The PDR will increase with the use of the Discovery System.
ID
Bron
Verkorte titel
Aandoening
Colorectal carcinoma, colorectal polyps, colorectal adenomas
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Polyp detection rate (PDR)
Achtergrond van het onderzoek
Rationale
Adenoma detection rate (ADR) is known to be inversely correlated with the incidence of colorectal cancer (CRC). Multiple factors are considered to have a negative impact on the adenoma detection rate (ADR), one of them being human error. In recent years, a new solution to the human error in detecting adenomas has been developed; computer-aided detection (CADe) systems. Albeit performance of these systems on offline images and videos seems promising, evidence during real-time clinical practice is lacking. Recently, Pentax introduced a novel CADe-system, named “Discovery”.
Objective
The primary objective of this study is to evaluate the feasibility and safety of the Pentax CADe-system during colonoscopy procedures. We hypothesize that the use of this CADe-system is feasible safe and enables detection of colonic adenomas.
Study design
Prospective, multicenter cohort study including a total of 90 patients.
Study population
Patients aged ≥ 18 years, referred and scheduled for either diagnostic, screening (non-iFOBT based) or surveillance colonoscopy.
Main study parameter
The main study parameter is the polyp detection rate. Other study parameters will include the mean number of polyps, the polyp location, shape and size and the ADR.
Nature and extent of the burden and risks associated with participation, benefit and groups relatedness
Patients will be enrolled for a period of 30 days, starting at the day of the procedure and ending after 30 days of follow up. It is likely that the Pentax CADe system will lead to the detection of more (adenomatous) polyps and thereby resulting in more polypectomies, therefore participation in the study might lead to a longer procedure time and more adverse events, especially the risk of intraprocedural or delayed bleeding. Nonetheless, the risk of intraprocedural or delayed bleeding is estimated to be low, i.e. 1.8% and ≤0.1%, respectively. The removal of additional polyps that are detected by the CADe system might have a beneficial effect on the morbidity and mortality resulting from colorectal carcinoma, depending on the type of polyp that is removed during the procedure. The follow-up of the procedure (e.g. the number of hospital visits) will take place according to local guidelines.
Doel van het onderzoek
The PDR will increase with the use of the Discovery System.
Onderzoeksopzet
Findings during colonoscopy, SAE's up to 30 days post-colonoscopy
Onderzoeksproduct en/of interventie
Usage of Pentax Discovery Computer Aided Detection System.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- ≥ 18 years;
- Referred and scheduled for either diagnostic, screening (non-iFOBT based) or surveillance colonoscopy.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Known colorectal tumor or polyp on referral;
- Referral for a therapeutic procedure (i.e. endoscopic mucosal resection, intervention for lower gastro-intestinal bleeding, etc.);
- Inadequately corrected anticoagulation disorders or anticoagulation medication use;
- American Society of Anesthesiologists (ASA) score ≥ 3;
- Known or suspected inflammatory bowel disease;
- Inability to provide informed consent.
Patients that have inadequate bowel preparation, as measured by the Boston Bowel Preparation Score (BBPS): adequate bowel cleansing is considered when the total BBPS is ≥ 6 points along with a score ≥ 2 in each segment of the colon, will be included in the analysis. As the performance of the system in an inadequately prepared colon will also be an important outcome in this feasibility trial.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8788 |
| Ander register | CMO Arnhem-Nijmegen : 2020-6242 |