Narrow Band Imaging Versus White Light for the Detection and Miss of Sessile Serrated Lesion

NCT ID: NCT05684328

Last Updated: 2024-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

840 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2024-05-28

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Sessile Serrated Lesion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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WLI Then NBI Withdrawal Group

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.

Group Type EXPERIMENTAL

WLI Then NBI Withdrawal

Intervention Type PROCEDURE

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 Withdrawal Group

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.

Group Type ACTIVE_COMPARATOR

NBI Then WLI Withdrawal

Intervention Type PROCEDURE

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.

Interventions

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WLI Then NBI Withdrawal

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.

Intervention Type PROCEDURE

NBI Then WLI Withdrawal

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

45 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital of Dalian Medical University

OTHER

Sponsor Role collaborator

The Second Hospital of Hebei Medical University

OTHER

Sponsor Role collaborator

Yantaishan Hospital

UNKNOWN

Sponsor Role collaborator

The Second Affiliated Hospital of Guangzhou University of Chinese Medicine

UNKNOWN

Sponsor Role collaborator

900 Hospital of Joint Logistics Support Force of PLA

OTHER

Sponsor Role collaborator

Heilongjiang provincial hospital

UNKNOWN

Sponsor Role collaborator

Ankang Central Hospital

OTHER

Sponsor Role collaborator

Nongken Jiansanjiang People Hospital of Heilongjiang Province

UNKNOWN

Sponsor Role collaborator

Huadong Hospital

OTHER

Sponsor Role collaborator

The Second Affiliated Hospital of Baotou Medical College

OTHER

Sponsor Role collaborator

Qilu Hospital, Shandong University

UNKNOWN

Sponsor Role collaborator

Shandong First Medical University

OTHER

Sponsor Role collaborator

Air Force Military Medical University, China

OTHER

Sponsor Role collaborator

Tengzhou Central People's Hospital

OTHER_GOV

Sponsor Role collaborator

Chongqing General Hospital

OTHER

Sponsor Role collaborator

Haikou People's Hospital

OTHER

Sponsor Role collaborator

Changhai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhaoshen Li

MD,Director, Head of Department of Gastroenterology and Digestive Endoscopy Center, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhaoshen Li, MD

Role: PRINCIPAL_INVESTIGATOR

Changhai Hospital

Locations

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Changhai Hospital, Second Military Medical University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhaoshen Li, MD

Role: CONTACT

86-021-31161365

Yu Bai, MD

Role: CONTACT

86-021-31161335

Facility Contacts

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Yu Bai, MD

Role: primary

86-021-81873241

References

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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.

Reference Type BACKGROUND
PMID: 36219172 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35390509 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25952085 (View on PubMed)

Other Identifiers

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NVWSDR-202212

Identifier Type: -

Identifier Source: org_study_id

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