CamProS-PC

Cambridge Prospective Cohort Study of Surgical Treatment of Patients with Symptomatic Pineal Cyst

Research summary

Pineal cyst are cysts arising in the pineal gland. They are a common finding on MRI scans in the brain, seen in 10-40% in healthy individuals with no known neurological or psychiatric illness. The vast majority of the pineal cysts are asymptomatic and, as such, an incidental finding on the scan. Rarely, pineal cyst can cause and present with hydrocephalus and management of such cyst is well-established.

Pineal cysts without hydrocephalus have been considered incidental, i.e. not involved in the causation of patients' symptoms. However, a growing body of neurosurgical literature describes a subset of pineal cysts that are symptomatic despite the absence of hydrocephalus. The most common symptoms described in patients with non-hydrocephalic pineal cysts which then improved following surgery include: headaches, nausea and vomiting. visual disturbances, gait instability, fatigue and hypersomnolence. The mechanism by which the pineal cysts cause this syndrome is yet largely unknown and several explanations have been venous system outflow, tectal compression, and intermittent cerebrospinal fluid (CSF) obstruction at the cerebral aqueduct (aqueduct of Sylvius).

Despite the growing number of clinical publications reporting improvement of symptoms in patients who underwent surgical treatment for non-hydrocephalic symptomatic pineal cysts remains controversial. In addition to the lack of clarity about the underlying mechanisms the controversy persists because of lack of sufficiently high quality of clinical evidence. Current this consists of case reports and retrospective case series. Clearly, a higher level of evidence is required. Although a randomised-controlled trial (RCT) will ultimately be needed, evidence from a prospective cohort study is a necessary step prior to an RCT. Cambridge Symptomatic Pineal Cyst Prospective Cohort Study (CamProS-PC) was designed to fill in this gap by collecting prospective evidence on the safety and efficacy of surgical intervention in patients with the nhSPC syndrome and to determine the feasibility of conducting a definitive RCT. 

research-protocol_2021-06-28_amendment_2022-1-v6_www-1-1.pdf

https://cam-pc.org/ 

ISRCTN - The UK's Clinical Study Registry
 


Main inclusion criteria

Inclusion Criteria: 

  • age ≥ 18 years
  • presence of a PC of size > 10 mm
  • Presence of severe symptoms consistent with the syndrome of nhSPC, defined as ≥6/10 on Eide-Ringstad pineal cyst symptom severity scale (Eide & Ringstad Acta Neurochirurgica, 2017)
  • ≥6 months of conservative treatment without improvement 

Main exclusion criteria

Exclusion Criteria:

  • radiological evidence of ventriculomegaly 
  • other diagnosis of CNS pathology
  • previous intracranial neurosurgical intervention


Chief investigator

Chief Investigator: Thomas Santarius

Contact details

Clinical Trials Coordinator: Riccardo Masina 

Email: [email protected]