Trial Outcomes & Findings for Contribution of Narrow Band Imaging (NBI) for the Characterization of Scalloped Polyps (NBI POLYPES COLIQUES) (NCT NCT03448653)

NCT ID: NCT03448653

Last Updated: 2024-11-29

Results Overview

Number of polyps characterized as scalloped (NICE II-) by NBI relative to the number of polyps characterized as scalloped in standard histology

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 314 participants
• Primary outcome timeframe: An average of 1 month
• Results posted on: 2024-11-29

Participant Flow

Participant milestones

Measure	Colonoscopy With NBI Colonoscopy with NBI: Colonoscopy with NBI
Overall Study STARTED	314
Overall Study COMPLETED	314
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Contribution of Narrow Band Imaging (NBI) for the Characterization of Scalloped Polyps (NBI POLYPES COLIQUES)

Baseline characteristics by cohort

Measure	Colonoscopy With NBI n=312 Participants Colonoscopy with NBI: Colonoscopy with NBI
Age, Continuous	67 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	117 Participants n=5 Participants
Sex: Female, Male Male	195 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	NA Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	NA Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	312 Participants n=5 Participants
Region of Enrollment France	312 participants n=5 Participants

PRIMARY outcome

Timeframe: An average of 1 month

Population: All polyps with histological analysis available in eligible patients

Number of polyps characterized as scalloped (NICE II-) by NBI relative to the number of polyps characterized as scalloped in standard histology

Outcome measures

Measure	Colonoscopy With NBI n=522 polyps Colonoscopy with NBI: Colonoscopy with NBI
Sensitivity of the NBI Compared to the Anatomopathological Analysis (= Reference Method)	0.844 proportion of positive cases Interval 0.803 to 0.879

Adverse Events

Colonoscopy With NBI

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Vincent MACE

Centre Hospitalier Départemental Vendée

Phone: 0251446572

Email: vincent.mace@ght85.fr

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place