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Colonic AdenomasSCARNCT01789749

Soft Coagulation for the Prevention of Adenoma Recurrence

A study testing Snare Tip Soft Coagulation and No Snare Tip Soft Coagulation in people with Colonic Adenomas, run by Professor Michael Bourke at 4 sites in Australia.

Completed

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

Official record
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Trial summary

Recurrence after endoscopic mucosal resection of laterally spreading lesions (LSL) >= 20mm in size occurs in approximately 20% of cases at surveillance colonoscopy. We aim to evaluate the efficacy of prophylactic adjuvant thermal ablation of the EMR mucosal defect margin in reducing adenoma recurrence following… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colonic Adenomas
What is being tested?
Snare Tip Soft Coagulation and No Snare Tip Soft Coagulation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
455 participants
Where
4 sitesAustralia
Study dates
Jul 2013to 16 Dec 2016
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

  • Referred for removal of a colonic polyp >= 20mm in size
  • Able to give informed consent to involvement in trial

Who cannot join

  • Younger than 18 years of age
  • Highly dependant on medical care
  • Women who are pregnant or may be pregnant.
  • Taken clopidogrel within 7 days
  • Taken warfarin within 5 days
  • Had full therapeutic dose unfractionated heparin within 6 hours
Show all 12Show fewer
  • Had full therapeutic dose low molecular weight heparin (LMWH) within 12 hours
  • Known clotting disorder
  • Previous attempt at EMR of the polyp referred for resection
  • Polyp located at the ileo-caecal valve, appendiceal orifice
  • Fully circumferential polyp
  • Incomplete snare resection of the polyp

Trial locations and contacts

4 sites in 1 country.

Australia4 sites

  • Lyell McEwin Hospital

    Adelaide, South Australia

  • Princess Alexandra Hospital

    Brisbane, Queensland

  • The Alfred Hospital

    Melbourne, VA

  • Westmead Endoscopy Unit

    Westmead, New South Wales, 2145

Other trials in Australia

About this study

Official title: Soft Coagulation for the Prevention of Adenoma Recurrence After Endoscopic Mucosal Resection (EMR) of Large Sessile Colonic Polyps: A Multicentre, Randomized Trial.

Recurrence after endoscopic mucosal resection of laterally spreading lesions (LSL) >= 20mm in size occurs in approximately 20% of cases at surveillance colonoscopy. We aim to evaluate the efficacy of prophylactic adjuvant thermal ablation of the EMR mucosal defect margin in reducing adenoma recurrence following colonic EMR.

Being tested
Snare Tip Soft Coagulation, No Snare Tip Soft Coagulation
Keywords
snare tip soft coagulation, endoscopic mucosal resection, adenoma recurrence, adenoma, colonoscopy
Medical subject headings
Adenoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Snare Tip Soft CoagulationOther

  • No Snare Tip Soft CoagulationOther

Study groups in NCT01789749
Study groupRoleWhat they receive
No Coagulation ArmActive comparatorPatients do not receive Snare Tip Soft Coagulation to the edge of the endoscopic resection defect
Receives: Other: No Snare Tip Soft Coagulation
Coagulation ArmExperimentalPatients to receive Snare Tip Soft Coagulation to the edge of the endoscopic resection defect
Receives: Other: Snare Tip Soft Coagulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Endoscopic recurrence

    Presence of residual/recurrent adenoma at the EMR scar at endoscopic follow-up

    Measured: 4-6 months and 18 months

Secondary outcomes (11)

  1. Histologic recurrence

    Presence of residual/recurrent adenoma on biopsy of the endoscopic resection scar

    Measured: 4-6 months and 18 months

  2. En bloc resection

    Rate of 'en bloc resection' (removing entire lesion in one snare) with histologically confirmed clear margins

    Measured: Index procedure

  3. Snare resections

    The number of snare resections needed to achieve complete clearance

    Measured: Index procedure

  4. Duration

    Time required for EMR

    Measured: Index procedure

  5. Perforation during EMR

    Perforation during EMR

    Measured: During index procedure

  6. Post EMR bleeding

    Bleeding after EMR requiring admission or repeat intervention

    Measured: Post Index procedure

  7. Number of injections for hemostasis

    Number of injections required for haemostasis

    Measured: Index procedure, if post EMR bleeding

  8. Location of bleeding vessels

    Location of bleeding vessels

    Measured: Index procedure, if post EMR bleeding

  9. Size/number of bleeding vessels

    Size/number of bleeding vessels

    Measured: Index procedure, if post EMR bleeding

  10. Delayed perforation

    Delayed perforation requiring intervention or readmission

    Measured: After index procedure

  11. Readmission

    Readmission after index procedure

    Measured: After index procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2013 (estimated)
  2. Study startJul 2013
  3. Primary completion16 May 2016
  4. Study completion16 Dec 2016

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
455 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01789749
Sponsor's protocol ID
HREC/12/WMEAD/139
Other IDs
HREC2012/5/4.6 (3512)
Acronym
SCAR
Status last verified
Mar 2021
First submitted
28 Nov 2012
Last updated
23 Mar 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • Klein A, Tate DJ, Jayasekeran V, Hourigan L, Singh R, Brown G, Bahin FF, Burgess N, Williams SJ, Lee E, Sidhu M, Byth K, Bourke MJ. Thermal Ablation of Mucosal Defect Margins Reduces Adenoma Recurrence After Colonic Endoscopic Mucosal Resection. Gastroenterology. 2019 Feb;156(3):604-613.e3. doi: 10.1053/j.gastro.2018.10.003. Epub 2018 Oct 6.

    PubMed 30296436

Questions about this trial

What is this clinical trial studying?

A study testing Snare Tip Soft Coagulation and No Snare Tip Soft Coagulation in people with Colonic Adenomas, run by Professor Michael Bourke at 4 sites 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 2 inclusion and 12 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 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

Endoscopic recurrence (time frame: 4-6 months and 18 months). 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 NCT01789749, 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 23 Mar 2021.

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