Recurrences After Standard EMR vs Plus Thermal Ablation EMR (RESPECT)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Polyps of Colon; Recurrence, Local Neoplasm
• Intervention / Treatment: Procedure: Snare tip soft coagulation

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.

• Study Type: Interventional
• Enrollment (Estimated): 306
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gijs Kemper, MD; Phone Number: 31 614945308; Email: gijs.kemper@radboudumc.nl

Study Locations

• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6525
      • Recruiting
      • Radboudumc
      • Contact: Gijs Kemper

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EMR plus snare tip soft coagulation; Post procedural prophylactic coagulation of the entire margin of the resection site creating a 2-3mm rim.	Procedure: Snare tip soft coagulation; Thermal ablation of the entire resection margin
No Intervention: Standard EMR; No prophylactic coagulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence	Adenoma recurrence at resection site	6 months

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Collaborators: Catharina Ziekenhuis Eindhoven; Maasstad Hospital; Evangelisches Krankenhaus Düsseldorf; Bernhoven Hospital; St Jansdal Hospital; Bravis Hospital; Maas Hospital Pantein
• Investigators: Principal Investigator: Peter Siersema, Radboud University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2022
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: November 4, 2021
• First Submitted That Met QC Criteria: November 4, 2021
• First Posted (Actual): November 16, 2021

Study Record Updates

• Last Update Posted (Actual): December 26, 2023
• Last Update Submitted That Met QC Criteria: December 19, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: EMR; Snare tip soft coagulation
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Disease Attributes; Pathological Conditions, Anatomical; Neoplastic Processes; Polyps; Intestinal Polyps; Recurrence; Colonic Polyps; Neoplasm Recurrence, Local
• Other Study ID Numbers: NL7463209120

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no particular plan. But the investigators are willing to share the data with colleagues depending which research question they want to answer.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No