Clinical trial NCT01943253: Water-jet Assisted ESD vs Conventional ESD Technique for Treating Early Gastric Cancer
Official title: Water-jet Assisted Endoscopic Submucosal Dissection (ESD) in Comparison to Conventional ESD Technique for Treatment of Early Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stomach Neoplasms
Keywords: Early gastric cancer,
endoscopic submucosal dissection (ESD)
water-jet assisted ESD
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
Collaborators: name: Evangelisches Krankenhaus Düsseldorf
First posted: 2013-09-16
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Procedure time
timeFrame: during procedure
Secondary outcomes:
measure: en bloc resection rate
timeFrame: in procedure
measure: histological R0 rate
timeFrame: 7 days after procedure
measure: Histologically incomplete resection
timeFrame: 7 days after procedure
measure: procedure related morbidity and mortality and complication rate
timeFrame: 30 days after procedure
measure: complication rate
timeFrame: 30 days after procedure
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: Evangelisches Krankenhaus Düsseldorf
Study officials:
affiliation: Evangelisches Krankenhaus Düsseldorf
name: Horst Neuhaus
role: STUDY_DIRECTOR
affiliation: Endoscopy Center, Zhongshan Hospital, Fudan University
name: Pinghong Zhou
role: PRINCIPAL_INVESTIGATOR
References: