PolypsNCT03868605
Endoscopic Full Thickness Resection Versus Standard Therapy of the Colorectal Neoplasia
A study testing EMR and ESD and Over- the- scope full- thickness resection device in people with Polyps and Colon Cancer, run by Military University Hospital, Prague at 1 site in Czechia.
Trial summary
Most of the cancers develop from the adenomatous polyps. The therapeutic methods have been established already - endoscopic polypectomy (EPE) for stalked polyps and endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) for non-pedunculated polyps. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polyps, Colon Cancer
- What is being tested?
- EMR and ESD and Over- the- scope full- thickness resection device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCzechia
- Study dates
- 31 May 2019to Dec 2022
- 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
- age ≥ 18 years
- colorectal lesions of 10-25 mm size with positive non-lifting sign
- signed informed consent with the study and with colonoscopy
Who cannot join
- age < 18 years
- lesions > 25 mm
- pedunculated polyps
- colorectal stenosis
- colonoscopy contraindication
- severe acute inflammatory bowel disease
- severe comorbidities
- patient not able to sign the informed consent
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Military University Hospital
Prague
Stepan Suchanek, Ph.D.
About this study
Official title: Endoscopic Full Thickness Resection Versus Standard Therapy of the Colorectal Neoplasia - Prospective Randomized Study
Most of the cancers develop from the adenomatous polyps. The therapeutic methods have been established already - endoscopic polypectomy (EPE) for stalked polyps and endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) for non-pedunculated polyps. EMR is preferred in European countries over ESD because of its higher feasibility. However, the local residual neoplasia (LRN) after EMR has been reported in 14 - 24 % cases. There is a higher LRN risk in sessile polyps which do not elevate sufficiently after the submucosal injection (non-lifting sign) and the piece-meal resection needs to be used. Therefore, the new method of endoscopic full-thickness resection (FTR) has been developed to resect these lesions.
Read the detailed description
In this project, 80 individuals (age ≥ 18 years) with colorectal lesions of 10-25 mm size with positive non-lifting sign will be included. Such lesions might be found during the colonoscopies at the trial endoscopy centers or at the cooperating referring endoscopy centers outside the study. Patient will be scheduled for the index therapeutic colonoscopy (iTC) and randomized in two groups - FTR group (therapy with FTRD) and ST group (standard therapy, EMR or ESD due to the indication, decided by the endoscopist). First follow-up colonoscopy (FC1) will be performed in 6 months interval. In case of LRN negativity at FC1, the second follow-up colonoscopy (FC2) will be done after 12 months (18 months since iTC). In case of LRN positivity at FC1, the LRN therapeutic colonoscopy (LRN-TC) will follow with the endoscopic method due the findings (patients will be divided into four groups): APC group (LRN ≤ 5 mm; APC therapy), EMR group (LRN > 5 mm and negative non-lifting sign negative; EMR therapy), FTR group (LRN > 5 mm and positive non-lifting sign; therapy with FTRD) and surgery group (complex lesion; surgical therapy). In some LRN positive cases, FC1 will be the same as LRN-TC. The first follow-up colonoscopy after LRN therapy (LRN-FC1) will be performed after 6 months (12 months since TC). In case of re-LRN negativity at LRN-FC1 the second follow-up colonoscopy after LRN therapy (LRN-FC2) will be done after 6 months (18 months since iTC). In case of re-LRN positivity at LRN- FC1 the therapy will be done same as during FC1 and next follow-up will be done outside this trial. In some re-LRN positive cases, LRN-FC1 will be the same as re-LRN-TC. In conclusion, all patients will be followed-up within the study for 18 months, if timely possible.
- Conditions
- Polyps, Colon Cancer
- Being tested
- EMR and ESD, Over- the- scope full- thickness resection device
- Medical subject headings
- Polyps, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMR and ESDDevice
Endoscopic mucosal resection using a resection snare Endoscopic submucosal dissection using an electrosurgical knife
Over- the- scope full- thickness resection deviceDevice
Endoscopic resection of neoplastic lesions of the colon using the over- the- scope full- thickness resection device
| Study group | Role | What they receive |
|---|---|---|
| EMR/ESD | Experimental | Standard EMR or ESD technique Receives: Device: EMR and ESD |
| Over- the- scope full- thickness resection device | Experimental | Endoscopic full thickness resection Receives: Device: Over- the- scope full- thickness resection device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of R0 procedures
proportion of patients with resection specimens with negative horizontal and vertical margins confirmed by histopathology
Measured: 3 months
Secondary outcomes (1)
Proportion of curative resections
Proportion of the LRN at 6 months and 12 months follow-up colonoscopy after the index therapeutic colonoscopy
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start31 May 2019
- Primary completionJun 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PolypsStudies of the same condition, open and under way.
- 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Military University Hospital, Prague
- Sponsor type
- University, hospital or other
- Collaborators
- Masaryk University, University Hospital Olomouc
- Responsible party
- Principal investigator, Stepan Suchanek, MD., Ph.D., Military University Hospital, Prague
- Investigators
- Stepan Suchanek, MD., Ph.D, Principal investigator, Military University Hospital, Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03868605
- Sponsor's protocol ID
- NV-18-08-00246
- Status last verified
- Apr 2022
- First submitted
- 7 Mar 2019
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Full Thickness Resection Versus Standard Therapy of the Colorectal Neoplasia - Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT03868605
- Acronym / sponsor ID
- NV-18-08-00246
- Conditions
- Polyps, Colon Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Military University Hospital, PragueUniversity, hospital or other
- Collaborators
- Masaryk University, University Hospital Olomouc
- Study start
- 31 May 2019 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 11 Mar 2019 (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.
Most of the cancers develop from the adenomatous polyps. The therapeutic methods have been established already - endoscopic polypectomy (EPE) for stalked polyps and endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) for non-pedunculated polyps. EMR is preferred in European countries over ESD because of its higher feasibility. However, the local residual neoplasia (LRN) after EMR has been reported in 14 - 24 % cases. There is a higher LRN risk in sessile polyps which do not elevate sufficiently after the submucosal injection (non-lifting sign) and the piece-meal resection needs to be used. Therefore, the new method of endoscopic full-thickness resection (FTR) has been developed to resect these lesions.
Detailed description
In this project, 80 individuals (age ≥ 18 years) with colorectal lesions of 10-25 mm size with positive non-lifting sign will be included. Such lesions might be found during the colonoscopies at the trial endoscopy centers or at the cooperating referring endoscopy centers outside the study. Patient will be scheduled for the index therapeutic colonoscopy (iTC) and randomized in two groups - FTR group (therapy with FTRD) and ST group (standard therapy, EMR or ESD due to the indication, decided by the endoscopist). First follow-up colonoscopy (FC1) will be performed in 6 months interval. In case of LRN negativity at FC1, the second follow-up colonoscopy (FC2) will be done after 12 months (18 months since iTC). In case of LRN positivity at FC1, the LRN therapeutic colonoscopy (LRN-TC) will follow with the endoscopic method due the findings (patients will be divided into four groups): APC group (LRN ≤ 5 mm; APC therapy), EMR group (LRN > 5 mm and negative non-lifting sign negative; EMR therapy), FTR group (LRN > 5 mm and positive non-lifting sign; therapy with FTRD) and surgery group (complex lesion; surgical therapy). In some LRN positive cases, FC1 will be the same as LRN-TC. The first follow-up colonoscopy after LRN therapy (LRN-FC1) will be performed after 6 months (12 months since TC). In case of re-LRN negativity at LRN-FC1 the second follow-up colonoscopy after LRN therapy (LRN-FC2) will be done after 6 months (18 months since iTC). In case of re-LRN positivity at LRN- FC1 the therapy will be done same as during FC1 and next follow-up will be done outside this trial. In some re-LRN positive cases, LRN-FC1 will be the same as re-LRN-TC. In conclusion, all patients will be followed-up within the study for 18 months, if timely possible.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMR/ESD | Experimental | Device: EMR and ESDStandard EMR or ESD technique |
| Over- the- scope full- thickness resection device | Experimental | Device: Over- the- scope full- thickness resection deviceEndoscopic full thickness resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age ≥ 18 years
- colorectal lesions of 10-25 mm size with positive non-lifting sign
- signed informed consent with the study and with colonoscopy
Key exclusion criteria (8 listed)
- age < 18 years
- lesions > 25 mm
- pedunculated polyps
- colorectal stenosis
- colonoscopy contraindication
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 |
|---|---|---|
| EMR and ESDEndoscopic mucosal resection using a resection snare Endoscopic submucosal dissection using an electrosurgical knife | Device | EMR/ESD |
| Over- the- scope full- thickness resection deviceEndoscopic resection of neoplastic lesions of the colon using the over- the- scope full- thickness resection device | Device | Over- the- scope full- thickness resection device |
Primary outcome
Proportion of R0 procedures
Time frame: 3 months
proportion of patients with resection specimens with negative horizontal and vertical margins confirmed by histopathology
1 secondary outcome
Proportion of curative resections
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Individual participant dataSharing planned: Undecided
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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.
Stepan Suchanek, MD., Ph.D principal investigator
Military University Hospital, Prague
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 and Over- the- scope full- thickness resection device in people with Polyps and Colon Cancer, run by Military University Hospital, Prague at 1 site in Czechia.
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 3 inclusion and 8 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 20 Apr 2022. 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 Czechia. 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 Stepan Suchanek, MD., Ph.D. (973208367 ext. 00420, stepan.suchanek@uvn.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of R0 procedures (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Apr 2022.