Colon PolypNCT01383265
Combined Chromoendoscopy and Water Method for Screening Colonoscopy
A study testing Water method and chromoendoscopy and Water method in people with Colon Polyp, run by VA Northern California Health Care System at 1 site in United States.
Trial summary
In a RCT in screening colonoscopy subjects, we will determine if chromoendoscopy using a dilute solution of Indigocarmine (IC) delivered by the water method (study method) will improve adenoma detection rate compared with the water method with plain water alone (control method). Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Colon Polyp
- What is being tested?
- Water method and chromoendoscopy and Water method
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,177 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Jun 2013
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (≥50 years old
- Male and female patients
- Scheduled for screening colonoscopy
- Consented and accept randomization to study or control method
Who cannot join
- Patients who decline to participate
- Unable to give informed consent
- Unable to complete questionnaires due to language or other difficulties
Trial locations and contacts
1 site in 1 country.
United States1 site
Sacramento VA Medical Center
Mather, California, 95655
About this study
Official title: Randomized Controlled Trial (RCT) to Compare Adenoma Detection Rate of Combined Chromoendoscopy (Indigo Carmine) With Water Infusion in Lieu of Air Insufflation (Water Method) vs. Water Method Alone in Screening Colonoscopy
In a RCT in screening colonoscopy subjects, we will determine if chromoendoscopy using a dilute solution of Indigocarmine (IC) delivered by the water method (study method) will improve adenoma detection rate compared with the water method with plain water alone (control method).
Read the detailed description
Background: Warm water infusion in lieu of air insufflation (water method) improves overall success of screening colonoscopy and our retrospective data indicate a higher adenoma detection rate. Dye spray methods to improve neoplastic polyp detection such as targeted staining or pancolonic chromoendoscopy have been described.
Aim: In a RCT in screening colonoscopy subjects, we will determine if chromoendoscopy using a dilute solution of Indigocarmine (IC) delivered by the water method (study method) will improve adenoma detection rate compared with the water method with plain water alone (control method).
Methods: After informed consent patients undergoing screening colonoscopy will be randomized to be examined by the study or control method. Study method will employ a 0.008% IC solution. Control method will employ plain water. The water method in both study and control groups will be applied as previously described. The colonoscopy will be performed under sedation. Primary outcome measure: adenoma detection rate; secondary outcome: relevant procedure-related variables.
- Conditions
- Colon Polyp
- Being tested
- Water method and chromoendoscopy, Water method
- Keywords
- screening colonoscopy, adenoma, water method
- Medical subject headings
- Colonic Polyps, Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water method and chromoendoscopyProcedure or surgery
Also called Water method, Chromoendoscopy, Screening colonoscopy
Study method will employ a 0.008% IC solution used with the water method for screening colonoscopy
Water methodProcedure or surgery
Also called Screening colonoscopy
Control method will use plain water with water method for screening colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| Water method and chromoendoscopy | Experimental | Combined water method with chromoendoscopy using 0.008% IC solution for screening colonoscopy Receives: Procedure: Water method and chromoendoscopy |
| Water method | Active comparator | Control method will use plain water with the water method for screening colonoscopy Receives: Procedure: Water method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of adenoma
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2011 (estimated)
- Study startMar 2010
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colon PolypStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,177 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Northern California Health Care System
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Joseph Leung, MD, Principal investigator, Sacramento VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01383265
- Sponsor's protocol ID
- VANCHCS-GI-006
- Status last verified
- Jun 2013
- First submitted
- 24 Jun 2011
- Last updated
- 17 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Leung JW, Mann SK, Siao-Salera R, Ransibrahmanakul K, Lim B, Cabrera H, Canete W, Barredo P, Gutierrez R, Leung FW. A randomized, controlled comparison of warm water infusion in lieu of air insufflation versus air insufflation for aiding colonoscopy insertion in sedated patients undergoing colorectal cancer screening and surveillance. Gastrointest Endosc. 2009 Sep;70(3):505-10. doi: 10.1016/j.gie.2008.12.253. Epub 2009 Jun 24.
PubMed 19555938Leung J, Mann S, Siao-Salera R, Ransibrahmanakul K, Lim B, Canete W, Samson L, Gutierrez R, Leung FW. A randomized, controlled trial to confirm the beneficial effects of the water method on U.S. veterans undergoing colonoscopy with the option of on-demand sedation. Gastrointest Endosc. 2011 Jan;73(1):103-10. doi: 10.1016/j.gie.2010.09.020.
PubMed 21184876Leung J, Mann S, Siao-Salera R, Ngo C, McCreery R, Canete W, Leung F. Indigocarmine added to the water exchange method enhances adenoma detection - a RCT. J Interv Gastroenterol. 2012 Jul;2(3):106-111. doi: 10.4161/jig.23728. Epub 2012 Jul 1.
PubMed 23805387
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial (RCT) to Compare Adenoma Detection Rate of Combined Chromoendoscopy (Indigo Carmine) With Water Infusion in Lieu of Air Insufflation (Water Method) vs. Water Method Alone in Screening Colonoscopy
- ClinicalTrials.gov ID
- NCT01383265
- Acronym / sponsor ID
- VANCHCS-GI-006
- Conditions
- Colon Polyp
- Keywords
- screening colonoscopy, adenoma, water method
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,177 participants (actual)
- Lead sponsor
- VA Northern California Health Care SystemUS federal agency
- Study start
- Mar 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 28 Jun 2011 (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.
In a RCT in screening colonoscopy subjects, we will determine if chromoendoscopy using a dilute solution of Indigocarmine (IC) delivered by the water method (study method) will improve adenoma detection rate compared with the water method with plain water alone (control method).
Detailed description
Background: Warm water infusion in lieu of air insufflation (water method) improves overall success of screening colonoscopy and our retrospective data indicate a higher adenoma detection rate. Dye spray methods to improve neoplastic polyp detection such as targeted staining or pancolonic chromoendoscopy have been described.
Aim: In a RCT in screening colonoscopy subjects, we will determine if chromoendoscopy using a dilute solution of Indigocarmine (IC) delivered by the water method (study method) will improve adenoma detection rate compared with the water method with plain water alone (control method).
Methods: After informed consent patients undergoing screening colonoscopy will be randomized to be examined by the study or control method. Study method will employ a 0.008% IC solution. Control method will employ plain water. The water method in both study and control groups will be applied as previously described. The colonoscopy will be performed under sedation. Primary outcome measure: adenoma detection rate; secondary outcome: relevant procedure-related variables.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Water method and chromoendoscopy | Experimental | Procedure: Water method and chromoendoscopyCombined water method with chromoendoscopy using 0.008% IC solution for screening colonoscopy |
| Water method | Active comparator | Procedure: Water methodControl method will use plain water with the water method for screening colonoscopy |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult (≥50 years old
- Male and female patients
- Scheduled for screening colonoscopy
- Consented and accept randomization to study or control method
Key exclusion criteria (3 listed)
- Patients who decline to participate
- Unable to give informed consent
- Unable to complete questionnaires due to language or other difficulties
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 |
|---|---|---|
| Water method and chromoendoscopyAlso: Water method, Chromoendoscopy, Screening colonoscopyStudy method will employ a 0.008% IC solution used with the water method for screening colonoscopy | Procedure or surgery | Water method and chromoendoscopy |
| Water methodAlso: Screening colonoscopyControl method will use plain water with water method for screening colonoscopy | Procedure or surgery | Water method |
Primary outcome
Diagnosis of adenoma
Time frame: 24 months
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 17 Jun 2013.
- Background: PubMed 19555938Leung JW, Mann SK, Siao-Salera R, Ransibrahmanakul K, Lim B, Cabrera H, Canete W, Barredo P, Gutierrez R, Leung FW. A randomized, controlled comparison of warm water infusion in lieu of air insufflation versus air insufflation for aiding colonoscopy insertion in sedated patients undergoing colorectal cancer screening and surveillance. Gastrointest Endosc. 2009 Sep;70(3):505-10. doi: 10.1016/j.gie.2008.12.253. Epub 2009 Jun 24.
- Background: PubMed 21184876Leung J, Mann S, Siao-Salera R, Ransibrahmanakul K, Lim B, Canete W, Samson L, Gutierrez R, Leung FW. A randomized, controlled trial to confirm the beneficial effects of the water method on U.S. veterans undergoing colonoscopy with the option of on-demand sedation. Gastrointest Endosc. 2011 Jan;73(1):103-10. doi: 10.1016/j.gie.2010.09.020.
- Derived from this study: PubMed 23805387Leung J, Mann S, Siao-Salera R, Ngo C, McCreery R, Canete W, Leung F. Indigocarmine added to the water exchange method enhances adenoma detection - a RCT. J Interv Gastroenterol. 2012 Jul;2(3):106-111. doi: 10.4161/jig.23728. Epub 2012 Jul 1.
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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.
Joseph Leung, MD principal investigator
Sacramento VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water method and chromoendoscopy and Water method in people with Colon Polyp, run by VA Northern California Health Care System at 1 site in United States.
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 4 inclusion and 3 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 17 Jun 2013. 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 United States. 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?
Diagnosis of adenoma (time frame: 24 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 NCT01383265, 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 17 Jun 2013.