Endoscopic AssessmentNCT01462123
Resect and Discard Strategy in Clinical Practice
An observational study of Endoscopic Assessment and Colonic Polyps, run by Valduce Hospital at 1 site in Italy.
Trial summary
Nowadays, post-polypectomy surveillance intervals are determined by combining endoscopic and pathologic data. Real-time imaging technologies, have shown promising results in discriminating adenomatous from non-adenomatous polyps. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Endoscopic Assessment, Colonic Polyps, Endoscopic Surveillance
- What is being tested?
- endoscopic assessment of colonic polyps
- How many people
- 286 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2011to not given
- Phase
- Observational
- 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
Study population: Consecutive adult outpatients undergoing colonoscopy for routine clinical indications
Who may be able to join
- consecutive adult outpatients undergoing colonoscopy for routine clinical indications
Who cannot join
- surveillance interval was not necessarily directed by endoscopic findings (history of colorectal cancer, inflammatory bowel disease, hereditary polyposis syndromes, hereditary non-polyposis colorectal cancer)
- colonoscopy was performed without NBI technology
- at least one lesion > 10 mm or < 10 mm but with morphologic features suspect for malignancy (depressed or ulcerated lesions) was detected
- bowel preparation was inadequate
- caecal intubation was not accomplished
- polyps could not be resected for concomitant anticoagulation treatment, 7) polyps were resected but not retrieved for pathology.
Trial locations and contacts
1 site in 1 country.
About this study
Nowadays, post-polypectomy surveillance intervals are determined by combining endoscopic and pathologic data. Real-time imaging technologies, have shown promising results in discriminating adenomatous from non-adenomatous polyps.
The "resect and discard strategy" for small polyps (based on real-time assessment of the histology and on the endoscopic resection without pathological examination) has been shown to be cost-effective in simulation models. No data exist about the impact of this strategy in clinical practice.
The aim of present study was to assess whether the systematic use, in the everyday clinical practice, of the "resect and discard strategy" allows to correctly manage patients with small colonic polyps.
- Conditions
- Endoscopic Assessment, Colonic Polyps, Endoscopic Surveillance, NBI
- Being tested
- endoscopic assessment of colonic polyps
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic assessment of colonic polypsOther
| Study group | Role | What they receive |
|---|---|---|
| small polyps patients | Patients with one small polyps at colonoscopy Receives: Other: endoscopic assessment of colonic polyps |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome of the study was to assess the agreement between "endoscopy-" and "histology-determined" surveillance strategies after small adenoma resection.
Secondary outcomes (5)
sensitivity of the endoscopic assessment (WL coupled with NBI) of small (<10 mm) adenomas
operative characteristics for the diagnosis of diminutive (< 5 mm) adenomas
the feasibility of non histologic evaluation, represented by the proportion of polyps in which a in-vivo diagnosis of adenoma can be made with high confidence
specificity of the endoscopic assessment
accuracy of the endoscopic assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2011 (estimated)
- Study startFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endoscopic AssessmentStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 286 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valduce Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01462123
- Sponsor's protocol ID
- RD 2010
- Status last verified
- Oct 2011
- First submitted
- 27 Oct 2011
- Last updated
- 31 Oct 2011
- Results posted
- No
Publications
Paggi S, Rondonotti E, Amato A, Terruzzi V, Imperiali G, Mandelli G, Terreni N, Lenoci N, Spinzi G, Radaelli F. Resect and discard strategy in clinical practice: a prospective cohort study. Endoscopy. 2012 Oct;44(10):899-904. doi: 10.1055/s-0032-1309891. Epub 2012 Aug 2.
PubMed 22859259
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resect and Discard Strategy in Clinical Practice
- ClinicalTrials.gov ID
- NCT01462123
- Acronym / sponsor ID
- RD 2010
- Conditions
- Endoscopic Assessment, Colonic Polyps, Endoscopic Surveillance, NBI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 286 participants (actual)
- Lead sponsor
- Valduce HospitalUniversity, hospital or other
- Study start
- Feb 2011
- First posted
- 31 Oct 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.
Nowadays, post-polypectomy surveillance intervals are determined by combining endoscopic and pathologic data. Real-time imaging technologies, have shown promising results in discriminating adenomatous from non-adenomatous polyps.
The "resect and discard strategy" for small polyps (based on real-time assessment of the histology and on the endoscopic resection without pathological examination) has been shown to be cost-effective in simulation models. No data exist about the impact of this strategy in clinical practice.
The aim of present study was to assess whether the systematic use, in the everyday clinical practice, of the "resect and discard strategy" allows to correctly manage patients with small colonic polyps.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| small polyps patients | – | Other: endoscopic assessment of colonic polypsPatients with one small polyps at colonoscopy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive adult outpatients undergoing colonoscopy for routine clinical indications
Key inclusion criteria (1 listed)
- consecutive adult outpatients undergoing colonoscopy for routine clinical indications
Key exclusion criteria (6 listed)
- surveillance interval was not necessarily directed by endoscopic findings (history of colorectal cancer, inflammatory bowel disease, hereditary polyposis syndromes, hereditary non-polyposis colorectal cancer)
- colonoscopy was performed without NBI technology
- at least one lesion > 10 mm or < 10 mm but with morphologic features suspect for malignancy (depressed or ulcerated lesions) was detected
- bowel preparation was inadequate
- caecal intubation was not accomplished
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 |
|---|---|---|
| endoscopic assessment of colonic polyps | Other | small polyps patients |
Primary outcome
The primary outcome of the study was to assess the agreement between "endoscopy-" and "histology-determined" surveillance strategies after small adenoma resection.
5 secondary outcomes
sensitivity of the endoscopic assessment (WL coupled with NBI) of small (<10 mm) adenomas
operative characteristics for the diagnosis of diminutive (< 5 mm) adenomas
the feasibility of non histologic evaluation, represented by the proportion of polyps in which a in-vivo diagnosis of adenoma can be made with high confidence
specificity of the endoscopic assessment
accuracy of the endoscopic assessment
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 31 Oct 2011.
- Derived from this study: PubMed 22859259Paggi S, Rondonotti E, Amato A, Terruzzi V, Imperiali G, Mandelli G, Terreni N, Lenoci N, Spinzi G, Radaelli F. Resect and discard strategy in clinical practice: a prospective cohort study. Endoscopy. 2012 Oct;44(10):899-904. doi: 10.1055/s-0032-1309891. Epub 2012 Aug 2.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endoscopic Assessment and Colonic Polyps, run by Valduce Hospital at 1 site in Italy.
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: finished, as of the sponsor's last update on 31 Oct 2011. 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 Italy. 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?
The primary outcome of the study was to assess the agreement between "endoscopy-" and "histology-determined" surveillance strategies after small adenoma resection.. 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 NCT01462123, which also lists 1 linked publication.
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 Oct 2011.