Recurrences After Standard EMR vs Plus Thermal Ablation EMR
RESPECT
1 other identifier
interventional
306
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 4, 2021
CompletedFirst Posted
Study publicly available on registry
November 16, 2021
CompletedStudy Start
First participant enrolled
March 17, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2024
CompletedDecember 26, 2023
March 1, 2023
2 years
November 4, 2021
December 19, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recurrence
Adenoma recurrence at resection site
6 months
Study Arms (2)
EMR plus snare tip soft coagulation
EXPERIMENTALPost procedural prophylactic coagulation of the entire margin of the resection site creating a 2-3mm rim.
Standard EMR
NO INTERVENTIONNo prophylactic coagulation
Interventions
Thermal ablation of the entire resection margin
Eligibility Criteria
You may qualify if:
- Proven colorectal sessile or lateral spreading polyps with a diameter of ≥ 20mm requiring piecemeal resection with EMR.
You may not qualify if:
- Previously attempted intervention
- Polyps with any signs of invasive malignancy
- Presence or suspicion of inflammatory bowel disease
- En bloc resection
- Incomplete resection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Radboud University Medical Centerlead
- Maas Hospital Panteincollaborator
- Evangelisches Krankenhaus Düsseldorfcollaborator
- Catharina Ziekenhuis Eindhovencollaborator
- Bernhoven Hospitalcollaborator
- Maasstad Hospitalcollaborator
- St Jansdal Hospitalcollaborator
- Bravis Hospitalcollaborator
Study Sites (1)
Radboudumc
Nijmegen, Gelderland, 6525, Netherlands
Related Publications (1)
Kemper G, Gerges C, Schoon EJ, Schreuder RM, Schrauwen RRW, Epping LSM, Beyna T, Drenth JPH, Gundug U, Siersema PD, van Geenen EJM; ENDOCARE study group. Recurrences of advanced sessile and lateral spreading colorectal adenoma after endoscopic mucosal resection (EMR) thermal ablation versus no adjuvant therapy (RESPECT): a protocol of an international randomized controlled trial. Trials. 2024 Feb 17;25(1):132. doi: 10.1186/s13063-024-07915-2.
PMID: 38368409DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Siersema
Radboud University Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 4, 2021
First Posted
November 16, 2021
Study Start
March 17, 2022
Primary Completion
April 1, 2024
Study Completion
September 1, 2024
Last Updated
December 26, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share
There is no particular plan. But the investigators are willing to share the data with colleagues depending which research question they want to answer.