AdenomaNCT01894191
Comparing the Adenoma Detection Rate With Air Insufflation, Water Immersion and Water Exchange
A study testing Air insufflation, water immersion and Water exchange in people with Adenoma, run by Dalin Tzu Chi General Hospital at 2 sites in 2 countries.
Trial summary
Interval (missed) cancers and lower than expected mortality reduction of proximal colon cancers in the United States and elsewhere after screening colonoscopy drew attention to quality indicators. Missed adenomas which are more likely to be in the proximal colon may be contributing factors. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Adenoma
- What is being tested?
- Air insufflation, water immersion and Water exchange
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 651 participants
- Where
- 2 sitesin 2 countries
- Study dates
- May 2013to Dec 2015
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing colonoscopy performed by the participating endoscopists
Who cannot join
- obstructive lesions of the colon known before colonoscopy
- massive ascites
- past history of partial colectomy
- refusal to provide written informed consent
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Sepulveda Ambulatory Care Center, Veterans Affairs Greater Los Angeles Healthcare System
North Hills, California, 91343
About this study
Official title: A Randomized, Controlled Trial Comparing the Adenoma Detection Rate With Air Insufflation, Water Immersion and Water Exchange During Colonoscopy
Interval (missed) cancers and lower than expected mortality reduction of proximal colon cancers in the United States and elsewhere after screening colonoscopy drew attention to quality indicators. Missed adenomas which are more likely to be in the proximal colon may be contributing factors. An independent predictor of the risk of interval cancers is adenoma detection rate. In pilot observations, the investigators showed that water exchange enhanced adenoma detection in the right colon (cecum to hepatic flexure). This prospective, randomized controlled trial will compare water exchange with water immersion and traditional air insufflation in patients undergoing colonoscopy. The investigators test the hypothesis that compared with air insufflation and water immersion, water exchange produces a significantly higher adenoma detection rate in the right colon.
Read the detailed description
All of the procedures will be recorded and stored as digital files.
- Conditions
- Adenoma
- Being tested
- Air insufflation, water immersion, Water exchange
- Keywords
- adenoma detection rate, colonoscopy, water exchange
- Medical subject headings
- Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air insufflationProcedure or surgery
Insufflation during colonoscopy including insertion phase
water immersionProcedure or surgery
Water will infused during insertion phase and removed during withdrawal phase of colonoscopy
Water exchangeProcedure or surgery
Water will infused and removed during insertion phase of colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| air insufflation | Active comparator | Air insufflation will be used throughout whole procedure of colonoscopy Receives: Procedure: Air insufflation |
| water immersion | Active comparator | Water will be infused during the insertion phase and removed during withdrawal phase of colonoscopy. Receives: Procedure: water immersion |
| water exchange | Active comparator | Water will be infused and removed during insertion phase of colonoscopy Receives: Procedure: Water exchange |
What is being measured
The primary outcome is the main question the study is designed to answer.
adenoma detection rate
Measured: one week
Secondary outcomes (1)
adenoma detection rate in proximal colon
the proportion of patients with the presence of adenoma in the proximal colon
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for AdenomaStudies 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
- None (open label)
- Enrolment
- 651 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dalin Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sepulveda Ambulatory Care Center, VAGLAHS
- Responsible party
- Principal investigator, Yu-Hsi hsieh, Dalin Tzu Chi General Hospital
- Investigators
- Yu-Hsi Hsieh, MD, Principal investigator, Buddhist Dalin Tzu Chi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01894191
- Sponsor's protocol ID
- DalinTCGH-hsieh-03
- Status last verified
- Jun 2016
- First submitted
- 3 Jul 2013
- Last updated
- 28 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bressler B, Paszat LF, Vinden C, Li C, He J, Rabeneck L. Colonoscopic miss rates for right-sided colon cancer: a population-based analysis. Gastroenterology. 2004 Aug;127(2):452-6. doi: 10.1053/j.gastro.2004.05.032.
PubMed 15300577Stock C, Pulte D, Haug U, Brenner H. Subsite-specific colorectal cancer risk in the colorectal endoscopy era. Gastrointest Endosc. 2012 Mar;75(3):621-30. doi: 10.1016/j.gie.2011.10.025.
PubMed 22341107Leung FW, Amato A, Ell C, Friedland S, Harker JO, Hsieh YH, Leung JW, Mann SK, Paggi S, Pohl J, Radaelli F, Ramirez FC, Siao-Salera R, Terruzzi V. Water-aided colonoscopy: a systematic review. Gastrointest Endosc. 2012 Sep;76(3):657-66. doi: 10.1016/j.gie.2012.04.467.
PubMed 22898423Radaelli F, Paggi S, Amato A, Terruzzi V. Warm water infusion versus air insufflation for unsedated colonoscopy: a randomized, controlled trial. Gastrointest Endosc. 2010 Oct;72(4):701-9. doi: 10.1016/j.gie.2010.06.025.
PubMed 20883846Hsieh YH, Lin HJ, Tseng KC. Limited water infusion decreases pain during minimally sedated colonoscopy. World J Gastroenterol. 2011 May 7;17(17):2236-40. doi: 10.3748/wjg.v17.i17.2236.
PubMed 21633535Hsieh YH, Tseng CW, Hu CT, Koo M, Leung FW. Prospective multicenter randomized controlled trial comparing adenoma detection rate in colonoscopy using water exchange, water immersion, and air insufflation. Gastrointest Endosc. 2017 Jul;86(1):192-201. doi: 10.1016/j.gie.2016.12.005. Epub 2016 Dec 15.
PubMed 27988288
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Trial Comparing the Adenoma Detection Rate With Air Insufflation, Water Immersion and Water Exchange During Colonoscopy
- ClinicalTrials.gov ID
- NCT01894191
- Acronym / sponsor ID
- DalinTCGH-hsieh-03
- Conditions
- Adenoma
- Keywords
- adenoma detection rate, colonoscopy, water exchange
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 651 participants (actual)
- Lead sponsor
- Dalin Tzu Chi General HospitalUniversity, hospital or other
- Collaborators
- Sepulveda Ambulatory Care Center, VAGLAHS
- Study start
- May 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 10 Jul 2013 (estimated)
- 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.
Interval (missed) cancers and lower than expected mortality reduction of proximal colon cancers in the United States and elsewhere after screening colonoscopy drew attention to quality indicators. Missed adenomas which are more likely to be in the proximal colon may be contributing factors. An independent predictor of the risk of interval cancers is adenoma detection rate. In pilot observations, the investigators showed that water exchange enhanced adenoma detection in the right colon (cecum to hepatic flexure). This prospective, randomized controlled trial will compare water exchange with water immersion and traditional air insufflation in patients undergoing colonoscopy. The investigators test the hypothesis that compared with air insufflation and water immersion, water exchange produces a significantly higher adenoma detection rate in the right colon.
Detailed description
All of the procedures will be recorded and stored as digital files.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| air insufflation | Active comparator | Procedure: Air insufflationAir insufflation will be used throughout whole procedure of colonoscopy |
| water immersion | Active comparator | Procedure: water immersionWater will be infused during the insertion phase and removed during withdrawal phase of colonoscopy. |
| water exchange | Active comparator | Procedure: Water exchangeWater will be infused and removed during insertion phase of colonoscopy |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing colonoscopy performed by the participating endoscopists
Key exclusion criteria (4 listed)
- obstructive lesions of the colon known before colonoscopy
- massive ascites
- past history of partial colectomy
- refusal to provide written informed consent
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 |
|---|---|---|
| Air insufflationInsufflation during colonoscopy including insertion phase | Procedure or surgery | air insufflation |
| water immersionWater will infused during insertion phase and removed during withdrawal phase of colonoscopy | Procedure or surgery | water immersion |
| Water exchangeWater will infused and removed during insertion phase of colonoscopy | Procedure or surgery | water exchange |
Primary outcome
adenoma detection rate
Time frame: one week
1 secondary outcome
adenoma detection rate in proximal colon
Time frame: one week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2016.
- Background: PubMed 15300577Bressler B, Paszat LF, Vinden C, Li C, He J, Rabeneck L. Colonoscopic miss rates for right-sided colon cancer: a population-based analysis. Gastroenterology. 2004 Aug;127(2):452-6. doi: 10.1053/j.gastro.2004.05.032.
- Background: PubMed 22341107Stock C, Pulte D, Haug U, Brenner H. Subsite-specific colorectal cancer risk in the colorectal endoscopy era. Gastrointest Endosc. 2012 Mar;75(3):621-30. doi: 10.1016/j.gie.2011.10.025.
- Background: PubMed 22898423Leung FW, Amato A, Ell C, Friedland S, Harker JO, Hsieh YH, Leung JW, Mann SK, Paggi S, Pohl J, Radaelli F, Ramirez FC, Siao-Salera R, Terruzzi V. Water-aided colonoscopy: a systematic review. Gastrointest Endosc. 2012 Sep;76(3):657-66. doi: 10.1016/j.gie.2012.04.467.
- Background: PubMed 20883846Radaelli F, Paggi S, Amato A, Terruzzi V. Warm water infusion versus air insufflation for unsedated colonoscopy: a randomized, controlled trial. Gastrointest Endosc. 2010 Oct;72(4):701-9. doi: 10.1016/j.gie.2010.06.025.
- Background: PubMed 21633535Hsieh YH, Lin HJ, Tseng KC. Limited water infusion decreases pain during minimally sedated colonoscopy. World J Gastroenterol. 2011 May 7;17(17):2236-40. doi: 10.3748/wjg.v17.i17.2236.
- Derived from this study: PubMed 27988288Hsieh YH, Tseng CW, Hu CT, Koo M, Leung FW. Prospective multicenter randomized controlled trial comparing adenoma detection rate in colonoscopy using water exchange, water immersion, and air insufflation. Gastrointest Endosc. 2017 Jul;86(1):192-201. doi: 10.1016/j.gie.2016.12.005. Epub 2016 Dec 15.
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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.
Yu-Hsi Hsieh, MD principal investigator
Buddhist Dalin Tzu Chi Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Air insufflation, water immersion and Water exchange in people with Adenoma, run by Dalin Tzu Chi General Hospital at 2 sites in 2 countries.
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 4 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: finished, as of the sponsor's last update on 28 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adenoma detection rate (time frame: one week). 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 NCT01894191, which also lists 6 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 28 Jun 2016; AzTrials last refreshed its copy on 6 Nov 2026.