Minimally Invasive Surgical Epilepsy Trial for Temporal Lobe Epilepsy

NCT05019404 | Unknown

• 1 other identifier: XJTU1AF2021LSK-194
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Temporal Lobe Epilepsy; Open Surgery; Minimally Invasive Surgery

Keywords

Temporal lobe epilepsy; Anterior temporal lobectomy; Functional anterior temporal lobectomy; Randomized controlled trial; Minicraniotomy

Outcome Measures

Primary Outcomes (6)

• Surgery duration

  Surgery duration in hours, the time from the beginning of incising the skin to the finish of suturing the skin.

  At the end of the surgery.

• Blood loss

  Blood loss in millilitres during the operation.

  At the end of the surgery.

• Skin incision

  Length of skin incision in centimetres

  At the end of the surgery.

• Bone flap

  Size of bone flap in square centimeter

  At the end of the surgery.

• Postoperative hospital stay

  Postoperative hospital stay in days, the time from the first postoperative day to discharge date.

  Up to 1 month after surgery.

• Complications

  The incidence of postoperative complications

  Up to 1 year after epilepsy surgery

Secondary Outcomes (3)

• Seizure outcomes classified by the International League Against Epilepsy (ILAE)

  Up to 1 year after epilepsy surgery

• Seizure outcomes classified by the Engel

  Up to 1 year after epilepsy surgery

• Quality of life assessed by the Quality of Life in Epilepsy Inventory- 89

  Up to 1 year after epilepsy surgery

Other Outcomes (3)

• Intelligence assessed by the Wechsler Adult Intelligence Scale

  Up to 1 year after epilepsy surgery

• Depression assessed by Beck's Depression Inventory

  Up to 1 year after epilepsy surgery

• Anxiety assessed by the State-Trait Anxiety Inventory

  Up to 1 year after epilepsy surgery

Study Arms (2)

Functional anterior temporal lobectomy (FATL)

EXPERIMENTAL

FATL via minicraniotomy is a new surgical approach, consisting of amygdalohippocampectomy and the lateral temporal lobotomy.

Procedure: Functional anterior temporal lobectomy (FATL)

Anterior temporal lobectomy (ATL)

ACTIVE COMPARATOR

ATL via large frontotemporal craniotomy is a conventional surgical approach, consisting of amygdalohippocampectomy and en bloc resection of the lateral temporal lobe.

Procedure: Anterior temporal lobectomy (ATL)

Interventions

Functional anterior temporal lobectomy (FATL) PROCEDURE

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.

Functional anterior temporal lobectomy (FATL)

Anterior temporal lobectomy (ATL) PROCEDURE

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.

Anterior temporal lobectomy (ATL)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

Related Publications (16)

• O'Dell CM, Das A, Wallace G 4th, Ray SK, Banik NL. Understanding the basic mechanisms underlying seizures in mesial temporal lobe epilepsy and possible therapeutic targets: a review. J Neurosci Res. 2012 May;90(5):913-24. doi: 10.1002/jnr.22829. Epub 2012 Feb 8.

  PMID: 22315182 BACKGROUND

• Falowski SM, Wallace D, Kanner A, Smith M, Rossi M, Balabanov A, Ouyang B, Byrne RW. Tailored temporal lobectomy for medically intractable epilepsy: evaluation of pathology and predictors of outcome. Neurosurgery. 2012 Sep;71(3):703-9; discussion 709. doi: 10.1227/NEU.0b013e318262161d.

  PMID: 22668889 BACKGROUND

• Jones AL, Cascino GD. Evidence on Use of Neuroimaging for Surgical Treatment of Temporal Lobe Epilepsy: A Systematic Review. JAMA Neurol. 2016 Apr;73(4):464-70. doi: 10.1001/jamaneurol.2015.4996.

  PMID: 26926529 BACKGROUND

• Wiebe S, Blume WT, Girvin JP, Eliasziw M; Effectiveness and Efficiency of Surgery for Temporal Lobe Epilepsy Study Group. A randomized, controlled trial of surgery for temporal-lobe epilepsy. N Engl J Med. 2001 Aug 2;345(5):311-8. doi: 10.1056/NEJM200108023450501.

  PMID: 11484687 BACKGROUND

• Engel J Jr, McDermott MP, Wiebe S, Langfitt JT, Stern JM, Dewar S, Sperling MR, Gardiner I, Erba G, Fried I, Jacobs M, Vinters HV, Mintzer S, Kieburtz K; Early Randomized Surgical Epilepsy Trial (ERSET) Study Group. Early surgical therapy for drug-resistant temporal lobe epilepsy: a randomized trial. JAMA. 2012 Mar 7;307(9):922-30. doi: 10.1001/jama.2012.220.

  PMID: 22396514 BACKGROUND

• Chang EF, Englot DJ, Vadera S. Minimally invasive surgical approaches for temporal lobe epilepsy. Epilepsy Behav. 2015 Jun;47:24-33. doi: 10.1016/j.yebeh.2015.04.033. Epub 2015 May 24.

  PMID: 26017774 BACKGROUND

• Engel J Jr, Wiebe S, French J, Sperling M, Williamson P, Spencer D, Gumnit R, Zahn C, Westbrook E, Enos B. Practice parameter: temporal lobe and localized neocortical resections for epilepsy. Epilepsia. 2003 Jun;44(6):741-51. doi: 10.1046/j.1528-1157.2003.48202.x.

  PMID: 12790886 BACKGROUND

• Choi H, Sell RL, Lenert L, Muennig P, Goodman RR, Gilliam FG, Wong JB. Epilepsy surgery for pharmacoresistant temporal lobe epilepsy: a decision analysis. JAMA. 2008 Dec 3;300(21):2497-505. doi: 10.1001/jama.2008.771.

  PMID: 19050193 BACKGROUND

• Tebo CC, Evins AI, Christos PJ, Kwon J, Schwartz TH. Evolution of cranial epilepsy surgery complication rates: a 32-year systematic review and meta-analysis. J Neurosurg. 2014 Jun;120(6):1415-27. doi: 10.3171/2014.1.JNS131694. Epub 2014 Feb 21.

  PMID: 24559222 BACKGROUND

• Wieser HG, Blume WT, Fish D, Goldensohn E, Hufnagel A, King D, Sperling MR, Luders H, Pedley TA; Commission on Neurosurgery of the International League Against Epilepsy (ILAE). ILAE Commission Report. Proposal for a new classification of outcome with respect to epileptic seizures following epilepsy surgery. Epilepsia. 2001 Feb;42(2):282-6. No abstract available.

  PMID: 11240604 BACKGROUND

• Zhao Y, Ding C, Wang Y, Li Z, Zhou Y, Huang Y. Reliability and validity of a Chinese version of the Quality of Life in Epilepsy Inventory (QOLIE-89). Epilepsy Behav. 2007 Aug;11(1):53-9. doi: 10.1016/j.yebeh.2007.03.013. Epub 2007 May 10.

  PMID: 17499025 BACKGROUND

• Brissart H, Planton M, Bilger M, Bulteau C, Forthoffer N, Guinet V, Hennion S, Kleitz C, Laguitton V, Mirabel H, Mosca C, Pecheux N, Pradier S, Samson S, Tramoni E, Voltzenlogel V, Denos M, Boutin M. French neuropsychological procedure consensus in epilepsy surgery. Epilepsy Behav. 2019 Nov;100(Pt A):106522. doi: 10.1016/j.yebeh.2019.106522. Epub 2019 Oct 15.

  PMID: 31627076 BACKGROUND

• Schmeiser B, Wagner K, Schulze-Bonhage A, Mader I, Wendling AS, Steinhoff BJ, Prinz M, Scheiwe C, Weyerbrock A, Zentner J. Surgical Treatment of Mesiotemporal Lobe Epilepsy: Which Approach is Favorable? Neurosurgery. 2017 Dec 1;81(6):992-1004. doi: 10.1093/neuros/nyx138.

  PMID: 28582572 BACKGROUND

• Tellez-Zenteno JF, Dhar R, Wiebe S. Long-term seizure outcomes following epilepsy surgery: a systematic review and meta-analysis. Brain. 2005 May;128(Pt 5):1188-98. doi: 10.1093/brain/awh449. Epub 2005 Mar 9.

  PMID: 15758038 BACKGROUND

• Brotis AG, Giannis T, Kapsalaki E, Dardiotis E, Fountas KN. Complications after Anterior Temporal Lobectomy for Medically Intractable Epilepsy: A Systematic Review and Meta-Analysis. Stereotact Funct Neurosurg. 2019;97(2):69-82. doi: 10.1159/000500136. Epub 2019 Jul 9.

  PMID: 31288240 BACKGROUND

• Bjellvi J, Flink R, Rydenhag B, Malmgren K. Complications of epilepsy surgery in Sweden 1996-2010: a prospective, population-based study. J Neurosurg. 2015 Mar;122(3):519-25. doi: 10.3171/2014.9.JNS132679. Epub 2014 Oct 31.

  PMID: 25361484 BACKGROUND

MeSH Terms

Conditions

Epilepsy, Temporal Lobe

Interventions

Anterior Temporal Lobectomy

Condition Hierarchy (Ancestors)

Epilepsies, Partial; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Neurosurgical Procedures

Study Officials

• Hua Zhang, PhD

  First Affiliated Hospital Xi'an Jiaotong University

  STUDY CHAIR

Central Study Contacts

Yong Liu, MD

CONTACT

+8618049529896; liu868yong@163.com

Qiang Meng, MD

CONTACT

+8618092586275; mengqiang2019@xjtu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessors are blinded to the treatment throughout the entire study. Blinding is maintained by having patients wear large hats during the interview to obscure skin incision and providing patients strict instruction not to reveal treatment arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: a single-center, prospective, single-blinded, double-arm, randomized, controlled trial

Study Record Dates

• First Submitted: July 9, 2021
• First Posted: August 24, 2021
• Study Start: April 25, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2025
• Last Updated: December 30, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)