A Study Comparing Two Treatments for Infants With Hydrocephalus

NCT ID: NCT00652470

Last Updated: 2018-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 182 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2018-05-01

Brief Summary

The purpose of this study is to study whether infants with triventricular hydrocephalus (TVH) have a better long-term outcome at 5 years when they are treated with a new procedure, endoscopic third ventriculostomy (ETV), than infants treated with the more traditional treatment, insertion of a cerebrospinal fluid (CSF) shunt.

Detailed Description

TVH is a relatively uncommon condition in infants, in which CSF accumulates in the brain's ventricles due to a blockage in outflow at the level of cerebral aqueduct. This can cause increased intracranial pressure, with adverse effect on brain development. The causes of this include congenital aqueductal stensois or acquired aqueductal stenosis from previous brain hemorrhage or infection.

TVH is currently treated through one of the following two approaches:

• Extra-cranial CSF diversion through ventricular shunts. Extra-cranial shunting has been the standard approach over the past few decades, since functional shunts were first developed and inserted successfully.
• Intra-cranial internal CSF diversion using endoscopic techniques. The principles of internal diversion were clear from the time neurosurgeons first understood the nature of hydrocephalus. However, internal diversion was never really practical or successful on a large scale until the more recent development of neuroendoscopy. There is currently a revived interest in diversionary hydrocephalus treatment through neuroendoscopic surgical techniques, with the primary focus on endoscopic third ventriculostomy (ETV).

Conditions

Hydrocephalus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ETV

Group Type: ACTIVE_COMPARATOR

Endoscopic Third Ventriculostomy

Intervention Type: PROCEDURE

A standard frontal burr hole will be made and an endoscopic camera used to visualize the floor of the third ventricle. A ventriculostomy will be created in the floor of the third using the surgeon's own preferred method of perforation.

CSF Shunt

Group Type: ACTIVE_COMPARATOR

CSF Shunt Insertion

Intervention Type: PROCEDURE

The procedure involves creating a burr hole in the frontal or occipital regions and cannulating the ventricle with a silastic catheter. This is then attached to a valve mechanism and distal silastic tubing which runs subcutaneously in the peritoneal cavity.

Interventions

Endoscopic Third Ventriculostomy

A standard frontal burr hole will be made and an endoscopic camera used to visualize the floor of the third ventricle. A ventriculostomy will be created in the floor of the third using the surgeon's own preferred method of perforation.

Intervention Type: PROCEDURE

CSF Shunt Insertion

The procedure involves creating a burr hole in the frontal or occipital regions and cannulating the ventricle with a silastic catheter. This is then attached to a valve mechanism and distal silastic tubing which runs subcutaneously in the peritoneal cavity.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Symptomatic TVH requiring treatment.
• No previous treatment for TVH
• Under 24 months of age at time of surgery
• Full-term pregnancy (>36 weeks)
• Mandatory pre-operative MRI that includes mid-sagittal T1 & T2 scans which show: Tri-ventricular pattern of hydrocephalus; proof of no flow through aqueduct; presence of CSF collection over the convexity and/or inter-hemispheric fissure is acceptable; configuration of third ventricle floor could vary; deformed tectal plate is acceptable; posterior fossa fluid collections may be included as long as: aqueduct is closed; vermis preserved (complete Dandy Walker Syndrome excluded); questionable flow in aqueduct acceptable as long as TVH exists
• History or suggestion of intra-ventricular bleed (intra-uterine or post-natal) or intracranial infection qualifies (excluding intraventricular hemorrhage of prematurity).
• Ability to participate in followup for at least 5 years

Exclusion Criteria

• Open Spina Bifida
• Complete Dandy Walker syndrome (vermian agenesis / dysgenesis)
• Prematurity
• Perinatal asphyxia
• Severe dysmorphic anatomical features or known chromos (e.g. agenesis of corpus callosum, heterotopias, large cysts)
• intracranial tumor

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The International Study Group for Neuroendoscopy (ISGNE)

UNKNOWN

Sponsor Role: collaborator

The International Society for Pediatric Neurosurgery

OTHER

Sponsor Role: collaborator

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Abhaya Kulkarni

Staff neurosurgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abhaya Kulkarni, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children, Toronto Canada

Shlomi Constantini, MD

Role: PRINCIPAL_INVESTIGATOR

Dana Children's Hospital, Tel Aviv Medical Center

Spyros Sgouros, MD

Role: PRINCIPAL_INVESTIGATOR

Birmingham Children's Hospital

Locations

Children's Medical Center of Dallas

Dallas, Texas, United States

Nacional de Pediatria

Buenos Aires, , Argentina

Biocor Instituto

Nova Lima, , Brazil

UNIFESP

São Paulo, , Brazil

The Hospital for Sick Children

Toronto, Ontario, Canada

University Hospital Gießen and Marburg

Giessen, , Germany

University of Debrecen

Debrecen, , Hungary

Sanjay Gandhi Postgraduate Institute of Medical Sciences

Lucknow, , India

All India Institute of Medical Sciences

New Delhi, , India

Dana Children's Hospital, Tel Aviv Medical Center

Tel Aviv, , Israel

Giannina Gaslini Hospital

Genova, , Italy

Catholic University Medical School Rome

Rome, , Italy

University Medical Center St Radboud

Nijmegen, , Netherlands

Medical University of Silesia

Katowice, , Poland

Polish Mother's Memorial Hospital

Lodz, , Poland

Children's Memorial Health Institute

Warsaw, , Poland

Burdenko Neurosurgical Institute

Moscow, , Russia

Institute for Neurosurgery

Belgrade, , Serbia

Hospital Sant Joan de Deu

Barcelona, , Spain

Hacettepe University Hospital

Ankara, , Turkey (Türkiye)

Birmingham Children's Hospital

Birmingham, , United Kingdom

Alder Hey Children's Hospital

Liverpool, , United Kingdom

Countries

United States; Argentina; Brazil; Canada; Germany; Hungary; India; Israel; Italy; Netherlands; Poland; Russia; Serbia; Spain; Turkey (Türkiye); United Kingdom

References

Kulkarni AV, Sgouros S, Leitner Y, Constantini S; International Infant Hydrocephalus Study Investigators. International Infant Hydrocephalus Study (IIHS): 5-year health outcome results of a prospective, multicenter comparison of endoscopic third ventriculostomy (ETV) and shunt for infant hydrocephalus. Childs Nerv Syst. 2018 Dec;34(12):2391-2397. doi: 10.1007/s00381-018-3896-5. Epub 2018 Jul 9.

Reference Type: DERIVED

PMID: 29987375 (View on PubMed)

Kulkarni AV, Sgouros S, Constantini S; International Infant Hydrocephalus Study Investigators. Outcome of treatment after failed endoscopic third ventriculostomy (ETV) in infants with aqueductal stenosis: results from the International Infant Hydrocephalus Study (IIHS). Childs Nerv Syst. 2017 May;33(5):747-752. doi: 10.1007/s00381-017-3382-5. Epub 2017 Mar 29.

Reference Type: DERIVED

PMID: 28357554 (View on PubMed)

Kulkarni AV, Sgouros S, Constantini S; IIHS Investigators. International Infant Hydrocephalus Study: initial results of a prospective, multicenter comparison of endoscopic third ventriculostomy (ETV) and shunt for infant hydrocephalus. Childs Nerv Syst. 2016 Jun;32(6):1039-48. doi: 10.1007/s00381-016-3095-1. Epub 2016 Apr 23.

Reference Type: DERIVED

PMID: 27107887 (View on PubMed)

Other Identifiers

1000007601

Identifier Type: -

Identifier Source: org_study_id