Endoscopic Resection of Gastrointestinal Neoplasms

• Sponsor: Arcispedale Santa Maria Nuova-IRCCS (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04780256
• Collaborator: (none)
• Enrollment: 2,000
• Location: 1
• Anticipated Duration (Months): 20.6
• Patients Per Site Per Month: 97.2

Study Details

Study Description

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	Phase
Endoscopic Mucosal Resection; Endoscopic Submucosal Dissection; Gastric Neoplasm; Colonic Neoplasms; Esophageal Neoplasms; Duodenal Neoplasms	Procedure: Endoscopic resection

Study Design

• Study Type: Observational
• Anticipated 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
• Actual Study Start Date: Mar 15, 2021
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Outcome Measures

Primary Outcome Measures

1. en bloc resection rate [one month]

   the en bloc resection is the ability to remove the neoplasia in a single piece

2. complete resection rate [one month]

   the complete resection is the ability to remove the neoplasia with clear margins (R0)

3. recurrence rate [one year]

   recurrence is the recurrence of the neoplasm at the resection site during follow-up

Secondary Outcome Measures

1. adverse events rate [one month]

   complication rate, early or late, related to the procedure used for endoscopic resection

2. costs [one month]

   evaluation of the costs incurred to perform the endoscopic resection

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IRCCS-AUSL Reggio Emilia	Reggio Emilia	RE	Italy

Sponsors and Collaborators

• Arcispedale Santa Maria Nuova-IRCCS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Paolo Cecinato, Principal Investigator, Arcispedale Santa Maria Nuova-IRCCS
• ClinicalTrials.gov Identifier: NCT04780256
• Other Study ID Numbers: CORE 3
• First Posted: Mar 3, 2021
• Last Update Posted: Jul 21, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Paolo Cecinato, Principal Investigator, 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: Neoplasms; Esophageal Neoplasms; Colonic Neoplasms; Stomach Neoplasms; Duodenal Neoplasms

Study Results

No Results Posted as of Jul 21, 2021