Study on Pathogenesis and Treatment of Sacral Tarlov Cysts

NCT05059275 | Completed

• 1 other identifier: SMU-Neurosurgery-spine
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tarlov Cysts

Keywords

Sacral perineural cyst; Tarlov cyst; Ostium closure; Surgical treatment

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• Evaluation of imaging results (magnetic resonance and computerized tomography)

  Maximum diameter of TCs.

  One days before surgery

• 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 Outcomes (3)

• Surgical characteristics

  During surgery

• Clinical manifestations

  Two days before surgery

• Demographic data

  Three days before surgery

Study Arms (1)

Modified operation group

EXPERIMENTAL

Undergo the modified ostium obstruction surgery due to symptomatic TCs.

Procedure: modified ostium obstruction surgery

Interventions

modified ostium obstruction surgery PROCEDURE

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

Modified operation group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Southern Medical University, China: lead

Study Sites (1)

The Second Affiliated Hospital of Shantou University Medical College

Shantou, Guangdong, 515000, China

Location

Related Publications (6)

• 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. Print 2019 May 1.

  PMID: 30738394 BACKGROUND

• 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.

  PMID: 19569467 BACKGROUND

• 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.

  PMID: 31270612 BACKGROUND

• 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.

  PMID: 30544388 BACKGROUND

• 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.

  PMID: 17538380 BACKGROUND

• 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.

  PMID: 13385699 BACKGROUND

MeSH Terms

Conditions

Tarlov Cysts

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 11, 2021
• First Posted: September 28, 2021
• Study Start: September 3, 2020
• Primary Completion: September 3, 2022
• Study Completion: March 3, 2023
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: From the completion of data collection to 1 month after the publication of the article

Locations

CN (1)