Symptoms and General Pathology

All Conditions

Neoplasms

Recurrence

Adenoma

Colonic Polyps

Polyps

Neoplasm Recurrence, Local

Disease Attributes

Intestinal Polyps

Pathological Conditions, Anatomical

Neoplastic Processes

Post procedural prophylactic coagulation of the entire margin of the resection site creating a 2-3mm rim.

Thermal ablation of the entire resection margin

Snare tip soft coagulation

Gijs Kemper, MD

Gijs Kemper

Peter Siersema

The primary objective of this trial is to investigate whether thermal ablation EMR with soft tip snare coagulation (STSC) reduces the recurrence rate of lateral spreading or sessile polyps ≥20mm compared to standard EMR.

Rationale:

Lowering the EMR recurrence rate will potentially lead to fewer colonoscopies resulting in less additional costs, less compliance burdens and less exposure to possible procedure related risks.

Objective:

To investigate whether thermal ablation EMR with snare tip soft coagulation (STSC) reduces the recurrence rate of lateral spreading or sessile polyps ≥20mm compared to standard EMR.

Study design:

This study entails a patient-blinded multicenter prospective randomized controlled trial that will be conducted between January 2022 and May 2025 in 1 academic and 7 non-academic hospitals in The Netherlands and it will take place in the outpatient clinics of the participating centers.

Study population:

All patients aged ≥ 18 years with proven colorectal sessile of lateral spreading polyps (Paris classification 0-IIa/b/c, Is) with a diameter of ≥ 20mm requiring piecemeal resection with EMR are eligible for inclusion.

Intervention:

Snare tip soft coagulation of the entire EMR margin is a technique for the removal of potential residual adenoma.

Main study endpoint:

Polyp recurrence after 6 months follow up. Recurrence is evaluated histologically and endoscopically with biopsies taken during follow up colonoscopy.

Recurrences After Standard EMR vs Plus Thermal Ablation EMR

Recurrences After Standard EMR vs Plus Thermal Ablation EMR of Advanced Sessile and Lateral Spreading Colorectal Adenoma

There is no particular plan. But the investigators are willing to share the data with colleagues depending which research question they want to answer.

Maas Hospital Pantein

Evangelisches Krankenhaus Düsseldorf

Catharina Ziekenhuis Eindhoven

Bernhoven Hospital

Maasstad Hospital

St Jansdal Hospital

Bravis Hospital

Radboud University Medical Center

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Herbal and Botanical

All Drugs and Chemicals

Cola

Patients do not receive Snare Tip Soft Coagulation to the edge of the endoscopic resection defect

Patients to receive Snare Tip Soft Coagulation to the edge of the endoscopic resection defect

Snare Tip Soft Coagulation

No Snare Tip Soft Coagulation

Michael Bourke, FRACP, MBBS

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.

Patients were blinded to the treatment allocation. The endoscopists performing the index and surveillance procedures were not blinded to the treatment.

Soft Coagulation for the Prevention of Adenoma Recurrence

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

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

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

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

The number of snare resections needed to achieve complete clearance

Bleeding after EMR requiring admission or repeat intervention

Number of injections required for haemostasis

Delayed perforation requiring intervention or readmission

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Recurrences After Standard EMR vs Plus Thermal Ablation EMR	NCT05121805	Polyps of Colon Recurrence, Loc...	Snare tip soft ...	18 Years -	Radboud University Medical Center
Recurrences After Standard EMR vs Plus Thermal Ablation EMR	NCT05121805	Polyps of Colon Recurrence, Loc...	Snare tip soft ...	18 Years -	Radboud University Medical Center
Soft Coagulation for the Prevention of Adenoma Recurrence	NCT01789749	Colonic Adenoma...	Snare Tip Soft ... No Snare Tip So...	18 Years -	Western Sydney Local Health District
Soft Coagulation for the Prevention of Adenoma Recurrence	NCT01789749	Colonic Adenoma...	Snare Tip Soft ... No Snare Tip So...	18 Years -	Western Sydney Local Health District

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