The goal of this prospective study at Baylor St. Luke's Medical Center is to investigate the the efficacy and safety of using the novel TTS helix tack suture device as a dynamic traction device during colon and gastric endoscopic submucosal dissection (ESD). The investigators of this study hypothesize that a dynamic traction during ESD can be less traumatic than with other traction devices.
The patient is ≥ 18 years old.
Patients can provide informed consent.
The patient is < 18 years old.
The patient refuses and/or is unable to provide consent.
The patient is a pregnant woman.
Lesions with morphology: pedunculated type (Paris Ip, Ips).
Patients undergoing ESD procedure at Baylor St. Luke's Medical Center - Houston, TX.
Cohort
Prospective
Traction Device
DeviceAfter circumferential incision and trimming the submucosa at the incision's edge, dissection is initiated until approximately 20 to 30% of the anal side (for colonic lesions) or oral side (for gastric lesions) of lesion has been dissected leaving a flap of at least 1 cm in length. Once the mucosal flap is created the X-tack device is introduced through the endoscope channel. The first tack is placed on the opposite wall of the lesion, the 2nd and 3rd tack will then be placed next to each other on the mucosal flap portion of the lesion. The 4th tack does not have to be placed but can be used to generate further traction at any time. Clips can be placed along the suture and clipped to the wall at any point to change angulation of traction. The sutures can then be cut and released from the tissue
Technical success
Being able to dissect the lesion to facilitate en bloc removal (removal of the entire tumor endoscopically in one piece)
Dissection speed
Length of time to perform endoscopic submucosal dissection by the operator as measured by calculating area of lesion divided by time (cm\^2/hours).
R0 and curative resection rates
As collected
Total procedure time
Total procedure time to perform ESD from scope in to scope out
NASA Task Load Index
Method assesses work load on five 7-point scales. Increments of high, medium and low
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