Adenoma and Polyp Detection RatesNBI;ADR;WENCT03781648
Water Exchange With Narrow Band Imaging on Adenoma Detection
A study testing NBI withdrawal method in people with Adenoma and Polyp Detection Rates, run by Yuqi He at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Adenoma and Polyp Detection Rates
- What is being tested?
- NBI withdrawal method
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2018to 20 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • 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
Who cannot join
- • (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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Gastroenterology, PLA Army General Hospital
Beijing, Dongcheng District, 100700
yuqi he
About this study
Official title: PLA Army General Hospital of Beijing
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
Read the 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.
- Conditions
- Adenoma and Polyp Detection Rates
- Being tested
- NBI withdrawal method
- Medical subject headings
- Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NBI withdrawal methodDiagnostic test
Also called Water exchange
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
| Study group | Role | What they receive |
|---|---|---|
| WL withdrawal method | Other | 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. Receives: Diagnostic Test: NBI withdrawal method |
| NBI withdrawal method | Experimental | 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. Receives: Diagnostic Test: NBI withdrawal method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma and polyp Detection Rate between the 290-NBI and the HD-WL group
Overall ADR detection rate
Measured: 6 months
Secondary outcomes (6)
Right and left colon Adenoma Detection Rate
ADR detection rate at different location
Measured: 6 months
Right and left colon <10 mm Adenoma Detection Rate
small polyp detection rate
Measured: 12 months
Mean adenomas resected per procedure
Total number of adenomas resected per subject
Measured: 6 months
Total withdrawal time
Total procedure time (including time required for polyp resection or biopsy)
Measured: 6 months
Amount of water used during the procedure
Amount of water used during insertion and withdrawal
Measured: 6 months
adenoma and polyp miss rate between the two groups
lesion miss rate
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study start20 Oct 2018
- Primary completion20 Oct 2024 (estimated)
- Study completion20 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adenoma and Polyp Detection RatesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yuqi He
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yuqi He, General Hospital of Beijing PLA Military Region
- Investigators
- tianyang zhang, Principal investigator, Medical department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03781648
- Sponsor's protocol ID
- PLA GH-water exchange-ADR
- Acronym
- NBI;ADR;WE
- Status last verified
- Feb 2024
- First submitted
- 18 Dec 2018
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: After the research has been finished
Publications
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.
PubMed 28282689
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PLA Army General Hospital of Beijing
- ClinicalTrials.gov ID
- NCT03781648
- Acronym / sponsor ID
- NBI;ADR;WE / PLA GH-water exchange-ADR
- Conditions
- Adenoma and Polyp Detection Rates
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Yuqi HeUniversity, hospital or other
- Study start
- 20 Oct 2018 (actual)
- Primary completion
- 20 Oct 2024 (estimated)
- Study completion
- 20 Oct 2024 (estimated)
- First posted
- 20 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WL withdrawal method | Other | Diagnostic Test: NBI withdrawal methodActive 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 | Experimental | Diagnostic Test: NBI withdrawal methodExperimental: 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- • 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
Key exclusion criteria (1 listed)
- • (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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NBI withdrawal methodAlso: Water exchangeThe newly available second generation of NBI using the 290 system (290-NBI) provides an at least twofold brighter image compared with the previous version | Diagnostic test | NBI withdrawal method, WL withdrawal method |
Primary outcome
Adenoma and polyp Detection Rate between the 290-NBI and the HD-WL group
Time frame: 6 months
Overall ADR detection rate
6 secondary outcomes
Right and left colon Adenoma Detection Rate
Time frame: 6 months
Right and left colon <10 mm Adenoma Detection Rate
Time frame: 12 months
Mean adenomas resected per procedure
Time frame: 6 months
Total withdrawal time
Time frame: 6 months
Amount of water used during the procedure
Time frame: 6 months
adenoma and polyp miss rate between the two groups
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Background: PubMed 28282689Cadoni 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.
- Individual participant dataSharing planned: Undecided. After the research has been finished
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
tianyang zhang principal investigator
Medical department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NBI withdrawal method in people with Adenoma and Polyp Detection Rates, run by Yuqi He at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yuqi he, doctor (+801066721299, endohe@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adenoma and polyp Detection Rate between the 290-NBI and the HD-WL group (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03781648, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.