NCT05019404

Minimally Invasive Surgical Epilepsy Trial for Temporal Lobe Epilepsy

Functional Anterior Temporal Lobectomy Via Minicraniotomy as a Novel Surgical Therapy for Temporal Lobe Epilepsy: a Randomized, Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: First Affiliated Hospital Xi'an Jiaotong University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Temporal lobe epilepsy (TLE) is a chronically neurological disease characterized by progressive seizures. TLE is the most frequent subtype of refractory focal epilepsy in adults. Epilepsy surgery has proven to be very efficient in TLE and superior to medical therapy in two randomized controlled trials. According to the previous experience, the investigators use functional anterior temporal lobectomy (FATL) via minicraniotomy for TLE. To date, this minimally invasive open surgery has been not reported. The investigators here present a protocol of a prospective trail which for the first time evaluates the outcomes of this new surgical therapy for TLE.

Detailed description

Temporal lobe epilepsy (TLE) is a chronically neurological disease characterized by progressive seizures, followed by a latency period of several years after various injuries including febrile seizures, infection, trauma, tumors, and vascular malformation. Hippocampal sclerosis is the most common histopathological finding. The macroscopic changes of TLE with hippocampal sclerosis include the diminished size, sclerosis, and reduced metabolism in mesial temporal structures (amygdala, hippocampus, and parahippocampal gyrus). The microscopic changes include neuronal loss, gliosis, and axonal reorganization. As TLE progresses, most of patients become resistant to current antiepileptic drugs. Therefore, TLE is the most frequent subtype of refractory focal epilepsy in adults. Epilepsy surgery has proven to be very efficient for TLE and superior to medical therapy in two randomized controlled trials. Patients with surgical therapy have high seizure-free rate with the range of 60% to 80 % while less than 5% with medical treatment. Anterior temporal lobectomy (ATL) is the most frequently used approach for TLE. For patients with TLE, Engel suggested referral to ATL should be strongly considered. The decision analysis showed that ATL increased life expectancy and quality- adjusted life expectancy in patients with TLE compared with medical management. Nevertheless, ATL is performed by large frontotemporal craniotomy. Although complication rates after temporal lobectomy have decreased dramatically over time, ATL creates a large cavity with temporal lobe resected, causing potential complications such as bleeding, brain shifts and subdural collections. With the advances in minimally invasive surgery, surgical techniques of ATL for TLE need to be continuously improved. For this reason, the investigators modify the surgical approach. Functional anterior temporal lobectomy (FATL) via minicraniotomy is established. Recently, 25 patients with TLE undergoing FATL obtained satisfactory outcomes in our center (unpublished data). To date, this new open surgery for TLE has been not reported. The safety and efficacy of FATL need to be verified. Therefore, the investigators here present a protocol of the minimally invasive surgical epilepsy trial for TLE (MISET-TLE) which for the first time evaluates the outcomes of FATL as a new surgical approach for TLE.

Conditions

• Temporal Lobe Epilepsy
• Open Surgery
• Minimally Invasive Surgery

Interventions

Type	Name	Description
PROCEDURE	Functional anterior temporal lobectomy (FATL)	Patients are placed in the supine position with the head contralaterally rotated 30°. The 3D model of incision and bone flap is printed prior to surgery by the slicer software based on the MRI data. Slightly curve incision with the length of about 6 cm in the temporal region is marked according to the 3D model. Temporal craniotomy via small bone window with the diameter of about 3 cm is performed. From the temporal pole along T1 about 5 cm posteriorly, temporal horn is opened by dissecting the middle temporal gyrus. The head of temporal horn is exposed. The amygdala is resected. Then, the parahippocampal gyrus and hippocampus are en bloc resected. The lateral temporal lobotomy is easy due to large view following the removal of mesial structures. The lateral posterior temporal lobotomy is no more than 5 cm from the temporal pole.
PROCEDURE	Anterior temporal lobectomy (ATL)	Patients are placed in the supine position with the head contralaterally rotated 30°. Large frontotemporal craniotomy is performed. Question mark-shaped incision with the length of 20- 25 cm in the frontotemporal region is marked. The size of the bone flap is approximately 5×7 cm for the exposure of lateral temporal lobe. ATL consists of en bloc resection of the anterior 5 cm of lateral temporal lobe, followed by the removal of mesial structures including the amygdala, parahippocampal gyrus, and hippocampus.

Timeline

• Start date: 2023-04-25
• Primary completion: 2024-09-01
• Completion: 2025-09-01
• First posted: 2021-08-24
• Last updated: 2022-12-30

Locations

1 site across 1 country: China