Recurrences After Standard EMR vs Plus Thermal Ablation EMR

Polyps of Colon Clinical Trial

— RESPECT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05121805
• Other study ID #: NL7463209120
• Status: Recruiting
• Phase: N/A
• Start date: March 17, 2022
• Est. completion date: September 2024

Study information

• Verified date: March 2023
• Source: Radboud University Medical Center
• Contact: Gijs Kemper, MD
• Phone: 31 614945308
• Email: gijs.kemper[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 306
• Est. completion date: September 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colonic Polyps
• Neoplasm Recurrence, Local
• Polyps of Colon
• Recurrence
• Recurrence, Local Neoplasm

Intervention

Procedure:
• Snare tip soft coagulation
Thermal ablation of the entire resection margin

Locations

Country	Name	City	State
Netherlands	Radboudumc	Nijmegen	Gelderland

Sponsors (8)

Lead Sponsor	Collaborator
Radboud University Medical Center	Bernhoven Hospital, Bravis Hospital, Catharina Ziekenhuis Eindhoven, Evangelisches Krankenhaus Düsseldorf, Maas Hospital Pantein, Maasstad Hospital, St Jansdal Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence	Adenoma recurrence at resection site	6 months