Water Exchange With Narrow Band Imaging on Adenoma Detection
NBI;ADR;WE
PLA Army General Hospital of Beijing
1 other identifier
interventional
360
1 country
1
Brief Summary
Colorectal cancer remains the third most common cause of death from cancer worldwide. The adenoma detection rate is correlated with quality of colonoscopy and risk of postcolonoscopy CRC. Low quality of bowel preparation with fecal residue and brown liquid in the colon may lower the adenoma detection rate (ADR). Optimal bowel preparation and novel approaches for colonoscopy increases the effectiveness of colonoscopic examination to improve ADR are desirable. Water exchange, which significantly increased colon cleanliness both in the right colon and the entire colon, is characterized by insertion to the cecum in clear water in lieu of gas insufflations. Water exchange led to an increase in ADR, particularly for the improvement in the right colon, providing adequate bowel preparation. NBI is an innovative imaging technology which efficiency for the early detection of superficial cancers in the head and neck region and the esophagus had been reported previously. In the colorectal region, different results have been reported for improvement in the adenoma detection rate of NBI compared with that of WLI. All procedures were performed up to the cecum by using a high-definition colonoscope (GIF-HQ290I; Olympus Optical ) However, whether NBI in high-definition colonoscope can increase the ADR after water exchange insertion, remains to be elucidated. The aim of this study was therefore to determine whether the use of NBI system as an adjunct to water exchange insertion would improve the ADR
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2018
Longer than P75 for not_applicable
1 active site
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
Study Start
First participant enrolled
October 20, 2018
CompletedFirst Submitted
Initial submission to the registry
December 18, 2018
CompletedFirst Posted
Study publicly available on registry
December 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 20, 2024
CompletedFebruary 28, 2024
February 1, 2024
6 years
December 18, 2018
February 25, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Adenoma and polyp Detection Rate between the 290-NBI and the HD-WL group
Overall ADR detection rate
6 months
Secondary Outcomes (6)
Right and left colon Adenoma Detection Rate
6 months
Right and left colon <10 mm Adenoma Detection Rate
12 months
Mean adenomas resected per procedure
6 months
Total withdrawal time
6 months
Amount of water used during the procedure
6 months
- +1 more secondary outcomes
Study Arms (2)
WL withdrawal method
OTHERActive Comparator: WL was used on withdrawal. During the insertion phase, air pump was turned off to avoid inadvertent insufflations. Water exchange with infusion pump was used to open the lumen and simultaneous suction of infused water to allow passage of the scope in clear water. Withdrawal phase done using air insufflation.
NBI withdrawal method
EXPERIMENTALExperimental: NBI was used on withdrawal. During the insertion phase, air pump was turned off to avoid inadvertent insufflations. Water exchange with infusion pump was used to open the lumen and simultaneous suction of infused water to allow passage of the scope in clear water. Withdrawal phase done using air insufflation.
Interventions
The newly available second generation of NBI using the 290 system (290-NBI) provides an at least twofold brighter image compared with the previous version
Eligibility Criteria
You may not qualify if:
- (1) history of inflammatory bowel disease;(2) familial adenomatous polyposis; (3) hereditary non-polyposis colorectal cancer syndrome; (4) personal history of colorectal cancer or had previous colonic resection; (5) haemodialysis; (6) an American Society of Anaesthesiologists class III or higher; (7) antiplatelet or anticoagulant therapy 5 days before the procedure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yuqi Helead
Study Sites (1)
Department of Gastroenterology, PLA Army General Hospital
Beijing, Dongcheng District, 100700, China
Related Publications (1)
Cadoni S, Falt P, Rondonotti E, Radaelli F, Fojtik P, Gallittu P, Liggi M, Amato A, Paggi S, Smajstrla V, Urban O, Erriu M, Koo M, Leung FW. Water exchange for screening colonoscopy increases adenoma detection rate: a multicenter, double-blinded, randomized controlled trial. Endoscopy. 2017 May;49(5):456-467. doi: 10.1055/s-0043-101229. Epub 2017 Mar 10.
PMID: 28282689BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
tianyang zhang
Medical department
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator, Clinical Professor
Study Record Dates
First Submitted
December 18, 2018
First Posted
December 20, 2018
Study Start
October 20, 2018
Primary Completion
October 20, 2024
Study Completion
October 20, 2024
Last Updated
February 28, 2024
Record last verified: 2024-02