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

Not Applicable

Completed

• Conditions: Stomach Neoplasms
• Interventions: Device: Conventional ESD; Device: Hybridknife ESD

• Registration Number: NCT01943253
• Lead Sponsor: Shanghai Zhongshan Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Primary Completion: 2012-07
• Study Completion: 2012-10
• Status Verified: 2013-09
• Study First Submitted: 2013-09-04
• Study First Submitted QC: 2013-09-11
• Last Update Submitted: 2013-09-11
• Study First Posted: 2013-09-16
• Last Update Posted: 2013-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 117

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional ESD	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
Hybridknife ESD	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)

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Evangelisches Krankenhaus Düsseldorf; 🇩🇪 Düsseldorf, Germany