Adenoma ColonNCT04464135
Effect of Water Exchange Plus Acetic Acid Staining on the Detection of Flat Polyps During Colonoscopy
A study testing acetic acid staining and Water exchange colonoscopy in people with Adenoma Colon, run by Air Force Military Medical University, China at 4 sites in China.
Trial summary
Our previous study (Am. J. Gastroenterol. 2017 04;112(4)) showed that water exchange (WE) colonoscopy was able to increase the detection of flat adenomas as well as overall ADR. We hypothesized that WE based whole-colon acetic acid（AA） staining might be useful to improve the detection of flat lesions compared with WE… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Adenoma Colon
- What is being tested?
- acetic acid staining and Water exchange colonoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 4 sitesChina
- Study dates
- 15 Jul 2020to 1 May 2021
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 40-70
- Undergoing colonoscopy after standard bowel preparation
Who cannot join
- Known familial polyposis
- Small amount of feces or semi-solid stool in last rectal effluent
- Inflammatory Bowel Disease
- Lactated or pregnant women
- Unable to provide informed content
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Recruiting
Department of Gastroenterology, Huaihe Hospital of Henan University
Kaifeng, Henan, 475000
Jianghai Zhao, MD, +8615191903630, 493109907@qq.com
- Recruiting
Department of Gastroenterology, Second Affiliated Hospital, Lanzhou University
Lanzhou, Gansu, 730030
Xiaojun Huang, MD, +8609318942279, haungxj62@163.com
- Recruiting
Department of Holistic Integrative Medicine, Shenzhen Hospital of Southern Medical University
Shenzhen, Guangdong, 510000
Xiaoying Zhang, MD, +8613116950266, 13116950266@163.com
- Recruiting
Department of Gastroenterology, Shaanxi Second People's Hospital
Xi'an, Shaanxi, 710005
Limei Wang, MD, +8615291680602, 15291680602@163.com
About this study
Official title: Effect of Water Exchange Plus Acetic Acid Staining on the Detection of Flat Polyps During Screening and Surveillance Colonoscopy: a Multi-centered, Randomized Controlled Study.
Our previous study (Am. J. Gastroenterol. 2017 04;112(4)) showed that water exchange (WE) colonoscopy was able to increase the detection of flat adenomas as well as overall ADR. We hypothesized that WE based whole-colon acetic acid（AA） staining might be useful to improve the detection of flat lesions compared with WE alone.
Read the detailed description
Water exchange colonoscopy was performed as described previously (Am. J. Gastroenterol. 2017 04;112(4)). Patients were randomly allocated to WE group or WE+AA group. In WE+AA group, water containing 1% of AA was used during insertion of colonoscopy instead of water alone. A bottle of 20ml pure AA was placed abutting the water pump, which make it possible to keep patients blinded to group allocation. Endoscopist using a high-definition wide-angle Olympus or Fujinum colonoscope performed all of the colonoscopies, with a withdrawal time of at least 6 min. The observation was initially performed without the assistance of cap or the use of magnification or electronic staining (NBI, BLI, LCI or AFI et al.). Scopolamine butylbromide or glucogon was not routinely administrated.
- Conditions
- Adenoma Colon
- Being tested
- acetic acid staining, Water exchange colonoscopy
- Keywords
- Water exchange colonoscopy, Flat Polyps, Acetic Acid Staining
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acetic acid stainingOther
The water exchange colonoscopy is used during insertion procedure, in which the water contains 1% acetic acid, and the liquid is absorbed during the withdrawal process for observation.
Water exchange colonoscopyOther
The water exchange colonoscopy is used during insertion procedure, and the liquid is absorbed during the withdrawal process for observation.
| Study group | Role | What they receive |
|---|---|---|
| WE+AA group | Experimental | Water containing 1% of AA was used during insertion of colonoscopy using water exchange method. Receives: Other: acetic acid staining |
| WE group | Active comparator | Water exchange colonoscopy was used for standard screening or surveillance colonoscopy. Receives: Other: Water exchange colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of flat polyps per patient
average numbers of flat polyps, defined by Paris classification IIa/IIb/IIc, for each patient
Measured: 9 months
Secondary outcomes (5)
Overall ADR
Adenoma detection rate, defined as the proportion of subjects with at least one adenoma of any size, in each group.
Measured: 9 months
Advanced ADR
Advanced adenoma detection rate. Advanced adenoma: any with 3 or more adenomas of any size, 1 or more large adenomas 1 cm, or 1 or more adenomas with villous architecture or highgrade dysplasia.
Measured: 9 months
SSA/P detection rate
SSA/P detection rate, defined as the proportion of subjects with at least one sessile serrated adenoma/polyp (SSA/P) of any size, in each group.
Measured: 9 months
Flat neoplasms located in proximal colon
Low-grade adenoma, adenoma with villous components, high-grade adenoma, noninvasive carcinoma, and invasive carcinoma in proximal colon
Measured: 9 months
Adverse events
the rate of bleeding and perforation during colonoscopy procedure and abdominal pain, diarrhea, hematochezia and change of defecation habit Within one week.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start15 Jul 2020 (estimated)
- Primary completion15 Apr 2021 (estimated)
- Study completion1 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Adenoma ColonStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanglin Pan, Air Force Military Medical University, China
- Investigators
- Yanglin Pan, MD, Principal investigator, Xijing Hospital of Digestive Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04464135
- Sponsor's protocol ID
- KY20200706-3
- Status last verified
- Jul 2020
- First submitted
- 7 Jul 2020
- Last updated
- 9 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shibagaki K, Amano Y, Ishimura N, Yuki T, Taniguchi H, Fujita H, Kobayashi K, Kinoshita Y. Magnification endoscopy with acetic acid enhancement and a narrow-band imaging system for pit pattern diagnosis of colorectal neoplasms. J Clin Gastroenterol. 2015 Apr;49(4):306-12. doi: 10.1097/MCG.0000000000000148.
PubMed 24804989Jia H, Pan Y, Guo X, Zhao L, Wang X, Zhang L, Dong T, Luo H, Ge Z, Liu J, Hao J, Yao P, Zhang Y, Ren H, Zhou W, Guo Y, Zhang W, Chen X, Sun D, Yang X, Kang X, Liu N, Liu Z, Leung F, Wu K, Fan D. Water Exchange Method Significantly Improves Adenoma Detection Rate: A Multicenter, Randomized Controlled Trial. Am J Gastroenterol. 2017 Apr;112(4):568-576. doi: 10.1038/ajg.2016.501. Epub 2016 Dec 6.
PubMed 27922025Zhao S, Wang S, Pan P, Xia T, Chang X, Yang X, Guo L, Meng Q, Yang F, Qian W, Xu Z, Wang Y, Wang Z, Gu L, Wang R, Jia F, Yao J, Li Z, Bai Y. Magnitude, Risk Factors, and Factors Associated With Adenoma Miss Rate of Tandem Colonoscopy: A Systematic Review and Meta-analysis. Gastroenterology. 2019 May;156(6):1661-1674.e11. doi: 10.1053/j.gastro.2019.01.260. Epub 2019 Feb 6.
PubMed 30738046Desai M, Sanchez-Yague A, Choudhary A, Pervez A, Gupta N, Vennalaganti P, Vennelaganti S, Fugazza A, Repici A, Hassan C, Sharma P. Impact of cap-assisted colonoscopy on detection of proximal colon adenomas: systematic review and meta-analysis. Gastrointest Endosc. 2017 Aug;86(2):274-281.e3. doi: 10.1016/j.gie.2017.03.1524. Epub 2017 Mar 29.
PubMed 28365356
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Water Exchange Plus Acetic Acid Staining on the Detection of Flat Polyps During Screening and Surveillance Colonoscopy: a Multi-centered, Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT04464135
- Acronym / sponsor ID
- KY20200706-3
- Conditions
- Adenoma Colon
- Keywords
- Water exchange colonoscopy, Flat Polyps, Acetic Acid Staining
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- 15 Jul 2020 (estimated)
- Primary completion
- 15 Apr 2021 (estimated)
- Study completion
- 1 May 2021 (estimated)
- First posted
- 9 Jul 2020 (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.
Our previous study (Am. J. Gastroenterol. 2017 04;112(4)) showed that water exchange (WE) colonoscopy was able to increase the detection of flat adenomas as well as overall ADR. We hypothesized that WE based whole-colon acetic acid（AA） staining might be useful to improve the detection of flat lesions compared with WE alone.
Detailed description
Water exchange colonoscopy was performed as described previously (Am. J. Gastroenterol. 2017 04;112(4)). Patients were randomly allocated to WE group or WE+AA group. In WE+AA group, water containing 1% of AA was used during insertion of colonoscopy instead of water alone. A bottle of 20ml pure AA was placed abutting the water pump, which make it possible to keep patients blinded to group allocation. Endoscopist using a high-definition wide-angle Olympus or Fujinum colonoscope performed all of the colonoscopies, with a withdrawal time of at least 6 min. The observation was initially performed without the assistance of cap or the use of magnification or electronic staining (NBI, BLI, LCI or AFI et al.). Scopolamine butylbromide or glucogon was not routinely administrated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WE+AA group | Experimental | Other: acetic acid stainingWater containing 1% of AA was used during insertion of colonoscopy using water exchange method. |
| WE group | Active comparator | Other: Water exchange colonoscopyWater exchange colonoscopy was used for standard screening or surveillance colonoscopy. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged 40-70
- Undergoing colonoscopy after standard bowel preparation
Key exclusion criteria (5 listed)
- Known familial polyposis
- Small amount of feces or semi-solid stool in last rectal effluent
- Inflammatory Bowel Disease
- Lactated or pregnant women
- Unable to provide informed content
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 |
|---|---|---|
| acetic acid stainingThe water exchange colonoscopy is used during insertion procedure, in which the water contains 1% acetic acid, and the liquid is absorbed during the withdrawal process for observation. | Other | WE+AA group |
| Water exchange colonoscopyThe water exchange colonoscopy is used during insertion procedure, and the liquid is absorbed during the withdrawal process for observation. | Other | WE group |
Primary outcome
Number of flat polyps per patient
Time frame: 9 months
average numbers of flat polyps, defined by Paris classification IIa/IIb/IIc, for each patient
5 secondary outcomes
Overall ADR
Time frame: 9 months
Advanced ADR
Time frame: 9 months
SSA/P detection rate
Time frame: 9 months
Flat neoplasms located in proximal colon
Time frame: 9 months
Adverse events
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
- Background: PubMed 24804989Shibagaki K, Amano Y, Ishimura N, Yuki T, Taniguchi H, Fujita H, Kobayashi K, Kinoshita Y. Magnification endoscopy with acetic acid enhancement and a narrow-band imaging system for pit pattern diagnosis of colorectal neoplasms. J Clin Gastroenterol. 2015 Apr;49(4):306-12. doi: 10.1097/MCG.0000000000000148.
- Results publication: PubMed 27922025Jia H, Pan Y, Guo X, Zhao L, Wang X, Zhang L, Dong T, Luo H, Ge Z, Liu J, Hao J, Yao P, Zhang Y, Ren H, Zhou W, Guo Y, Zhang W, Chen X, Sun D, Yang X, Kang X, Liu N, Liu Z, Leung F, Wu K, Fan D. Water Exchange Method Significantly Improves Adenoma Detection Rate: A Multicenter, Randomized Controlled Trial. Am J Gastroenterol. 2017 Apr;112(4):568-576. doi: 10.1038/ajg.2016.501. Epub 2016 Dec 6.
- Results publication: PubMed 30738046Zhao S, Wang S, Pan P, Xia T, Chang X, Yang X, Guo L, Meng Q, Yang F, Qian W, Xu Z, Wang Y, Wang Z, Gu L, Wang R, Jia F, Yao J, Li Z, Bai Y. Magnitude, Risk Factors, and Factors Associated With Adenoma Miss Rate of Tandem Colonoscopy: A Systematic Review and Meta-analysis. Gastroenterology. 2019 May;156(6):1661-1674.e11. doi: 10.1053/j.gastro.2019.01.260. Epub 2019 Feb 6.
- Results publication: PubMed 28365356Desai M, Sanchez-Yague A, Choudhary A, Pervez A, Gupta N, Vennalaganti P, Vennelaganti S, Fugazza A, Repici A, Hassan C, Sharma P. Impact of cap-assisted colonoscopy on detection of proximal colon adenomas: systematic review and meta-analysis. Gastrointest Endosc. 2017 Aug;86(2):274-281.e3. doi: 10.1016/j.gie.2017.03.1524. Epub 2017 Mar 29.
- Individual participant dataSharing planned: No
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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.
Yanglin Pan, MD principal investigator
Xijing Hospital of Digestive Diseases
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acetic acid staining and Water exchange colonoscopy in people with Adenoma Colon, run by Air Force Military Medical University, China at 4 sites 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 2 inclusion and 5 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 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 Gui Ren, MD (+86298477136, renguigz@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of flat polyps per patient (time frame: 9 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 NCT04464135, which also lists 4 linked publications.
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 9 Jul 2020.