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Completed

NCT Number: NCT01789749

Soft Coagulation for the Prevention of Adenoma Recurrence

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.

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Key information

Conditions

Colonic Adenomas Adenoma Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Westmead Endoscopy Unit, Westmead, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Snare Tip Soft Coagulation

Other

No Snare Tip Soft Coagulation

Other

Primary outcomes

  1. Endoscopic recurrence

    Time frame: 4-6 months and 18 months

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

Secondary outcomes

  1. Histologic recurrence

    Time frame: 4-6 months and 18 months

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

  2. En bloc resection

    Time frame: Index procedure

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

  3. Snare resections

    Time frame: Index procedure

    The number of snare resections needed to achieve complete clearance

  4. Duration

    Time frame: Index procedure

    Time required for EMR

  5. Perforation during EMR

    Time frame: During index procedure

    Perforation during EMR

  6. Post EMR bleeding

    Time frame: Post Index procedure

    Bleeding after EMR requiring admission or repeat intervention

  7. Number of injections for hemostasis

    Time frame: Index procedure, if post EMR bleeding

    Number of injections required for haemostasis

  8. Location of bleeding vessels

    Time frame: Index procedure, if post EMR bleeding

    Location of bleeding vessels

  9. Size/number of bleeding vessels

    Time frame: Index procedure, if post EMR bleeding

    Size/number of bleeding vessels

  10. Delayed perforation

    Time frame: After index procedure

    Delayed perforation requiring intervention or readmission

  11. Readmission

    Time frame: After index procedure

    Readmission after index procedure

Sponsors and collaborators

Lead sponsor

Professor Michael Bourke

Other

Registry information

Official study title

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

Acronym: SCAR

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Feb 12, 2013
Registry last updated
Mar 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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