Polyps of ColonRESPECTNCT05121805
Recurrences After Standard EMR vs Plus Thermal Ablation EMR
A study testing Snare tip soft coagulation in people with Polyps of Colon and Recurrence, Local Neoplasm, run by Radboud University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polyps of Colon, Recurrence, Local Neoplasm
- What is being tested?
- Snare tip soft coagulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- 1 siteNetherlands
- Study dates
- 17 Mar 2022to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Proven colorectal sessile or lateral spreading polyps with a diameter of ≥ 20mm requiring piecemeal resection with EMR.
Who cannot join
- Previously attempted intervention
- Polyps with any signs of invasive malignancy
- Presence or suspicion of inflammatory bowel disease
- En bloc resection
- Incomplete resection
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Radboudumc
Nijmegen, Gelderland, 6525
Gijs Kemper
About this study
Official title: 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.
Read the 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.
- Conditions
- Polyps of Colon, Recurrence, Local Neoplasm
- Being tested
- Snare tip soft coagulation
- Keywords
- Snare tip soft coagulation, EMR
- Medical subject headings
- Colonic Polyps, Neoplasm Recurrence, Local
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Snare tip soft coagulationProcedure or surgery
Thermal ablation of the entire resection margin
| Study group | Role | What they receive |
|---|---|---|
| EMR plus snare tip soft coagulation | Experimental | Post procedural prophylactic coagulation of the entire margin of the resection site creating a 2-3mm rim. Receives: Procedure: Snare tip soft coagulation |
| Standard EMR | No intervention | No prophylactic coagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence
Adenoma recurrence at resection site
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start17 Mar 2022
- Primary completionApr 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polyps of ColonStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 306 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Maas Hospital Pantein, Evangelisches Krankenhaus Düsseldorf, Catharina Ziekenhuis Eindhoven, Bernhoven Hospital, Maasstad Hospital, St Jansdal Hospital, Bravis Hospital
- Responsible party
- Sponsor
- Investigators
- Peter Siersema, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05121805
- Sponsor's protocol ID
- NL7463209120
- Acronym
- RESPECT
- Status last verified
- Mar 2023
- First submitted
- 4 Nov 2021
- Last updated
- 26 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no particular plan. But the investigators are willing to share the data with colleagues depending which research question they want to answer.
Publications
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.
PubMed 38368409
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recurrences After Standard EMR vs Plus Thermal Ablation EMR of Advanced Sessile and Lateral Spreading Colorectal Adenoma
- ClinicalTrials.gov ID
- NCT05121805
- Acronym / sponsor ID
- RESPECT / NL7463209120
- Conditions
- Polyps of Colon, Recurrence, Local Neoplasm
- Keywords
- Snare tip soft coagulation, EMR
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 306 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Maas Hospital Pantein, Evangelisches Krankenhaus Düsseldorf, Catharina Ziekenhuis Eindhoven, Bernhoven Hospital, Maasstad Hospital, St Jansdal Hospital, Bravis Hospital
- Study start
- 17 Mar 2022 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 16 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMR plus snare tip soft coagulation | Experimental | Procedure: Snare tip soft coagulationPost procedural prophylactic coagulation of the entire margin of the resection site creating a 2-3mm rim. |
| Standard EMR | No intervention | –No prophylactic coagulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Proven colorectal sessile or lateral spreading polyps with a diameter of ≥ 20mm requiring piecemeal resection with EMR.
Key exclusion criteria (5 listed)
- Previously attempted intervention
- Polyps with any signs of invasive malignancy
- Presence or suspicion of inflammatory bowel disease
- En bloc resection
- Incomplete resection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Snare tip soft coagulationThermal ablation of the entire resection margin | Procedure or surgery | EMR plus snare tip soft coagulation |
Primary outcome
Recurrence
Time frame: 6 months
Adenoma recurrence at resection site
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
- Derived from this study: PubMed 38368409Kemper 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.
- Individual participant dataSharing planned: No. There is no particular plan. But the investigators are willing to share the data with colleagues depending which research question they want to answer.
Related trials for Polyps of Colon
Active, not recruiting
Virtual Incision Robotically Assisted Surgical Device Use in Minimally Invasive Colectomy
Colon Cancer, Colon Polyp
Enrolling by invitation
Cold Snare Piecemeal Resection vs Cold Snare Endoscopic Mucosal Resection
Colon Polyp, Colon Adenoma
Enrolling by invitation
Six Versus Twelve Month Index Follow-up After Large Colon Polyp Resection
Colon Polyp, Adenoma
Recruiting
Comparison of Adenoma Detection Rate in 3D vs. 2D Surveillance Colonoscopy
Colonoscopy, Adenoma Detection Rate
Recruiting
Reducing Neoplasia Recurrence After Endoscopic Resection of Large Colorectal Polyps
Colorectal Cancer, Polyp of Colon
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Siersema principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Snare tip soft coagulation in people with Polyps of Colon and Recurrence, Local Neoplasm, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gijs Kemper, MD (31 614945308, gijs.kemper@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05121805, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2023; AzTrials last refreshed its copy on 6 Nov 2026.