Colorectal NeoplasmsMATILDANCT02657044
EMR Versus ESD for Resection of Large Distal Non-pedunculated Colorectal Adenomas
A study testing EMR and ESD in people with Colorectal Neoplasms, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
Endoscopic resection of adenomas in the colon is the cornerstone of effective colorectal cancer prevention. Endoscopic mucosal resection (EMR) is currently the most used technique for resection of large distal colorectal adenomas, however, maintains some important limitations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- EMR and ESD
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2016to Dec 2020
- 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
- non-pedunculated polyp larger than 20 mm in the rectum, sigmoid or descending colon found during colonoscopy
- indication for endoscopic treatment
- ≥18 years old
- Written informed consent
Who cannot join
- suspicion of malignancy, as determined by endoscopic findings (invasive Kudo pit pattern, Hiroshima type C) or proven malignancy at histology
- prior endoscopic resection attempt
- presence of synchronous distal advanced carcinoma that requires surgical resection
- the risk exceeds the benefit of endoscopic treatment, such as patient's with an extremely poor general condition or a very short life expectancy
- the inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
UMC Utrecht
Utrecht, Utrecht, 3508GA
Yara Backes, MD, +31 88 75 507 22, y.backes@umcutrecht.nl
About this study
Official title: Multicenter, Randomised Controlled Trial Comparing Endoscopic Mucosal Resection (EMR) And Endoscopic Submucosal dissecTIon (ESD) for Resection of Large Distal Non-pedunculated Colorectal Adenomas (MATILDA-trial)
Endoscopic resection of adenomas in the colon is the cornerstone of effective colorectal cancer prevention. Endoscopic mucosal resection (EMR) is currently the most used technique for resection of large distal colorectal adenomas, however, maintains some important limitations. In large lesions, EMR can often only be performed in a piecemeal fashion resulting in relatively low R0-resection rates and high recurrence rates. Endoscopic submucosal dissection (ESD) is a newer procedure that is more difficult resulting in a longer procedural time, but is promising due to the high en-bloc resection rates and the very low recurrence rates. The aim of this multicenter randomized study is to compare EMR and ESD with regard to recurrence rates and radical (R0) resection rates, and to put this into perspective against the costs and complication rates of both strategies and the burden perceived by patients on the long term-term.
- Conditions
- Colorectal Neoplasms
- Being tested
- EMR, ESD
- Keywords
- EMR, ESD, endoscopic mucosal resection, endoscopic submucosal resection, colorectal adenomas
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMRProcedure or surgery
Also called Endoscopic Mucosal Resection
ESDProcedure or surgery
Also called Endoscopic Submucosal Dissection
| Study group | Role | What they receive |
|---|---|---|
| EMR | Active comparator | In the EMR-arm, endoscopic resection will be performed using the (p)EMR technique. Receives: Procedure: EMR |
| ESD | Active comparator | In the ESD-arm, endoscopic resection will be performed using the (h)ESD technique. Receives: Procedure: ESD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate at follow-up colonoscopy after 6 months
Observed from resected residual disease or, if not present, from biopsies of the scar
Measured: 6 months
Secondary outcomes (6)
Long-term recurrence rate at follow-up colonoscopy after 36 months
Observed from resected residual disease or, if not present, from biopsies of the scar
Measured: 36 months
Health care resource utilization and consts
Healthcare costs will be calculated by multiplying used healthcare services with unit prices. The cost-effectiveness of ESD against EMR will be expressed as incremental cost-effectiveness ratios (ICER) showing additional costs per recurrence free patient and as ICER showing additional costs per QALY.
Measured: 36 months
Perceived burden and quality of life among patients
Measurement of the patients' burden of ESD versus EMR will be evaluated with regard to colorectal cancer anxiety, burden of the procedure itself, functional complaints and overall quality of life. Meaurement will be performed using validated questionnaires.
Measured: 36 months
Complication rate
Complications will be assessed on day 30: intraprocedural perforation, Intraprocedural bleeding, Postprocedural bleeding, Postprocedural perforation, Postprocedural serositis.
Measured: 30 days
Surgical referral rate
Defined as the number of patients that are referred for surgical management at 36 months
Measured: 36 months
R0-resection rate
Defined as dysplasia free vertical and lateral resection margins at histology
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2016 (estimated)
- Study startApr 2016
- Primary completionSep 2018 (estimated)
- Study completionDec 2020 (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 Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe 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
- None (open label)
- Enrolment
- 212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Comprehensive Cancer Centre The Netherlands
- Responsible party
- Principal investigator, L.M.G. Moons, UMC Utrecht
- Investigators
- L.M.G. Moons, MD, PhD, Principal investigator, UMC UtrechtA.D. Koch, MD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02657044
- Sponsor's protocol ID
- 15-610/D
- Other IDs
- TDM-H1/8051
- Acronym
- MATILDA
- Status last verified
- Oct 2016
- First submitted
- 8 Jan 2016
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Backes Y, Moons LM, van Bergeijk JD, Berk L, Ter Borg F, Ter Borg PC, Elias SG, Geesing JM, Groen JN, Hadithi M, Hardwick JC, Kerkhof M, Mangen MJ, Straathof JW, Schroder R, Schwartz MP, Spanier BW, de Vos Tot Nederveen Cappel WH, Wolfhagen FH, Koch AD. Endoscopic mucosal resection (EMR) versus endoscopic submucosal dissection (ESD) for resection of large distal non-pedunculated colorectal adenomas (MATILDA-trial): rationale and design of a multicenter randomized clinical trial. BMC Gastroenterol. 2016 May 26;16(1):56. doi: 10.1186/s12876-016-0468-6.
PubMed 27229709
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomised Controlled Trial Comparing Endoscopic Mucosal Resection (EMR) And Endoscopic Submucosal dissecTIon (ESD) for Resection of Large Distal Non-pedunculated Colorectal Adenomas (MATILDA-trial)
- ClinicalTrials.gov ID
- NCT02657044
- Acronym / sponsor ID
- MATILDA / 15-610/D
- Conditions
- Colorectal Neoplasms
- Keywords
- EMR, ESD, endoscopic mucosal resection, endoscopic submucosal resection, colorectal adenomas
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Comprehensive Cancer Centre The Netherlands
- Study start
- Apr 2016
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 15 Jan 2016 (estimated)
- 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.
Endoscopic resection of adenomas in the colon is the cornerstone of effective colorectal cancer prevention. Endoscopic mucosal resection (EMR) is currently the most used technique for resection of large distal colorectal adenomas, however, maintains some important limitations. In large lesions, EMR can often only be performed in a piecemeal fashion resulting in relatively low R0-resection rates and high recurrence rates. Endoscopic submucosal dissection (ESD) is a newer procedure that is more difficult resulting in a longer procedural time, but is promising due to the high en-bloc resection rates and the very low recurrence rates. The aim of this multicenter randomized study is to compare EMR and ESD with regard to recurrence rates and radical (R0) resection rates, and to put this into perspective against the costs and complication rates of both strategies and the burden perceived by patients on the long term-term.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMR | Active comparator | Procedure: EMRIn the EMR-arm, endoscopic resection will be performed using the (p)EMR technique. |
| ESD | Active comparator | Procedure: ESDIn the ESD-arm, endoscopic resection will be performed using the (h)ESD technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- non-pedunculated polyp larger than 20 mm in the rectum, sigmoid or descending colon found during colonoscopy
- indication for endoscopic treatment
- ≥18 years old
- Written informed consent
Key exclusion criteria (5 listed)
- suspicion of malignancy, as determined by endoscopic findings (invasive Kudo pit pattern, Hiroshima type C) or proven malignancy at histology
- prior endoscopic resection attempt
- presence of synchronous distal advanced carcinoma that requires surgical resection
- the risk exceeds the benefit of endoscopic treatment, such as patient's with an extremely poor general condition or a very short life expectancy
- the inability to provide informed consent
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 |
|---|---|---|
| EMRAlso: Endoscopic Mucosal Resection | Procedure or surgery | EMR |
| ESDAlso: Endoscopic Submucosal Dissection | Procedure or surgery | ESD |
Primary outcome
Recurrence rate at follow-up colonoscopy after 6 months
Time frame: 6 months
Observed from resected residual disease or, if not present, from biopsies of the scar
6 secondary outcomes
Long-term recurrence rate at follow-up colonoscopy after 36 months
Time frame: 36 months
Health care resource utilization and consts
Time frame: 36 months
Perceived burden and quality of life among patients
Time frame: 36 months
Complication rate
Time frame: 30 days
Surgical referral rate
Time frame: 36 months
R0-resection rate
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
- Derived from this study: PubMed 27229709Backes Y, Moons LM, van Bergeijk JD, Berk L, Ter Borg F, Ter Borg PC, Elias SG, Geesing JM, Groen JN, Hadithi M, Hardwick JC, Kerkhof M, Mangen MJ, Straathof JW, Schroder R, Schwartz MP, Spanier BW, de Vos Tot Nederveen Cappel WH, Wolfhagen FH, Koch AD. Endoscopic mucosal resection (EMR) versus endoscopic submucosal dissection (ESD) for resection of large distal non-pedunculated colorectal adenomas (MATILDA-trial): rationale and design of a multicenter randomized clinical trial. BMC Gastroenterol. 2016 May 26;16(1):56. doi: 10.1186/s12876-016-0468-6.
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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.
L.M.G. Moons, MD, PhD principal investigator
UMC Utrecht
A.D. Koch, MD, PhD principal investigator
Erasmus 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 EMR and ESD in people with Colorectal Neoplasms, run by UMC Utrecht 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 4 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 Oct 2016. 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 Y. Backes, MD (003187550722, y.backes@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate at follow-up colonoscopy after 6 months (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 NCT02657044, 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 Oct 2016.