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Endoscopic Resection of Gastrointestinal Neoplasms

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ClinicalTrials.gov Identifier: NCT04780256
Recruitment Status : Not yet recruiting
First Posted : March 3, 2021
Last Update Posted : March 12, 2021
Sponsor:
Information provided by (Responsible Party):
Paolo Cecinato, Arcispedale Santa Maria Nuova-IRCCS

Brief 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. 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.

Condition or disease Intervention/treatment
Endoscopic Mucosal Resection Endoscopic Submucosal Dissection Gastric Neoplasm Colonic Neoplasms Esophageal Neoplasms Duodenal Neoplasms Procedure: Endoscopic resection

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Study of Efficacy and Safety of the Endoscopic Removal of Cancerous and Precancerous Lesions of the Upper and Lower Digestive Tract
Estimated Study Start Date : March 15, 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy


Intervention Details:
  • Procedure: Endoscopic resection

    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:

    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


Primary Outcome Measures :
  1. en bloc resection rate [ Time Frame: one month ]
    the en bloc resection is the ability to remove the neoplasia in a single piece

  2. complete resection rate [ Time Frame: one month ]
    the complete resection is the ability to remove the neoplasia with clear margins (R0)

  3. recurrence rate [ Time Frame: one year ]
    recurrence is the recurrence of the neoplasm at the resection site during follow-up


Secondary Outcome Measures :
  1. adverse events rate [ Time Frame: one month ]
    complication rate, early or late, related to the procedure used for endoscopic resection

  2. costs [ Time Frame: one month ]
    evaluation of the costs incurred to perform the endoscopic resection



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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
Criteria

Inclusion Criteria:

  • 18 years or older
  • all patients who have undergone endoscopic resection of an upper or lower digestive tract tumor

Exclusion Criteria:

  • age under 18
  • inability to provide informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04780256


Contacts
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Contact: Paolo Cecinato, MD +393476117414 paolo.cecinato@ausl.re.it

Locations
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Italy
IRCCS-AUSL Reggio Emilia
Reggio Emilia, RE, Italy
Contact: Matteo Lucarini, MD       matteo.lucarini@ausl.re.it   
Sponsors and Collaborators
Arcispedale Santa Maria Nuova-IRCCS
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Responsible Party: Paolo Cecinato, Principal Investigator, Arcispedale Santa Maria Nuova-IRCCS
ClinicalTrials.gov Identifier: NCT04780256    
Other Study ID Numbers: CORE 3
First Posted: March 3, 2021    Key Record Dates
Last Update Posted: March 12, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Paolo Cecinato, Arcispedale Santa Maria Nuova-IRCCS:
Endoscopic mucosal resection (EMR)
Endoscopic submucosal dissection (ESD)
Endoscopic full thickness resection (EFTR)
Colorectal ESD
Colorectal EMR
Additional relevant MeSH terms:
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Neoplasms
Esophageal Neoplasms
Colonic Neoplasms
Stomach Neoplasms
Duodenal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Colonic Diseases
Intestinal Diseases
Stomach Diseases
Duodenal Diseases