Clinical trial NCT05019404: Minimally Invasive Surgical Epilepsy Trial for Temporal Lobe Epilepsy
Official title: Functional Anterior Temporal Lobectomy Via Minicraniotomy as a Novel Surgical Therapy for Temporal Lobe Epilepsy: a Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Temporal Lobe Epilepsy
Open Surgery
Minimally Invasive Surgery
Keywords: Temporal lobe epilepsy
Anterior temporal lobectomy
Functional anterior temporal lobectomy
Randomized controlled trial
Minicraniotomy
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2021-08-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a single-center, prospective, single-blinded, double-arm, randomized, controlled trial
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. male or female aged between 18 and 60 years;
2. drug- resistant temporal lobe epilepsy, remaining seizures after two or more tolerated and appropriately chosen antiepileptic drugs;
3. monthly or more seizures during the preceding year prior to trial;
4. the full- scale intelligence quotient (IQ) more than 70, understanding and completing the trial;
5. signing the informed consent;
6. good compliance, at least 12- month follow- up after surgery.

Exclusion Criteria:

1. tumor in temporal lobe;
2. extratemporal epilepsy and temporal plus epilepsy;
3. drug- responsive epilepsy, seizure freedom with current drugs in recent one year;
4. pseudoseizures;
5. seizures arising from bilateral temporal lobes;
6. significant comorbidities including progressive neurological disorders, active psychosis, and drug abuse;
7. a full- scale IQ lower than 70, unable to complete tests;
8. previous epilepsy surgery;
9. poor compliance and inadequate follow- up.

Primary outcomes:
measure: Surgery duration
timeFrame: At the end of the surgery.
measure: Blood loss
timeFrame: At the end of the surgery.
measure: Skin incision
timeFrame: At the end of the surgery.
measure: Bone flap
timeFrame: At the end of the surgery.
measure: Postoperative hospital stay
timeFrame: Up to 1 month after surgery.
measure: Complications
timeFrame: Up to 1 year after epilepsy surgery
Secondary outcomes:
measure: Seizure outcomes classified by the International League Against Epilepsy (ILAE)
timeFrame: Up to 1 year after epilepsy surgery
measure: Seizure outcomes classified by the Engel
timeFrame: Up to 1 year after epilepsy surgery
measure: Quality of life assessed by the Quality of Life in Epilepsy Inventory- 89
timeFrame: Up to 1 year after epilepsy surgery
Other outcomes:
measure: Intelligence assessed by the Wechsler Adult Intelligence Scale
timeFrame: Up to 1 year after epilepsy surgery
measure: Depression assessed by Beck's Depression Inventory
timeFrame: Up to 1 year after epilepsy surgery
measure: Anxiety assessed by the State-Trait Anxiety Inventory
timeFrame: Up to 1 year after epilepsy surgery
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Hua Zhang, PhD
role: STUDY_CHAIR
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