Endoscopic Third Ventriculostomy for Adults: A Prognostic Model for Success

NCT04773938 | Unknown DMC

• 1 other identifier: NordicETV
• Study Type: observational
• Target: 1,000
• Locations: 4 countries
• Sites: 19

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.

Conditions

Hydrocephalus

Keywords

Endoscopic third ventriculostomy; Adult

Outcome Measures

Primary Outcomes (1)

• ETV success

  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.

  Evaluated 1 year after operation

Secondary Outcomes (2)

• ETV survival

  From procedure to latest documented follow-up, adressed up to 31 dec. 2020.

• ETV related adverse events

  Up to 3 months after operation.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population is all first time ETV performed at the participating centres between January 1st 2010 and December 31st 2018.

You may qualify if:

• ETV procedure performed
• ≥18 years old at time of first ETV

You may not qualify if:

• \<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.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (19)

Department of Neurosurgery, Aalborg University Hospital

Aalborg, Denmark

COMPLETED

Department of Neurosurgery, Aarhus University Hospital

Aarhus, Denmark

COMPLETED

Department of Neurosurgery, Copenhagen University Hospital Rigshospitalet

Copenhagen, Denmark

RECRUITING

Department of Neurosurgery, Odense University Hospital

Odense, Denmark

COMPLETED

Department of Neurosurgery, Helsinki University Hospital and University of Helsinki

Helsinki, Finland

RECRUITING

Department of Neurosurgery NeuroCenter Kuopio University Hospital

Kuopio, Finland

RECRUITING

Department of Neurosurgery, Oulu University Hospital, Oulu, Finland & Research Unit of Clinical Neuroscience, Oulu University

Oulu, Finland

RECRUITING

Neurocenter, Department of Neurosurgery and Turku Brain Injury Center, Turku University Hospital and University of Turku

Turku, Finland

RECRUITING

Department of Neurosurgery, Haukeland University Hospital

Bergen, Norway

RECRUITING

Department of Neurosurgery, Oslo University Hospital Rikshospitalet

Oslo, Norway

RECRUITING

Department of Neurosurgery, Oslo University Hospital Ullevål

Oslo, Norway

RECRUITING

Department of Neurosurgery, University Hospital of North Norway

Tromsø, Norway

RECRUITING

Department of Neurosurgery, St. Olavs University Hospital

Trondheim, Norway

RECRUITING

Department of Neurosurgery, Sahlgrenska University Hospital

Gothenburg, Sweden

RECRUITING

Department of Neurosurgery in Linköping, and Department of Biomedical and Clinical Sciences, Linköping University

Linköping, Sweden

RECRUITING

Department of Neurosurgery, Lund University Hospital

Lund, Sweden

COMPLETED

Department of Neurosurgery, Karolinska University Hospital

Stockholm, Sweden

RECRUITING

Department of Neurosurgery, Umeå University Hospital

Umeå, Sweden

RECRUITING

Department of Neurosurgery, Uppsala University Hospital

Uppsala, Sweden

RECRUITING

Related Publications (29)

• Kulkarni AV, Drake JM, Mallucci CL, Sgouros S, Roth J, Constantini S; Canadian Pediatric Neurosurgery Study Group. Endoscopic third ventriculostomy in the treatment of childhood hydrocephalus. J Pediatr. 2009 Aug;155(2):254-9.e1. doi: 10.1016/j.jpeds.2009.02.048. Epub 2009 May 15.

  PMID: 19446842 BACKGROUND

• Reddy GK, Bollam P, Caldito G, Willis B, Guthikonda B, Nanda A. Ventriculoperitoneal shunt complications in hydrocephalus patients with intracranial tumors: an analysis of relevant risk factors. J Neurooncol. 2011 Jun;103(2):333-42. doi: 10.1007/s11060-010-0393-4. Epub 2010 Sep 15.

  PMID: 20842407 BACKGROUND

• Merkler AE, Ch'ang J, Parker WE, Murthy SB, Kamel H. The Rate of Complications after Ventriculoperitoneal Shunt Surgery. World Neurosurg. 2017 Feb;98:654-658. doi: 10.1016/j.wneu.2016.10.136. Epub 2016 Nov 5.

  PMID: 27826086 BACKGROUND

• Reddy GK, Bollam P, Shi R, Guthikonda B, Nanda A. Management of adult hydrocephalus with ventriculoperitoneal shunts: long-term single-institution experience. Neurosurgery. 2011 Oct;69(4):774-80; discussion 780-1. doi: 10.1227/NEU.0b013e31821ffa9e.

  PMID: 21508873 BACKGROUND

• Grand W, Leonardo J, Chamczuk AJ, Korus AJ. Endoscopic Third Ventriculostomy in 250 Adults With Hydrocephalus: Patient Selection, Outcomes, and Complications. Neurosurgery. 2016 Jan;78(1):109-19. doi: 10.1227/NEU.0000000000000994.

  PMID: 26295500 BACKGROUND

• Bouras T, Sgouros S. Complications of endoscopic third ventriculostomy. J Neurosurg Pediatr. 2011 Jun;7(6):643-9. doi: 10.3171/2011.4.PEDS10503.

  PMID: 21631203 BACKGROUND

• Dusick JR, McArthur DL, Bergsneider M. Success and complication rates of endoscopic third ventriculostomy for adult hydrocephalus: a series of 108 patients. Surg Neurol. 2008 Jan;69(1):5-15. doi: 10.1016/j.surneu.2007.08.024.

  PMID: 18054606 BACKGROUND

• Labidi M, Lavoie P, Lapointe G, Obaid S, Weil AG, Bojanowski MW, Turmel A. Predicting success of endoscopic third ventriculostomy: validation of the ETV Success Score in a mixed population of adult and pediatric patients. J Neurosurg. 2015 Dec;123(6):1447-55. doi: 10.3171/2014.12.JNS141240. Epub 2015 Jul 24.

  PMID: 26207604 BACKGROUND

• Foley RW, Ndoro S, Crimmins D, Caird J. Is the endoscopic third ventriculostomy success score an appropriate tool to inform clinical decision-making? Br J Neurosurg. 2017 Jun;31(3):314-319. doi: 10.1080/02688697.2016.1229744. Epub 2016 Sep 14.

  PMID: 27624099 BACKGROUND

• Breimer GE, Sival DA, Brusse-Keizer MG, Hoving EW. An external validation of the ETVSS for both short-term and long-term predictive adequacy in 104 pediatric patients. Childs Nerv Syst. 2013 Aug;29(8):1305-11. doi: 10.1007/s00381-013-2122-8. Epub 2013 May 5.

  PMID: 23644629 BACKGROUND

• Durnford AJ, Kirkham FJ, Mathad N, Sparrow OC. Endoscopic third ventriculostomy in the treatment of childhood hydrocephalus: validation of a success score that predicts long-term outcome. J Neurosurg Pediatr. 2011 Nov;8(5):489-93. doi: 10.3171/2011.8.PEDS1166.

  PMID: 22044375 BACKGROUND

• Waqar M, Ellenbogen JR, Stovell MG, Al-Mahfoudh R, Mallucci C, Jenkinson MD. Long-Term Outcomes of Endoscopic Third Ventriculostomy in Adults. World Neurosurg. 2016 Oct;94:386-393. doi: 10.1016/j.wneu.2016.07.028. Epub 2016 Jul 17.

  PMID: 27436208 BACKGROUND

• Dlouhy BJ, Capuano AW, Madhavan K, Torner JC, Greenlee JD. Preoperative third ventricular bowing as a predictor of endoscopic third ventriculostomy success. J Neurosurg Pediatr. 2012 Feb;9(2):182-90. doi: 10.3171/2011.11.PEDS11495.

  PMID: 22295925 BACKGROUND

• Kehler U, Regelsberger J, Gliemroth J, Westphal M. Outcome prediction of third ventriculostomy: a proposed hydrocephalus grading system. Minim Invasive Neurosurg. 2006 Aug;49(4):238-43. doi: 10.1055/s-2006-950382.

  PMID: 17041837 BACKGROUND

• Isaacs AM, Bezchlibnyk YB, Yong H, Koshy D, Urbaneja G, Hader WJ, Hamilton MG. Endoscopic third ventriculostomy for treatment of adult hydrocephalus: long-term follow-up of 163 patients. Neurosurg Focus. 2016 Sep;41(3):E3. doi: 10.3171/2016.6.FOCUS16193.

  PMID: 27581315 BACKGROUND

• Hong S, Hirokawa D, Usami K, Ogiwara H. The long-term outcomes of endoscopic third ventriculostomy in pediatric hydrocephalus, with an emphasis on future intellectual development and shunt dependency. J Neurosurg Pediatr. 2019 Jan 1;23(1):104-108. doi: 10.3171/2018.7.PEDS18220. Epub 2018 Oct 12.

  PMID: 30497212 BACKGROUND

• Dewan MC, Lim J, Shannon CN, Wellons JC 3rd. The durability of endoscopic third ventriculostomy and ventriculoperitoneal shunts in children with hydrocephalus following posterior fossa tumor resection: a systematic review and time-to-failure analysis. J Neurosurg Pediatr. 2017 May;19(5):578-584. doi: 10.3171/2017.1.PEDS16536. Epub 2017 Mar 10.

  PMID: 28291428 BACKGROUND

• Stovell MG, Zakaria R, Ellenbogen JR, Gallagher MJ, Jenkinson MD, Hayhurst C, Mallucci CL. Long-term follow-up of endoscopic third ventriculostomy performed in the pediatric population. J Neurosurg Pediatr. 2016 Jun;17(6):734-8. doi: 10.3171/2015.11.PEDS15212. Epub 2016 Feb 12.

  PMID: 26870897 BACKGROUND

• Faggin R, Calderone M, Denaro L, Meneghini L, d'Avella D. Long-term operative failure of endoscopic third ventriculostomy in pediatric patients: the role of cine phase-contrast MR imaging. Neurosurg Focus. 2011 Apr;30(4):E1. doi: 10.3171/2011.1.FOCUS10303.

  PMID: 21456920 BACKGROUND

• Beuriat PA, Puget S, Cinalli G, Blauwblomme T, Beccaria K, Zerah M, Sainte-Rose C. Hydrocephalus treatment in children: long-term outcome in 975 consecutive patients. J Neurosurg Pediatr. 2017 Jul;20(1):10-18. doi: 10.3171/2017.2.PEDS16491. Epub 2017 Apr 21.

  PMID: 28430083 BACKGROUND

• Sacko O, Boetto S, Lauwers-Cances V, Dupuy M, Roux FE. Endoscopic third ventriculostomy: outcome analysis in 368 procedures. J Neurosurg Pediatr. 2010 Jan;5(1):68-74. doi: 10.3171/2009.8.PEDS08108.

  PMID: 20043738 BACKGROUND

• Kadrian D, van Gelder J, Florida D, Jones R, Vonau M, Teo C, Stening W, Kwok B. Long-term reliability of endoscopic third ventriculostomy. Neurosurgery. 2005 Jun;56(6):1271-8; discussion 1278. doi: 10.1227/01.neu.0000159712.48093.ad.

  PMID: 15918943 BACKGROUND

• Gangemi M, Mascari C, Maiuri F, Godano U, Donati P, Longatti PL. Long-term outcome of endoscopic third ventriculostomy in obstructive hydrocephalus. Minim Invasive Neurosurg. 2007 Oct;50(5):265-9. doi: 10.1055/s-2007-990305.

  PMID: 18058641 BACKGROUND

• Vulcu S, Eickele L, Cinalli G, Wagner W, Oertel J. Long-term results of endoscopic third ventriculostomy: an outcome analysis. J Neurosurg. 2015 Dec;123(6):1456-62. doi: 10.3171/2014.11.JNS14414. Epub 2015 Jul 31.

  PMID: 26230473 BACKGROUND

• Vogel TW, Bahuleyan B, Robinson S, Cohen AR. The role of endoscopic third ventriculostomy in the treatment of hydrocephalus. J Neurosurg Pediatr. 2013 Jul;12(1):54-61. doi: 10.3171/2013.4.PEDS12481. Epub 2013 May 17.

  PMID: 23682819 BACKGROUND

• Rahme R, Rahme RJ, Hourani R, Moussa R, Nohra G, Okais N, Samaha E, Rizk T. Endoscopic third ventriculostomy: the Lebanese experience. Pediatr Neurosurg. 2009;45(5):361-7. doi: 10.1159/000257525. Epub 2009 Nov 11.

  PMID: 19907200 BACKGROUND

• Gliemroth J, Kasbeck E, Kehler U. Ventriculocisternostomy versus ventriculoperitoneal shunt in the treatment of hydrocephalus: a retrospective, long-term observational study. Clin Neurol Neurosurg. 2014 Jul;122:92-6. doi: 10.1016/j.clineuro.2014.03.022. Epub 2014 Mar 26.

  PMID: 24908225 BACKGROUND

• Woodworth GF, See A, Bettegowda C, Batra S, Jallo GI, Rigamonti D. Predictors of surgery-free outcome in adult endoscopic third ventriculostomy. World Neurosurg. 2012 Sep-Oct;78(3-4):312-7. doi: 10.1016/j.wneu.2011.09.018. Epub 2011 Nov 7.

  PMID: 22120264 BACKGROUND

• Tefre S, Lilja-Cyron A, Arvidsson L, Bartek J, Corell A, Forsse A, Glud AN, Hamdeh SA, Hansen FL, Huotarinen A, Johansson C, Kamarainen OP, Korhonen T, Kotkansalo A, Mansoor NM, Mendoza Mireles EE, Miscov R, Munthe S, Nittby-Redebrandt H, Obad N, Pedersen LK, Posti J, Raj R, Satopaa J, Stahl N, Tetri S, Tobieson L, Juhler M. Endoscopic third ventriculostomy for adults with hydrocephalus: creating a prognostic model for success: protocol for a retrospective multicentre study (Nordic ETV). BMJ Open. 2022 Jan 31;12(1):e055570. doi: 10.1136/bmjopen-2021-055570.

  PMID: 35105647 DERIVED

MeSH Terms

Conditions

Hydrocephalus

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Sondre Tefre

  Department of Neurosurgery, Copenhagen University Hospital Rigshospitalet

  PRINCIPAL INVESTIGATOR

• Marianne Juhler

  Department of Neurosurgery, Copenhagen University Hospital Rigshospitalet

  STUDY DIRECTOR

Central Study Contacts

Sondre Tefre

CONTACT

81755740; sondre.tefre@regionh.dk

Alexander Lilja-Cyron

CONTACT

alexander.lilja-cyron@regionh.dk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: February 26, 2021
• Study Start: May 27, 2020
• Primary Completion: June 1, 2022
• Study Completion: August 1, 2022
• Last Updated: May 3, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share

Locations

NO (5); DK (4); FI (4); SE (6)