Gastric CancerNCT05930860
Efficacy and Safety of ESD for the Treatment of Superficial Gastric Neoplasms
An observational study of Gastric Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Endoscopic submucosal dissection (ESD) is the technique that has replaced surgery in the treatment of early neoplastic lesions of the stomach (LNPS). ESD of LNPS allows: a) less invasiveness compared to surgery; b) greater chances of "en bloc" resection and R0 resection compared to mucosectomy for lesions larger than… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Endoscopic Submucosal Dissection
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 12 Dec 2021to 12 Dec 2031
- 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 years and older
- All sexes
- Adult, Older adult
Study population: All patients with gastric superficial neoplasms that can be treated by ESD according to ESGE guidelines or with gastric neoplasm outside of latest ESD guidelines criteria that are unfit for surgery.
Who may be able to join
- Age > 18 years old
- Endoscopic and histologic diagnosis of gastric superficial neoplasm that can be treated by ESD according to ESGE guidelines.
- Gastric neoplasm outside of latest ESD guidelines criteria in patients unfit for surgery
Who cannot join
- Final diagnosis of non neoplastic lesion.
- Gastric neoplasm outside of latest ESD guidelines criteria in patients fit for surgery
- Evidence of muscolar layer invasion or limph nodes or other organs metastasis at EUS or TC when performed.
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
Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome
About this study
Official title: Efficacy and Safety of Endoscopic Submucosal Dissection for the Treatment of Superficial Gastric Neoplasms - An Italian Society of Digestive Endoscopy (SIED) Study
Endoscopic submucosal dissection (ESD) is the technique that has replaced surgery in the treatment of early neoplastic lesions of the stomach (LNPS). ESD of LNPS allows: a) less invasiveness compared to surgery; b) greater chances of "en bloc" resection and R0 resection compared to mucosectomy for lesions larger than 15 mm. Recent 2015 ESGE guidelines provide precise recommendations for the use of ESD in the treatment of LNPS, but Italy lacks prospective data on the efficacy and safety of ESD in a large sample of patients. A multicenter prospective observational study to create a database on the use of ESD in LNPS is essential to provide information regarding the efficacy and safety of ESD in Italy. This database would also provide information regarding the criteria applied in the use of ESD in the treatment of early gastric neoplasia
- Conditions
- Gastric Cancer
- Being tested
- Endoscopic Submucosal Dissection
- Keywords
- Endoscopic Submucosal Dissection, Endoscopic Resection
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Submucosal DissectionProcedure or surgery
Endoscopic Submucosal Dissection
What is being measured
The primary outcome is the main question the study is designed to answer.
En bloc resection rate
removal of the lesion into a single piece.
Measured: 10 years
R0 resection rate
complete removal of the tumor with histologically lateral and vertical margins of the specimen free from dysplasia
Measured: 10 years
Curative resection rate
R0 resection with combined microstaging parameters not suggestive for high metastatic potential risk.
Measured: 10 years
Complication rate
bleeding, perforation and stenosis.
Measured: 10 years
Recurrence rate
dysplastic tissue at the site of resection at follow-up endoscopy.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start12 Dec 2021
- Primary completion12 Aug 2025 (estimated)
- Study completion12 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Federico Barbaro, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05930860
- Sponsor's protocol ID
- 4349
- Status last verified
- Mar 2025
- First submitted
- 2 Mar 2023
- Last updated
- 14 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Endoscopic Submucosal Dissection for the Treatment of Superficial Gastric Neoplasms - An Italian Society of Digestive Endoscopy (SIED) Study
- ClinicalTrials.gov ID
- NCT05930860
- Acronym / sponsor ID
- 4349
- Conditions
- Gastric Cancer
- Keywords
- Endoscopic Submucosal Dissection, Endoscopic Resection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 12 Dec 2021 (actual)
- Primary completion
- 12 Aug 2025 (estimated)
- Study completion
- 12 Dec 2031 (estimated)
- First posted
- 5 Jul 2023 (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.
Endoscopic submucosal dissection (ESD) is the technique that has replaced surgery in the treatment of early neoplastic lesions of the stomach (LNPS). ESD of LNPS allows: a) less invasiveness compared to surgery; b) greater chances of "en bloc" resection and R0 resection compared to mucosectomy for lesions larger than 15 mm. Recent 2015 ESGE guidelines provide precise recommendations for the use of ESD in the treatment of LNPS, but Italy lacks prospective data on the efficacy and safety of ESD in a large sample of patients. A multicenter prospective observational study to create a database on the use of ESD in LNPS is essential to provide information regarding the efficacy and safety of ESD in Italy. This database would also provide information regarding the criteria applied in the use of ESD in the treatment of early gastric neoplasia
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients with gastric superficial neoplasms that can be treated by ESD according to ESGE guidelines or with gastric neoplasm outside of latest ESD guidelines criteria that are unfit for surgery.
Key inclusion criteria (3 listed)
- Age > 18 years old
- Endoscopic and histologic diagnosis of gastric superficial neoplasm that can be treated by ESD according to ESGE guidelines.
- Gastric neoplasm outside of latest ESD guidelines criteria in patients unfit for surgery
Key exclusion criteria (3 listed)
- Final diagnosis of non neoplastic lesion.
- Gastric neoplasm outside of latest ESD guidelines criteria in patients fit for surgery
- Evidence of muscolar layer invasion or limph nodes or other organs metastasis at EUS or TC when performed.
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 Submucosal DissectionEndoscopic Submucosal Dissection | Procedure or surgery | – |
Primary outcome
En bloc resection rate
Time frame: 10 years
removal of the lesion into a single piece.
R0 resection rate
Time frame: 10 years
complete removal of the tumor with histologically lateral and vertical margins of the specimen free from dysplasia
Curative resection rate
Time frame: 10 years
R0 resection with combined microstaging parameters not suggestive for high metastatic potential risk.
Complication rate
Time frame: 10 years
bleeding, perforation and stenosis.
Recurrence rate
Time frame: 10 years
dysplastic tissue at the site of resection at follow-up endoscopy.
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 14 Mar 2025.
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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.
Federico Barbaro principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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 Gastric Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli 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 3 inclusion and 3 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 14 Mar 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 Federico Barbaro (3921101013, federico.barbaro@policlinicogemelli.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: 10 years). The study lists 5 primary outcomes in all. 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 14 Mar 2025.