The Effectiveness and Safety of Resective Epilepsy Surgery for TRE

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-12

Study Completion Date

2027-03-15

Brief Summary

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A prospective cohort studies to identify clinical seizure control, cognitive changes, and safety in resective epilepsy surgery in patients with TSC-related drug-resistant epilepsy.

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Detailed Description

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Two hundred candidates are recruited and assigned to the control and surgery groups with 100 cases in each group, respectively. All patients will accept first-stage pre-enrollment evaluations and patients in surgery group will accept second-stage invasive evaluation.

All patients will be advised to visit the hospitals for examination each year after enrollment. Seizure outcomes will be assessed with reference to patients' seizure diaries and caregivers' oral statements by both neurosurgeons and neurologists.

All adverse effects will be classified according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 (2017).

Statistical analyses were conducted using SPSS (version 26.0, IBM, USA), Stata (version 16.0, Stata Corp LLC, USA), and R (version 4.3.3, R Foundation for Statistical Computing, Austria). Outcomes were presented according to data type as percentages, mean ± standard deviation, or median (interquartile range, IQR).

Multiple imputation was employed to address missing data for IQ and QOL at enrollment and the 2-year follow-up. A sensitivity analysis was conducted to assess the robustness of the multiple imputation results. The "mi impute regress" statement in Stata facilitated the multiple imputations. 20 T-tests were utilized for comparing continuous variables, with results reported as mean ± standard deviation. The Mann-Whitney U test was applied for non-normally distributed continuous variables, presenting results as median values and IQRs. Chi-square and Fisher's exact tests were used for univariate analyses. A significance level of p \< 0.05 was established.

To account for differences in covariates between the surgery and medicine groups, propensity score matching (PSM) was performed. Based on PSM, Kaplan-Meier curves and the log-rank test were utilized to analyze time-to-seizure recurrence differences between the surgery and medicine groups. Additionally, multivariable Cox proportional hazards regression was applied to predict risk factors for postoperative seizure recurrence within a 51-month follow-up period after PSM.

Conditions

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Tuberous Sclerosis Complex Epilepsy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Control Group

Patients in the surgery group will accept exclusive rational medicine therapy.

No interventions assigned to this group

Surgery Group

Patients in the surgery group will undergo resective surgery combined with rational medicine therapy.

Surgery

Intervention Type PROCEDURE

Resective surgery included lobectomy (partial or total brain lobe resection), tuberectomy (epileptogenic tuber resection), and tuberectomy plus (resection of epileptogenic tuber and perituberal gyri). Tuberectomy was typically performed on the epileptogenic tuber within or near an eloquent area. Lobectomy was performed in patients with large epileptogenic tubers in the brain lobes. Multiple lobectomies, tuberectomies, tuberectomies plus, and lobectomy combined with tuberectomy/tuberectomies plus were further performed in patients with multiple epileptogenic tubers.

Interventions

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Surgery

Resective surgery included lobectomy (partial or total brain lobe resection), tuberectomy (epileptogenic tuber resection), and tuberectomy plus (resection of epileptogenic tuber and perituberal gyri). Tuberectomy was typically performed on the epileptogenic tuber within or near an eloquent area. Lobectomy was performed in patients with large epileptogenic tubers in the brain lobes. Multiple lobectomies, tuberectomies, tuberectomies plus, and lobectomy combined with tuberectomy/tuberectomies plus were further performed in patients with multiple epileptogenic tubers.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 2 years old and above, no gender restriction, TSC gene monitoring with or without abnormality
* Diagnosis of tuberous sclerosis- related drug-resistant epilepsy
* Epilepsy course for more than 1 year
* Patients who have taken 3 or more reasonable choices with appropriate and tolerable antiepileptic drugs (excluding mTOR inhibitors and traditional Chinese medicine and prescriptions) had seizures more than 12 times in the 3 months before enrollment
* The family members agreed to enroll and signed the informed consent.

Exclusion Criteria

* Obvious renal angiomyolipoma, pulmonary lymphoma leiomyomatosis, and subventricular giant cell astrocytoma
* Abnormal heart, lung, liver, and kidney functions and coagulation function
* Preoperative evaluation, it is considered that no surgical treatment is needed
* The patient received other craniocerebral surgical treatment within 1 year during the follow-up period

Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No