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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ESD with TRACMOTION | Other | Patients already scheduled for ESD will undergo an ESD procedure with the aid of the TRACMOTION device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRACMOTION | Device | Patients already scheduled for ESD will undergo an ESD procedure with the aid of the Tracmotion device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Procedure time | Procedure time of the endoscopic submucosal dissection will be measured from start incision to end incision (in minutes) | 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) | 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 (%). | 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) | Immediately after endoscopic submucosal dissection |
| Measure | Description | Time Frame |
|---|---|---|
| En-bloc rate | The incidence of en-bloc resections in percentages (%) | Determined Immediately after endoscopic submucosal dissection |
| R0 rate | The incidence of R0 resections in percentages (%) |
| Measure | Description | Time Frame |
|---|---|---|
| Age | Age in years | At baseline (after informed consent is signed) |
| Gender | Gender (male/female) | At baseline (after informed consent is signed) |
Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Determined during the pathology review (on average 2 weeks after endoscopic submucosal dissection) |
| 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 (%) | During endoscopic submucosal dissection procedure and 2 weeks after |
| Tumor length | Tumor length in millimeter (mm) | During endoscopic submucosal dissection, before incision starts |
| Tumor location | Tumor location in centimeter (cm) measured from incisors | During endoscopic submucosal dissection, before incision starts |
| Tumor histology | Tumor histology conform the pathology review | After endoscopic submucosal dissection when the pathologist has reviewed the tissue (on average 2 weeks after endoscopic submucosal dissection) |
| Prior treatment | Prior treatment of oesophageal neoplasms (such as chemotherapy, radiotherapy) | At baseline (after informed consent is signed) |
| Use of symptomatic medication | Use of symptomatic medication during 2 weeks after endoscopic submucosal dissection (analgesics, antiemetics, proton pump inhibitors) | 2 weeks after endoscopic submucosal dissection |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |