Clinical trial · Interventional
ESD Versus EMR for Treatment of Early Barrett's Adenocarcinoma
Water-jet Assisted Endoscopic Submucosal Dissection (ESD) Versus Endoscopic Mucosal Resection (EMR) for Treatment of Early Barrett's Adenocarcinoma
- 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)
Conventional techniques of endoscopic mucosal resection (EMR) by snare resection do usually not achieve resection of gastrointestinal mucosal neoplastic lesions larger than 1 cm in diameter in a single piece. Complete R0 resection cannot be histologically confirmed. In contrast to EMR the technique of endoscopic submucosal dissection (ESD) allows en-bloc resection even of large neoplastic lesions. The waterjet-assisted ESD technology (WESD) allows pressure controlled injection of fluids through the tip of a recently developed HybridKnife®. Submucosal injection, circumferential cutting and dissection of lesions as well as coagulation of bleeding sources can be performed with the same device without need for changing the instrument. Our group reported on effective en-bloc resection of esophageal areas in all of 14 cases of an Erlangen porcine model. We subsequently compared WESD with EMR of predefined esophageal mucosal lesions in anesthetizised pigs in a randomized controlled trial. The results demonstrated that WESD more frequently achieved a complete resection with a significantly lower number of specimen. WESD caused no perforations and bleedings could be endoscopically managed during the procedure. In addition we recently reported on this technology in a first clinical trial on WESD for early Barrett's neoplasia . The results indicated that WESD can be safely and effectively performed in the esophagus. Therefore the primary objective of this study is to compare the R0 resection rate of ESD and EMR for visible lesions of HIgh grade intraepithelial neoplasia (HGIN) or esophageal adenocarcinoma (EAC). Secondary objectives are related to completeness of resection, safety of the procedures, the medium term outcome and comparison of costs.
Conditions
Conditions (2)
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 |
| High Grade Intraepithelial Neoplasia | High Grade Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic mucosal resection | Procedure | — | UNRESOLVED |
| HybridKnife | Device | — | UNRESOLVED |
| Waterjet-assisted ESD | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- endoscopic mucosal resection
- description
- Endoscopic mucosal resection removes tissue in a piece meal technique or by snare limited to the mucosa.
- interventionNames
- Procedure: Endoscopic mucosal resection
- Procedure: Waterjet-assisted ESD
- type
- ACTIVE_COMPARATOR
- label
- Waterjet-assisted ESD
- description
- The waterjet-assisted endoscopic submucosal dissection (WESD) technology allows pressure controlled injection of fluids through the tip of a recently developed HybridKnife®. Submucosal injection, circumferential cutting and dissection of lesions.
- interventionNames
- Procedure: Endoscopic mucosal resection
- Procedure: Waterjet-assisted ESD
- Device: HybridKnife
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male, Female * At least 18 years old Exclusion Criteria: * \- Age under 18 years * Health status ASA 4 * Pregnancy * INR\>2.0, Platelets \< 70/nl * Previous endoscopic or surgical treatment of BE neoplasia * Neoplastic lesions which do not meet the inclusion criteria, in particular flat lesions (type 0-IIb) * Additional areas of HGIN or AC * Absence of a signed informed consent
References
Publications (1)
- DERIVEDTerheggen G, Horn EM, Vieth M, Gabbert H, Enderle M, Neugebauer A, Schumacher B, Neuhaus H. A randomised trial of endoscopic submucosal dissection versus endoscopic mucosal resection for early Barrett's neoplasia. Gut. 2017 May;66(5):783-793. doi: 10.1136/gutjnl-2015-310126. Epub 2016 Jan 22. PMID 26801885