Vergelijking van de prestaties tussen conventionele colonoscopie en 3D-coloscopie in een positieve fecale immunochemische testgroep
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.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Hsuan-Ho Lin, MD
- Telefoonnummer: 886-9-72-654-359
- E-mail: tostart21@gmail.com
Studie Locaties
-
-
-
Hsinchu, Taiwan
- Werving
- National Taiwan University Hospital, Hsinchu Branch
-
Contact:
- Hsuan-Ho Lin
- Telefoonnummer: 886-9-72-654-359
- E-mail: tostart21@gmail.com
-
Hoofdonderzoeker:
- Hsuan-Ho Lin, MD
-
Taipei, Taiwan
- Werving
- National Taiwan University Hospital
-
Contact:
- Li-Chun Chang, MD. PhD.
- Telefoonnummer: 886-9-72-651-258
- E-mail: lichunchang@ntu.edu.tw
-
Taipei, Taiwan
- Werving
- National Taiwan University Cancer Center
-
Contact:
- Hao-Che Chang, MD
- Telefoonnummer: 886-2-23123456
- E-mail: andrewhcchang@gmail.com
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Diagnostisch
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 3D colonoscopy
Use 3D machine to generate the 3D image |
Use 3D machine to generate the 3D image |
|
Geen tussenkomst: 2D colonoscopy
Traditional colonoscopy |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Detectiepercentage van adenoom
Tijdsspanne: 30 minuten
|
30 minuten
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Detectiepercentage poliepen
Tijdsspanne: 30 minuten
|
30 minuten
|
|
|
adenoomaantal per colonoscopie,
Tijdsspanne: 30 minuten
|
30 minuten
|
|
|
poliepaantal per colonoscopie,
Tijdsspanne: 30 minuten
|
30 minuten
|
|
|
Flat-ADR
Tijdsspanne: 30 minutes
|
detection rate of flat adenoma |
30 minutes
|
|
Proximal ADR
Tijdsspanne: 30 minutes
|
detection rate of adenoma at proximal colon |
30 minutes
|
|
SSLDR
Tijdsspanne: 30 minutes
|
detection rate of sessile serrated lesion |
30 minutes
|
|
AADR
Tijdsspanne: 30 minutes
|
detection rate of advanced adenoma |
30 minutes
|
Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- 202311028DIPA
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
product vervaardigd in en geëxporteerd uit de V.S.
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .