Study of Choroid Plexus Cauderization in Patients With Hydrocephalus



Status:Recruiting
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:18 - Any
Updated:11/21/2018
Start Date:September 2016
End Date:September 2020
Contact:Ronald Benveniste, MD, PhD
Email:rbenveniste@med.miami.edu
Phone:305-575-7059

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Study of Endoscopic Choroid Plexus Cauterization for Adult Patients With Hydrocephalus and Risk Factors for Perioperative Complications Following Shunt Surgery.

The purpose of this study is to determine whether endoscopic choroid plexus coagulation is
safe in adult patients with communicating hydrocephalus and risk factors for complications
from the standard surgical treatment. It may also help determine whether the endoscopic
choroid plexus coagulation is effective in treating your communicating hydrocephalus. The
Investigators hope that this research will allow us to place fewer shunts in patients with
conditions similar to yours, avoiding complications.

The patient will undergo endoscopic choroid plexus coagulation surgery to treat communicating
hydrocephalus. Before the surgery, the patient will be examined by his/her doctors and
undergo brain MRI, as part of routine clinical care. For the surgery, he/she will be placed
under general anesthesia. An incision will be made on the top of the head, and a small
opening made in the bone of the skull. An endoscope, which is a long, thin metal tube with an
attached video camera and channels for passing small instruments, will be passed into the
ventricles of the brain through the opening. After the surgeon identifies the choroid plexus
on one side of the brain using the endoscope, an electrical current will be used to destroy
as much of the choroid plexus on that side as possible. A balloon or other instrument will be
used to open the membrane that separates the right and left halves of the brain. The
endoscope will then be used to identify the choroid plexus on the opposite side of the brain,
and the electrical current will be used to destroy as much of the choroid plexus on that
side, as possible. The ventricles of the brain will be washed with a saline solution to
remove blood and debris, and the endoscope will be removed from the brain. A temporary
drainage tube may be left in place to monitor fluid pressures after surgery. The openings in
the skull and scalp will be closed. The patient will be awakened from anesthesia and brought
to either the recovery room or intensive care unit. The patient will be observed in the
hospital for at least one night, and will undergo MRI of the brain after surgery as part of
routine clinical care.

The patient will have follow up visits after surgery, as part of routine clinical care.
During hospitalization for the procedure, and during follow up clinic visits, the treating
doctors will examine and interview the patient as part of routine clinical care. The
researchers will collect information from these examinations, interviews, and, when
appropriate, brain imaging studies in order to determine whether the surgery caused any
complications, and whether it prevented the patient from requiring a ventricular shunt.

Inclusion Criteria:

- Adult patients (age 18 or older) with communicating hydrocephalus, who have risk
factors for complications following shunt surgery. Risk factors include loculated
hydrocephalus (i.e., imaging evidence that the ventricles of the brain do not
communicate with each other, in the setting of known communicating hydrocephalus);
prior episodes of ventriculitis and/or shunt infection; subdural hematoma associated
with shunt placement; inability to place a distal catheter in the peritoneal cavity
due to scarring or prior infection; and multiple prior episodes of shunt failure.

- In patients with communicating hydrocephalus who have significantly increased lateral
and third ventricular size and normal fourth ventricular size, an endoscopic third
ventriculostomy will be performed in conjunction with the choroid plexus
cauterization, provided that communicating hydrocephalus is thought to be present,
based on either the history (for example, past meningitis or other infectious or
inflammatory disease, or history of communicating hydrocephalus without disproportion
of the ventricles in the past; or imaging findings, such as patency of the foramina of
Magendie and Luschka).

Exclusion Criteria:

- Exclusion criteria include patients who have non-communicating hydrocephalus; patients
who are undergoing emergency surgery because of rapid decline in neurologic condition;
and patients with medical conditions such as coagulopathy or severe cardiac
conditions, that preclude neurosurgical intervention.

- In the case of adults unable to consent, informed consent will be obtained from
appointed health care proxies. Minors, pregnant women, and prisoners will be excluded
from the study.
We found this trial at
1
site
Miami, Florida 33124
(305) 284-2211
Phone: 305-575-7059
University of Miami A private research university with more than 15,000 students from around the...
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