ESD (Endoscopic Sub-mucosal Dissection)is the first-intent method to treat superficial neoplasms of the digestive tract at it allows an en-bloc R0 resection. Following marking of the lesion margins, ESD comprises 3 steps: 1) liquid injection into the sub-mucosal space 2) circumferential (complete or partial) incision and 3) dissection of the submucosa. Several tools are necessary to perform ESD with the standard technique. Development of water jet with bi functional (injection and cutting) catheter allows time and significant reduction of perforation risk (due to multiple changes of instruments). For this purpose, Nestis introduced the Enki 2 pulsed jet technology with high pressure system to inject efficiently and at any time viscous solutions in direct viewing and retroflexion. Preliminary pig studies indicate that injection of glycerol, hyaluronate and hydroxyethlstarch with Enki 2 are possible. In addition, preclinical studies on living pig colon models using saline solutions have demonstrated that perforation rates and operating times are significantly reduced compared to a standard electrosurgical knife. The present clinical study is being performed to confirm this system capability to perform ESD in humans.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Hôpital Edouard Herriot
Lyon, France
Safety outcome
Safety is measured in term of perforation rate and bleeding rate with immediate complication or delayed one after the procedure, at one month complications are not linked to the ESD procedure
Time frame: At 1 month
Effectiveness of the procedure in terms of complete neoplasia resections
Procedure is successful when the resection is complete with no residual tissue on the margins in depth and in the lateral part of the lesions.
Time frame: less than one month to get the pathology examination report
Effectiveness of the procedure in terms of complete neoplasia resections
no macroscopic nor microscopic local recurrence during follow up endoscopy
Time frame: three month
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