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

Stomach Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01943253
• Other study ID #: Hybrid ESD
• 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

• Stomach Neoplasms

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