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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05121805
Acronym
RESPECT
Enrollment
306
Registered
2021-11-16
Start date
2022-03-17
Completion date
2024-09-30
Last updated
2023-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polyps of Colon, Recurrence, Local Neoplasm

Keywords

Snare tip soft coagulation, EMR

Brief summary

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.

Detailed description

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.

Interventions

Thermal ablation of the entire resection margin

Sponsors

Maas Hospital Pantein
CollaboratorOTHER
Evangelisches Krankenhaus Düsseldorf
CollaboratorOTHER
Catharina Ziekenhuis Eindhoven
CollaboratorOTHER
Bernhoven Hospital
CollaboratorOTHER
Maasstad Hospital
CollaboratorOTHER
St Jansdal Hospital
CollaboratorOTHER
Bravis Hospital
CollaboratorOTHER
Radboud University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Proven colorectal sessile or lateral spreading polyps with a diameter of ≥ 20mm requiring piecemeal resection with EMR.

Exclusion criteria

* Previously attempted intervention * Polyps with any signs of invasive malignancy * Presence or suspicion of inflammatory bowel disease * En bloc resection * Incomplete resection

Design outcomes

Primary

MeasureTime frameDescription
Recurrence6 monthsAdenoma recurrence at resection site

Countries

Netherlands

Contacts

Primary ContactGijs Kemper, MD
gijs.kemper@radboudumc.nl31 614945308

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026