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

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ClinicalTrials.gov Identifier: NCT03781648
Recruitment Status : Recruiting
First Posted : December 20, 2018
Last Update Posted : December 20, 2018
Sponsor:
Information provided by (Responsible Party):
Yuqi He, General Hospital of Beijing PLA Military Region

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 and MAP, 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


Condition or disease Intervention/treatment Phase
Adenoma and Polyp Detection Rates Diagnostic Test: NBI withdrawal method Not Applicable

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 performed all procedures (each with over 1000 colonoscopies performed). 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.

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. In all arms, withdrawal lasted at least 6 minutes and was done using air insufflation to obtain adequate distension. A stopwatch was used to time the procedures.

Colon cleanliness was assessed using the Boston Bowel Preparation Scale (BBPS) [19]. Cardiopulmonary function was monitored throughout. The amount of water infused and suctioned during insertion and withdrawal, and adverse outcomes were recorded. Study end points The primary outcome was overall ADR. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Diagnostic
Official Title: PLA Army General Hospital of Beijing
Actual Study Start Date : October 20, 2018
Estimated Primary Completion Date : October 20, 2019
Estimated Study Completion Date : October 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

Arm Intervention/treatment
WL withdrawal method
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.
Diagnostic Test: NBI withdrawal method
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
Other Name: Water exchange

Experimental: NBI withdrawal method
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.
Diagnostic Test: NBI withdrawal method
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
Other Name: Water exchange




Primary Outcome Measures :
  1. Adenoma and polyp Detection Rate [ Time Frame: 12 months ]
    Proportion of subjects with at least one adenoma or polyp of any size


Secondary Outcome Measures :
  1. Right and left colon Adenoma Detection Rate [ Time Frame: 12 months ]
    Proportion of subjects with at least one adenoma of any size in the proximal colon

  2. Right and left colon <10 mm Adenoma Detection Rate [ Time Frame: 12 months ]
    Proportion of subjects with at least one adenoma <10 mm in the proximal colon

  3. Mean adenomas resected per procedure [ Time Frame: 12 months ]
    Total number of adenomas resected per subject

  4. Total withdrawal time [ Time Frame: 1 hour ]
    Total procedure time (including time required for polyp resection or biopsy)

  5. Amount of water used during the procedure [ Time Frame: 1 hour ]
    Amount of water used during insertion and withdrawal



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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) polyposis of the alimentary tract; (3) antiplatelet or anticoagulant therapy 5 days before the procedure; (4) pregnancy; (5) haemodialysis; (6) an American Society of Anaesthesiologists class III or higher; (7)depressed lesions and (8) lesions highly suspected to be cancerous based on endoscopic appearance

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03781648


Contacts
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Contact: yuqi he, doctor +801066721299 endohe@163.com

Locations
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China, Dongcheng District
Department of Gastroenterology, PLA Army General Hospital Recruiting
Beijing, Dongcheng District, China, 100700
Contact: yuqi he         
Sponsors and Collaborators
Yuqi He
Investigators
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Principal Investigator: tianyang zhang Medical department

Publications:
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Responsible Party: Yuqi He, Principal Investigator, Clinical Professor, General Hospital of Beijing PLA Military Region
ClinicalTrials.gov Identifier: NCT03781648    
Other Study ID Numbers: PLA GH-water exchange-ADR
First Posted: December 20, 2018    Key Record Dates
Last Update Posted: December 20, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: After the research has been finished

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms