Colorectal cancer is a major public health issue. In France, in 2015, there were 40,000 new cases and 17,000 deaths. It develops from adenomas or scalloped polyps, which are usually accessible for endoscopic resection.
Piece-meal mucosectomy is the standard technique in Europe and the USA for lesions larger than 2 cm. It has certain advantages, such as its ease of learning, low morbidity and speed of execution. However, it has one major disadvantage, namely the low rate of monobloc resection and R0 for lesions larger than 2 cm.
Submucosal dissection (SMD) has become the standard technique for endoscopic resection of superficial colorectal lesions larger than 2 cm, particularly if the lesion presents a risk of superficial degeneration. Unlike mucosectomy, this technique allows for monobloc resection targeting R0 for all types of superficial lesions without size limitations, enabling histological analysis without data loss and with a recurrence rate of less than 2%.
However, there are numerous disadvantages to dissection:
* SMD is more difficult than mucosectomy, with a long learning curve, limiting its use to expert centres. * The morbidity of dissection is higher than that of mucosectomy, with a risk of perforation of 4% vs. 1%. * The procedure takes on average three times longer than mucosectomy.
From a technical standpoint, various methods have been described to facilitate the procedure, in particular traction using clips and elastic bands, which is the most widely used method in France.
Micro-Tech offers a new traction device, SureTrac, which is designed to perform single or multi-polar traction and to adjust the intensity of traction during dissection. The product is CE marked but has not yet been distributed in France. No data are currently available in the literature on this product other than a case report submitted for publication. A pilot study conducted by an expert centre is therefore necessary. This is why this study is being initiated.
Patient, male or female, aged ≥ 18 years old
Patient with a colorectal lesion larger than 2 cm
Patient eligible for SMD with elastic traction
Patient affiliated with or beneficiary of a social security scheme
Patients in poor general health who should not undergo endoscopy.
Patients with an upper digestive tract that cannot be accessed by the endoscope.
Patients with severe coagulation disorders and diseases associated with a risk of haemorrhage (platelets <50G/L, PT < 50%, INR > 1.5, APTT >1.5).
Patients who are allergic to the instrument and to the drugs administered during the operation
Single group
SureTrac is designed to perform single or multi-polar traction and to adjust the traction intensity during dissection.
DeviceThe SureTrac device consists of a main attachment clip to which an elastic silicone device comprising four aligned rings is attached. The device is designed to retract and release elastic potential energy for dynamic traction. This allows for better visualisation of tissues and facilitates Submucosal dissection of colorectal lesions.
Submucosal dissection feasibility with the SureTrac traction device.
Feasibilty will be the rate of monobloc resection with the SureTrac device. Monobloc resection requiring another device or fragmented resection (regardless of the device) will be considered a failure.
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This trial is not recruiting at the moment. You can still explore other options:
