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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01943253
Other study ID # Hybrid ESD
Secondary ID
Status Completed
Phase N/A
First received September 4, 2013
Last updated September 11, 2013
Start date May 2011
Est. completion date October 2012

Study information

Verified date September 2013
Source Shanghai Zhongshan Hospital
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 117
Est. completion date October 2012
Est. primary completion date July 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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
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)

Locations

Country Name City State
Germany Evangelisches Krankenhaus Düsseldorf Düsseldorf

Sponsors (2)

Lead Sponsor Collaborator
Shanghai Zhongshan Hospital Evangelisches Krankenhaus Düsseldorf

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary en bloc resection rate Resection of the targeted lesion including coagulation markers in one piece. in procedure Yes
Secondary histological R0 rate En-bloc resection and histological confirmation of horizontal and vertical free margins of neoplasia. 7 days after procedure Yes
Secondary Histologically incomplete resection Tumor infiltrated (R1) or undetermined (RX) margins of the resected specimen. 7 days after procedure Yes
Secondary procedure related morbidity and mortality and complication rate procedure related morbidity and mortality 30 days after procedure Yes
Secondary complication rate any complication occurs after procedure within 30 days, such as bleeding or perforation rates 30 days after procedure Yes
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