Adenoma
Conditions
Keywords
Polyp Detection, Quality Monitoring, Artificial Intelligence
Brief summary
An artificial intelligence-based system, named EndoAngel,has been constructed previously,which has polyp detection and quality monitoring functions. This study aims to evaluate the two different functions of EndoAngle in improving adenoma detection rate.
Detailed description
The detection and removal of precancerous polyps via colonoscopy can reduce the the risk of colon cancer. However, the detection rate of adenomatous polyps can vary significantly among endoscopists. EndoAngel is an artificial intelligence-based system,consisting of polyp detection and quality monitoring functions. The polyp detection function can remind endoscopists of the location of the polyp. The quality monitoring function can monitor the velocity of insertion of the endoscope, record the time of insertion and withdrawal of the endoscope, and remind endoscopists of the blind areas caused by intestinal segment slipping.This study aims to evaluate the two different functions of EndoAngle by 2 × 2 factorial design in improving adenoma detection rate and the quality of colonscopy .
Interventions
DIAGNOSTIC_TESTColonoscopy with the assistance of EndoAngel's polyp detection function.
Patient in this group will receive colonoscopy with assistance of EndoAngel's polyp detection function,which can remind endoscopists of the location of the polyp.
DIAGNOSTIC_TESTColonoscopy with the assistance of EndoAngel's quality monitoring function.
Patient in this group will receive colonoscopy with assistance of EndoAngel's quality monitoring function,which can monitor the withdrawal speed of the endoscope.
DIAGNOSTIC_TESTColonoscopy without the assistance of EndoAngel's any function.
Patient in this group will receive colonoscopy with assistance of EndoAngel's both functions.
Sponsors
Renmin Hospital of Wuhan University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Male or female aged 18 years or above; 2. Colonoscopy is needed to further characterize gastrointestinal diseases; 3. Ability to read, understand and sign informed consent forms; 4. The researchers believe that the subjects can understand the process of the clinical study and are willing and able to complete all the study procedures and follow-up visits to cooperate with the study procedures.
Exclusion criteria
1. Participated in other clinical trials, signed informed consent forms and followed up in other clinical trials； 2. Participate in a drug clinical trial and during the elution period of the trial or control drug； 3. Drug or alcohol abuse or mental disorder in the last 5 years; 4. Pregnant or lactating women; 5. Patients with multiple polyp syndrome; 6. Patients with a history of inflammatory bowel disease, colorectal cancer, or colorectal surgery; 7. Patients with known perforation or colonic obstruction; 8. Patients with a contraindication for biopsy; 9. The researchers did not consider the subjects suitable for colonoscopy; 10. The researchers determined that the subjects had high-risk diseases or other special conditions that were not appropriate for clinical trials.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adenoma detection rate | 3 Months | The numerator is the number of cases of adenomas detected by colonoscopy, and the denominator is the total number of cases of patients undergoing colonoscopy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The mean number of polyps per procedure | 3 months | The numerator is the total number of polyps detected by colonoscopy, and the denominator is the total number of patients undergoing colonoscopy. |
| The mean number of adenomas per procedure | 3 months | The numerator is the total number of adenomas detected by colonoscopy, and the denominator is the total number of patients undergoing colonoscopy. |
| Detection rate of large, small and diminutive polyps | 3 months | The numerator was the number of patients with large (≥10 mm), small (\>5 to \<10 mm), and diminutive(≤5 mm) polyps detected by colonoscopy, and the denominator was the total number of patients receiving colonoscopy. |
| The mean number of large, small and diminutive polyps per procedure | 3 months | The numerator was the number of large (≥10 mm), small (\>5 to \<10 mm), and diminutive(≤5 mm) polyps detected by colonoscopy, and the denominator was the total number of patients receiving colonoscopy. |
| Detection rate of large, small and diminutive adenomas | 3 months | The numerator was the number of patients with large (≥10 mm), small (\>5 to \<10 mm), and diminutive(≤5 mm) adenomas detected by colonoscopy, and the denominator was the total number of patients receiving colonoscopy. |
| Polyp detection rate | 3 months | The numerator is the number of cases of polyps detected by colonoscopy, and the denominator is the total number of cases of patients undergoing colonoscopy. |
| Detection rate of adenoma in different sites | 3 months | The numerator is the number of cases of adenoma detected in the rectum, sigmoid colon, descending colon, transverse colon, ascending colon and ileocecal region during colonoscopy, and the denominator is the total number of patients undergoing colonoscopy. |
| The mean number of adenomas in different sites per procedure | 3 months | The numerator is the total number of adenomas detected in the rectum, sigmoid colon, descending colon, transverse colon, ascending colon and ileocecal region during colonoscopy, and the denominator is the total number of patients undergoing colonoscopy. |
| Time of colonoscopic insertion | 3 months | The duration of colonoscopic insertion from rectum to ileocecal valve or appendiceal opening |
| Time of colonoscopic withdrawal | 3 months | The duration of colonoscopic withdrawal from ileocecal valve or appendiceal opening to colonoscopy finished. |
| Cecal intubation rate | 3 months | The numerator is the number of cases of colonoscopy reaching ileocecal valve or appendiceal opening, and the denominator is the total number of colonoscopy cases. |
| The mean number of large, small and diminutive adenomas per procedure | 3 months | The numerator was the number of large (≥10 mm), small (\>5 to \<10 mm), and diminutive(≤5 mm) adenomas detected by colonoscopy, and the denominator was the total number of patients receiving colonoscopy. |
Countries
China
Contacts
Primary ContactHonggang Yu, MD
Outcome results
None listed