Endoscopic Third Ventriculostomy for Adults With Hydrocephalus: Creating a Prognostic Model for Success - A Retrospective Multicenter Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 1,000
- Locations
- 19
- Primary Endpoint
- ETV success
Study Overview
Brief Summary
Endoscopic Third Ventriculostomy for Adults with Hydrocephalus: Creating a Prognostic Model for Success - A Retrospective Multicenter Study
Background: Endoscopic third ventriculostomy (ETV) is becoming an increasingly widespread treatment for hydrocephalus, but most of the research is based on paediatric populations. The ETV Success Score (ETVSS) was developed in 2009 to predict the outcome of ETV in children. There is no similar tool for predicting outcome in adults.
Objective: The purpose of this study is to create a prognostic model to predict the success of ETV for adult patients with hydrocephalus
Methods: The study will adhere to the TRIPOD reporting guidelines and will be conducted as a retrospective chart review of all patients ≥18 years old treated with ETV at the participating centres between Jan 1st, 2010 and Dec 31st, 2018. Data collection is conducted locally in REDCap. Univariate analyses will be used to identify several strong predictors to be included in a multivariate logistic regression model. The model will be validated using K-fold cross validation. Discrimination will be assesses using AUROC and calibration with calibration belt plots.
Expected outcomes: The ability to predict who will benefit from an ETV will allow better primary patient selection both for ETV and shunting. This would reduce additional second procedures due to primary treatment failure. A success score specific for adults could also be used as a communication tool to provide better information and guidance to patients.
Detailed Description
Endoscopic Third Ventriculostomy for Adults with Hydrocephalus: Creating a Prognostic Model for Success - a retrospective multicenter study
Background:
The most common treatment for hydrocephalus is a ventriculoperitoneal shunt (VPS), to divert excess CSF from the ventricles to be absorbed in the peritoneum. The treatment can be applied to different aetiologies of hydrocephalus, but there is a high complication risk both short and long term. A retrospective review of 17,035 adult patients who had undergone their first VPS surgery for hydrocephalus, report that one third (33.4%) of the patients experienced at least one complication, during the follow up (3.9 years), and 22% required revision. 21.4% of the complications occurred within the first year. Another revew of 683 adult patients, found that 32% experienced shunt failure, with 74% occurring within 6 months.
Endoscopic third ventriculostomy (ETV) is an alternative treatment option, creating a passage between the ventricles and the subarachnoid space, by perforating the floor of the third ventricle. It is minimally invasive and leaves no mechanical foreign body behind, thereby avoiding many of the implant complications associated with VPS.
The overwhelming majority of research on endoscopic third ventriculostomy (ETV) is conducted in paediatric or mixed paediatric/adult populations. ETV Success Score (ETVSS) was created in 2009 to predict the outcome of ETV treatment in children. The ETVSS consists of three factors: age, aetiology and shunt history. Based on these factors a score from 0-90 is given, representing the predicted probability of successful ETV outcome 6 months postoperatively. The ETVSS was tested in a mixed population of 168 patients with a mean age of 40 years (range 3-85 years) and found to have inadequate discrimination with an AUC of 0.61 but good calibration.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •ETV procedure performed
- •≥18 years old at time of first ETV
Exclusion Criteria
- •<18 years old at time of first ETV
- •Permanent intraventricular foreign bodies left behind after the ETV. eg. Shunt or stents. Temporary external ventricular drains, ICP-monitoring probes or ligated shunts where the ventricular drain is removed, are not excluded.
Outcomes
Primary Outcomes
ETV success
Time Frame: Evaluated 1 year after operation
The procedure is considered successful if the patient experience clinical improvement at first follow up and receives no further CSF diversion procedures, within one year of the initial procedure.
Secondary Outcomes
- ETV related adverse events(Up to 3 months after operation.)
- ETV survival(From procedure to latest documented follow-up, adressed up to 31 dec. 2020.)
Investigators
Sondre Tefre, MD
Principal investigator
Rigshospitalet, Denmark