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Water Exchange With Narrow Band Imaging on Adenoma Detection (NBI; ADR; WE)

Primary Purpose

Adenoma and Polyp Detection Rates

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
NBI withdrawal method
Sponsored by
Yuqi He
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Adenoma and Polyp Detection Rates

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • • Any patient ≥40 and <85 who underwent colonoscopy, does not meet exclusion criteria mentioned below and provide written informed consent will be eligible for enrolment

Exclusion Criteria:

  • • (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

Sites / Locations

  • Department of Gastroenterology, PLA Army General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

WL withdrawal method

NBI withdrawal method

Arm Description

Active 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.

Experimental: 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.

Outcomes

Primary Outcome Measures

Adenoma and polyp Detection Rate between the 290-NBI and the HD-WL group
Overall ADR detection rate

Secondary Outcome Measures

Right and left colon Adenoma Detection Rate
ADR detection rate at different location
Right and left colon <10 mm Adenoma Detection Rate
small polyp detection rate
Mean adenomas resected per procedure
Total number of adenomas resected per subject
Total withdrawal time
Total procedure time (including time required for polyp resection or biopsy)
Amount of water used during the procedure
Amount of water used during insertion and withdrawal
adenoma and polyp miss rate between the two groups
lesion miss rate

Full Information

First Posted
December 18, 2018
Last Updated
January 1, 2022
Sponsor
Yuqi He
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1. Study Identification

Unique Protocol Identification Number
NCT03781648
Brief Title
Water Exchange With Narrow Band Imaging on Adenoma Detection
Acronym
NBI; ADR; WE
Official Title
PLA Army General Hospital of Beijing
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 20, 2018 (Actual)
Primary Completion Date
October 20, 2022 (Anticipated)
Study Completion Date
October 20, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yuqi He

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
Detailed Description
Design: Prospective single-blinded randomized controlled trial. Patients were randomly assigned to control group or study group through a computer-based randomization list by a technician. See also inclusion and exclusion criteria. Colonoscopy was performed using high-definition colonoscope (GIF-HQ290I) after bowel preparation. Experienced endoscopists (each with over 3000 colonoscopies performed) and fellows (performed more than 600 colonoscopies) performed all procedures. 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. Suction of water can maximize cleanliness and minimize distension. Air pockets at any location of the lumen were always aspirated. In a collapsed colon, water turbulence formation at the tip of the scope facilitates residual feces removal, salvage cleansing also be provided during insertion. Simethicone was used to remove bubbles over the mucosa. Cecal intubation was defined as the passage of the scope tip beyond the ileocecal valve with visualization of the cecal appendix. After cecal intubation, as much residual water as possible was aspirated before beginning the withdrawal phase. The same endoscopist uses the same assigned method to perform tandem or back-to-back colonoscopy on all patients. After the first colonoscopic examination with the colonoscope removed from the anus, using the same entry method for insertion and the same assigned method for the second colon examination. In all arms, withdrawal lasted at least 9 minutes and was done using air insufflation to obtain adequate distension. A stopwatch was used to time the procedures, and time for polypectomy was not included. Colon cleanliness was assessed using the Boston Bowel Preparation Scale (BBPS) and bubble scores. Cardiopulmonary function was monitored throughout, and adverse outcomes were recorded. Study end points The primary outcome was to compare the ADR of the 290-NBI with the HD-WL. Secondary outcomes included Right and left colon Adenoma Detection Rate. Right and left colon <10 mm Adenoma Detection Rate. Mean adenomas resected per procedure. Cecal intubation rate. Cecal intubation time. Total withdrawal time. Amount of water used during the procedure. Adenoma and polyp miss rate between the two group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenoma and Polyp Detection Rates

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
640 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
WL withdrawal method
Arm Type
Other
Arm Description
Active 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.
Arm Title
NBI withdrawal method
Arm Type
Experimental
Arm Description
Experimental: 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.
Intervention Type
Diagnostic Test
Intervention Name(s)
NBI withdrawal method
Other Intervention Name(s)
Water exchange
Intervention Description
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
Primary Outcome Measure Information:
Title
Adenoma and polyp Detection Rate between the 290-NBI and the HD-WL group
Description
Overall ADR detection rate
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Right and left colon Adenoma Detection Rate
Description
ADR detection rate at different location
Time Frame
6 months
Title
Right and left colon <10 mm Adenoma Detection Rate
Description
small polyp detection rate
Time Frame
12 months
Title
Mean adenomas resected per procedure
Description
Total number of adenomas resected per subject
Time Frame
6 months
Title
Total withdrawal time
Description
Total procedure time (including time required for polyp resection or biopsy)
Time Frame
6 months
Title
Amount of water used during the procedure
Description
Amount of water used during insertion and withdrawal
Time Frame
6 months
Title
adenoma and polyp miss rate between the two groups
Description
lesion miss rate
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: • Any patient ≥40 and <85 who underwent colonoscopy, does not meet exclusion criteria mentioned below and provide written informed consent will be eligible for enrolment Exclusion Criteria: • (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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
yuqi he, doctor
Phone
+801066721299
Email
endohe@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
tianyang zhang
Organizational Affiliation
Medical department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Gastroenterology, PLA Army General Hospital
City
Beijing
State/Province
Dongcheng District
ZIP/Postal Code
100700
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yuqi he

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
After the research has been finished
Citations:
PubMed Identifier
28282689
Citation
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.
Results Reference
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Water Exchange With Narrow Band Imaging on Adenoma Detection

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