Colorectal CancerCSP-EMRNCT02967107
Cold Snare Polypectomy Versus Endoscopic Mucosal Resection for Colonic Sessile Serrated Polyps
A study testing Cold snare polypectomy and Endoscopic mucosal resection in people with Colorectal Cancer and Adenoma, run by Western Sydney Local Health District at 1 site in Australia.
Trial summary
Comparing the efficacy of cold snare polypectomy with endoscopic mucosal resection Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Adenoma
- What is being tested?
- Cold snare polypectomy and Endoscopic mucosal resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 474 participants
- Where
- 1 siteAustralia
- Study dates
- Jun 2016to Aug 2022
- 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 able to give informed consent to involvement in trial. For patients who do not speak English, an interpreter will be asked to translate the informed consent
- Patients referred to Westmead and Auburn Hospital Endoscopy Unit for a colonoscopy for all indications
- Age > 18 years
- At least one SSP 8-20 mm beyond the rectosigmoid junction without any endoscopic features of malignancy
- At least one SSP 8-20 mm beyond the rectosigmoid junction that according to the proceduralist, can be removed safely using either CSP or EMR
Who cannot join
- Current use of antiplatelets (excluding aspirin) or anticoagulants which have not appropriately been interrupted according to the guidelines [21]
- Known coagulopathy
- Pregnancy
- If any doubt about the morphology of the polyp, the patient will be excluded from the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cold Snare Polypectomy Versus Endoscopic Mucosal Resection for Colonic Sessile Serrated Polyps - A Randomised Controlled Trial
Comparing the efficacy of cold snare polypectomy with endoscopic mucosal resection
Read the detailed description
Colorectal cancer (CRC) is the third most common cancer and it remains the second most commonly diagnosed malignancy in Australia. Colonoscopic polypectomy reduces the incidence and mortality from CRC by disrupting the adenoma-carcinoma sequence. Screening for CRC has proven to be effective in reducing mortality and morbidity from CRC and has become common practice. Interval cancers (development of a CRC within 6 to 60 months of a colonoscopy) occur in 6% of patients and estimations showed that up to 27% of these are due to incomplete adenoma resection.
The serrated neoplasia pathway accounts for 20- 30% of sporadic cancers. Serrated precursor lesions are thought to be a major contributor to the relative failure of colonoscopy in the prevention of proximal colorectal cancer (CRC) and to the 5- 7% of CRCs which occur in the period after complete colonoscopy and prior to surveillance, termed 'interval' cancer.
In addition to being difficult to detect, sessile serrated polyps (SSPs) are more likely to be incompletely resected than conventional adenomas. The CARE study demonstrated that 31% of SSPs had remnant tissue in the resection defect compared with 7.2% of conventional adenomas, and in lesions greater than 10 mm in size, residual tissue remained in 47.5%. SSPs may have indistinct margins, and smaller lesions may prove difficult to entrap with the snare because of their flat nature. SSPs also may contain dysplastic foci within the lesion, with an endoscopic appearance indistinguishable from conventional adenomas, and the surrounding serrated component may be overlooked and incompletely resected if this is not recognized.
The technique of colonoscopic polypectomy is continually evolving, leading to better outcomes with regard to polyp detection rate, complete resection rate (CRR) of polyps, patient comfort, safety and cost-efficacy. Although colonoscopy is considered the 'gold standard' for detecting and removing polyps, the technique is still imperfect. Questions about best practice for polypectomy remain, so optimizing the technique is expected to lead to better patient outcomes. The optimal treatment of SSPs should be effective, safe and inexpensive.
Such lesions can be removed by cold snare polypectomy or by endoscopic mucosal resection. Cold snare polypectomy (CSP) is now common practice and has proven to be a safe and effective technique for removal of any small polyps (<10 mm). Because of their physical characteristics, use of thin wire snares leads to a fast tissue transection and ability to remove SSP relatively swiftly. The size of snares suitable for SSP CSP is approximately 9 mm. Thus lesions greater than this size would need to be removed in more than one piece, introducing the possibility of incomplete resection. Endoscopic mucosal resection (EMR) is well established for laterally spreading colorectal lesions. It involves submucosal injection and diathermy assisted snare resection by piecemeal or en-bloc depending on polyp size. En bloc resection is possible for lesions up to 20 mm and facilitates histopathological evaluation. EMR is more time consuming than CSP and may be associated with diathermy related complications such as postpolypectomy bleeding, perforation and pain. The most efficient and safe method of removal of SSP has not been established.
- Conditions
- Colorectal Cancer, Adenoma
- Being tested
- Cold snare polypectomy, Endoscopic mucosal resection
- Keywords
- adenoma, colorectal cancer, polypectomy, colonoscopy
- Medical subject headings
- Colorectal Neoplasms, Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold snare polypectomyProcedure or surgery
Also called CSP
Use of a polypectomy snare closed over a polyp without electrocautery
Endoscopic mucosal resectionProcedure or surgery
Also called EMR
Use of injected chromogelofusine solution to raise a lesion prior to snare resection with electrocautery
| Study group | Role | What they receive |
|---|---|---|
| Cold snare polypectomy | Active comparator | Cold snare resection, if necessary, multi-piece to resect sessile serrated adenoma (SSA) 8-20mm Receives: Procedure: Cold snare polypectomy |
| Endoscopic mucosal resection | Active comparator | Endoscopic mucosal resection (EMR), if necessary, multi-piece to resect sessile serrated adenoma (SSA) 8-20mm Receives: Procedure: Endoscopic mucosal resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with residual or recurrent adenoma as assessed at surveillance endoscopy
Measured: 4-6 months
Secondary outcomes (3)
Number of participants with bleeding after the EMR procedure has finished as assessed by telephone interview at 2 weeks
Measured: 2 weeks
Number of participants with residual or recurrent adenoma as assessed at admission or telephone interview at 2 weeks
Measured: 2 weeks
Number of participants with pain after EMR as assessed by VAS score and telephone interview at 2 weeks
Pain after EMR
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2016 (estimated)
- Study startJun 2016
- Primary completionJan 2020
- Study completionAug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 474 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Sydney Local Health District
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Michael Bourke, Western Sydney Local Health District
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02967107
- Sponsor's protocol ID
- HREC/15/WMEAD/507
- Acronym
- CSP-EMR
- Status last verified
- Jun 2023
- First submitted
- 13 Aug 2016
- Last updated
- 29 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cold Snare Polypectomy Versus Endoscopic Mucosal Resection for Colonic Sessile Serrated Polyps - A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02967107
- Acronym / sponsor ID
- CSP-EMR / HREC/15/WMEAD/507
- Conditions
- Colorectal Cancer, Adenoma
- Keywords
- adenoma, colorectal cancer, polypectomy, colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 474 participants (actual)
- Lead sponsor
- Western Sydney Local Health DistrictUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- Aug 2022 (actual)
- First posted
- 17 Nov 2016 (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.
Comparing the efficacy of cold snare polypectomy with endoscopic mucosal resection
Detailed description
Colorectal cancer (CRC) is the third most common cancer and it remains the second most commonly diagnosed malignancy in Australia. Colonoscopic polypectomy reduces the incidence and mortality from CRC by disrupting the adenoma-carcinoma sequence. Screening for CRC has proven to be effective in reducing mortality and morbidity from CRC and has become common practice. Interval cancers (development of a CRC within 6 to 60 months of a colonoscopy) occur in 6% of patients and estimations showed that up to 27% of these are due to incomplete adenoma resection.
The serrated neoplasia pathway accounts for 20- 30% of sporadic cancers. Serrated precursor lesions are thought to be a major contributor to the relative failure of colonoscopy in the prevention of proximal colorectal cancer (CRC) and to the 5- 7% of CRCs which occur in the period after complete colonoscopy and prior to surveillance, termed 'interval' cancer.
In addition to being difficult to detect, sessile serrated polyps (SSPs) are more likely to be incompletely resected than conventional adenomas. The CARE study demonstrated that 31% of SSPs had remnant tissue in the resection defect compared with 7.2% of conventional adenomas, and in lesions greater than 10 mm in size, residual tissue remained in 47.5%. SSPs may have indistinct margins, and smaller lesions may prove difficult to entrap with the snare because of their flat nature. SSPs also may contain dysplastic foci within the lesion, with an endoscopic appearance indistinguishable from conventional adenomas, and the surrounding serrated component may be overlooked and incompletely resected if this is not recognized.
The technique of colonoscopic polypectomy is continually evolving, leading to better outcomes with regard to polyp detection rate, complete resection rate (CRR) of polyps, patient comfort, safety and cost-efficacy. Although colonoscopy is considered the 'gold standard' for detecting and removing polyps, the technique is still imperfect. Questions about best practice for polypectomy remain, so optimizing the technique is expected to lead to better patient outcomes. The optimal treatment of SSPs should be effective, safe and inexpensive.
Such lesions can be removed by cold snare polypectomy or by endoscopic mucosal resection. Cold snare polypectomy (CSP) is now common practice and has proven to be a safe and effective technique for removal of any small polyps (<10 mm). Because of their physical characteristics, use of thin wire snares leads to a fast tissue transection and ability to remove SSP relatively swiftly. The size of snares suitable for SSP CSP is approximately 9 mm. Thus lesions greater than this size would need to be removed in more than one piece, introducing the possibility of incomplete resection. Endoscopic mucosal resection (EMR) is well established for laterally spreading colorectal lesions. It involves submucosal injection and diathermy assisted snare resection by piecemeal or en-bloc depending on polyp size. En bloc resection is possible for lesions up to 20 mm and facilitates histopathological evaluation. EMR is more time consuming than CSP and may be associated with diathermy related complications such as postpolypectomy bleeding, perforation and pain. The most efficient and safe method of removal of SSP has not been established.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cold snare polypectomy | Active comparator | Procedure: Cold snare polypectomyCold snare resection, if necessary, multi-piece to resect sessile serrated adenoma (SSA) 8-20mm |
| Endoscopic mucosal resection | Active comparator | Procedure: Endoscopic mucosal resectionEndoscopic mucosal resection (EMR), if necessary, multi-piece to resect sessile serrated adenoma (SSA) 8-20mm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- - Patients able to give informed consent to involvement in trial. For patients who do not speak English, an interpreter will be asked to translate the informed consent
- Patients referred to Westmead and Auburn Hospital Endoscopy Unit for a colonoscopy for all indications
- Age > 18 years
- At least one SSP 8-20 mm beyond the rectosigmoid junction without any endoscopic features of malignancy
- At least one SSP 8-20 mm beyond the rectosigmoid junction that according to the proceduralist, can be removed safely using either CSP or EMR
Key exclusion criteria (4 listed)
- Current use of antiplatelets (excluding aspirin) or anticoagulants which have not appropriately been interrupted according to the guidelines [21]
- Known coagulopathy
- Pregnancy
- If any doubt about the morphology of the polyp, the patient will be excluded from the study
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 |
|---|---|---|
| Cold snare polypectomyAlso: CSPUse of a polypectomy snare closed over a polyp without electrocautery | Procedure or surgery | Cold snare polypectomy |
| Endoscopic mucosal resectionAlso: EMRUse of injected chromogelofusine solution to raise a lesion prior to snare resection with electrocautery | Procedure or surgery | Endoscopic mucosal resection |
Primary outcome
Number of participants with residual or recurrent adenoma as assessed at surveillance endoscopy
Time frame: 4-6 months
3 secondary outcomes
Number of participants with bleeding after the EMR procedure has finished as assessed by telephone interview at 2 weeks
Time frame: 2 weeks
Number of participants with residual or recurrent adenoma as assessed at admission or telephone interview at 2 weeks
Time frame: 2 weeks
Number of participants with pain after EMR as assessed by VAS score and telephone interview at 2 weeks
Time frame: 2 weeks
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 29 Jun 2023.
- Individual participant dataSharing planned: Undecided
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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?
A study testing Cold snare polypectomy and Endoscopic mucosal resection in people with Colorectal Cancer and Adenoma, run by Western Sydney Local Health District at 1 site in Australia.
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 5 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 29 Jun 2023. 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 Australia. 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?
Number of participants with residual or recurrent adenoma as assessed at surveillance endoscopy (time frame: 4-6 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 29 Jun 2023.