AdenomaNCT03416322
Water-assisted Colonoscopy vs Second Forward View Examination of the Right Colon on Adenoma Detection
A study testing Water exchange in people with Adenoma and Colorectal Cancer, run by Barretos Cancer Hospital at 1 site in Brazil.
Trial summary
Introduction and objectives: The adenoma detection rate (ADR) has been investigated as a formal method in the evaluation of a trainee or resident physician. Several studies have suggested that water-assisted colonoscopy methods increase the ADR, especially in the right colon, when compared to air-insufflated methods… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenoma, Colorectal Cancer
- What is being tested?
- Water exchange
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 708 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Feb 2018to 1 Nov 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing diagnostic colonoscopy and surveillance colonoscopy
Who cannot join
- Contraindication for performing the endoscopic procedure.
- Refusal to provide inform consent.
- Past history of partial colectomy, familial adenomatous polyposis, inflammatory bowel disease, coagulopathy or thrombocytopenia.
- Incomplete colonoscopy
- Inadequate bowel preparation
- Pregnant patients.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Denise Guimaraes
Barretos, São Paulo, 14783062
DENISE GUIMARAES, PhD, 551733216600 ext. 7267, guimaraes.dp@gmail.com
About this study
Official title: Impact of Water-assisted Colonoscopy vs Second Forward View Examination of the Right Colon on Adenoma Detection
Introduction and objectives: The adenoma detection rate (ADR) has been investigated as a formal method in the evaluation of a trainee or resident physician. Several studies have suggested that water-assisted colonoscopy methods increase the ADR, especially in the right colon, when compared to air-insufflated methods alone. The objective of this study is to compare the adenoma detection rates between the techniques of the second frontal view examination and "Underwater" examination by residents, supervised by a senior endoscopist.
Patients and methods: This is a prospective, comparative and randomized clinical trial. The patients referred to the Cancer Hospital of Barretos for colonoscopy, and who agreed with the study, were divided into two groups, one with the use of water and the other only with air insufflation. The primary endpoint of this study is to compare adenoma detection rate. Secondary outcomes were withdrawal time, proportion of intubation of the cecum, preparation of the colon, and number of previously performed colonoscopies in the ADR in both techniques.
Read the detailed description
Introduction Colorectal cancer (CRC) is one of the most common cancers in the world. In Brazil, it is the second most incident tumor in women and the third in men. Colonoscopy is considered the gold standard test for colorectal cancer screening through the detection and removal of adenomas or detection of early cancers. However, this protection is not perfect and even less effective in the right colon (cecum and ascending colon) when compared to the distal colon, which leads to underdiagnosis of neoplasias and precursor lesions (eg adenomas). In this context, the performance and quality of colonoscopy play an important role in minimizing colonoscopy deficiencies. The American Society for Gastrointestinal Endoscopy (ASGE) determines three indispensable indicators for measuring the quality of colonoscopy: cecal intubation (≥95% in screening colonoscopies), adenoma detection rate (ADR) (≥25% in men and women, on screening colonoscopies) and withdrawal time (≥6 minutes on screening, negative colonoscopies).
In addition, for a better detection of lesions, it is necessary that the assessed colonic segment be cleaned of residues, and, therefore, proper colonic preparation is one of the quality items of the examination. Inadequate preparation impairs the detection of polyps and flat lesions, increases the time of the examination, increases the chances of complications and the costs of colonoscopy. One way to measure the quality of bowel preparation is the Boston Intestinal Prepare Scale. This scale uses a classification from 0 to 9 evaluating the preparation in three segments (right colon, transverse colon and left colon) after cleaning maneuvers. The score ranges from 0 (poor preparation) to 9 (excellent preparation).
In order to increase the quality of the colonoscopic examinations by increasing the ADR and reducing the incidence of the interval CRC, some methods have been investigated, including the Second Foward View Examination of the right-side colon (SFVE) and examination with Water Aid or Underwater colonoscopy (UW).
The first method is to evaluate the right colon with air and, upon reaching the hepatic flexsure, return to the cecum and re-evaluate the colonic segment. The second method, is to evaluate the right colon by inserting the colonoscope with the device completely immersed in water and withdrawn from the colonoscope with air after complete aspiration of the water, also known as the "Exchange method". The principle is that water cleans the colon and allows an increase of the image that is visualized by the colonoscope, and in that way, would improve the visualization of the mucosa.
Clark et al. demonstrated that, after performing SFVE, additional adenomas were found in 43 of 280 patients evaluated (15.4%, p <0.05) and the overall adenoma detection rate increased by 3.2% (p <0.05). The ADR in the right colon increased by 6.7% (p <0.05).
A retrospective study conducted by Leung et al. demonstrated that the UW technique increased the ADR in the right colon - at least one adenoma of any size was detected in 26.8% of patients in the air-evaluated group and in 34, 9% of patients in the group evaluated with water.
The two techniques showed to increase the ADR. Both are easy to carry out, do not require extra training or additional equipment, and have low cost. However, the impact of water exchange method colonoscopy on adenoma detection rate have not benn completely calrified. Further there is no evidence in the literature comparing these two techniques.
During colonoscopy learning curve, objective criteria are increasingly being suggested to assess the competence of "trainees". Traditionally, this evaluation is made by the number of procedures performed by them, but recently other criteria such as quality indicators, the ADR and intubation of the cecum have been investigated as formal methods in the evaluation of a trainee or resident. During the endoscopy residency in Barretos Cancer Hospital, surveillance colonoscopies are performed by residents supervised by the senior endoscopistThere is currently no evaluation of the colonoscopy technique performed by the resident. In addition, there is no evaluation of the ADR during the learning curve of the endoscopy resident in our department.
Justification The need to ensure adequate ADR among endoscopy residents. Absence of studies comparing UW and SEVF techniques of the right colon for the adenoma detection rate.
Primary objective To compare the ADR between combined SEFV and UW techniques in the right colon in patients undergoing colonoscopy for high-risk screening, diagnosis and follow-up after polypectomy, performed by residents supervised by a senior endoscopist.
Secondary objectives To estimate the association between withdrawal time, proportion of independent intubation of the cecum, preparation of the colon and the number of previously performed colonoscopies in the ADR in both techniques previously performed.
- Conditions
- Adenoma, Colorectal Cancer
- Being tested
- Water exchange
- Keywords
- Adenoma, Adenoma detection rate, Colorectal cancer
- Medical subject headings
- Adenoma, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water exchangeOther
Infusion and remove water during inertion and withdrawal of colonoscope
| Study group | Role | What they receive |
|---|---|---|
| Second Examination of the right colon | No intervention | Second forward view examination of the right colon once the right colon (cecum to hepatic flexure) has been examined |
| Water exchange | Experimental | Water infusion during colonoscope insertion in the right colon (from hepatic flexure to cecum) and remove water during withdrawn ("Exchange method"). Receives: Other: Water exchange |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma detection rate
Proportion of individuals with at least one adenoma
Measured: up to 12 months
Secondary outcomes (6)
Detection rate of any clinically significant lesion
Proportion of participants with at least one clinically significant lesion (adenoma, serrated or cancer)
Measured: up to 12 months
Detection rate of serrated adenoma
Proportion of participants with at least one serrated adenoma total and per resident
Measured: up to 12 monthas
Colonoscopy completion rate per resident
Proportion of complete colonoscopies per resident, independently of the senior examiner
Measured: up to 12 months
Cecal intubation time
Time it takes from anal insertion ti the time the tip of colonoscope in the the cecum
Measured: up to 12 months
Colonoscopy withdrawal time
time it takes to withdraw colonoscope
Measured: up to 12 months
Boston Intestinal Preparation Scale
Proportion of participants with boston scale grade
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study start1 Feb 2018 (estimated)
- Primary completion1 Jun 2018 (estimated)
- Study completion1 Nov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clinical, prospective and comparative, randomized study. Patients referred to the Endoscopy Department of the Barretos Cancer Hospital from August 2017 to August 2018 will be invited to participate in the study, with an indication of performing a diagnostic colonoscopy for high-risk CCR screening (Lynch and Li Fraumeni Syndrome) or who are in post-polypectomy follow-up. After agreeing and signing the Informed Consent Term (ICF), the included patients will be divided into two groups. The first group will be submitted to the technique of "second right frontal view of the right colon" (SEVF), which consists in reexamining the right colon after reaching the hepatic angle on colonoscope withdrawal. The second group will be submitted to the "Underwater" technique, which consists in evaluating the right colon after this segment has been cleaned with water, injected water and aspirated after. During aspiration of water, the colon will be examined.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 708 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barretos Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Denise Peixoto Guimarães, Barretos Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03416322
- Sponsor's protocol ID
- BarretosCH-20173
- Status last verified
- Jan 2018
- First submitted
- 24 Jan 2018
- Last updated
- 31 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Water-assisted Colonoscopy vs Second Forward View Examination of the Right Colon on Adenoma Detection
- ClinicalTrials.gov ID
- NCT03416322
- Acronym / sponsor ID
- BarretosCH-20173
- Conditions
- Adenoma, Colorectal Cancer
- Keywords
- Adenoma, Adenoma detection rate, Colorectal cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 708 participants (estimated)
- Lead sponsor
- Barretos Cancer HospitalUniversity, hospital or other
- Study start
- 1 Feb 2018 (estimated)
- Primary completion
- 1 Jun 2018 (estimated)
- Study completion
- 1 Nov 2018 (estimated)
- First posted
- 31 Jan 2018 (actual)
- 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.
Introduction and objectives: The adenoma detection rate (ADR) has been investigated as a formal method in the evaluation of a trainee or resident physician. Several studies have suggested that water-assisted colonoscopy methods increase the ADR, especially in the right colon, when compared to air-insufflated methods alone. The objective of this study is to compare the adenoma detection rates between the techniques of the second frontal view examination and "Underwater" examination by residents, supervised by a senior endoscopist.
Patients and methods: This is a prospective, comparative and randomized clinical trial. The patients referred to the Cancer Hospital of Barretos for colonoscopy, and who agreed with the study, were divided into two groups, one with the use of water and the other only with air insufflation. The primary endpoint of this study is to compare adenoma detection rate. Secondary outcomes were withdrawal time, proportion of intubation of the cecum, preparation of the colon, and number of previously performed colonoscopies in the ADR in both techniques.
Detailed description
Introduction Colorectal cancer (CRC) is one of the most common cancers in the world. In Brazil, it is the second most incident tumor in women and the third in men. Colonoscopy is considered the gold standard test for colorectal cancer screening through the detection and removal of adenomas or detection of early cancers. However, this protection is not perfect and even less effective in the right colon (cecum and ascending colon) when compared to the distal colon, which leads to underdiagnosis of neoplasias and precursor lesions (eg adenomas). In this context, the performance and quality of colonoscopy play an important role in minimizing colonoscopy deficiencies. The American Society for Gastrointestinal Endoscopy (ASGE) determines three indispensable indicators for measuring the quality of colonoscopy: cecal intubation (≥95% in screening colonoscopies), adenoma detection rate (ADR) (≥25% in men and women, on screening colonoscopies) and withdrawal time (≥6 minutes on screening, negative colonoscopies).
In addition, for a better detection of lesions, it is necessary that the assessed colonic segment be cleaned of residues, and, therefore, proper colonic preparation is one of the quality items of the examination. Inadequate preparation impairs the detection of polyps and flat lesions, increases the time of the examination, increases the chances of complications and the costs of colonoscopy. One way to measure the quality of bowel preparation is the Boston Intestinal Prepare Scale. This scale uses a classification from 0 to 9 evaluating the preparation in three segments (right colon, transverse colon and left colon) after cleaning maneuvers. The score ranges from 0 (poor preparation) to 9 (excellent preparation).
In order to increase the quality of the colonoscopic examinations by increasing the ADR and reducing the incidence of the interval CRC, some methods have been investigated, including the Second Foward View Examination of the right-side colon (SFVE) and examination with Water Aid or Underwater colonoscopy (UW).
The first method is to evaluate the right colon with air and, upon reaching the hepatic flexsure, return to the cecum and re-evaluate the colonic segment. The second method, is to evaluate the right colon by inserting the colonoscope with the device completely immersed in water and withdrawn from the colonoscope with air after complete aspiration of the water, also known as the "Exchange method". The principle is that water cleans the colon and allows an increase of the image that is visualized by the colonoscope, and in that way, would improve the visualization of the mucosa.
Clark et al. demonstrated that, after performing SFVE, additional adenomas were found in 43 of 280 patients evaluated (15.4%, p <0.05) and the overall adenoma detection rate increased by 3.2% (p <0.05). The ADR in the right colon increased by 6.7% (p <0.05).
A retrospective study conducted by Leung et al. demonstrated that the UW technique increased the ADR in the right colon - at least one adenoma of any size was detected in 26.8% of patients in the air-evaluated group and in 34, 9% of patients in the group evaluated with water.
The two techniques showed to increase the ADR. Both are easy to carry out, do not require extra training or additional equipment, and have low cost. However, the impact of water exchange method colonoscopy on adenoma detection rate have not benn completely calrified. Further there is no evidence in the literature comparing these two techniques.
During colonoscopy learning curve, objective criteria are increasingly being suggested to assess the competence of "trainees". Traditionally, this evaluation is made by the number of procedures performed by them, but recently other criteria such as quality indicators, the ADR and intubation of the cecum have been investigated as formal methods in the evaluation of a trainee or resident. During the endoscopy residency in Barretos Cancer Hospital, surveillance colonoscopies are performed by residents supervised by the senior endoscopistThere is currently no evaluation of the colonoscopy technique performed by the resident. In addition, there is no evaluation of the ADR during the learning curve of the endoscopy resident in our department.
Justification The need to ensure adequate ADR among endoscopy residents. Absence of studies comparing UW and SEVF techniques of the right colon for the adenoma detection rate.
Primary objective To compare the ADR between combined SEFV and UW techniques in the right colon in patients undergoing colonoscopy for high-risk screening, diagnosis and follow-up after polypectomy, performed by residents supervised by a senior endoscopist.
Secondary objectives To estimate the association between withdrawal time, proportion of independent intubation of the cecum, preparation of the colon and the number of previously performed colonoscopies in the ADR in both techniques previously performed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Clinical, prospective and comparative, randomized study. Patients referred to the Endoscopy Department of the Barretos Cancer Hospital from August 2017 to August 2018 will be invited to participate in the study, with an indication of performing a diagnostic colonoscopy for high-risk CCR screening (Lynch and Li Fraumeni Syndrome) or who are in post-polypectomy follow-up. After agreeing and signing the Informed Consent Term (ICF), the included patients will be divided into two groups. The first group will be submitted to the technique of "second right frontal view of the right colon" (SEVF), which consists in reexamining the right colon after reaching the hepatic angle on colonoscope withdrawal. The second group will be submitted to the "Underwater" technique, which consists in evaluating the right colon after this segment has been cleaned with water, injected water and aspirated after. During aspiration of water, the colon will be examined.
| Arm | Type | Receives |
|---|---|---|
| Second Examination of the right colon | No intervention | –Second forward view examination of the right colon once the right colon (cecum to hepatic flexure) has been examined |
| Water exchange | Experimental | Other: Water exchangeWater infusion during colonoscope insertion in the right colon (from hepatic flexure to cecum) and remove water during withdrawn ("Exchange method"). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing diagnostic colonoscopy and surveillance colonoscopy
Key exclusion criteria (6 listed)
- Contraindication for performing the endoscopic procedure.
- Refusal to provide inform consent.
- Past history of partial colectomy, familial adenomatous polyposis, inflammatory bowel disease, coagulopathy or thrombocytopenia.
- Incomplete colonoscopy
- Inadequate bowel preparation
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 exchangeInfusion and remove water during inertion and withdrawal of colonoscope | Other | Water exchange |
Primary outcome
Adenoma detection rate
Time frame: up to 12 months
Proportion of individuals with at least one adenoma
6 secondary outcomes
Detection rate of any clinically significant lesion
Time frame: up to 12 months
Detection rate of serrated adenoma
Time frame: up to 12 monthas
Colonoscopy completion rate per resident
Time frame: up to 12 months
Cecal intubation time
Time frame: up to 12 months
Colonoscopy withdrawal time
Time frame: up to 12 months
Boston Intestinal Preparation Scale
Time frame: up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2018.
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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.
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 exchange in people with Adenoma and Colorectal Cancer, run by Barretos Cancer Hospital at 1 site in Brazil.
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 6 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 31 Jan 2018. 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 Brazil. 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 DENISE GUIMARAES, MD, PhD (17981524444, guimaraes.dp@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adenoma detection rate (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jan 2018.