Sammenligning af ydeevnen mellem konventionel koloskopi og 3D koloskopi i positiv fækal immunokemisk 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.
Studieoversigt
Status
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Hsuan-Ho Lin, MD
- Telefonnummer: 886-9-72-654-359
- E-mail: tostart21@gmail.com
Studiesteder
-
-
-
Hsinchu, Taiwan
- Rekruttering
- National Taiwan University Hospital, Hsinchu Branch
-
Kontakt:
- Hsuan-Ho Lin
- Telefonnummer: 886-9-72-654-359
- E-mail: tostart21@gmail.com
-
Ledende efterforsker:
- Hsuan-Ho Lin, MD
-
Taipei, Taiwan
- Rekruttering
- National Taiwan University Hospital
-
Kontakt:
- Li-Chun Chang, MD. PhD.
- Telefonnummer: 886-9-72-651-258
- E-mail: lichunchang@ntu.edu.tw
-
Taipei, Taiwan
- Rekruttering
- National Taiwan University Cancer Center
-
Kontakt:
- Hao-Che Chang, MD
- Telefonnummer: 886-2-23123456
- E-mail: andrewhcchang@gmail.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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 undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 3D colonoscopy
Use 3D machine to generate the 3D image |
Use 3D machine to generate the 3D image |
|
Ingen indgriben: 2D colonoscopy
Traditional colonoscopy |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Adenomdetektionshastighed
Tidsramme: 30 minutter
|
30 minutter
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Polyp detektionshastighed
Tidsramme: 30 minutter
|
30 minutter
|
|
|
adenomtal pr. koloskopi,
Tidsramme: 30 minutter
|
30 minutter
|
|
|
polyptal pr. 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
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 202311028DIPA
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