AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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.

Australia1 site
  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

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.

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 groups in NCT02967107
Study groupRoleWhat they receive
Cold snare polypectomyActive comparatorCold snare resection, if necessary, multi-piece to resect sessile serrated adenoma (SSA) 8-20mm
Receives: Procedure: Cold snare polypectomy
Endoscopic mucosal resectionActive comparatorEndoscopic 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.

  1. Number of participants with residual or recurrent adenoma as assessed at surveillance endoscopy

    Measured: 4-6 months

Secondary outcomes (3)
  1. Number of participants with bleeding after the EMR procedure has finished as assessed by telephone interview at 2 weeks

    Measured: 2 weeks

  2. Number of participants with residual or recurrent adenoma as assessed at admission or telephone interview at 2 weeks

    Measured: 2 weeks

  3. 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.

  1. First posted17 Nov 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionJan 2020
  4. Study completionAug 2022

Resources

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)
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

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; AzTrials last refreshed its copy on 6 Nov 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in