Colorectal NeoplasmsNCT05502276
Full Thickness Resection or Endoscopic Submucosal Dissection for Difficult Colorectal Lesions.
A study testing Endoscopic Full-Thickness Resection (EFTR) and Endoscopic Submucosal Dissection (ESD) in people with Colorectal Neoplasms, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
Compare the efficacy and safety of endoscopic resection a full thickness (EFTR) with Full Thickness Resection Device (FTRD) System versus endoscopic submucosal dissection (ESD) in the treatment of Laterally Spreading Tumor Non Granular Type (LST-NG), "no lift" lesions colon and residual / relapse on scars from… 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?
- Endoscopic Full-Thickness Resection (EFTR) and Endoscopic Submucosal Dissection (ESD)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2019to 30 Sep 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
- patients of age >18 years
- Laterally Spreading Tumor Non Granular Type (LST-NG) ≤ 3cm in diameter
- "no-lift" colic injuries ≤ 3cm in diameter
- residual / recurrence on the scar of previous endoscopic resections of the colon ≤ 3cm in diameter
Who cannot join
- pregnant women
- failure to accept or understand the consent to participate in the study
- patients with severe coagulopathies
- patients with short life expectancy (Charlson comorbidity index ≥8)
- patients with expired general clinical conditions (American Society of Anesthesiologists score ≥3)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endoscopic Full Thickness Resection (EFTR) Versus Endoscopic Submucosal Dissection (ESD) in the Treatment of Difficult Colorectal Lesions With Dimensional Cut-off ≤ 30mm: Laterally Spreading Tumor Non Granular Type (LST-NG), "no Lift" Lesions and Residual / Relapses of Previous Resections. Endoscopic.
Compare the efficacy and safety of endoscopic resection a full thickness (EFTR) with Full Thickness Resection Device (FTRD) System versus endoscopic submucosal dissection (ESD) in the treatment of Laterally Spreading Tumor Non Granular Type (LST-NG), "no lift" lesions colon and residual / relapse on scars from previous resections endoscopic colon. The dimensional cut off of these lesions is ≤30mm
- Conditions
- Colorectal Neoplasms
- Being tested
- Endoscopic Full-Thickness Resection (EFTR), Endoscopic Submucosal Dissection (ESD)
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Full-Thickness Resection (EFTR)Procedure or surgery
Full Thickness Endoscopic Resection using the FTRD Ovesco Device
Endoscopic Submucosal Dissection (ESD)Procedure or surgery
Standard Endoscopic Submucosal Dissection using standard procedure described in international guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic Submucosal Dissection (ESD) | Active comparator | The Endoscopic Submucosal Dissection (ESD) procedures will be performed with the devices commonly used at the Services of Endoscopy of the Centers participating in the study. There are several models of knives on the market, produced by different companies, all considered equally effective by international guidelines. Receives: Procedure: Endoscopic Submucosal Dissection (ESD) |
| Endoscopic Full-Thickness Resection (EFTR) | Experimental | The FTRD® (Full Thickness Resection Device; Ovesco Endoscopy, Tübingen, Germany) is the only over-the-scope device designed to undergo Endoscopic Full-Thickness Resection (EFTR) using a "clip-and-cut" technique. It consists of a 14 mm modified over-the-scope-clip (OTSC) mounted on the outside of a 23 mm cap, which has a preloaded 13 mm monofilament loop at the end. This device received the CE mark for the lower digestive tract in September 2014 and its efficacy and safety have been evaluated in preclinical studies and clinical trials. Receives: Procedure: Endoscopic Full-Thickness Resection (EFTR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
En-bloc resection rate
the rate of one-piece resection of the lesions
Measured: 1 year
R0 resection rate
percentage of patients with histologically negative lateral and deep margins
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start1 Jan 2019
- Primary completion28 Feb 2022
- Study completion30 Sep 2022
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.
- 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giulio Antonelli, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05502276
- Sponsor's protocol ID
- RESECT
- Status last verified
- Nov 2022
- First submitted
- 12 Aug 2022
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Andrisani G, Hassan C, Pizzicannella M, Pugliese F, Mutignani M, Campanale C, Valerii G, Barbera C, Antonelli G, Di Matteo FM. Endoscopic full-thickness resection versus endoscopic submucosal dissection for challenging colorectal lesions: a randomized trial. Gastrointest Endosc. 2023 Dec;98(6):987-997.e1. doi: 10.1016/j.gie.2023.06.009. Epub 2023 Jun 28.
PubMed 37390864
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Full Thickness Resection (EFTR) Versus Endoscopic Submucosal Dissection (ESD) in the Treatment of Difficult Colorectal Lesions With Dimensional Cut-off ≤ 30mm: Laterally Spreading Tumor Non Granular Type (LST-NG), "no Lift" Lesions and Residual / Relapses of Previous Resections. Endoscopic.
- ClinicalTrials.gov ID
- NCT05502276
- Acronym / sponsor ID
- RESECT
- Conditions
- Colorectal Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 16 Aug 2022 (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.
Compare the efficacy and safety of endoscopic resection a full thickness (EFTR) with Full Thickness Resection Device (FTRD) System versus endoscopic submucosal dissection (ESD) in the treatment of Laterally Spreading Tumor Non Granular Type (LST-NG), "no lift" lesions colon and residual / relapse on scars from previous resections endoscopic colon. The dimensional cut off of these lesions is ≤30mm
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic Submucosal Dissection (ESD) | Active comparator | Procedure: Endoscopic Submucosal Dissection (ESD)The Endoscopic Submucosal Dissection (ESD) procedures will be performed with the devices commonly used at the Services of Endoscopy of the Centers participating in the study. There are several models of knives on the market, produced by different companies, all considered equally effective by international guidelines. |
| Endoscopic Full-Thickness Resection (EFTR) | Experimental | Procedure: Endoscopic Full-Thickness Resection (EFTR)The FTRD® (Full Thickness Resection Device; Ovesco Endoscopy, Tübingen, Germany) is the only over-the-scope device designed to undergo Endoscopic Full-Thickness Resection (EFTR) using a "clip-and-cut" technique. It consists of a 14 mm modified over-the-scope-clip (OTSC) mounted on the outside of a 23 mm cap, which has a preloaded 13 mm monofilament loop at the end. This device received the CE mark for the lower digestive tract in September 2014 and its efficacy and safety have been evaluated in preclinical studies and clinical trials. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients of age >18 years
- Laterally Spreading Tumor Non Granular Type (LST-NG) ≤ 3cm in diameter
- "no-lift" colic injuries ≤ 3cm in diameter
- residual / recurrence on the scar of previous endoscopic resections of the colon ≤ 3cm in diameter
Key exclusion criteria (5 listed)
- pregnant women
- failure to accept or understand the consent to participate in the study
- patients with severe coagulopathies
- patients with short life expectancy (Charlson comorbidity index ≥8)
- patients with expired general clinical conditions (American Society of Anesthesiologists score ≥3)
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 |
|---|---|---|
| Endoscopic Full-Thickness Resection (EFTR)Full Thickness Endoscopic Resection using the FTRD Ovesco Device | Procedure or surgery | Endoscopic Full-Thickness Resection (EFTR) |
| Endoscopic Submucosal Dissection (ESD)Standard Endoscopic Submucosal Dissection using standard procedure described in international guidelines. | Procedure or surgery | Endoscopic Submucosal Dissection (ESD) |
Primary outcome
En-bloc resection rate
Time frame: 1 year
the rate of one-piece resection of the lesions
R0 resection rate
Time frame: 1 year
percentage of patients with histologically negative lateral and deep margins
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Derived from this study: PubMed 37390864Andrisani G, Hassan C, Pizzicannella M, Pugliese F, Mutignani M, Campanale C, Valerii G, Barbera C, Antonelli G, Di Matteo FM. Endoscopic full-thickness resection versus endoscopic submucosal dissection for challenging colorectal lesions: a randomized trial. Gastrointest Endosc. 2023 Dec;98(6):987-997.e1. doi: 10.1016/j.gie.2023.06.009. Epub 2023 Jun 28.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic Full-Thickness Resection (EFTR) and Endoscopic Submucosal Dissection (ESD) in people with Colorectal Neoplasms, run by University of Roma La Sapienza at 1 site in Italy.
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: finished, as of the sponsor's last update on 3 Nov 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
En-bloc resection rate (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT05502276, 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 3 Nov 2022; AzTrials last refreshed its copy on 29 Oct 2026.