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Cold Snare Endoscopic Mucosal Resection (EMR) vs Cold EMR With Margin Snare Tip Soft Coagulation (STSC)

ConditionsColorectal PolypColon AdenomaColon Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWestern Sydney Local Health District

About this trial

Randomised controlled trial comparing cold snare endoscopic mucosal resection (EMR) with cold snare EMR and adjuvant margin STSC in the complete resection of 15-40mm lateral-spreading adenomas

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Localisation in the colon or rectum

Benign adenomatous surface features (Kudo III / IV, Japan NBI Expert Team (JNET) 2a)

Granular or non-granular topography

Paris classification 0-IIa/IIb +/- Is

Disqualifiers

Current use of antiplatelet (excluding aspirin) or anticoagulants which have not appropriately been interrupted according to the guidelines.

Known bleeding disorder or coagulopathy.

Pregnancy

History of inflammatory bowel disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cold Snare Endoscopic mucosal resection with adjuvant snare tip soft coagulation

    Procedure/Surgery

    Use of injected chromogelofusine solution to raise a lesion prior to polypectomy. Lesion then removed with a stiff thin-wired snare. Following this defect margins are treated with electrocautery to create a rim of ablated tissue.

  • Cold Snare Endoscopic Mucosal Resection

    Procedure/Surgery

    Use of injected chromogelofusine solution to raise a lesion prior to polypectomy. Lesion then removed with a stiff thin-wired snare.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Cold EMR with adjuvant STSC to marginsExperimental treatment 1 intervention
Group B: Cold EMRActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Complete resection rate (CRR)

Determined by endoscopic assessment (no visible residual adenoma) and histological assessment (biopsies of resection margin)

Time frame
1 day
2

Adenoma recurrence rate (ARR)

ARR at first surveillance colonoscopy (SC1) as determined by endoscopic assessment (no visible recurrent adenoma) and histological assessment (scar biopsies)

Time frame
4-6 months

Secondary outcomes

1

Intra-procedural and post-procedural complication rates

Intraprocedural bleeding, clinically significant post-polypectomy bleeding, deep mural injury, post polypectomy coagulation syndrome

Time frame
30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Western Sydney Local Health District

Lead sponsor

Source ClinicalTrials.gov
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