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ESD Versus EMR for Treatment of Early Barrett`s Adenocarcinoma

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ClinicalTrials.gov Identifier: NCT01871636
Recruitment Status : Completed
First Posted : June 7, 2013
Last Update Posted : September 9, 2015
Sponsor:
Information provided by (Responsible Party):
Evangelisches Krankenhaus Düsseldorf

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.


Condition or disease Intervention/treatment Phase
High Grade Intraepithelial Neoplasia Barrett Adenocarcinoma Procedure: Endoscopic mucosal resection Procedure: Waterjet-assisted ESD Device: HybridKnife Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Water-jet Assisted Endoscopic Submucosal Dissection (ESD) Versus Endoscopic Mucosal Resection (EMR) for Treatment of Early Barrett`s Adenocarcinoma
Study Start Date : December 2012
Actual Primary Completion Date : May 2014
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Active Comparator: endoscopic mucosal resection
Endoscopic mucosal resection removes tissue in a piece meal technique or by snare limited to the mucosa.
Procedure: Endoscopic mucosal resection
Endoscopic mucosal resection removes tissue in a piece meal technique or by snare limited to the mucosa.

Procedure: Waterjet-assisted ESD
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.

Active Comparator: Waterjet-assisted ESD
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
Endoscopic mucosal resection removes tissue in a piece meal technique or by snare limited to the mucosa.

Procedure: Waterjet-assisted ESD
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.

Device: HybridKnife
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.




Primary Outcome Measures :
  1. Histologically complete resection (R0 resection) of BE - HGIN or EAC [ Time Frame: 6 month ]

Secondary Outcome Measures :
  1. Complete resection of the targeted neoplastic area [ Time Frame: 6 month ]
  2. Complete en-bloc resection of the targeted neoplastic area [ Time Frame: 6 month ]
  3. Determination of the procedural duration [ Time Frame: 6 month ]
  4. Determination of the 30-day morbidity and mortality [ Time Frame: 6 month ]
  5. Determination of the costs to achieve CR from HGIN or EAC [ Time Frame: 6 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01871636


Locations
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Germany
Evangelisches Krankenhaus
Duesseldorf, Germany, 40217
Sponsors and Collaborators
Evangelisches Krankenhaus Düsseldorf
Investigators
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Principal Investigator: Horst Neuhaus, MD Evangelisches Krankenhaus Duesseldorf

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Evangelisches Krankenhaus Düsseldorf
ClinicalTrials.gov Identifier: NCT01871636     History of Changes
Other Study ID Numbers: EVKendo2013
First Posted: June 7, 2013    Key Record Dates
Last Update Posted: September 9, 2015
Last Verified: September 2015
Keywords provided by Evangelisches Krankenhaus Düsseldorf:
endoscopy
WESD
EMR
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms