Brief 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. 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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

840

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Feb 2023

Geographic Reach

1 country

1 active site

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.3 years study duration

First Submitted

Initial submission to the registry

January 5, 2023

Completed

8 days until next milestone

First Posted

Study publicly available on registry

January 13, 2023

Completed

19 days until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed

1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2024

Completed

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2024

Completed

Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

1.2 years

First QC Date

January 5, 2023

Last Update Submit

March 14, 2024

Conditions

Colorectal Sessile Serrated Lesion

Keywords

Sessile Serrated Lesions Miss RateSessile Serrated Lesions Detection RateNarrow Band ImagingColonoscopy

Outcome Measures

Primary Outcomes (1)

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.
60 minutes

Secondary Outcomes (3)

sessile serrated lesions detection rate(SSLDR)
60 minutes
adenoma miss rate(AMR)
60 minutes
adenoma detection rate(ADR)
60 minutes

Study Arms (2)

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.

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.

Procedure: NBI Then WLI Withdrawal

Interventions

WLI Then NBI WithdrawalPROCEDURE

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.

WLI Then NBI Withdrawal Group

NBI Then WLI WithdrawalPROCEDURE

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.

NBI Then WLI Withdrawal Group

Eligibility Criteria

Age45 Years - 85 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients whose age are between 45-85
Patients who have indications for screening
Patients who have signed inform consent form.

You may not qualify if:

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).
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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Changhai Hospitallead
The First Affiliated Hospital of Dalian Medical Universitycollaborator
The Second Hospital of Hebei Medical Universitycollaborator
Yantaishan Hospitalcollaborator
The Second Affiliated Hospital of Guangzhou University of Chinese Medicinecollaborator
900 Hospital of Joint Logistics Support Force of PLAcollaborator
Heilongjiang provincial hospitalcollaborator
Ankang Central Hospitalcollaborator
Nongken Jiansanjiang People Hospital of Heilongjiang Provincecollaborator
Huadong Hospitalcollaborator
The Second Affiliated Hospital of Baotou Medical Collegecollaborator
Qilu Hospital of Shandong Universitycollaborator
Shandong First Medical Universitycollaborator
Air Force Military Medical University, Chinacollaborator
Tengzhou Central People's Hospitalcollaborator
Chongqing General Hospitalcollaborator
Haikou People's Hospitalcollaborator

Study Sites (1)

Changhai Hospital, Second Military Medical University

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Related Publications (4)

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.
PMID: 36219172BACKGROUND
Li 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.
PMID: 35390509BACKGROUND
Rex 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.
PMID: 25952085BACKGROUND
Wei 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 Feb 2:S1542-3565(26)00055-8. doi: 10.1016/j.cgh.2026.01.027. Online ahead of print.
PMID: 41638419DERIVED

Study Officials

Zhaoshen Li, MD
Changhai Hospital
PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhaoshen Li, MD

CONTACT

86-021-31161365 li.zhaoshen@hotmail.com

Yu Bai, MD

CONTACT

86-021-31161335 baiyu1998@hotmail.com

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: PARTICIPANT
Purpose: DIAGNOSTIC
Intervention Model: CROSSOVER
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: MD,Director, Head of Department of Gastroenterology and Digestive Endoscopy Center, Principal Investigator

Study Record Dates

First Submitted

January 5, 2023

First Posted

January 13, 2023

Study Start

February 1, 2023

Primary Completion

March 28, 2024

Study Completion

May 28, 2024

Last Updated

March 15, 2024

Record last verified: 2024-03

Locations

CN(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

WLI Then NBI Withdrawal Group

NBI Then WLI Withdrawal Group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (4)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Locations