Clinical trial · Interventional
Neoplastic Barrett Esophagus: Endoscopic Piecemeal vs. En Bloc Resection
Prospektiv-randomisierter Vergleich Von En-bloc- Versus Piecemeal-Resektion Von Barrett Neoplasien Des Ösophagus Neoplastic Barrett Esophagus: Endoscopic Piecemeal vs. En Bloc Resection
NCT03427346CI-TRIAL-00067632BEEPERunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study will compare EMR versus ESD technique (both combined with subsequent ablative therapy) of mucosal resection in Barrett's esophagus with regard to efficacy and risk in a long term setting.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett Adenocarcinoma | Barrett Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Barrett Esophagus | — | UNRESOLVED | — |
| Esophagus Neoplasm | Esophageal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic mucosal resection | Procedure | — | UNRESOLVED |
| Endoscopic submucosal dissection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- EMR
- description
- Endoscopic mucosal resection
- interventionNames
- Procedure: Endoscopic mucosal resection
- type
- ACTIVE_COMPARATOR
- label
- ESD
- description
- Endoscopic submucosal dissection
- interventionNames
- Procedure: Endoscopic submucosal dissection
Primary outcomes (4)
- measure
- Eradication rate of neoplastic Barrett's Esophagus, initial therapy success
- timeFrame
- 3 months after end of therapy (resection and ablation)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * patients to be treated for Barrett's esophagus by mucosal resection and following ablative therapy * Barrett's mucosal extension up to 10 cm maximum. * patient's ability for compliance to therapy * signed Informed Consent Exclusion Criteria: * any lesion questionable to be resectable by mucosectomy, e.g. bulky lesions ≥10 mm in endoscopy und endosonography, suspected deep submucosal infiltration, ulcers, suspected or by FNA confirmed lymph node infiltration * Barrett's esophagus \> 10 cm * lesions that would afford resection of more than 2/3rd of esophagal circumference * two or more single Barrett's lesions with bulky HGIN or early cancer histology, not to be resectable in one half of esophageal circumference * planned circumferencial resections * very serious general illness and metastatic carcinoma * coagulation disorder or anticoagulants that make biopsies and resections impossible * American Society of Anesthesiologists (ASA) status \> III * pregnancy and lactation * remainders or recurrences after therapeutic history of Barrett's espohagus
References
Publications (11)
- BACKGROUNDAnders M, Bahr C, El-Masry MA, Marx AH, Koch M, Seewald S, Schachschal G, Adler A, Soehendra N, Izbicki J, Neuhaus P, Pohl H, Rosch T. Long-term recurrence of neoplasia and Barrett's epithelium after complete endoscopic resection. Gut. 2014 Oct;63(10):1535-43. doi: 10.1136/gutjnl-2013-305538. Epub 2014 Jan 3. PMID 24389236
- BACKGROUNDBARRETT NR. The oesophagus lined by columnar epithelium. Gastroenterologia. 1956;86(3):183-6. doi: 10.1159/000200553. No abstract available. PMID 13384591
- BACKGROUNDBARRETT NR. The lower esophagus lined by columnar epithelium. Surgery. 1957 Jun;41(6):881-94. No abstract available. PMID 13442856
- BACKGROUNDDunbar KB, Spechler SJ. Controversies in Barrett esophagus. Mayo Clin Proc. 2014 Jul;89(7):973-84. doi: 10.1016/j.mayocp.2014.01.022. Epub 2014 May 24. PMID 24867396
- BACKGROUNDEdgren G, Adami HO, Weiderpass E, Nyren O. A global assessment of the oesophageal adenocarcinoma epidemic. Gut. 2013 Oct;62(10):1406-14. doi: 10.1136/gutjnl-2012-302412. Epub 2012 Aug 23. PMID 22917659
- BACKGROUNDHobel S, Dautel P, Baumbach R, Oldhafer KJ, Stang A, Feyerabend B, Yahagi N, Schrader C, Faiss S. Single center experience of endoscopic submucosal dissection (ESD) in early Barrett's adenocarcinoma. Surg Endosc. 2015 Jun;29(6):1591-7. doi: 10.1007/s00464-014-3847-5. Epub 2014 Oct 8. PMID 25294533
- BACKGROUNDLabenz J, Koop H, Tannapfel A, Kiesslich R, Holscher AH. The epidemiology, diagnosis, and treatment of Barrett's carcinoma. Dtsch Arztebl Int. 2015 Mar 27;112(13):224-33; quiz 234. doi: 10.3238/arztebl.2015.0224. PMID 25869347
- BACKGROUNDNeuhaus H. Endoscopic mucosal resection and endoscopic submucosal dissection in the West--too many concerns and caveats? Endoscopy. 2010 Oct;42(10):859-61. doi: 10.1055/s-0030-1255724. Epub 2010 Sep 30. No abstract available.