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NCT Number: NCT04780256

Endoscopic Resection of Gastrointestinal Neoplasms

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.

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Key information

Conditions

Endoscopic Mucosal Resection Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Duodenal Diseases Duodenal Neoplasms Endoscopic Submucosal Dissection Esophageal Diseases Esophageal Neoplasms Gastric Neoplasm Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS-AUSL Reggio Emilia

Reggio Emilia, RE, Italy

Location status: Recruiting

Location contact

Matteo Lucarini, MD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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:

  • Endoscopic mucosal resection (EMR): it allows to remove mucosal lesions
  • Endoscopic submucosal dissection: it allows to remove mucosal lesions that involved submucosal layer and large lesions
  • Full-thickness resection: it allows to remove infiltrating lesions by the resection of a little piece of the entire gastrointestinal wall

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Paolo Cecinato, MD

CONTACT

[email protected]

+390522296111

Sponsors and collaborators

Lead sponsor

Azienda USL Reggio Emilia - IRCCS

Other Gov

Registry information

Official study title

Retrospective Study of Efficacy and Safety of the Endoscopic Removal of Cancerous and Precancerous Lesions of the Upper and Lower Digestive Tract

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Mar 3, 2021
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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