Advanced Adenoma Detection With 3D Imaging Device During Colonoscopy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorXijing Hospital of Digestive Diseases
About this trial
The goal of this clinical trial is to learn if 3-dimensional (3D) imaging device works to identify patients with high risk adenomas during colonoscopy to guide proper follow-up strategy. It will also learn about the safety of 3-dimensional (3D) imaging device. The main questions it aims to answer are:
Does 3-dimensional (3D) imaging device improve the identification of patients with high risk adenomas? What adverse events do participants experience during colonoscopy? Researchers will compare 3-dimensional (3D) imaging device to traditional 2-dimensional (2D) imaging device to see if 3-dimensional (3D) imaging device works to improve high risk adenoma identification.
Participants will:
Undertake colonoscopy examination using 3-dimensional (3D) imaging device or 2-dimensional (2D) imaging device. Be followed-up to 30 days to record potential colonoscopy-relevant adverse events.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Aged 18-75 years;
Patients with indications for colonoscopy and receiving diagnostic colonoscopy, without history of inflammatory bowel disease, colorectal cancer, polypectomy or polyposis syndromes;
Signing the written informed consent;
Disqualifiers
Patients with polyposis syndromes (e.g., Peutz-Jeghers syndrome, Cronkhite-Canada syndrome, familial adenomatous polyposis [FAP], Lynch syndrome, etc.);
Patients with a history of colorectal polypectomy and pathological diagnosed as adenoma;
Patients with a history of colorectal adenocarcinoma or alarming symptoms;
Patients with a history of inflammatory bowel disease;
Trial design
Design model
Parallel
Treatments tested in this trial
Colonoscopy after bowel cleansing with 2D imaging device
Procedure/Surgeryparticipants will undergo colonoscopy examination using 2D imaging colonoscope to detect potential adenomas or polyps. The classification of the detected lession will be determined by the edoscopic diagnosis based on the JNET classification system or by the pathological diagnosis with tissues from biopsy or polypectomy.
Colonoscopy after bowel cleansing with 3D imaging device
Procedure/Surgeryparticipants will undergo colonoscopy examination using 3D imaging colonoscope to detect potential adenomas or polyps. The classification of the detected lession will be determined by the edoscopic diagnosis based on the JNET classification system or by the pathological diagnosis with tissues from biopsy or polypectomy.
Treatment groups
1,566 Participants
are divided into 2 treatment groupsGroup A: 2D imaging armActive comparator 1 intervention
Group B: 3D imaging armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
High-risk adenoma (HRA) detection rate
HRA were defined with one of the following features:1. diameter ≥10 mm or 2. (tubulo)villous adenomas or 3. with high-grade dysplasia or 4. sessile serrated lesions (SSLs) or 5. ≥ 3 adenomas. SSLs were defined as lesions with at least one crypt showing a characteristic sessile serrated lesion-type appearance. HRA detection rate is defined as the number of participants diagnosed with HRA divided by the total number of participants
Time frame
1-7 days after polypectomySecondary outcomes
1
Adenoma detection rate (ADR)
The number of participants with at least 1 adenoma divided by the total number of participants
Time frame
1-7 days after polypectomy2
Polyp detection rate (PDR)
The number of participants with at least 1 polyp divided by the total number of participants
Time frame
1-7 days after polypectomy3
Clinically relevant serrated polyp detection rate
Clinically relevant serrated polyps are defined as ≥10 mm serrated polyps (SPs, including hyperplastic polyps, SSLs, and traditional serrated adenomas) and \>5 mm SPs in the proximal colon. Clinically relevant serrated polyp detection rate is defined as the number of participants with at least 1 clinically relevant serrated polyp divided by the total number of participants.
Time frame
1-7 days after polypectomy4
Modified advanced adenoma detection rate
Modified advanced adenoma are defined with one of the following features:1. diameter ≥10 mm or 2. (tubulo)villous adenomas or 3. with high-grade dysplasia or 4. sessile serrated lesions (SSLs). SSLs were defined as lesions with at least one crypt showing a characteristic sessile serrated lesion-type appearance. Modified advanced adenoma detection rate is defined as the number of participants diagnosed with modified advanced adenoma divided by the total number of participants
Time frame
1-7 days after polypectomySponsors and contacts
Click on the lead sponsor to view all of their trials.
Xijing Hospital of Digestive Diseases
Lead sponsor
Beijing Friendship Hospital
Collaborator
Qilu Hospital of Shandong University
Collaborator
Source ClinicalTrials.gov