Adenomatous PolypsCARENCT01224444
Complete Histologic Resection of Adenomatous Polyps?
An observational study of Adenomatous Polyps, run by White River Junction Veterans Affairs Medical Center at 2 sites in United States.
Trial summary
Colorectal cancer is the second most common cause of cancer death in the US. Colonoscopy is considered the best test colorectal cancer screening. It allows resection of adenomatous polyps (a known cancer precursor) and thus, interrupt the adenoma-carcinoma sequence. Read more about this study
- Who is it for?
- Ages 40 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Adenomatous Polyps
- What is being tested?
- standard polypectomy snare
- How many people
- 269 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2008to Jan 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants eligible for recruitment are patients who present for a colonoscopy to the VAMC or DHMC Gastroenterology department conducting this study. Upon arrival for a scheduled colonoscopy patient records will be reviewed to determine eligibility.
Who may be able to join
- Any patient ≥40 and <85 who presents for a colonoscopy and does not meet any of the exclusion criteria mentioned below will be asked to participate
- All patients who are found to have colonic polyp between 5 and 20mm in size will be included in the study
Who cannot join
- Pedunculated polyps (estimated stalk diameter < 50% polyp head diameter, stalk at least 5 mm)
- Any suspicion of perforation or deeper defects after polypectomy, irrespective whether treated or not.
- Post-polypectomy bleeding requiring hemostasis.
- Patients with known inflammatory bowel disease or active colitis
- Patients who are receiving an emergency colonoscopy
- Poor general health (ASA class>3)
Show all 10Show fewer
- Patients on coumadin or with coagulopathy with an elevated INR ≥1.8, or platelets <50.
- Poor bowel preparation
- Patients who do not consent
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
White River Junction VAMC
White River Junction, Vermont, 05009
About this study
Official title: Complete Histologic Resection of Adenomatous Polyps? (Complete Adenoma REsection Trial - CARE Trial)
Colorectal cancer is the second most common cause of cancer death in the US. Colonoscopy is considered the best test colorectal cancer screening. It allows resection of adenomatous polyps (a known cancer precursor) and thus, interrupt the adenoma-carcinoma sequence. Despite the potential benefit of screening colonoscopy recent studies have reported cases of colorectal cancers in a short interval after prior screening or surveillance colonoscopies. One possible cause of such interval cancers may be incomplete resection of adenomatous polyps and hence ongoing growth and cancer development in such lesions. Complete resection may be particularly important for polyps of at least 5mm in size as up 10% of such polyps higher risk lesions as villous adenoma, tubulovillous adenoma, high grade dysplasia, or early carcinoma.
Although adenoma resection of sessile and flat adenomatous polyps between 5 and 20mm is believed to be well standardized data on complete resection of adenomatous tissue are sparse. This may be related to the assumption that using a snare with electro-cautery will successfully remove the polyp and cauterize remaining marginal adenomatous tissue and hence completely remove and or destroy the lesion.
The investigators are interested in examining how often sessile adenomatous polyps between 5 and 20mm are completely removed using standard polypectomy snare. The investigation was also directed at a comparison between complete resection of polyps between 5 and 9mm and 10 and 20mm.
Read the detailed description
All patients who present for a colonoscopy and meet inclusion and exclusion criteria will be asked to participate, and all patients with resectable polyps will be included. See also inclusion and exclusion criteria.
All patients will have undergone a regular bowel preparation with polyethylene glycol lavage with 4-6 L until clear rectal fluid is evacuated.
Polyp resection will be performed by experienced endoscopists (each with over 500 colonoscopies performed). All polyps between 5 and 20mm will be removed with an electro-cautery snare. Polyp size will be estimated using the snare catheter (2.5mm) or the snare diameter (10x20mm, 15x30mm, 20x20mm) before resection. The endoscopist will grade the difficulty of resection. Following the resection, the endoscopist will closely examine the resection margins. Biopsies will be taken from resection margins: 2 biopsies will be obtained from opposite margins for polyps 5-9mm, and 4 biopsies will be taken for polyps 10-20mm from all four quadrants of the resection margins. In case of assumed incomplete resection this will be documented and further (piecemeal) resections should be done, if this is not feasible, margins can be cauterized according to standard polypectomy resection (e.g. by argon beamer coagulation) after previous biopsy. Only those polyps that are found to be adenomatous polyps will be included in the analysis.
If polyp resection is complicated by bleeding (not self-sustained), no biopsies will be taken and any additional polyps that will be found during the remaining examination will be excluded from analysis. Any bleeding from the margins after polypectomy will be treated by endoscopic injection using diluted epinephrine (1:10.000).
A single research subject may have many eligible polyps. To avoid taking many biopsies, the investigators will not include more than 5 eligible polyps (the first 5 that are detected) per patient in the study.
Laboratory Analysis:
Polyps and biopsies will be sent to the pathology lab of each center. The polyps will be evaluated according to common practice. In addition information regarding resection margins will be provided for each polyp: R0= free of adenomatous tissue, R1=adenomatous tissue detected in the margin. This information is not routinely provided by the pathologist as there is so far no data whether this information is reliable. Only adenomatous polyps will be included in the analysis. Hyperplastic polyps will not be included. Biopsies will only be processed after the diagnosis of an adenomatous polyp was made. Biopsies will be evaluated for presence of adenomatous tissue. The additional impact for the pathology lab includes a) processing of biopsies belonging to the polyp specimens, and b) providing information on polyp margins. The VA pathology lab estimated the financial impact to be low and there will be no financial requests. The pathological diagnosis, including the reading of the biopsies, will become part of the medical record. If biopsies contain adenomatous tissue the patient will be ask to return for a follow-up colonoscopy within 1 year. This is within current standard of care to repeat a colonoscopy to assure complete adenoma resection.
- Conditions
- Adenomatous Polyps
- Being tested
- standard polypectomy snare
- Keywords
- colon polyps, adenoma resection, colon cancer screening, colonoscopy
- Medical subject headings
- Adenomatous Polyps, Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard polypectomy snareOther
Electrocautery snare resection of sessile colonic polyps
| Study group | Role | What they receive |
|---|---|---|
| All adenomatous polyps | Standard polypectomy snare of adenomatous polyps (included serrated adenomas) from ≤5mm to ≤20mm. Receives: Other: standard polypectomy snare |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Incompletely Resected Adenomatous Polyps
Proportion of incompletely resected adenomatous polyps (5 to 20mm), defined by remaining adenomatous tissue in marginal biopsies after snare resection.
Measured: 1 year
Secondary outcomes (1)
Incomplete Adenoma Resection of Small and Large Adenomas
Comparison of the proportion of incompletely resected adenomatous polyps by size (5-9mm versus 10-20mm).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2010 (estimated)
- Study startMay 2008
- Primary completionDec 2011
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adenomatous PolypsStudies 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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 269 participants (actual)
Sponsor and investigators
- Lead sponsor
- White River Junction Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Dartmouth-Hitchcock Medical Center
- Responsible party
- Principal investigator, Dr. Heiko Pohl, White River Junction Veterans Affairs Medical Center
- Investigators
- Heiko Pohl, MD, Principal investigator, White River Junction VAMC, Dartmouth Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01224444
- Sponsor's protocol ID
- DMS-21237
- Acronym
- CARE
- Status last verified
- Dec 2014
- First submitted
- 19 Oct 2010
- Last updated
- 12 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Pohl H, Srivastava A, Bensen SP, Anderson P, Rothstein RI, Gordon SR, Levy LC, Toor A, Mackenzie TA, Rosch T, Robertson DJ. Incomplete polyp resection during colonoscopy-results of the complete adenoma resection (CARE) study. Gastroenterology. 2013 Jan;144(1):74-80.e1. doi: 10.1053/j.gastro.2012.09.043. Epub 2012 Sep 25.
PubMed 23022496
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complete Histologic Resection of Adenomatous Polyps? (Complete Adenoma REsection Trial - CARE Trial)
- ClinicalTrials.gov ID
- NCT01224444
- Acronym / sponsor ID
- CARE / DMS-21237
- Conditions
- Adenomatous Polyps
- Keywords
- colon polyps, adenoma resection, colon cancer screening, colonoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 269 participants (actual)
- Lead sponsor
- White River Junction Veterans Affairs Medical CenterUS federal agency
- Collaborators
- Dartmouth-Hitchcock Medical Center
- Study start
- May 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 20 Oct 2010 (estimated)
- Results
- Posted 12 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Colorectal cancer is the second most common cause of cancer death in the US. Colonoscopy is considered the best test colorectal cancer screening. It allows resection of adenomatous polyps (a known cancer precursor) and thus, interrupt the adenoma-carcinoma sequence. Despite the potential benefit of screening colonoscopy recent studies have reported cases of colorectal cancers in a short interval after prior screening or surveillance colonoscopies. One possible cause of such interval cancers may be incomplete resection of adenomatous polyps and hence ongoing growth and cancer development in such lesions. Complete resection may be particularly important for polyps of at least 5mm in size as up 10% of such polyps higher risk lesions as villous adenoma, tubulovillous adenoma, high grade dysplasia, or early carcinoma.
Although adenoma resection of sessile and flat adenomatous polyps between 5 and 20mm is believed to be well standardized data on complete resection of adenomatous tissue are sparse. This may be related to the assumption that using a snare with electro-cautery will successfully remove the polyp and cauterize remaining marginal adenomatous tissue and hence completely remove and or destroy the lesion.
The investigators are interested in examining how often sessile adenomatous polyps between 5 and 20mm are completely removed using standard polypectomy snare. The investigation was also directed at a comparison between complete resection of polyps between 5 and 9mm and 10 and 20mm.
Detailed description
All patients who present for a colonoscopy and meet inclusion and exclusion criteria will be asked to participate, and all patients with resectable polyps will be included. See also inclusion and exclusion criteria.
All patients will have undergone a regular bowel preparation with polyethylene glycol lavage with 4-6 L until clear rectal fluid is evacuated.
Polyp resection will be performed by experienced endoscopists (each with over 500 colonoscopies performed). All polyps between 5 and 20mm will be removed with an electro-cautery snare. Polyp size will be estimated using the snare catheter (2.5mm) or the snare diameter (10x20mm, 15x30mm, 20x20mm) before resection. The endoscopist will grade the difficulty of resection. Following the resection, the endoscopist will closely examine the resection margins. Biopsies will be taken from resection margins: 2 biopsies will be obtained from opposite margins for polyps 5-9mm, and 4 biopsies will be taken for polyps 10-20mm from all four quadrants of the resection margins. In case of assumed incomplete resection this will be documented and further (piecemeal) resections should be done, if this is not feasible, margins can be cauterized according to standard polypectomy resection (e.g. by argon beamer coagulation) after previous biopsy. Only those polyps that are found to be adenomatous polyps will be included in the analysis.
If polyp resection is complicated by bleeding (not self-sustained), no biopsies will be taken and any additional polyps that will be found during the remaining examination will be excluded from analysis. Any bleeding from the margins after polypectomy will be treated by endoscopic injection using diluted epinephrine (1:10.000).
A single research subject may have many eligible polyps. To avoid taking many biopsies, the investigators will not include more than 5 eligible polyps (the first 5 that are detected) per patient in the study.
Laboratory Analysis:
Polyps and biopsies will be sent to the pathology lab of each center. The polyps will be evaluated according to common practice. In addition information regarding resection margins will be provided for each polyp: R0= free of adenomatous tissue, R1=adenomatous tissue detected in the margin. This information is not routinely provided by the pathologist as there is so far no data whether this information is reliable. Only adenomatous polyps will be included in the analysis. Hyperplastic polyps will not be included. Biopsies will only be processed after the diagnosis of an adenomatous polyp was made. Biopsies will be evaluated for presence of adenomatous tissue. The additional impact for the pathology lab includes a) processing of biopsies belonging to the polyp specimens, and b) providing information on polyp margins. The VA pathology lab estimated the financial impact to be low and there will be no financial requests. The pathological diagnosis, including the reading of the biopsies, will become part of the medical record. If biopsies contain adenomatous tissue the patient will be ask to return for a follow-up colonoscopy within 1 year. This is within current standard of care to repeat a colonoscopy to assure complete adenoma resection.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All adenomatous polyps | – | Other: standard polypectomy snareStandard polypectomy snare of adenomatous polyps (included serrated adenomas) from ≤5mm to ≤20mm. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants eligible for recruitment are patients who present for a colonoscopy to the VAMC or DHMC Gastroenterology department conducting this study. Upon arrival for a scheduled colonoscopy patient records will be reviewed to determine eligibility.
Key inclusion criteria (2 listed)
- Any patient ≥40 and <85 who presents for a colonoscopy and does not meet any of the exclusion criteria mentioned below will be asked to participate
- All patients who are found to have colonic polyp between 5 and 20mm in size will be included in the study
Key exclusion criteria (10 listed)
- Pedunculated polyps (estimated stalk diameter < 50% polyp head diameter, stalk at least 5 mm)
- Any suspicion of perforation or deeper defects after polypectomy, irrespective whether treated or not.
- Post-polypectomy bleeding requiring hemostasis.
- Patients with known inflammatory bowel disease or active colitis
- Patients who are receiving an emergency colonoscopy
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 |
|---|---|---|
| standard polypectomy snareElectrocautery snare resection of sessile colonic polyps | Other | All adenomatous polyps |
Primary outcome
Percent of Incompletely Resected Adenomatous Polyps
Time frame: 1 year
Proportion of incompletely resected adenomatous polyps (5 to 20mm), defined by remaining adenomatous tissue in marginal biopsies after snare resection.
1 secondary outcome
Incomplete Adenoma Resection of Small and Large Adenomas
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23022496Pohl H, Srivastava A, Bensen SP, Anderson P, Rothstein RI, Gordon SR, Levy LC, Toor A, Mackenzie TA, Rosch T, Robertson DJ. Incomplete polyp resection during colonoscopy-results of the complete adenoma resection (CARE) study. Gastroenterology. 2013 Jan;144(1):74-80.e1. doi: 10.1053/j.gastro.2012.09.043. Epub 2012 Sep 25.
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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.
Heiko Pohl, MD principal investigator
White River Junction VAMC, Dartmouth Medical School
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adenomatous Polyps, run by White River Junction Veterans Affairs Medical Center at 2 sites 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 2 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: finished, as of the sponsor's last update on 12 Jan 2015. 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. 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?
Yes. Results are posted in the registry (first posted 12 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent of Incompletely Resected Adenomatous Polyps (time frame: 1 year). 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 NCT01224444, 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 12 Jan 2015.