Video-Assisted Cordotomy Study

In patients with severe refractory pain due to cancer, or in case of too many side effects, a cordotomy may be needed to achieve pain control. This is a proved to be successful treatment, increases quality of life and has low costs. However, the procedure is currently performed by just a few specialists due to the high requirements with regard to technical skills and safety. By adding a video endoscope to the cordotomy, we aim to rehabilitate the cordotomy by showing that this new video endoscopic cordotomy technique is safe, provides effective pain control and has very few and manageable complications.

Video endoscopic cordotomy technique is safe, provides effective pain control and has very few and manageable complications

Baseline: QST, MRI, Questionnaires (EORTC, BPI, HADS), Clinical evaluation (NRS, pain medication, etc)
Treatment: SAEs and procedure related details
Hospitalization: SAEs, Clinical evaluation (NRS, pain medication, etc)
Two weeks: SAEs, MRI, Questionnaires (EORTC, BPI, HADS PGIC), Clinical evaluation (NRS, pain medication, etc)
Six weeks: SAEs, MRI, Questionnaires (EORTC, BPI, HADS PGIC), Clinical evaluation (NRS, pain medication, etc)

In this study a video endoscope will be added to the cordotomy in two consecutive parts.

Study part A: Just like with the regular cordotomy technique a cannula will be inserted in the spinal space under fluoroscopy and with the use of a contrast medium. Before the regular technique continues, the video endoscope will be inserted via the already brought in cannula to visualize anatomical structures in the spinal space. After identification of the different anatomical structures, the video endoscope will be removed. Then the regular technique continues, by placement of a RF probe with the use of X-ray in the spinal cord. After safety checks to confirm whether the RF probe is placed correctly in the spinal cord, a RF thermolesion (=treatment) will be made.

Study part B: Just like with the regular cordotomy technique a cannula will be inserted in the spinal space under fluoroscopy and with the use of a contrast medium. However, the cannula is replaced by a cannula with two entry channels. In the first channel the video endoscope will be inserted. After video endoscopic identification of the spinal cord, a RF probe is inserted via the second channel in the spinal space. Under video endoscopic visualization the RF probe will be placed in the spinal cord. After safety checks to confirm whether the RF probe is placed correctly in the spinal cord, a thermolesion (=treatment) will be made.