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EMR-C VS EMR-S in Colonic Lateral Spreading Tumors Treatment (LST)

NCT03498664 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2019-01-11

No results posted yet for this study

Summary

"Lateral Spreading Tumors" (LSTs) are dysplastic lesions whose protrusion within the lumens the colon is not more than twice as compared to the surrounding non-dysplastic mucosa.

They can be divided into two groups:

Granular type (LST-G) and Non Granular type (LST-NG) Endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD) are currently the most used techniques to resect this type of lesions. Compared to other methods of tissue ablation, EMR allows to carry out the histological evaluation of the resected fragments and ESD of the lesion in toto ("en bloc") EMR is currently the most used technique for removal of LST, but for lesions of ≥ 30 mm the resection is performed "piecemeal", i.e. fragmentary. This can compromise an adequate histological evaluation of the lateral and deep margins of the lesion.

Colonic EMR (EMR-S) is usually performed using a polypectomy snare, after lifting the lesion from the underlying layers with a submucosal injection of liquid (EMR standard or "inject-and-cut"). The aspiration of the lesion inside a plastic cap preloaded on the tip of the colonoscope ("cap-assisted EMR" - EMR-C) is almost exclusively used for the treatment of gastric and esophageal lesions. Its use for lesions of the colon and duodenum has been reported in limited experiences The principal aim of this study is to evaluate the efficacy and the safety of the EMR-C for the removal of large colonic LST-G and LST-NG, comparing it with EMR-S.

Conditions

  • Endoscopic Mucosal Resection

Interventions

DEVICE

cap for mucosectomy

endoscopic mucosal resection of colonic lesions with a plastic cap for mucosectomy

DEVICE

standard snare for polypectomy

endoscopic mucosal resection of colonic lesions with standard inject and cut mucosectomy

Sponsors & Collaborators

  • Azienda USL 1 Imperiese

    collaborator OTHER

  • Azienda Ospedaliera Niguarda Cà Granda

    collaborator OTHER

  • Azienda Ospedaliera Universitaria Senese

    lead OTHER

Principal Investigators

  • Mario Marini, MD · Gastroenterology and Operative Endoscopy Unit, Santa Maria Alle Scotte Hospital, Siena, Italy.

  • Massimo Conio, MD · ASL 1 imperiese

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-15
Primary Completion
2019-09-15
Completion
2019-09-15

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03498664 on ClinicalTrials.gov