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NCT Number: NCT01943253

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

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.

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Key information

Conditions

Stomach Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Evangelisches Krankenhaus Düsseldorf

Düsseldorf, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional ESD

Device

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

Hybridknife ESD

Device

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

Primary outcomes

  1. Procedure time

    Time frame: 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 outcomes

  1. en bloc resection rate

    Time frame: in procedure

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

  2. histological R0 rate

    Time frame: 7 days after procedure

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

  3. Histologically incomplete resection

    Time frame: 7 days after procedure

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

  4. procedure related morbidity and mortality and complication rate

    Time frame: 30 days after procedure

    procedure related morbidity and mortality

  5. complication rate

    Time frame: 30 days after procedure

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

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Collaborators

  • Evangelisches Krankenhaus Düsseldorf

Registry information

Official study title

Water-jet Assisted Endoscopic Submucosal Dissection (ESD) in Comparison to Conventional ESD Technique for Treatment of Early Gastric Cancer

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 16, 2013
Registry last updated
Sep 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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