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

Study Overview
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Brief Summary
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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. 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.

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

Conditions
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Stomach Neoplasms

Intervention / Treatment
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* Device: Conventional ESD
* Device: Hybridknife ESD


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional ESD<br>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<br>* 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<br>|
| Active Comparator: Hybridknife ESD<br>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<br>* 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)<br>* Other names: Water-jet assisted HybridKnife® ESD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure time | 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. | during procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| en bloc resection rate | Resection of the targeted lesion including coagulation markers in one piece. | in procedure | 
| histological R0 rate | En-bloc resection and histological confirmation of horizontal and vertical free margins of neoplasia. | 7 days after procedure | 
| Histologically incomplete resection | Tumor infiltrated (R1) or undetermined (RX) margins of the resected specimen. | 7 days after procedure | 
| procedure related morbidity and mortality and complication rate | procedure related morbidity and mortality | 30 days after procedure | 
| complication rate | any complication occurs after procedure within 30 days, such as bleeding or perforation rates | 30 days after procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Early gastric cancer,, endoscopic submucosal dissection (ESD), water-jet assisted ESD