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AdenomaNCT02880748

Effect of Water Exchange Method on Adenoma Miss Rates in Patients Undergoing Selective Polypectomy

A study testing Water exchange (WE) method and Air insufflation (AI) method. in people with Adenoma, run by Air Force Military Medical University, China at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Patients with colorectal adenomas are suggested to receive polypectomy. A substantial number of adenomas may be missed in patients with polyps found by previous colonoscopy. And water exchange (WE) method may increase the detection of missed adenoma compared with traditional air insufflation (AI) colonoscopy. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Adenoma
What is being tested?
Water exchange (WE) method and Air insufflation (AI) method.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
450 participants
Where
1 siteChina
Study dates
Aug 2016to Aug 2017
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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-80 patients undergoing selective polypectomy

Who cannot join

  • Polyps found more than 6 months
  • Patients with polyposis syndrome or hereditary nonpolyposis colorectal cancer
  • Patients with history of inflammatory bowel disease
  • Patients with planning to undergo Endoscopic Submucosal Dissection(ESD)
  • Patients not undergoing standard bowel preparation
  • Patients with solid feces in the last stool after bowel preparation
Show all 10Show fewer
  • Patients considered to be high risk for bleeding during Endoscopic mucosal resection (EMR), e.g. using antiplatelet drugs (clopidogrel) within 5 days before the current colonoscopy
  • Hemodynamically unstable
  • Pregnant women
  • Unable to provide informed consent

Trial locations and contacts

1 site in 1 country.

Gui Ren, MD contact

+86298477136

renguigz@hotmail.com

China1 site, 1 recruiting

  • Endoscopic center, Xijing Hospital of Digestive Diseases

    Xi'an, Shaanxi, 710032

    Gui Ren, MD, +862984771536, renguigz@hotmail.com

    Gui Ren, MD

    Recruiting

Other trials in China

About this study

Official title: Effect of Water Exchange Method on Adenoma Miss Rates in Patients Undergoing Selective Polypectomy: a Single-centered, Randomized Controlled Study

Patients with colorectal adenomas are suggested to receive polypectomy. A substantial number of adenomas may be missed in patients with polyps found by previous colonoscopy. And water exchange (WE) method may increase the detection of missed adenoma compared with traditional air insufflation (AI) colonoscopy. The investigators aim to investigate whether water exchange colonoscopy method, compared with air insufflation method, can improve the detection of missed adenomas in patients undergoing selective polypectomy.

Read the detailed description

For WE method, the air pump was turned off for the full duration of insertion to avoid inadvertent air insufflations and colon elongation. Residual air in the lumen was suctioned to minimize angulations at flexures. Water at 37°C was infused with a pump (Olympus) through the biopsy channel to confirm correct tip orientation for scope advancement. The infused water was removed predominantly by suction when the colonoscope was smoothly advanced during the insertion phase, and turbid luminal water due to residual feces was exchanged by clean water until the lumen was clearly visualized. Occasionally, if it was difficult to determine whether the colonoscope tip was in the cecum, air was allowed to be insufflated for observation. If the position of the scope tip was confirmed to be not in the cecum, insufflated air would be removed by suction and the WE method would be continuously used until successful intubation.

For the AI method, water was not used, and air was insufflated during insertion.

Air was insufflated to distend the lumen for inspection and biopsy or polypectomy during withdrawal for both methods. Polyps will be removed by forceps biopsy (polyps size <3mm), cold snare technique (3-6mm) or endoscopic mucosal resection (size≥6mm).

Conditions
Adenoma
Being tested
Water exchange (WE) method, Air insufflation (AI) method.
Keywords
Water exchange colonoscopy, Adenoma miss rate, Polyps
Medical subject headings
Adenoma, Polyps

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Water exchange (WE) methodOther

    Water exchange (WE) method was used for insertion to the cecum. And air was insufflated to distend the lumen for inspection and biopsy or polypectomy during withdrawal procedure.

  • Air insufflation (AI) method.Other

    Air insufflation (AI) method was used for insertion to the cecum. And air was insufflated to distend the lumen for inspection and biopsy or polypectomy during withdrawal procedure.

Study groups in NCT02880748
Study groupRoleWhat they receive
Water exchange (WE) methodExperimentalWater exchange (WE) method was used for insertion to the cecum.
Receives: Other: Water exchange (WE) method
Air insufflation (AI) methodActive comparatorAir insufflation (AI) method was used for insertion to the cecum.
Receives: Other: Air insufflation (AI) method.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adenoma miss rate

    Adenoma miss rate was calculated as the number of patients with one and more additional adenomas during polypectomy procedure divided by the total number of patients in each group.

    Measured: 12 months

Secondary outcomes (6)

  1. adenoma-level miss rate

    Adenoma-level miss rate was calculated as the number of additional adenomas detected in polypectomy procedure divided by the total number of adenomas in each group.

    Measured: 12 months

  2. Advanced adenoma miss rate/Miss advanced adenoma per colonoscopy

    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: 12 months

  3. Adenoma per positive patient (APP)

    The mean number of adenoma per positive patient

    Measured: 12 months

  4. Quality of Bowel Preparation

    The Boston Bowel Preparation Scale (BBPS): cleanliness of each part of the colon: 0=unprepared colon segment with mucosa not seen because of solid stool that cannot be cleared; 1=portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen because of staining, residual stool, and/or opaque liquid; 2=minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3=entire mucosa of colon segment seen well with no residual staining, small fragments of stool, or opaque liquid.

    Measured: 12 months

  5. Complication rate

    Bleeding, perforation and others

    Measured: 12 months

  6. Pain Scores on the Visual Analog Scale compared with previous colonoscopy

    0 = no pain, to 10 = most severe pain

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2016 (estimated)
  2. Study startAug 2016
  3. Primary completionAug 2017 (estimated)
  4. Study completionAug 2017 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02880748
Sponsor's protocol ID
KY20162059-2
Status last verified
Aug 2016
First submitted
19 Aug 2016
Last updated
26 Aug 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Veitch AM, Vanbiervliet G, Gershlick AH, Boustiere C, Baglin TP, Smith LA, Radaelli F, Knight E, Gralnek IM, Hassan C, Dumonceau JM. Endoscopy in patients on antiplatelet or anticoagulant therapy, including direct oral anticoagulants: British Society of Gastroenterology (BSG) and European Society of Gastrointestinal Endoscopy (ESGE) guidelines. Gut. 2016 Mar;65(3):374-89. doi: 10.1136/gutjnl-2015-311110.

    PubMed 26873868

  • Hewett DG, Rex DK. Cap-fitted colonoscopy: a randomized, tandem colonoscopy study of adenoma miss rates. Gastrointest Endosc. 2010 Oct;72(4):775-81. doi: 10.1016/j.gie.2010.04.030. Epub 2010 Jun 25.

    PubMed 20579648

  • Ren G, Wang X, Luo H, Yao S, Liang S, Zhang L, Dong T, Chen L, Tao Q, Guo X, Han Y, Pan Y. Effect of water exchange method on adenoma miss rate of patients undergoing selective polypectomy: A randomized controlled trial. Dig Liver Dis. 2021 May;53(5):625-630. doi: 10.1016/j.dld.2020.11.012. Epub 2020 Dec 31.

    PubMed 33390353

Questions about this trial

What is this clinical trial studying?

A study testing Water exchange (WE) method and Air insufflation (AI) method. in people with Adenoma, run by Air Force Military Medical University, China 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 10 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 26 Aug 2016. 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 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?

Adenoma miss rate (time frame: 12 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 NCT02880748, which also lists 3 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 26 Aug 2016.

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