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Water-jet Assisted ESD vs Conventional ESD Technique for Treating Early Gastric Cancer

Sponsor
Shanghai Zhongshan Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01943253
Collaborator
Evangelisches Krankenhaus Düsseldorf (Other)
117
Enrollment
1
Location
2
Arms
17.1
Duration (Months)
6.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

  1. Introduction The aim of the study is to evaluate the efficacy and safety of ESD by use of a new water-jet assisted ESD system using the HybridKnife® in patients with early gastric neoplastic lesions in comparison to the conventional ESD established in Japan. The water-assisted ESD technology 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 can be performed with the same device without need for changing the instrument. These options should accelerate the procedure and may increase its safety and efficacy.

  2. Hypothesis The water-jet assisted ESD technique using the HybridKnife® bears the advantage of less instrument changes due to the combination of high-frequency cutting and water-jet application in one single instrument. This should lead to a simplified ESD procedure, shorter learn-ing curve and especially to a shorter procedure time.

The water-jet assisted ESD technique should be shorter than the conventional ESD techniques using IT2-, Dual- and Hook-Knifes at least with the same safety and effectiveness.

Condition or Disease Intervention/Treatment Phase
  • Device: Conventional ESD
  • Device: Hybridknife ESD
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
117 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Water-jet Assisted Endoscopic Submucosal Dissection (ESD) in Comparison to Conventional ESD Technique for Treatment of Early Gastric Cancer
Study Start Date :
May 1, 2011
Actual Primary Completion Date :
Jul 1, 2012
Actual Study Completion Date :
Oct 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Conventional ESD

Conventional ESD: Conventional ESD technique using IT2-Knife, Dual-Knife, Hook-Knife (Olympus Europe, Hamburg, Germany) ERBE VIO 300D (V2.1.4) RF-surgery system (ERBE Elektromedizin GmbH, Tübingen, Germany) Injection of fluid: Syringe

Device: Conventional ESD
Conventional ESD: Conventional ESD technique using IT2-Knife, Dual-Knife, Hook-Knife (Olympus Europe, Hamburg, Germany; Olympus Japan) ERBE VIO 300D (V2.1.4) RF-surgery system (ERBE Elektromedizin GmbH, Tübingen, Germany) Injection of fluid: Syringe
Active Comparator: Hybridknife ESD

Group 2: Water-jet assisted HybridKnife® ESD technique using HybridKnife® (Erbe Elektromedizin GmbH, Tübingen, Germany) ERBE VIO 300D (V2.1.4) RF-surgery system (ERBE Elektromedizin GmbH, Tübingen, Germany) Injection of fluid: Integrated in HybridKnife® with ERBEJet 2 water-jet surgery system (ERBE Elektromedizin GmbH, Tübingen, Germany)

Device: Hybridknife ESD
Group 2: Water-jet assisted HybridKnife® ESD technique using HybridKnife® (Erbe Elektromedizin GmbH, Tübingen, Germany) ERBE VIO 300D (V2.1.4) RF-surgery system (ERBE Elektromedizin GmbH, Tübingen, Germany) Injection of fluid: Integrated in HybridKnife® with ERBEJet 2 water-jet surgery system (ERBE Elektromedizin GmbH, Tübingen, Germany)
Other Names:
  • Water-jet assisted HybridKnife® ESD

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Procedure time [during procedure]

      The primary objective of the study is the procedure time of ESD using the conventional ESD technique in comparison to the water-jet assisted HybridKnife®-ESD technique.

    Secondary Outcome Measures

    1. en bloc resection rate [in procedure]

      Resection of the targeted lesion including coagulation markers in one piece.

    2. histological R0 rate [7 days after procedure]

      En-bloc resection and histological confirmation of horizontal and vertical free margins of neoplasia.

    3. Histologically incomplete resection [7 days after procedure]

      Tumor infiltrated (R1) or undetermined (RX) margins of the resected specimen.

    4. procedure related morbidity and mortality and complication rate [30 days after procedure]

      procedure related morbidity and mortality

    5. complication rate [30 days after procedure]

      any complication occurs after procedure within 30 days, such as bleeding or perforation rates

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • adults (≥ 18 years) with confirmed diagnosis of gastric adenoma or early gastric adenocarcinoma

    • differentiated mucosal adenocarinoma without ulcer findings ≤ 60 mm in diameter.

    • Lesions with ulceration ≤ 30 mm in diameter.

    • undifferentiated type of mucosal cancer is ≤ 20 mm.

    • The patient has given written informed consent.

    Exclusion Criteria:

    • pregnancy

    • coagulopathy (INR>2.0, platelets < 70/nl)

    • mucosal lesions which did not meet the inclusion criteria

    • evidence of local or distant metastases according to endoscopic ultrasound (EUS) and/or CT scan, EUS (7.5 MHz probe) findings of tumor infiltration into deep layers of the submucosa or muscularis propria. -Patients unfit for deep sedation by use of propofol

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Evangelisches Krankenhaus Düsseldorf Düsseldorf Germany

    Sponsors and Collaborators

    • Shanghai Zhongshan Hospital
    • Evangelisches Krankenhaus Düsseldorf

    Investigators

    • Study Director: Horst Neuhaus, Evangelisches Krankenhaus Düsseldorf
    • Principal Investigator: Pinghong Zhou, Endoscopy Center, Zhongshan Hospital, Fudan University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shanghai Zhongshan Hospital
    ClinicalTrials.gov Identifier:
    NCT01943253
    Other Study ID Numbers:
    • Hybrid ESD
    First Posted:
    Sep 16, 2013
    Last Update Posted:
    Sep 16, 2013
    Last Verified:
    Sep 1, 2013
    Keywords provided by Shanghai Zhongshan Hospital
    Early gastric cancer,
    endoscopic submucosal dissection (ESD)
    water-jet assisted ESD
    Additional relevant MeSH terms:
    Stomach Neoplasms

    Study Results

    No Results Posted as of Sep 16, 2013