Colorectal Sessile Serrated LesionNCT05684328
Narrow Band Imaging Versus White Light for the Detection and Miss of Sessile Serrated Lesion
A study testing WLI Then NBI Withdrawal and NBI Then WLI Withdrawal in people with Colorectal Sessile Serrated Lesion, run by Changhai Hospital at 1 site in China.
Trial summary
Narrow band imaging(NBI) could improve the detection of colorectal lesions, previous investigations demonstrated its potential in detecting not only colorectal adenoma but non-adenomatous polyps, including sessile serrated lesions. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Colorectal Sessile Serrated Lesion
- What is being tested?
- WLI Then NBI Withdrawal and NBI Then WLI Withdrawal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 840 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2023to 28 May 2024
- 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 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients whose age are between 45-85
- Patients who have indications for screening
- Patients who have signed inform consent form.
Who cannot join
- Patients who have undergone colonic resection
- Patients with alarming signs and symptoms of colorectal cancer: hematochezia, melena, anemia, weight loss, abdominal mass, positive digital rectal examination
- Patients with highly suspected or confirmed colorectal cancers by radiographic and laboratory tests
- Patients with abnormal blood coagulation or taking antiplatelets or anticoagulants within 7 days before colonoscopy
- Patients with inflammatory bowel diseases
- Patients with hereditary colorectal cancer syndrome (including familial adenomatous polyposis).
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- Patients with pregnancy, severe chronic cardiopulmonary and renal disease.
- Patients with therapeutic colonoscopy for existing lesions
- Patients with failed cecal intubation
- Patients with poor bowel preparation quality that necessitated a second bowel preparation
- Patients refusing to participate or to provide informed consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Changhai Hospital, Second Military Medical University
Shanghai, Shanghai Municipality, 200433
Yu Bai, MD, 86-021-81873241, baiyu1998@hotmail.com
Zhaoshen Li, MD
About this study
Official title: Narrow Band Imaging Versus White Light for the Detection and Miss of Sessile Serrated Lesions：a Multicenter，Random，Back-to-back Trial
Narrow band imaging(NBI) could improve the detection of colorectal lesions, previous investigations demonstrated its potential in detecting not only colorectal adenoma but non-adenomatous polyps, including sessile serrated lesions. But no randomized controlled trials with NBI versus white light imaging(WLI) have been conducted to give a definitive conclusion with statistically significant differences. Therefore, we performed a multicenter, prospective, back to back, randomized controlled trial to compare sessile serrated lesions detection and miss rate of withdraw by NBI and WLI in colonoscopy.
- Conditions
- Colorectal Sessile Serrated Lesion
- Being tested
- WLI Then NBI Withdrawal, NBI Then WLI Withdrawal
- Keywords
- Sessile Serrated Lesions Miss Rate, Sessile Serrated Lesions Detection Rate, Narrow Band Imaging, Colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WLI Then NBI WithdrawalProcedure or surgery
Patients in WLI then NBI withdrawal group will first be carefully inspected by white light imaging(WLI), each polyp found should be removed. According to the ESGE guideline of colorectal polypectomy, the lesions which size between 4-9mm should by removed by cold snare. Cold biopsy forceps could be utilized considering the difficulty in resection of flat and diminutive polyps(size ≤ 3mm). Then change to narrow band imaging(NBI) for the second withdraw to detect the lesions which found in second time but not the first.
NBI Then WLI WithdrawalProcedure or surgery
Patients in NBI then WLI withdrawal group will first be carefully inspected by narrow band imaging(NBI), each polyp found should be removed. According to the ESGE guideline of colorectal polypectomy, the lesions which size between 4-9mm should by removed by cold snare. Cold biopsy forceps could be utilized considering the difficulty in resection of flat and diminutive polyps(size ≤ 3mm). Then change to white light imaging(WLI) for the second withdraw to detect the lesions which found in second time but not the first.
| Study group | Role | What they receive |
|---|---|---|
| WLI Then NBI Withdrawal Group | Experimental | After successful intubation of the cecum, carefully inspect the whole colorectal mucosa by white light imaging(WLI) during the first colonoscopy withdraw. Then reinsert to the cecum and withdraw with narrow band imaging(NBI). Stop watch will be utilized to remind endoscopists. Receives: Procedure: WLI Then NBI Withdrawal |
| NBI Then WLI Withdrawal Group | Active comparator | After successful intubation of the cecum, carefully inspect the whole colorectal mucosa by narrow band imaging(NBI) during the first colonoscopy withdraw. Then reinsert to the cecum and withdraw with white light imaging(WLI). Stop watch will be utilized to remind endoscopists. Receives: Procedure: NBI Then WLI Withdrawal |
What is being measured
The primary outcome is the main question the study is designed to answer.
sessile serrated lesions miss rate(SSLMR)
Sessile serrated lesions(SSLs) detected in the second-pass examination were defined as missed SSLs; the sessile serrated lesions miss rate(SSLMR) was defined as follows: number of SSLs detected in the second-pass examination/total number of SSLs detected in both two pass.
Measured: 60 minutes
Secondary outcomes (3)
sessile serrated lesions detection rate(SSLDR)
Sessile serrated lesions detection rate(SSLDR) is the number of patients with at least one sessile serrated lesion detected by narrow band imaging or white light imaging, divided by the total number of patients.
Measured: 60 minutes
adenoma miss rate(AMR)
Adenomas detected in the second-pass examination were defined as missed adenomas; the adenoma miss rate(AMR) was defined as follows: number of adenomas detected in the second-pass examination/total number of adenomas detected in the two pass.
Measured: 60 minutes
adenoma detection rate(ADR)
Adenoma detection rate(ADR) is the number of patients with at least one adenoma detected by narrow band imaging or white light imaging, divided by the total number of patients.
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start1 Feb 2023
- Primary completion28 Mar 2024 (estimated)
- Study completion28 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Colorectal Sessile Serrated LesionStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 840 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Dalian Medical University, The Second Hospital of Hebei Medical University, Yantaishan Hospital, The Second Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine, 900th Hospital of PLA Joint Logistic Support Force, Heilongjiang Provicial Hospital, Ankang Central Hospital, Nongken Jiansanjiang People Hospital of Heilongjiang Province, Huadong Hospital, The Second Affiliated Hospital of Baotou Medical College, Qilu Hospital of Shandong University, Shandong First Medical University, Air Force Military Medical University, China, Tengzhou Central People's Hospital, Chongqing General Hospital, Haikou People's Hospital
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
- Investigators
- Zhaoshen Li, MD, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05684328
- Sponsor's protocol ID
- NVWSDR-202212
- Status last verified
- Mar 2024
- First submitted
- 5 Jan 2023
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhao S, Song Y, Wang S, Wang R, Feng Z, Gong A, Yang X, Pan P, Yao D, Zhang J, Zhu Y, Li T, Bi J, Ren X, Tang X, Li Q, Yu D, Zheng J, Song B, Wang P, Chen W, Shang G, Xu Y, Xu P, Lai Y, Xu H, Yang X, Sheng J, Tao Y, Li X, Zhu Y, Zhang X, Shen H, Ma Y, Wang F, Wu L, Wang X, Li Z, Bai Y. Reduced Adenoma Miss Rate With 9-Minute vs 6-Minute Withdrawal Times for Screening Colonoscopy: A Multicenter Randomized Tandem Trial. Am J Gastroenterol. 2023 May 1;118(5):802-811. doi: 10.14309/ajg.0000000000002055. Epub 2022 Oct 11.
PubMed 36219172Li J, Zhang D, Wei Y, Chen K, Wu R, Peng K, Hou X, Li L, Huang C, Wang Y, Xun L, Xu H, Wang J, Chen Z, Shen M, Liu F. Colorectal Sessile Serrated Lesion Detection Using Linked Color Imaging: A Multicenter, Parallel Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2023 Feb;21(2):328-336.e2. doi: 10.1016/j.cgh.2022.03.033. Epub 2022 Apr 4.
PubMed 35390509Rex DK, Clodfelter R, Rahmani F, Fatima H, James-Stevenson TN, Tang JC, Kim HN, McHenry L, Kahi CJ, Rogers NA, Helper DJ, Sagi SV, Kessler WR, Wo JM, Fischer M, Kwo PY. Narrow-band imaging versus white light for the detection of proximal colon serrated lesions: a randomized, controlled trial. Gastrointest Endosc. 2016 Jan;83(1):166-71. doi: 10.1016/j.gie.2015.03.1915. Epub 2015 May 5.
PubMed 25952085Wei J, Zhang S, Fang Q, Sui X, Tang X, Shi L, Zhao Y, Hu H, Huang Z, Huang X, Zhang H, Wang S, Li X, Wang C, Guo Y, Xu B, Wu W, Su Y, Chen L, Wei R, Li P, Shi L, Tang B, Qiao X, Xu M, Zhang J, Ji R, Ji D, Gong A, Li B, Ren J, Jiang Z, Xu H, Li M, Wang W, Yu J, Feng Z, Zhang J, Yao D, Li Z, Zhao S, Bai Y. Impact of Narrow-Band Imaging on Sessile Serrated Lesion Miss Rate: A Multicenter Randomized Tandem Colonoscopy Trial. Clin Gastroenterol Hepatol. 2026 Jul;24(7):1823-1835. doi: 10.1016/j.cgh.2026.01.027. Epub 2026 Feb 3.
PubMed 41638419
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Narrow Band Imaging Versus White Light for the Detection and Miss of Sessile Serrated Lesions：a Multicenter，Random，Back-to-back Trial
- ClinicalTrials.gov ID
- NCT05684328
- Acronym / sponsor ID
- NVWSDR-202212
- Conditions
- Colorectal Sessile Serrated Lesion
- Keywords
- Sessile Serrated Lesions Miss Rate, Sessile Serrated Lesions Detection Rate, Narrow Band Imaging, Colonoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 840 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Dalian Medical University, The Second Hospital of Hebei Medical University, Yantaishan Hospital, The Second Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine, 900th Hospital of PLA Joint Logistic Support Force, Heilongjiang Provicial Hospital, Ankang Central Hospital, Nongken Jiansanjiang People Hospital of Heilongjiang Province, Huadong Hospital, The Second Affiliated Hospital of Baotou Medical College, Qilu Hospital of Shandong University, Shandong First Medical University, Air Force Military Medical University, China, Tengzhou Central People's Hospital, Chongqing General Hospital, Haikou People's Hospital
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 28 Mar 2024 (estimated)
- Study completion
- 28 May 2024 (estimated)
- First posted
- 13 Jan 2023 (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.
Narrow band imaging(NBI) could improve the detection of colorectal lesions, previous investigations demonstrated its potential in detecting not only colorectal adenoma but non-adenomatous polyps, including sessile serrated lesions. But no randomized controlled trials with NBI versus white light imaging(WLI) have been conducted to give a definitive conclusion with statistically significant differences. Therefore, we performed a multicenter, prospective, back to back, randomized controlled trial to compare sessile serrated lesions detection and miss rate of withdraw by NBI and WLI in colonoscopy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WLI Then NBI Withdrawal Group | Experimental | Procedure: WLI Then NBI WithdrawalAfter successful intubation of the cecum, carefully inspect the whole colorectal mucosa by white light imaging(WLI) during the first colonoscopy withdraw. Then reinsert to the cecum and withdraw with narrow band imaging(NBI). Stop watch will be utilized to remind endoscopists. |
| NBI Then WLI Withdrawal Group | Active comparator | Procedure: NBI Then WLI WithdrawalAfter successful intubation of the cecum, carefully inspect the whole colorectal mucosa by narrow band imaging(NBI) during the first colonoscopy withdraw. Then reinsert to the cecum and withdraw with white light imaging(WLI). Stop watch will be utilized to remind endoscopists. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients whose age are between 45-85
- Patients who have indications for screening
- Patients who have signed inform consent form.
Key exclusion criteria (11 listed)
- Patients who have undergone colonic resection
- Patients with alarming signs and symptoms of colorectal cancer: hematochezia, melena, anemia, weight loss, abdominal mass, positive digital rectal examination
- Patients with highly suspected or confirmed colorectal cancers by radiographic and laboratory tests
- Patients with abnormal blood coagulation or taking antiplatelets or anticoagulants within 7 days before colonoscopy
- Patients with inflammatory bowel diseases
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 |
|---|---|---|
| WLI Then NBI WithdrawalPatients in WLI then NBI withdrawal group will first be carefully inspected by white light imaging(WLI), each polyp found should be removed. According to the ESGE guideline of colorectal polypectomy, the lesions which size between 4-9mm should by removed by cold snare. Cold biopsy forceps could be utilized considering the difficulty in resection of flat and diminutive polyps(size ≤ 3mm). Then change to narrow band imaging(NBI) for the second withdraw to detect the lesions which found in second time but not the first. | Procedure or surgery | WLI Then NBI Withdrawal Group |
| NBI Then WLI WithdrawalPatients in NBI then WLI withdrawal group will first be carefully inspected by narrow band imaging(NBI), each polyp found should be removed. According to the ESGE guideline of colorectal polypectomy, the lesions which size between 4-9mm should by removed by cold snare. Cold biopsy forceps could be utilized considering the difficulty in resection of flat and diminutive polyps(size ≤ 3mm). Then change to white light imaging(WLI) for the second withdraw to detect the lesions which found in second time but not the first. | Procedure or surgery | NBI Then WLI Withdrawal Group |
Primary outcome
sessile serrated lesions miss rate(SSLMR)
Time frame: 60 minutes
Sessile serrated lesions(SSLs) detected in the second-pass examination were defined as missed SSLs; the sessile serrated lesions miss rate(SSLMR) was defined as follows: number of SSLs detected in the second-pass examination/total number of SSLs detected in both two pass.
3 secondary outcomes
sessile serrated lesions detection rate(SSLDR)
Time frame: 60 minutes
adenoma miss rate(AMR)
Time frame: 60 minutes
adenoma detection rate(ADR)
Time frame: 60 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Background: PubMed 36219172Zhao S, Song Y, Wang S, Wang R, Feng Z, Gong A, Yang X, Pan P, Yao D, Zhang J, Zhu Y, Li T, Bi J, Ren X, Tang X, Li Q, Yu D, Zheng J, Song B, Wang P, Chen W, Shang G, Xu Y, Xu P, Lai Y, Xu H, Yang X, Sheng J, Tao Y, Li X, Zhu Y, Zhang X, Shen H, Ma Y, Wang F, Wu L, Wang X, Li Z, Bai Y. Reduced Adenoma Miss Rate With 9-Minute vs 6-Minute Withdrawal Times for Screening Colonoscopy: A Multicenter Randomized Tandem Trial. Am J Gastroenterol. 2023 May 1;118(5):802-811. doi: 10.14309/ajg.0000000000002055. Epub 2022 Oct 11.
- Background: PubMed 35390509Li J, Zhang D, Wei Y, Chen K, Wu R, Peng K, Hou X, Li L, Huang C, Wang Y, Xun L, Xu H, Wang J, Chen Z, Shen M, Liu F. Colorectal Sessile Serrated Lesion Detection Using Linked Color Imaging: A Multicenter, Parallel Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2023 Feb;21(2):328-336.e2. doi: 10.1016/j.cgh.2022.03.033. Epub 2022 Apr 4.
- Background: PubMed 25952085Rex DK, Clodfelter R, Rahmani F, Fatima H, James-Stevenson TN, Tang JC, Kim HN, McHenry L, Kahi CJ, Rogers NA, Helper DJ, Sagi SV, Kessler WR, Wo JM, Fischer M, Kwo PY. Narrow-band imaging versus white light for the detection of proximal colon serrated lesions: a randomized, controlled trial. Gastrointest Endosc. 2016 Jan;83(1):166-71. doi: 10.1016/j.gie.2015.03.1915. Epub 2015 May 5.
- Derived from this study: PubMed 41638419Wei J, Zhang S, Fang Q, Sui X, Tang X, Shi L, Zhao Y, Hu H, Huang Z, Huang X, Zhang H, Wang S, Li X, Wang C, Guo Y, Xu B, Wu W, Su Y, Chen L, Wei R, Li P, Shi L, Tang B, Qiao X, Xu M, Zhang J, Ji R, Ji D, Gong A, Li B, Ren J, Jiang Z, Xu H, Li M, Wang W, Yu J, Feng Z, Zhang J, Yao D, Li Z, Zhao S, Bai Y. Impact of Narrow-Band Imaging on Sessile Serrated Lesion Miss Rate: A Multicenter Randomized Tandem Colonoscopy Trial. Clin Gastroenterol Hepatol. 2026 Jul;24(7):1823-1835. doi: 10.1016/j.cgh.2026.01.027. Epub 2026 Feb 3.
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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.
Zhaoshen Li, MD principal investigator
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WLI Then NBI Withdrawal and NBI Then WLI Withdrawal in people with Colorectal Sessile Serrated Lesion, run by Changhai Hospital 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 3 inclusion and 11 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 15 Mar 2024. 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 Zhaoshen Li, MD (86-021-31161365, li.zhaoshen@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sessile serrated lesions miss rate(SSLMR) (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05684328, which also lists 4 linked publications.
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 15 Mar 2024.