Endoscopic Resection of Gastrointestinal Neoplasms

NCT04780256 | Recruiting

• 1 other identifier: CORE 3
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• en bloc resection rate

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

  one month

• complete resection rate

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

  one month

• recurrence rate

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

  one year

Secondary Outcomes (2)

• adverse events rate

  one month

• costs

  one month

Interventions

Endoscopic resection PROCEDURE

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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• age under 18
• inability to provide informed consent

Sponsors & Collaborators

• Azienda USL Reggio Emilia - IRCCS: lead

Study Sites (1)

IRCCS-AUSL Reggio Emilia

Reggio Emilia, RE, Italy

RECRUITING

Related Publications (1)

• 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.

  PMID: 36542136 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms; Colonic Neoplasms; Esophageal Neoplasms; Duodenal Neoplasms

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Duodenal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Central Study Contacts

Paolo Cecinato, MD

CONTACT

+390522296111; paolo.cecinato@ausl.re.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2021
• First Posted: March 3, 2021
• Study Start: March 15, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)