Water-jet Assisted ESD vs Conventional ESD Technique for Treating Early Gastric Cancer
Stomach Neoplasms
About this trial
This is an interventional treatment trial for Stomach Neoplasms focused on measuring Early gastric cancer,, endoscopic submucosal dissection (ESD), water-jet assisted ESD
Eligibility Criteria
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
Sites / Locations
- Evangelisches Krankenhaus Düsseldorf
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Conventional ESD
Hybridknife 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
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)