Diminutive Colorectal PolypsNCT03903497
WASP Classification in Diagnosis of Diminutive Colorectal Polyps
A study testing NBI in people with Diminutive Colorectal Polyps, run by Shanghai Jiao Tong University School of Medicine at 2 sites in China.
Trial summary
Adenomas, serrated adenomas and hyperplastic polyps are polypoid lesion in the colorectum. At the present moment, all polyps should be resected endoscopically, although only adenomas and serrated adenomas, but not hyperplastic polyps have the potential to develop colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diminutive Colorectal Polyps
- What is being tested?
- NBI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,640 participants
- Where
- 2 sitesChina
- Study dates
- 15 Apr 2019to 30 May 2023
- Phase
- Interventional
- 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
Who may be able to join
- Patients aged more than 18 years old
- Patients with at least one diminutive colorectal polyp
Who cannot join
- Patients with poor bowel preparation
- Paitents with history of colorectal surgery, familial adenomatous polyposis or inflammatory bowel disease
- Patients with advanced colorectal cancer
- Patients with missed histology information of resected polyps or missed resected specimen
- Patients with emergency operation during colonoscopy
- Patients with unfinished colonoscopy due to any reason
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Beijing Friendship Hospital
Beijing, Beijing Municipality, 100050
Shu-Tian Zhang
Shu-Tian Zhang, MD
- Recruiting
Renji Hospital
Shanghai, Shanghai Municipality, 200001
Zhi-Zheng Ge, 021-58752345, zhizhengge@aliyun.com
Zhi-Zheng Ge, MD
About this study
Official title: Efficacy of WASP Classification in the Histological Evaluation of Diminutive Colorectal Polyps
Adenomas, serrated adenomas and hyperplastic polyps are polypoid lesion in the colorectum. At the present moment, all polyps should be resected endoscopically, although only adenomas and serrated adenomas, but not hyperplastic polyps have the potential to develop colorectal cancer. Some studies have investigated the value of the narrow-band imaging (NBI) on histological prediction of the polyp. This method is conducted in real time during colonoscopy, which leads to simplification of diagnostic procedures. For instance, it would be conceivable to resect diminutive polyps and discard them without further assessment by a pathologist. One problem in this context is a correct differentiation between hyperplastic polyps and serrated adenomas. These two polyp entities are known to show similar optical features. However, while serrated adenomas are premalignant lesions hyperplastic polyps have benign histology and never develop into cancer. It is therefore important to sufficiently distinguish hyperplastic polyps from serrated lesions.
In this study the investigators want to investigate whether the use of NBI would be capable to get accuracy of optical polyp predictions by more than 90% using the WASP (Workgroup serrAted polypS and Polyposis) classification. NBI is a light filter tool which can be activated by pressing a button at the endoscope. The use of NBI leads to an endoscopic picture which appears blue and enables endoscopists to better assess surface structures and vascular patterns. All polyps will be resected and send to pathology for further microscopic assessment. After completing the trial the investigators aim to compare accuracy of the optical diagnosis.
- Conditions
- Diminutive Colorectal Polyps
- Being tested
- NBI
- Keywords
- Narrow band imaging, WASP classification, Diminutive colorectal polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NBIDevice
optical assessment of diminutive colorectal polyps by NBI mode using the WASP assessment
| Study group | Role | What they receive |
|---|---|---|
| NBI assessment using the WASP classification | Other | Not described Receives: Device: NBI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Surveillance time prediction of patients with at least one diminutive polyps under high confidence of diagnosis
Measured: Within two weeks after polypectomy
Negative predictive value of diminutive polyps located in rectum and sigmoid colon under high confidence of diagnosis
Measured: Within two weeks after polypectomy
Accuracy of WASP classification in histological prediction of diminutive polyps under high confidence of diagnosis
Measured: Within two weeks after polypectomy
Secondary outcomes (1)
Learning curve of accuracy of endoscopists using NBI in assessment of diminutive polyps
Measured: Within two weeks after polypectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start15 Apr 2019
- Primary completion30 Dec 2022 (estimated)
- Study completion30 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diminutive Colorectal PolypsStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Colonoscopy with NBI using the WASP classification
- Masking
- None (open label)
- Enrolment
- 2,640 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Friendship Hospital, Jilin Provincial People's Hospital, Wafangdian Third Hospital, Dezhou People's Hospital, Liaocheng People's Hospital, Wenzhou Central Hospital, Yichun People's Hospital, The Third Xiangya Hospital of Central South University, Shenzhen Baoan District People's Hospital, Xinxiang Central Hospital, Wuwei Cancer Hospital, Zunyi Medical College, Yan'an People's Hospital
- Responsible party
- Principal investigator, Zhizheng Ge, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03903497
- Sponsor's protocol ID
- rj[2018]086
- Status last verified
- May 2022
- First submitted
- 1 Apr 2019
- Last updated
- 18 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of WASP Classification in the Histological Evaluation of Diminutive Colorectal Polyps
- ClinicalTrials.gov ID
- NCT03903497
- Acronym / sponsor ID
- rj[2018]086
- Conditions
- Diminutive Colorectal Polyps
- Keywords
- Narrow band imaging, WASP classification, Diminutive colorectal polyps
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,640 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Beijing Friendship Hospital, Jilin Provincial People's Hospital, Wafangdian Third Hospital, Dezhou People's Hospital, Liaocheng People's Hospital, Wenzhou Central Hospital, Yichun People's Hospital, The Third Xiangya Hospital of Central South University, Shenzhen Baoan District People's Hospital, Xinxiang Central Hospital, Wuwei Cancer Hospital, Zunyi Medical College, Yan'an People's Hospital
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 May 2023 (estimated)
- First posted
- 4 Apr 2019 (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.
Adenomas, serrated adenomas and hyperplastic polyps are polypoid lesion in the colorectum. At the present moment, all polyps should be resected endoscopically, although only adenomas and serrated adenomas, but not hyperplastic polyps have the potential to develop colorectal cancer. Some studies have investigated the value of the narrow-band imaging (NBI) on histological prediction of the polyp. This method is conducted in real time during colonoscopy, which leads to simplification of diagnostic procedures. For instance, it would be conceivable to resect diminutive polyps and discard them without further assessment by a pathologist. One problem in this context is a correct differentiation between hyperplastic polyps and serrated adenomas. These two polyp entities are known to show similar optical features. However, while serrated adenomas are premalignant lesions hyperplastic polyps have benign histology and never develop into cancer. It is therefore important to sufficiently distinguish hyperplastic polyps from serrated lesions.
In this study the investigators want to investigate whether the use of NBI would be capable to get accuracy of optical polyp predictions by more than 90% using the WASP (Workgroup serrAted polypS and Polyposis) classification. NBI is a light filter tool which can be activated by pressing a button at the endoscope. The use of NBI leads to an endoscopic picture which appears blue and enables endoscopists to better assess surface structures and vascular patterns. All polyps will be resected and send to pathology for further microscopic assessment. After completing the trial the investigators aim to compare accuracy of the optical diagnosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Colonoscopy with NBI using the WASP classification
| Arm | Type | Receives |
|---|---|---|
| NBI assessment using the WASP classification | Other | Device: NBI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged more than 18 years old
- Patients with at least one diminutive colorectal polyp
Key exclusion criteria (6 listed)
- Patients with poor bowel preparation
- Paitents with history of colorectal surgery, familial adenomatous polyposis or inflammatory bowel disease
- Patients with advanced colorectal cancer
- Patients with missed histology information of resected polyps or missed resected specimen
- Patients with emergency operation during colonoscopy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NBIoptical assessment of diminutive colorectal polyps by NBI mode using the WASP assessment | Device | NBI assessment using the WASP classification |
Primary outcome
Accuracy of Surveillance time prediction of patients with at least one diminutive polyps under high confidence of diagnosis
Time frame: Within two weeks after polypectomy
Negative predictive value of diminutive polyps located in rectum and sigmoid colon under high confidence of diagnosis
Time frame: Within two weeks after polypectomy
Accuracy of WASP classification in histological prediction of diminutive polyps under high confidence of diagnosis
Time frame: Within two weeks after polypectomy
1 secondary outcome
Learning curve of accuracy of endoscopists using NBI in assessment of diminutive polyps
Time frame: Within two weeks after polypectomy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NBI in people with Diminutive Colorectal Polyps, run by Shanghai Jiao Tong University School of Medicine at 2 sites 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 2 inclusion and 6 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 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Zhi-Zheng Ge (021-58752345, zhizhengge@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Surveillance time prediction of patients with at least one diminutive polyps under high confidence of diagnosis (time frame: Within two weeks after polypectomy). The study lists 3 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 18 May 2022.