Endoscopic mucosal resection (EMR) versus endoscopic submucosal dissection (ESD) for early Barrett´s neoplasia: a retrospective single center analysis of efficacy, complication and recurrence rates

Recruiting

Conditions: K22.7
C15.5
Barrett oesophagus
Lower third of oesophagus

Registration Number: DRKS00025016

Lead Sponsor: Klinikum Oldenburg AöR

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 150

Inclusion Criteria

EMR or ESD in the period from 01/01/2003 to 12/31/2020 with endoscopic visible suspicious Barrett´s lesion or a histologically confirmed Barrett´s associated HGIEN or an early Barrett's carcinoma

Exclusion Criteria

- age <18 years
- squamous cell neoplasia
- signs for tumor infiltration of the tunica muscularis in endoscopic ultrasound
- Metastasis at the time of index intervention

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
combined primary endpoint of<br>1. endoscopically complete resection of Barrett's neoplasia (carcinoma or HGIEN) with neoplasia-free resection margin vertical - R0, L0, V0 - and -<br>2. Neoplasia-free survival in the follow-up of 12 months, defined by excluding Barrett's carcinoma or HGIEN in endoscopic follow-up

Secondary Outcome Measures

Name	Time	Method
- complication rate, defined as perforation requiring intervention (haemoclip, stent, surgery) or major bleeding (endoscopic intervention, blood transfusion) periinterventionally and within 30 days<br>- Peri- or post-interventional minor bleeding within 30 days<br>- Percentage of post-interventional strictures requiring further therapeutic interventions<br>- Mortality within 30 days and 3 months<br>- Recurrence-free survival in follow-up of at least 6, 12, 24, 36, 48 and 60 months<br>- en bloc resection of Barrett's neoplasia<br>- Percentage of required re-resection if the R0 resection is primarily absent<br>- duration of the procedure