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

NCT ID: NCT04464135

Last Updated: 2020-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-15

Study Completion Date

2021-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Adenoma Colon

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

WE+AA group

Water containing 1% of AA was used during insertion of colonoscopy using water exchange method.

Group Type EXPERIMENTAL

acetic acid staining

Intervention Type OTHER

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.

WE group

Water exchange colonoscopy was used for standard screening or surveillance colonoscopy.

Group Type ACTIVE_COMPARATOR

Water exchange colonoscopy

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

acetic 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.

Intervention Type OTHER

Water exchange colonoscopy

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Air Force Military Medical University, China

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yanglin Pan

Associated professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yanglin Pan, MD

Role: PRINCIPAL_INVESTIGATOR

Xijing Hospital of Digestive Diseases

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Gastroenterology, Second Affiliated Hospital, Lanzhou University

Lanzhou, Gansu, China

Site Status RECRUITING

Department of Holistic Integrative Medicine, Shenzhen Hospital of Southern Medical University

Shenzhen, Guangdong, China

Site Status RECRUITING

Department of Gastroenterology, Huaihe Hospital of Henan University

Kaifeng, Henan, China

Site Status RECRUITING

Department of Gastroenterology, Shaanxi Second People's Hospital

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Gui Ren, MD

Role: CONTACT

+86298477136

Yanglin Pan, MD

Role: CONTACT

+862984771536

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Xiaojun Huang, MD

Role: primary

+8609318942279

Xiaoying Zhang, MD

Role: primary

+8613116950266

Jianghai Zhao, MD

Role: primary

+8615191903630

Limei Wang, MD

Role: primary

+8615291680602

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 24804989 (View on PubMed)

Jia 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.

Reference Type RESULT
PMID: 27922025 (View on PubMed)

Zhao 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.

Reference Type RESULT
PMID: 30738046 (View on PubMed)

Desai 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.

Reference Type RESULT
PMID: 28365356 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KY20200706-3

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.