Endoscopic Mucosal ResectionNCT04780256
Endoscopic Resection of Gastrointestinal Neoplasms
An observational study of Endoscopic Mucosal Resection and Endoscopic Submucosal Dissection, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
Trial summary
The study aims to retrospectively investigate the endoscopic resection procedures of cancerous and precancerous lesions of the upper and lower digestive tract in order to evaluate the efficacy and safety outcomes and to compare different resection techniques. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Endoscopic Mucosal Resection, Endoscopic Submucosal Dissection, Gastric Neoplasm
- What is being tested?
- Endoscopic resection
- Type of treatment
- Surgery or procedure
- How many people
- 2,000 participants
- Where
- 1 siteItaly
- Study dates
- 15 Mar 2021to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients> 18 years of age who have undergone endoscopic resection of cancerous or pre-cancerous lesions of the digestive tract will be included in the study
Who may be able to join
- 18 years or older
- all patients who have undergone endoscopic resection of an upper or lower digestive tract tumor
Who cannot join
- age under 18
- inability to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS-AUSL Reggio Emilia
Reggio Emilia, RE
Matteo Lucarini, MD, matteo.lucarini@ausl.re.it
About this study
Official title: Retrospective Study of Efficacy and Safety of the Endoscopic Removal of Cancerous and Precancerous Lesions of the Upper and Lower Digestive Tract
The study aims to retrospectively investigate the endoscopic resection procedures of cancerous and precancerous lesions of the upper and lower digestive tract in order to evaluate the efficacy and safety outcomes and to compare different resection techniques. In particular, the resection techniques investigated will be mucosectomy, en bloc and piecemeal, endoscopic submucosal dissection (ESD) and its variants, full-thickness resection. The anatomical districts involved will be the esophagus, stomach, duodenum, colon and rectum.
- Conditions
- Endoscopic Mucosal Resection, Endoscopic Submucosal Dissection, Gastric Neoplasm, Colonic Neoplasms, Esophageal Neoplasms, Duodenal Neoplasms
- Being tested
- Endoscopic resection
- Keywords
- Endoscopic mucosal resection (EMR), Endoscopic submucosal dissection (ESD), Endoscopic full thickness resection (EFTR), Colorectal ESD, Colorectal EMR
- Medical subject headings
- Stomach Neoplasms, Colonic Neoplasms, Esophageal Neoplasms, Duodenal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic resectionProcedure or surgery
The endoscopic resection is the procedure that allows to remove cancerous or precancerous conditions of digestive tract. Endoscopic resection can be preformed by several techniques:
- Endoscopic mucosal resection (EMR): it allows to remove mucosal lesions
- Endoscopic submucosal dissection: it allows to remove mucosal lesions that involved submucosal layer and large lesions
- Full-thickness resection: it allows to remove infiltrating lesions by the resection of a little piece of the entire gastrointestinal wall
What is being measured
The primary outcome is the main question the study is designed to answer.
en bloc resection rate
the en bloc resection is the ability to remove the neoplasia in a single piece
Measured: one month
complete resection rate
the complete resection is the ability to remove the neoplasia with clear margins (R0)
Measured: one month
recurrence rate
recurrence is the recurrence of the neoplasm at the resection site during follow-up
Measured: one year
Secondary outcomes (2)
adverse events rate
complication rate, early or late, related to the procedure used for endoscopic resection
Measured: one month
costs
evaluation of the costs incurred to perform the endoscopic resection
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start15 Mar 2021
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (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 Endoscopic Mucosal ResectionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04780256
- Sponsor's protocol ID
- CORE 3
- Status last verified
- Jan 2025
- First submitted
- 28 Feb 2021
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cecinato P, Lisotti A, Azzolini F, Lucarini M, Bassi F, Fusaroli P, Sassatelli R. Left colonic localization, non-granular morphology, and pit pattern independently predict submucosal fibrosis of naive colorectal neoplasms before endoscopic submucosal dissection. Surg Endosc. 2023 Apr;37(4):3037-3045. doi: 10.1007/s00464-022-09828-0. Epub 2022 Dec 21.
PubMed 36542136
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study of Efficacy and Safety of the Endoscopic Removal of Cancerous and Precancerous Lesions of the Upper and Lower Digestive Tract
- ClinicalTrials.gov ID
- NCT04780256
- Acronym / sponsor ID
- CORE 3
- Conditions
- Endoscopic Mucosal Resection, Endoscopic Submucosal Dissection, Gastric Neoplasm, Colonic Neoplasms, Esophageal Neoplasms, Duodenal Neoplasms
- Keywords
- Endoscopic mucosal resection (EMR), Endoscopic submucosal dissection (ESD), Endoscopic full thickness resection (EFTR), Colorectal ESD, Colorectal EMR
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCSOther government
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 3 Mar 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 study aims to retrospectively investigate the endoscopic resection procedures of cancerous and precancerous lesions of the upper and lower digestive tract in order to evaluate the efficacy and safety outcomes and to compare different resection techniques. In particular, the resection techniques investigated will be mucosectomy, en bloc and piecemeal, endoscopic submucosal dissection (ESD) and its variants, full-thickness resection. The anatomical districts involved will be the esophagus, stomach, duodenum, colon and rectum.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients> 18 years of age who have undergone endoscopic resection of cancerous or pre-cancerous lesions of the digestive tract will be included in the study
Key inclusion criteria (2 listed)
- 18 years or older
- all patients who have undergone endoscopic resection of an upper or lower digestive tract tumor
Key exclusion criteria (2 listed)
- age under 18
- 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 |
|---|---|---|
| Endoscopic resectionThe endoscopic resection is the procedure that allows to remove cancerous or precancerous conditions of digestive tract. Endoscopic resection can be preformed by several techniques: 1. Endoscopic mucosal resection (EMR): it allows to remove mucosal lesions 2. Endoscopic submucosal dissection: it allows to remove mucosal lesions that involved submucosal layer and large lesions 3. Full-thickness resection: it allows to remove infiltrating lesions by the resection of a little piece of the entire gastrointestinal wall | Procedure or surgery | – |
Primary outcome
en bloc resection rate
Time frame: one month
the en bloc resection is the ability to remove the neoplasia in a single piece
complete resection rate
Time frame: one month
the complete resection is the ability to remove the neoplasia with clear margins (R0)
recurrence rate
Time frame: one year
recurrence is the recurrence of the neoplasm at the resection site during follow-up
2 secondary outcomes
adverse events rate
Time frame: one month
costs
Time frame: one month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Derived from this study: PubMed 36542136Cecinato P, Lisotti A, Azzolini F, Lucarini M, Bassi F, Fusaroli P, Sassatelli R. Left colonic localization, non-granular morphology, and pit pattern independently predict submucosal fibrosis of naive colorectal neoplasms before endoscopic submucosal dissection. Surg Endosc. 2023 Apr;37(4):3037-3045. doi: 10.1007/s00464-022-09828-0. Epub 2022 Dec 21.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endoscopic Mucosal Resection and Endoscopic Submucosal Dissection, run by Azienda USL Reggio Emilia - IRCCS 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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 3 Oct 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paolo Cecinato, MD (+390522296111, paolo.cecinato@ausl.re.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
en bloc resection rate (time frame: one month). The study lists 3 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 NCT04780256, 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 Oct 2025.