Endoscopic Resection of Gastrointestinal Neoplasms

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorAzienda USL Reggio Emilia - IRCCS

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years or older

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

Disqualifiers

age under 18

inability to provide informed consent

Trial 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

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Endoscopic resection

    Procedure/Surgery

    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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

en bloc resection rate

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

Time frame
one month
2

complete resection rate

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

Time frame
one month
3

recurrence rate

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

Time frame
one year

Secondary outcomes

1

adverse events rate

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

Time frame
one month
2

costs

evaluation of the costs incurred to perform the endoscopic resection

Time frame
one month

Other outcomes

Sponsors and contacts

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