR could reduce subsequent risk of CRC5.
Equipment and technique to improve ADR: To be noted, among all colorectal neoplasm, non-polypoid lesions, such as flat or depressed lesions, carries higher likelihood to be overlooked during conventional colonoscopy and these overlooked lesions were the main etiology of post-colonoscopy colorectal cancer (PCCRC)6. Nowadays, several colonoscopy technologies had been developed to enhance the detection of colorectal adenoma such as using digital or dye-spray chromoendoscopy7 or add-on device such as Cap/Endocuff/third eye/FUSE-assisted endoscopy8. Among them, some had showed the potential to enhance the detection of non-polypoid lesion, for example, the next-generation NBI9 or iSCAN10.
Application of 3D endoscopy on GI disease: 3D endoscopy is a new technology that using image processing technique to offer more information on tissue depth in comparison with conventional 2D endoscopy. The utility of 3D endoscopy on GI tract was mainly from upper GI tract and it was proved to enhance the diagnostic accuracy on superficial gastric tumors11 and shortened the procedure time during performing gastric endoscopic submucosal dissection (ESD)12. However, few is known that whether 3D colonoscopy could enhance the ADR, especially for non-polypoid lesion detection, during colonoscopy examination.
Positive fecal immunochemical test(FIT) group Among subjects who receive colonoscopy examination, higher advanced adenoma or invasive caners were found in FIT positive group. However, still about half of positive FIT subjects who received colonoscopy exam, have negative colonoscopy result. Non polypoid lesions could be overlooked during the colonoscopy. Therefore, we tried to use this prospective, multicenter, randomized control study to demonstrate the efficacy of 3D colonoscopy on adenoma detection in comparison with conventional 2D colonoscopy in this kind of high risk group.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Hsuan-Ho Lin, MD
- Telefonnummer: 886-9-72-654-359
- E-post: tostart21@gmail.com
Studiesteder
-
-
-
Hsinchu, Taiwan
- Rekruttering
- National Taiwan University Hospital, Hsinchu Branch
-
Ta kontakt med:
- Hsuan-Ho Lin
- Telefonnummer: 886-9-72-654-359
- E-post: tostart21@gmail.com
-
Hovedetterforsker:
- Hsuan-Ho Lin, MD
-
Taipei, Taiwan
- Rekruttering
- National Taiwan University Hospital
-
Ta kontakt med:
- Li-Chun Chang, MD. PhD.
- Telefonnummer: 886-9-72-651-258
- E-post: lichunchang@ntu.edu.tw
-
Taipei, Taiwan
- Rekruttering
- National Taiwan University Cancer Center
-
Ta kontakt med:
- Hao-Che Chang, MD
- Telefonnummer: 886-2-23123456
- E-post: andrewhcchang@gmail.com
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Subjects who are 40 years of older
- Subjects who have positive fecal immunochemical test
Exclusion Criteria:
- Contraindication for colonoscopy
- Subjects with familiar or hereditary polyposis
- Subjects with history of colectomy
- Inadequate bowel cleansing level
- Subjects with inflammatory bowel disease
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 3D colonoscopy
Use 3D machine to generate the 3D image |
Use 3D machine to generate the 3D image |
|
Ingen inngripen: 2D colonoscopy
Traditional colonoscopy |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Adenomadeteksjonshastighet
Tidsramme: 30 minutter
|
30 minutter
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Deteksjonshastighet for polypper
Tidsramme: 30 minutter
|
30 minutter
|
|
|
adenomtall per koloskopi,
Tidsramme: 30 minutter
|
30 minutter
|
|
|
polypptall per koloskopi,
Tidsramme: 30 minutter
|
30 minutter
|
|
|
Flat-ADR
Tidsramme: 30 minutes
|
detection rate of flat adenoma |
30 minutes
|
|
Proximal ADR
Tidsramme: 30 minutes
|
detection rate of adenoma at proximal colon |
30 minutes
|
|
SSLDR
Tidsramme: 30 minutes
|
detection rate of sessile serrated lesion |
30 minutes
|
|
AADR
Tidsramme: 30 minutes
|
detection rate of advanced adenoma |
30 minutes
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 202311028DIPA
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