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NCT Number: NCT05059275

Study on Pathogenesis and Treatment of Sacral Tarlov Cysts

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.

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Key information

Conditions

Tarlov Cysts Cysts Neoplasms Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Affiliated Hospital of Shantou University Medical College

Shantou, Guangdong, 515000, China

About this study

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. The visual analogue scale (VAS)

    Time frame: Three months after surgery

    The visual analogue scale (VAS)，Score range: 0-10, with a higher score indicating more severe pain

  2. Scoring System for the Clinical Evaluation of Patients with Spinal Processes

    Time frame: One year after surgery

    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.

  3. Evaluation of imaging results (magnetic resonance and computerized tomography)

    Time frame: One days before surgery

    Maximum diameter of TCs.

  4. Histological examination results

    Time frame: One day after surgery

    Part of the intact cyst wall was stained with Sirius red and its anatomical membranous layers were observed under a microscope.

Secondary outcomes

  1. Surgical characteristics

    Time frame: During surgery

    Operating time

  2. Clinical manifestations

    Time frame: Two days before surgery

    Duration of symptoms

  3. Demographic data

    Time frame: Three days before surgery

    Age

Sponsors and collaborators

Lead sponsor

Southern Medical University, China

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Sep 28, 2021
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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