To hear about similar clinical trials, please enter your email below
Trial Title:
Efficacy and Safety of ESD for the Treatment of Superficial Gastric Neoplasms
NCT ID:
NCT05930860
Condition:
Gastric Cancer
Conditions: Official terms:
Neoplasms
Stomach Neoplasms
Conditions: Keywords:
Endoscopic Submucosal Dissection
Endoscopic Resection
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Endoscopic Submucosal Dissection
Description:
Endoscopic Submucosal Dissection
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 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
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Locations:
Facility:
Name:
Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Address:
City:
Rome
Country:
Italy
Status:
Recruiting
Start date:
December 12, 2021
Completion date:
December 12, 2031
Lead sponsor:
Agency:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Agency class:
Other
Source:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05930860
