STSC-HybridAPC Trial
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWestern Sydney Local Health District
About this trial
Margin thermal ablation after piecemeal EMR significantly reduces recurrence of large colorectal polyps. As recurrence rates are now low, the key implementation question relates to efficiency and reproducibility of different ablation techniques. This randomized controlled trial compares snare tip soft coagulation (STSC) with Hybrid APC (ERBE), with procedural time as the primary endpoint.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
Undergoing piecemeal EMR of a non-pedunculated colorectal lesion ≥20 mm in size
Macroscopically complete resection achieved prior to margin ablation (no visible residual adenomatous tissue at the resection base)
Ability to provide written informed consent
Disqualifiers
Lesions requiring en bloc resection by ESD
Lesions with suspected deep submucosal invasion based on endoscopic assessment (e.g., depressed morphology, non-lifting sign, NICE type 3 pattern, or equivalent advanced imaging criteria)
Inflammatory bowel disease with active colitis at the lesion site
Overt invasive carcinoma requiring surgical management
Trial design
Design model
Parallel
Treatments tested in this trial
Snare Tip Soft Coagulation (STSC)
Procedure/SurgeryCircumferential thermal ablation of the resection margin will be performed using the distal tip of a standard polypectomy snare in soft coagulation mode. The tip will be applied sequentially to the entire visible mucosal defect margin to achieve complete circumferential treatment.
Hybrid APC (ERBE)
Procedure/SurgeryCircumferential thermal ablation of the resection margin will be performed using Hybrid APC (ERBE) in standard APC mode. The argon plasma beam will be applied sequentially to the entire visible mucosal defect margin to achieve complete circumferential treatment. Electrosurgical settings will be standardized according to unit protocol (effect and wattage predefined for Hybrid APC use).
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: Snare Tip Soft Coagulation (STSC)Active comparator 1 intervention
Group B: Hybrid APC (ERBE)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Net margin ablation time
Net margin ablation time (seconds), defined as the elapsed time from the first application of thermal energy to the resection margin (first activation in soft coagulation mode) until the operator declares completion of circumferential margin ablation. Time will be recorded using a standardized stopwatch method by a trained assistant/nurse (or captured from time-stamped video, if available). Interruptions unrelated to margin ablation (e.g., equipment troubleshooting) will be documented and excluded from net time where feasible, with sensitivity analyses planned.
Time frame
during the procedureSecondary outcomes
1
Time (total)
Total procedure time (minutes): from first endoscopic view of the lesion to scope withdrawal.
Time frame
during procedure2
Technical success of margin ablation
Technical success of margin ablation: completion of circumferential thermal treatment of the entire visible mucosal defect margin as judged by the supervising endoscopist and recorded as yes/no.
Time frame
during procedure3
Instrument exchanges (count)
Instrument exchanges (count): number of device exchanges required after completion of EMR to achieve margin ablation.
Time frame
during procedure4
Need for additional haemostatic therapy (yes/no)
Need for additional haemostatic therapy (yes/no): including clips, APC outside assigned intervention, injectable agents, or other modalities used for bleeding control.
Time frame
during procedureSponsors and contacts
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Source ClinicalTrials.gov
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