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Effect of Water Exchange Plus Acetic Acid Staining on the Detection of Flat Polyps During Colonoscopy

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.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04464135
Enrollment
300
Registered
2020-07-09
Start date
2020-07-15
Completion date
2021-05-01
Last updated
2020-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenoma Colon

Keywords

Water exchange colonoscopy, Flat Polyps, Acetic Acid Staining

Brief 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 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.

Interventions

OTHERacetic acid staining

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.

The water exchange colonoscopy is used during insertion procedure, and the liquid is absorbed during the withdrawal process for observation.

Sponsors

Air Force Military Medical University, China
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Aged 40-70 * Undergoing colonoscopy after standard bowel preparation

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Number of flat polyps per patient9 monthsaverage numbers of flat polyps, defined by Paris classification IIa/IIb/IIc, for each patient

Secondary

MeasureTime frameDescription
Overall ADR9 monthsAdenoma detection rate, defined as the proportion of subjects with at least one adenoma of any size, in each group.
Advanced ADR9 monthsAdvanced 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.
SSA/P detection rate9 monthsSSA/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.
Flat neoplasms located in proximal colon9 monthsLow-grade adenoma, adenoma with villous components, high-grade adenoma, noninvasive carcinoma, and invasive carcinoma in proximal colon
Adverse events9 monthsthe rate of bleeding and perforation during colonoscopy procedure and abdominal pain, diarrhea, hematochezia and change of defecation habit Within one week.

Countries

China

Contacts

Primary ContactGui Ren, MD
renguigz@hotmail.com+86298477136
Backup ContactYanglin Pan, MD
yanglinpan@hotmail.com+862984771536

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026