Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-30 @ 3:25 PM
Study NCT ID:
NCT05019404
Status:
UNKNOWN
Last Update Posted:
2022-12-30
First Post:
2021-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Minimally Invasive Surgical Epilepsy Trial for Temporal Lobe Epilepsy
Sponsor:
First Affiliated Hospital Xi'an Jiaotong University
Organization:
Study Overview
Official Title:
Functional Anterior Temporal Lobectomy Via Minicraniotomy as a Novel Surgical Therapy for Temporal Lobe Epilepsy: a Randomized, Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2022-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MISET-TLE
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: