Study on Pathogenesis and Treatment of Sacral Tarlov Cysts

Tarlov Cysts Clinical Trial

Official title:

Study on Pathogenesis and Treatment of Sacral Tarlov Cysts

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05059275
• Other study ID #: SMU-Neurosurgery-spine
• Status: Completed
• Phase: N/A
• Start date: September 3, 2020
• Est. completion date: March 3, 2023

Study information

• Verified date: May 2024
• Source: Southern Medical University, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The pathogenesis of sacral Tarlov cysts (TCs) is still unclear. In this study, histological techniques were used to clarify the anatomical membranous layers of TCs and further explore the pathogenesis of them.Although many approaches have been used to treat TCs, there is no consensus on the optimal treatment. Microsurgery is now increasingly recommended as the preferred treatment with the best long-term outcomes.However, some authors have proposed the opposite view because current microsurgical techniques fail to completely close the ostium between the cyst and subarachnoid space.Consequently, could lead to leakage of cerebrospinal fluid, pseudomeningocele , or a high frequency of cysts recurrence, which are the main reasons for surgical failure and also the biggest scruple when microsurgery is chosen. Herein, we present a new method of cyst separation and ostium closure, and evaluate its clinical reliability and effectiveness for surgical treatment of Tarlov cysts through the prospective study.

Description:

1. Part of the intact cyst wall was removed under the microscope and fixed in 10% formalin solution. After dehydration and paraffin embedding, tissue sections (thickness: 6μm) were prepared and dewaxed to water. Sirius red stain drops were stained for 1 hour. The staining liquid on the surface of the slices was removed after a little flushing with water. The slices were dehydrated and transparent, sealed with neutral gum, and the membranous layers of the capsule walls were observed under a microscope.It has been observed in previous surgeries that all cysts were incompressible and remained filled after opening the distal wall of the cyst to release cerebrospinal fluid（CSF). These findings lent support for the proposed valve mechanism as the etiology of the entity becoming symptomatic. In this study, the cyst was observed in the following way: the dural sac was opened to expose the ostium to observe whether the cystic fluid would reverse outflow and shrink the cyst; In this way, the existence of a "one-way valve" can be further verified.

2. Modified microsurgical method is used to treat patients who met the inclusion criteria. To evaluate the surgical effect, we record and statistically compare the patients'outcomes before surgery and at the postoperative follow-up, which include the following: 1) Demographic data: sex, age, height, weight, body mass index (BMI), etc.; 2) clinical manifestations: symptoms and their features, complications, and long-term recovery; 3) Imaging findings: maximum diameter, location, shape, number, intracapsular nerve root condition, and postoperative outcome of TCs. 4) Surgical characteristics: operative process and time, intraoperative blood loss, assistive technologies, etc.; 5) Neurologic assessment using the following tools: The visual analogue scale (VAS), Scoring System for the Clinical Evaluation of Patients with Spinal Processes (hereinafter referred to as SCPS), Oswestry Disability Index (ODI), Japanese Orthopedic Association Scores 29 (JOA), and modified evaluation criteria for the efficacy of lumbar function (MacNab).All patients are required to return for MRI review and neurofunctional assessment at 3 and 12 months postoperatively, followed by annual examinations thereafter.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 3, 2023
• Est. primary completion date: September 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Conform to the surgical indications and undergo modified microscopic surgery in our department;

• Undergo regular review and long-term clinical effect evaluation;

• Agree to participate in this study.

Exclusion Criteria:

• Ineligible for modified microscopic surgery or unwilling to undergo it;

• Failure to cooperate with follow-up work or lost to follow-up;

• Did not agree to participate in the study.

Related Conditions & MeSH terms

• Cysts
• Tarlov Cysts

Intervention

Procedure:
• modified ostium obstruction surgery
An ostium at the end of the site where the nerve root enters the dural sac, from which CSF could flow continuously along the subarachnoid space, was identified An appropriate amount of autologous soft adipose tissue was removed under the skin of the incision or deep in the upper part of the buttock (Iliac spine incision, for less subcutaneous fat patients). It was then trimmed to resemble a gourd or dumbbell, with a relatively small middle section and two relatively large end sections. Trimmed graft was inserted into the neck of the sac and subarachnoid space below the dural sac so that it plugs the ostium inside and outside After filling the graft, Prolene 6-0 was used to continuously suture and close the ostium and dural sac starting from the lower part of the nerve root sheath and the ostium.The residual cyst cavity filled with autologous fat and gelatin sponge

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Shantou University Medical College	Shantou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Southern Medical University, China

Country where clinical trial is conducted

China, 

References & Publications (6)

ABBOTT KH, LEIMBACH WH, RETTER RH. The role of perineurial sacral cysts in the sciatic and sacrococcygeal syndromes; a review of the literature and report of 9 cases. J Neurosurg. 1957 Jan;14(1):5-21. doi: 10.3171/jns.1957.14.1.0005. No abstract available. — View Citation

Fletcher-Sandersjoo A, Mirza S, Burstrom G, Pedersen K, Kuntze Soderqvist A, Grane P, Fagerlund M, Edstrom E, Elmi-Terander A. Management of perineural (Tarlov) cysts: a population-based cohort study and algorithm for the selection of surgical candidates. Acta Neurochir (Wien). 2019 Sep;161(9):1909-1915. doi: 10.1007/s00701-019-04000-5. Epub 2019 Jul 3. — View Citation

Guo D, Shu K, Chen R, Ke C, Zhu Y, Lei T. Microsurgical treatment of symptomatic sacral perineurial cysts. Neurosurgery. 2007 Jun;60(6):1059-65; discussion 1065-6. doi: 10.1227/01.NEU.0000255457.12978.78. — View Citation

Liu B, Wang Z, Lin G, Zhang J. Radiculoplasty with reconstruction using 3D-printed artificial dura mater for the treatment of symptomatic sacral canal cysts: Two case reports. Medicine (Baltimore). 2018 Dec;97(49):e13289. doi: 10.1097/MD.0000000000013289. — View Citation

Sharma M, SirDeshpande P, Ugiliweneza B, Dietz N, Boakye M. A systematic comparative outcome analysis of surgical versus percutaneous techniques in the management of symptomatic sacral perineural (Tarlov) cysts: a meta-analysis. J Neurosurg Spine. 2019 Feb 8;30(5):623-634. doi: 10.3171/2018.10.SPINE18952. — View Citation

Singh PK, Singh VK, Azam A, Gupta S. Tarlov cyst and infertility. J Spinal Cord Med. 2009;32(2):191-7. doi: 10.1080/10790268.2009.11760771. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The visual analogue scale (VAS)	The visual analogue scale (VAS),Score range: 0-10, with a higher score indicating more severe pain	Three months after surgery
Primary	Scoring System for the Clinical Evaluation of Patients with Spinal Processes	Scoring System for the Clinical Evaluation of Patients with Spinal Processes (hereinafter referred to as SCPS),score range:0- 25.The higher the score, the better the spinal cord function state.	One year after surgery
Primary	Evaluation of imaging results (magnetic resonance and computerized tomography)	Maximum diameter of TCs.	One days before surgery
Primary	Histological examination results	Part of the intact cyst wall was stained with Sirius red and its anatomical membranous layers were observed under a microscope.	One day after surgery
Secondary	Surgical characteristics	Operating time	During surgery
Secondary	Clinical manifestations	Duration of symptoms	Two days before surgery
Secondary	Demographic data	Age	Three days before surgery