Jämförelse av prestandan mellan konventionell koloskopi och 3D-koloskopi i positiv fekal immunokemisk testgrupp
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.
Studieöversikt
Status
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Hsuan-Ho Lin, MD
- Telefonnummer: 886-9-72-654-359
- E-post: tostart21@gmail.com
Studieorter
-
-
-
Hsinchu, Taiwan
- Rekrytering
- National Taiwan University Hospital, Hsinchu Branch
-
Kontakt:
- Hsuan-Ho Lin
- Telefonnummer: 886-9-72-654-359
- E-post: tostart21@gmail.com
-
Huvudutredare:
- Hsuan-Ho Lin, MD
-
Taipei, Taiwan
- Rekrytering
- National Taiwan University Hospital
-
Kontakt:
- Li-Chun Chang, MD. PhD.
- Telefonnummer: 886-9-72-651-258
- E-post: lichunchang@ntu.edu.tw
-
Taipei, Taiwan
- Rekrytering
- National Taiwan University Cancer Center
-
Kontakt:
- Hao-Che Chang, MD
- Telefonnummer: 886-2-23123456
- E-post: andrewhcchang@gmail.com
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 3D colonoscopy
Use 3D machine to generate the 3D image |
Use 3D machine to generate the 3D image |
|
Inget ingripande: 2D colonoscopy
Traditional colonoscopy |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Adenomdetektionshastighet
Tidsram: 30 minuter
|
30 minuter
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Polypdetekteringshastighet
Tidsram: 30 minuter
|
30 minuter
|
|
|
adenomtal per koloskopi,
Tidsram: 30 minuter
|
30 minuter
|
|
|
polypnummer per koloskopi,
Tidsram: 30 minuter
|
30 minuter
|
|
|
Flat-ADR
Tidsram: 30 minutes
|
detection rate of flat adenoma |
30 minutes
|
|
Proximal ADR
Tidsram: 30 minutes
|
detection rate of adenoma at proximal colon |
30 minutes
|
|
SSLDR
Tidsram: 30 minutes
|
detection rate of sessile serrated lesion |
30 minutes
|
|
AADR
Tidsram: 30 minutes
|
detection rate of advanced adenoma |
30 minutes
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 202311028DIPA
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