Colorectal AdenomaNCT04444908
Development and Validation of an Artificial Intelligence-assisted Strategy Selection System for Colonoscopy Cleaning
An observational study of Colorectal Adenoma, run by Renmin Hospital of Wuhan University at 1 site in China.
Trial summary
Patients with poor inadequate bowel preparation need to undergo secondary colonoscopy. but the evaluation of intestinal cleanliness is judged by doctors subjectively. there are no objective and effective criteria to guide the evaluation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Adenoma
- How many people
- 657 participants
- Where
- 1 siteChina
- Study dates
- 11 May 2020to 16 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The primary endpoint was the detection rate of Adenomas and the percentage of 1 score to get a correlation curve. In order to calculate the sample size more accurately, we prepare to collect 200 colonoscopies to explore the sample distribution, and then calculate the sample size according to the sample distribution.
Who may be able to join
- Male or female aged 18 or above;
- Colonoscopy is needed to further clarify the characteristics of digestive tract diseases;
- Patients able to give informed consent were eligible to participate.
- Able and willing to comply with all study process.
- No intestinal organic disease.
Who cannot join
- Has participated in other clinical trials, signed informed consent and was in the follow-up period of other clinical trials.
- Has participated in clinical trials of the drug and is in the elution period of the experimental drug or control drug.
- Drug or alcohol abuse or psychological disorder in the last 5 years.
- Patients in pregnancy or lactation.
- Known polyposis syndromes.
- Gastrointestinal Bleeding.
Show all 12Show fewer
- A history of inflammatory bowel disease, colorectal cancer and colorectal surgery.
- A history of colorectal surgery.
- Patients with a contraindication for biopsy.
- Previous history of allergy to ingredient of bowel cleanser.
- Patients with intestinal obstruction or perforation, toxic megacolon, Colectomy, heart failure (Grade III or IV) , severe cardiovascular disease, severe liver failure or renal insufficiency, etc. .
- Researchers believe that the patient is not suitable to participate in the trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renmin hospital
Wuhan, Hubei, 430000
Honggang Yu, Doctor, 13871281899, yuhonggang@wnu.edu.cn
Huiling Wu, Doctor, 13260647836, 3405291416@qq.com
About this study
Patients with poor inadequate bowel preparation need to undergo secondary colonoscopy. but the evaluation of intestinal cleanliness is judged by doctors subjectively. there are no objective and effective criteria to guide the evaluation. We use the deep learning technique to develop the EndoAngel with real-time intestinal cleanliness assessment. It can derive a decision curve for bowel cleanliness based on the relationship between the percentage of bowel segments with a Boston score of 1 and the adenoma detection rate. It can help doctors to identify patients who need a second colonoscopy, and provide a new way for artificial intelligence in improving the detection rate of colonoscopic adenomas.
Read the detailed description
Colorectal disease as a common human disease seriously affects the health of human life. With the aging of the population, the change of diet structure and the aggravation of environmental pollution, the incidence of colorectal diseases, such as colon cancer, Colon Polyp and inflammatory bowel disease, has gradually increased.
Colonoscopy is the simplest and most widely available screening procedure for colorectal cancer(CRC) prevention and early detection. Colonoscopy can clearly observe the small changes in the terminal ileum and the colorectal, such as erosion, ulcers, bleeding, congestion, edema, polyps, early cancer, and so on. Colonoscopy can biopsy the lesion site for pathological examination, to histologically qualitative the characterization of mucosal lesions, such as inflammation, polyp nature, the degree of differentiation of cancer, and so on. It is helpful to understand the severity of the lesion and guide the formulation of the correct treatment plan or judgment of treatment effect. Colonoscopy can also be the minimally invasive endoscopic treatment of colorectal polyps, early cancer, bleeding, foreign bodies and other diseases.
Because the quality of bowel preparation affects the colonoscopy's ability to detect adenomas and polyps, adequate bowel preparation is necessary to ensure optimal use of colonoscopy in CRC prevention. Almost all clinical guidelines recommend adequate bowel preparation before colonoscopy. However, up to one third of colonoscopies have been found to show inadequate bowel preparation, which is estimated to increase the cost of colonoscopies by 12% to 22%. And there are 20% of patients' bowel is not adequately prepared. When the patient's bowel preparation is inadequate, the difficulty of flushing may lead to missed detection of adenomas. so doctors need to accurately identify such patients and tell them to have a second colonoscopy after a full bowel cleanse. However, the evaluation of intestinal cleanliness is decided by doctors subjectively, and there is no objective and effective scoring standard to guide the patients to accept the second colonoscopy.
Deep learning is an important breakthrough in the field of artificial intelligence in the past decade. It has great potential in extracting tiny features in image analysis and image classification. In 2017, the journal Nature published a paper showing that using artificial intelligence to diagnose skin diseases can reach the level of experts. Subsequently, in the field of digestive endoscopy, more and more studies began to apply artificial intelligence to assist doctors to find polyps and improve the detection rate of polyps and adenomas.Urban, G. team used artificial intelligence to identify polyps with 95% sensitivity. Misawa, M team used artificial intelligence to identify polyps with 90% sensitivity. The purpose of our research group is to develop the EndoAngel with real-time intestinal cleanliness assessment. It can derive a decision curve for bowel cleanliness based on the relationship between the percentage of bowel segments with a Boston score of 0-1 and the detection rate of adenomas. It can help endoscopists to identify patients who need a second colonoscopy, to avoid the missed adenomas and the high cost of cleaning time caused by the wrong decision-making. At the same time, artificial intelligence is in the preliminary research stage in the field of digestive endoscopy, our research results are expected to provide new ideas in improving the detection rate of colonoscopic adenomas.
The study Process is: Subjects who met all inclusion criteria and did not meet all exclusion criteria were included in the study before colonoscopy. During the colonoscopy, the endoscopists need to remain in the same without withdrawal while flushing the bowel. The biopsied patients are followed up for one week. the non-biopsied patients are followed up at the end of their colonoscopy , and the results are sent to an independent data analysis team for review. We will collect the patients' video and exclude the clips of irrigation, biopsy, and observation of polyp. Then the EndoAngel evaluates the Boston Bowel Preparation Scale of the ascending colon, transverse colon and descending colon, and calculates the proportion of 1 Score.
- Conditions
- Colorectal Adenoma
What is being measured
The primary outcome is the main question the study is designed to answer.
The adenoma detection rate (ADR)
ADR was calculated by dividing the total number of patients being detected adenomas by the number of colonoscopies.
Measured: 2020.08.7
Cleanliness assessment of different intestinal segment in the artificial intelligence system
The Artificial intelligence evaluates the Boston Bowel Preparation score of the ascending colon, transverse colon and descending colon in real-time, and calculates the proportion of 1 Score
Measured: 2020.08.7
Secondary outcomes (12)
The polyp detection rate (PDR)
PDR was calculated by dividing the total number of patients being detected polyps by the number of colonoscopies
Measured: 2020.08.7
The mean number of polyps per patient (MNP)
MNP was calculated by dividing the total number of polyps by the number of colonoscopies.
Measured: 2020.08.7
The mean number of adenomas per patient (MAP)
MAP was calculated by dividing the total number of adenomas by the number of colonoscopies
Measured: 2020.08.7
PDR of different sizes
It was calculated by dividing the number of patients with polyps that large (≥10 mm), small (6-9 mm) and diminutive (≤5 mm) by the number of patients undergoing colonoscopy.
Measured: 2020.08.7
MNP of different sizes
It was calculated by dividing the number of polyps that large (≥10 mm), small (6-9 mm) and diminutive≤5 mm) by the number of patients undergoing colonoscopy.
Measured: 2020.08.07
ADR of different sizes
It was calculated by dividing the number of patients with adenomas that large (≥10 mm), small (6-9 mm) and diminutive≤5 mm) by the number of patients undergoing colonoscopy.
Measured: 2020.08.07
MAP of different sizes
It was calculated by dividing the number of adenomas that large (≥10 mm), small (6-9 mm) and diminutive≤5 mm) by the number of patients undergoing colonoscopy.
Measured: 2020.08.07
ADR of different location
It was calculated by dividing the number of patients with adenomas detected in the rectum, sigmoid colon, descending colon, transverse colon, ascending colon, ileocecal region etc. by the Total number of patients undergoing colonoscopy.
Measured: 2020.08.07
MAP of different location
It was calculated by dividing the number of adenomas detected in the rectum, sigmoid colon, descending colon, transverse colon, ascending colon, ileocecal region etc. by the Total number of patients undergoing colonoscopy.
Measured: 2020.08.07
Scope-forward time and Withdrawal time
Scope-forward time: The time is taken to go from the the rectum to the ileocecal region. Withdrawal time. The time is taken to finish the examination from the beginning of the ileocecal region.
Measured: 2020.08.07
Boston Bowel Preparation Score of endoscopists
Endoscopists evaluate the different intestinal segment according Boston Bowel Preparation Scale(BBPS)
Measured: 2020.08.07
Cecal intubation rate
It was calculated by dividing the number of colonoscopies that get to the ileocecal region by the total number of colonoscopies.
Measured: 2020.08.07
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study start11 May 2020
- Primary completion15 Oct 2020
- Study completion16 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal AdenomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 657 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Renmin Hospital of Wuhan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Honggang Yu, Doctor, Principal investigator, Renmin Hospital of Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04444908
- Sponsor's protocol ID
- WDRY2019-KK073
- Status last verified
- Nov 2020
- First submitted
- 20 Jun 2020
- Last updated
- 17 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual de-identified participant data that underlie the results reported in this article and study protocol will be shared for investigators whose proposed use of the data has been approved by an independent review committee. Data can only be used to achieve aims in the approved proposal. Data disclosure begins 9 months and ends 36 months after article publication. To gain access, data requesters will need to sign a data access agreement. Proposals should be directed to the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of an Artificial Intelligence-assisted Strategy Selection System for Colonoscopy Cleaning
- ClinicalTrials.gov ID
- NCT04444908
- Acronym / sponsor ID
- WDRY2019-KK073
- Conditions
- Colorectal Adenoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 657 participants (estimated)
- Lead sponsor
- Renmin Hospital of Wuhan UniversityUniversity, hospital or other
- Study start
- 11 May 2020 (actual)
- Primary completion
- 15 Oct 2020 (actual)
- Study completion
- 16 Nov 2020 (estimated)
- First posted
- 24 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with poor inadequate bowel preparation need to undergo secondary colonoscopy. but the evaluation of intestinal cleanliness is judged by doctors subjectively. there are no objective and effective criteria to guide the evaluation. We use the deep learning technique to develop the EndoAngel with real-time intestinal cleanliness assessment. It can derive a decision curve for bowel cleanliness based on the relationship between the percentage of bowel segments with a Boston score of 1 and the adenoma detection rate. It can help doctors to identify patients who need a second colonoscopy, and provide a new way for artificial intelligence in improving the detection rate of colonoscopic adenomas.
Detailed description
Colorectal disease as a common human disease seriously affects the health of human life. With the aging of the population, the change of diet structure and the aggravation of environmental pollution, the incidence of colorectal diseases, such as colon cancer, Colon Polyp and inflammatory bowel disease, has gradually increased.
Colonoscopy is the simplest and most widely available screening procedure for colorectal cancer(CRC) prevention and early detection. Colonoscopy can clearly observe the small changes in the terminal ileum and the colorectal, such as erosion, ulcers, bleeding, congestion, edema, polyps, early cancer, and so on. Colonoscopy can biopsy the lesion site for pathological examination, to histologically qualitative the characterization of mucosal lesions, such as inflammation, polyp nature, the degree of differentiation of cancer, and so on. It is helpful to understand the severity of the lesion and guide the formulation of the correct treatment plan or judgment of treatment effect. Colonoscopy can also be the minimally invasive endoscopic treatment of colorectal polyps, early cancer, bleeding, foreign bodies and other diseases.
Because the quality of bowel preparation affects the colonoscopy's ability to detect adenomas and polyps, adequate bowel preparation is necessary to ensure optimal use of colonoscopy in CRC prevention. Almost all clinical guidelines recommend adequate bowel preparation before colonoscopy. However, up to one third of colonoscopies have been found to show inadequate bowel preparation, which is estimated to increase the cost of colonoscopies by 12% to 22%. And there are 20% of patients' bowel is not adequately prepared. When the patient's bowel preparation is inadequate, the difficulty of flushing may lead to missed detection of adenomas. so doctors need to accurately identify such patients and tell them to have a second colonoscopy after a full bowel cleanse. However, the evaluation of intestinal cleanliness is decided by doctors subjectively, and there is no objective and effective scoring standard to guide the patients to accept the second colonoscopy.
Deep learning is an important breakthrough in the field of artificial intelligence in the past decade. It has great potential in extracting tiny features in image analysis and image classification. In 2017, the journal Nature published a paper showing that using artificial intelligence to diagnose skin diseases can reach the level of experts. Subsequently, in the field of digestive endoscopy, more and more studies began to apply artificial intelligence to assist doctors to find polyps and improve the detection rate of polyps and adenomas.Urban, G. team used artificial intelligence to identify polyps with 95% sensitivity. Misawa, M team used artificial intelligence to identify polyps with 90% sensitivity. The purpose of our research group is to develop the EndoAngel with real-time intestinal cleanliness assessment. It can derive a decision curve for bowel cleanliness based on the relationship between the percentage of bowel segments with a Boston score of 0-1 and the detection rate of adenomas. It can help endoscopists to identify patients who need a second colonoscopy, to avoid the missed adenomas and the high cost of cleaning time caused by the wrong decision-making. At the same time, artificial intelligence is in the preliminary research stage in the field of digestive endoscopy, our research results are expected to provide new ideas in improving the detection rate of colonoscopic adenomas.
The study Process is: Subjects who met all inclusion criteria and did not meet all exclusion criteria were included in the study before colonoscopy. During the colonoscopy, the endoscopists need to remain in the same without withdrawal while flushing the bowel. The biopsied patients are followed up for one week. the non-biopsied patients are followed up at the end of their colonoscopy , and the results are sent to an independent data analysis team for review. We will collect the patients' video and exclude the clips of irrigation, biopsy, and observation of polyp. Then the EndoAngel evaluates the Boston Bowel Preparation Scale of the ascending colon, transverse colon and descending colon, and calculates the proportion of 1 Score.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The primary endpoint was the detection rate of Adenomas and the percentage of 1 score to get a correlation curve. In order to calculate the sample size more accurately, we prepare to collect 200 colonoscopies to explore the sample distribution, and then calculate the sample size according to the sample distribution.
Key inclusion criteria (5 listed)
- Male or female aged 18 or above;
- Colonoscopy is needed to further clarify the characteristics of digestive tract diseases;
- Patients able to give informed consent were eligible to participate.
- Able and willing to comply with all study process.
- No intestinal organic disease.
Key exclusion criteria (12 listed)
- Has participated in other clinical trials, signed informed consent and was in the follow-up period of other clinical trials.
- Has participated in clinical trials of the drug and is in the elution period of the experimental drug or control drug.
- Drug or alcohol abuse or psychological disorder in the last 5 years.
- Patients in pregnancy or lactation.
- Known polyposis syndromes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The adenoma detection rate (ADR)
Time frame: 2020.08.7
ADR was calculated by dividing the total number of patients being detected adenomas by the number of colonoscopies.
Cleanliness assessment of different intestinal segment in the artificial intelligence system
Time frame: 2020.08.7
The Artificial intelligence evaluates the Boston Bowel Preparation score of the ascending colon, transverse colon and descending colon in real-time, and calculates the proportion of 1 Score
12 secondary outcomes
The polyp detection rate (PDR)
Time frame: 2020.08.7
The mean number of polyps per patient (MNP)
Time frame: 2020.08.7
The mean number of adenomas per patient (MAP)
Time frame: 2020.08.7
PDR of different sizes
Time frame: 2020.08.7
MNP of different sizes
Time frame: 2020.08.07
ADR of different sizes
Time frame: 2020.08.07
MAP of different sizes
Time frame: 2020.08.07
ADR of different location
Time frame: 2020.08.07
MAP of different location
Time frame: 2020.08.07
Scope-forward time and Withdrawal time
Time frame: 2020.08.07
Boston Bowel Preparation Score of endoscopists
Time frame: 2020.08.07
Cecal intubation rate
Time frame: 2020.08.07
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
- Individual participant dataSharing planned: Yes. Individual de-identified participant data that underlie the results reported in this article and study protocol will be shared for investigators whose proposed use of the data has been approved by an independent review committee. Data can only be used to achieve aims in the approved proposal. Data disclosure begins 9 months and ends 36 months after article publication. To gain access, data requesters will need to sign a data access agreement. Proposals should be directed to the corresponding author.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Honggang Yu, Doctor principal investigator
Renmin Hospital of Wuhan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Adenoma, run by Renmin Hospital of Wuhan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Honggang Yu, Doctor (13871281899, yuhonggang@whu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The adenoma detection rate (ADR) (time frame: 2020.08.7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2020.