ESD Versus EMR for Treatment of Early Barrett's Adenocarcinoma

NCT01871636 | Completed

• 1 other identifier: EVKendo2013
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

High Grade Intraepithelial Neoplasia; Barrett Adenocarcinoma

Keywords

endoscopy; WESD; EMR

Outcome Measures

Primary Outcomes (1)

• Histologically complete resection (R0 resection) of BE - HGIN or EAC

  6 month

Secondary Outcomes (5)

• Complete resection of the targeted neoplastic area

  6 month

• Complete en-bloc resection of the targeted neoplastic area

  6 month

• Determination of the procedural duration

  6 month

• Determination of the 30-day morbidity and mortality

  6 month

• Determination of the costs to achieve CR from HGIN or EAC

  6 month

Study Arms (2)

endoscopic mucosal resection

ACTIVE COMPARATOR

Endoscopic mucosal resection removes tissue in a piece meal technique or by snare limited to the mucosa.

Procedure: Endoscopic mucosal resection; Procedure: Waterjet-assisted ESD

Waterjet-assisted ESD

ACTIVE COMPARATOR

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.

Procedure: Endoscopic mucosal resection; Procedure: Waterjet-assisted ESD; Device: HybridKnife

Interventions

Endoscopic mucosal resection PROCEDURE

Endoscopic mucosal resection removes tissue in a piece meal technique or by snare limited to the mucosa.

Waterjet-assisted ESD; endoscopic mucosal resection

Waterjet-assisted ESD PROCEDURE

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.

Waterjet-assisted ESD; endoscopic mucosal resection

HybridKnife DEVICE

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.

Waterjet-assisted ESD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male, Female
• At least 18 years old

You may not qualify if:

• \- Age under 18 years
• Health status ASA 4
• Pregnancy
• INR\>2.0, Platelets \< 70/nl
• Previous endoscopic or surgical treatment of BE neoplasia
• Additional areas of HGIN or AC
• Absence of a signed informed consent

Sponsors & Collaborators

• Evangelisches Krankenhaus Düsseldorf: lead

Study Sites (1)

Evangelisches Krankenhaus

Düsseldorf, 40217, Germany

Location

Related Publications (1)

• Terheggen 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 DERIVED

MeSH Terms

Interventions

Endoscopic Mucosal Resection

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Horst Neuhaus, MD

  Evangelisches Krankenhaus Duesseldorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2013
• First Posted: June 7, 2013
• Study Start: December 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: August 1, 2015
• Last Updated: September 9, 2015

Record last verified: 2015-09

Locations

DE (1)