Skip to main content
OpenTrials
Completed

NCT Number: NCT03021135

Conventional Endoscopic Mucosal Resection vs Underwater Resection for Colorectal Non-pedunculated Colorectal Lesions

Randomized, comparative and prospective study between Conventional Endoscopic Mucosal Resection for the removal of flat or sessile colorectal lesions without previous attempt to resection.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Adenoma Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto do Cancer do Estado de Sao Paulo

São Paulo, 01246-000, Brazil

About this study

This prospective randomized trial was conducted in 2 academic services: Instituto do Câncer do Estado de São Paulo and Centro de Diagnóstico em Gastroenterologia, both linked to the University of São Paulo. The clinical study was performed in accordance to the Declaration of Helsinki.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients age >18 years with sessile or flat Colorectal Lesions (measuring between 10 and 40mm), who consent to this study

Exclusion criteria

  • Patients who refuse to participate in the study.
  • Patients with pedunculated, depressed or mixed lesions.
  • Patients with lesions smaller than 10 mm or larger than 40 mm.
  • Patients with lesions that are inflammatory, neuroendocrine or stromal at the pathology.
  • Patients with lesions that were submitted to prior attempt to endoscopic resection.

Treatment and study plan

Conventional Endoscopic Mucosal Resection

Procedure

Conventional Endoscopic Mucosal Resection

Other names: EMR

underwater endoscopic mucosal resection

Procedure

Underwater Endoscopic Mucosal Resection

Other names: U-EMR

Primary outcomes

  1. Technical success rate

    Time frame: three years

  2. Safety (incidence of complications);

    Time frame: three years

  3. Local recurrence.

    Time frame: Four years

Secondary outcomes

  1. Resection rate en bloc

    Time frame: three years

  2. Time of resection

    Time frame: Three years

  3. Sydney resection ratio (characterized by the following equation - lesion size in millimeters

    Time frame: Three years

Sponsors and collaborators

Lead sponsor

Instituto do Cancer do Estado de São Paulo

Other

Collaborators

  • University of Sao Paulo

Registry information

Official study title

Conventional Endoscopic Mucosal Resection (With Submucosal Injection) Versus Underwater Endoscopic Mucosal Resection (Without Submucosal Injection) for Colorectal Non-pedunculated Colorectal Lesions

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jan 13, 2017
Registry last updated
Jul 5, 2023

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.