A single center non-randomized prospective clinical study, to evaluate the feasibility and added value of the CE-certified Tracmotion device in patients scheduled consecutively for ESD in the upper and lower gastrointestinal tract. After ESD, the endoscopists' opinion will be evaluated with a short questionnaire on experience with the Tracmotion device. The pathology report will be checked for radicality and microscopic damage of the removed lesion.
Objective: The purpose of this study is to establish feasibility of the Tracmotion device for ESD and to define its added value during ESD in both upper and lower GI procedures, both in antegrade and in retroflex positions. Study design: Single center prospective observational non-randomized clinical study. Study population: A total of 20 consecutive cases scheduled for ESD will be included. Sample size calculation does not apply for this type of study. Patients already scheduled for ESD will undergo an ESD procedure as planned with the aid of the Tracmotion device. It is anticipated that the Tracmotion will provide superior traction and counter traction compared to off-label tools. Intervention: Patients already scheduled for ESD will undergo an ESD procedure with the aid of the Tracmotion device. Main study parameters/endpoints: Feasibility: procedure time, dissection speed, lesional damage (tearing or grasping injury to the mucosa on macroscopy and pathological review) Added value: subjective evaluation of the Tracmotion device by the performing endoscopist (contentment of use of Tracmotion, difference in procedure time, stability of, control of and accessibility to the lesion).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Patients already scheduled for ESD will undergo an ESD procedure with the aid of the Tracmotion device
Procedure time
Procedure time of the endoscopic submucosal dissection will be measured from start incision to end incision (in minutes)
Time frame: During endoscopic submucosal dissection procedure
Dissection speed
Dissection speed of ESD will be measured from start incision to end incision (square millimeter of dissected tissue per minute)
Time frame: During endoscopic submucosal dissection procedure
Lesional damage
Any tearing or grasping injury to the mucosa on macroscopy (yes vs. no) observed by the endoscopist and at pathological review (yes/no) observed by the pathologist expressed in percentages (%).
Time frame: During endoscopic submucosal dissection and during pathology review (on average 2 weeks after endoscopic submucosal dissection)
Subjective evaluation of the added value of the TRACMOTION device
Directly after the endoscopic mucosal dissection the endoscopist will fill in a questionnaire using the Likert scale (1= worst experience possible, 5 = best experience possible) about their experience with the TRACMOTION device during ESD (overall contentment, difference of procedure time, stability of, control of and accessibility to the lesion that was resected)
Time frame: Immediately after endoscopic submucosal dissection
En-bloc rate
The incidence of en-bloc resections in percentages (%)
Time frame: Determined Immediately after endoscopic submucosal dissection
R0 rate
The incidence of R0 resections in percentages (%)
Time frame: Determined during the pathology review (on average 2 weeks after endoscopic submucosal dissection)
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Complications after during and after endoscopic submucosal dissection
Complications will be measured during and after endoscopic submucosal dissection (bleeding yes/no, perforation yes/no) and will be expressed as percentages (%)
Time frame: During endoscopic submucosal dissection procedure and 2 weeks after