BEEPER Study

• Research type

  Research Study

• Full title

  Prospective, Randomized Trial Comparing En Bloc with Piecemeal Resection of Neoplasia in Barrett’s Oesophagus

• IRAS ID

  289043

• Contact name

  Rehan Haidry

• Contact email

  rehan.haidry@nhs.net

• Sponsor organisation

  Professor

• Clinicaltrials.gov Identifier

  NCT03427346

• Duration of Study in the UK

  6 years, 0 months, 0 days

• Research summary

  Barrett’s Esophagus occurs especially in patients with long-term gastroesophageal reflux disease (GERD). The chronic exposure of the esophageal mucosa to gastric acid from the stomach can lead to a metaplastic transformation of normal squamous epithelium into intestinal differentiated columnar epithelium in a small number of affected patients. Although Barrett‘s metaplasia itself is asymptomatic, the medical relevance arises from the risk of developing an adenocarcinoma.).
  Endoscopy enables the removal of atypical Barrett’s mucosa and early Barrett’s carcinoma. The standard procedure is the piece by piece removal of a lesion using a snare, usually after submucosal saline injection. This technique is referred to as piecemeal resection or piecemeal EMR (endoscopic mucosal resection). Endoscopic Submucosal Dissection (ESD) is an alternative method. This technique allows the en bloc resection of the lesion after elevation by submucosal injection, circumferential incision and submucosal dissection.

  The current concept in management of Barrett’s esophagus involves the complete eradication of neoplastic and the residual preneoplastic Barrett mucosa. A combination of resection of visible neoplastic areas and thermoablation (radiofrequency ablation/RFA, argon plasma coagulation/APC) of the residual, mostly non-neoplastic Barrett mucosa is used in practice.

  This randomized study aims to resolve inconclusive data regarding EMR versus En ESD in terms of efficacy (histological completeness, recurrence rate) and risks (perforations, stricture/stenosis due to scarring) in combination with RFA. To date there have been no randomized comparative data on the long-term after treatment phase.

• REC name

  London - Stanmore Research Ethics Committee

• REC reference

  21/LO/0086

• Date of REC Opinion

  21 Feb 2022

• REC opinion

  Further Information Favourable Opinion