Symptomatic pineal cyst - an observational study
Research type
Research Study
Full title
Assessment of changes in quality of life and symptoms over time in patients with symptomatic pineal cyst treated with surgery or conservatively - a prospective observational cohort study
IRAS ID
292313
Contact name
Thomas Santarius
Contact email
Sponsor organisation
Cambridge University Hospitals
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
Pineal cyst (PC) is a benign cyst arsing in the pineal gland. Most PCs don’t cause symptoms, but some cause headaches, problems with vision, hearing, balance, cognition etc. As a result, patients struggle with their jobs and roles in the family. Until recently, this condition was not widely recognised and there was no effective treatment for patients with symptomatic pineal cysts (SPCs).
In the last 5 years several studies have been published that reported improvement of symptom in 90-100% patients after surgery to remove pineal cysts. These studies have been retrospective, i.e. based on review of patients records. As valuable as the result are in introducing a new concept, the quality evidence of retrospective studies is limited.
The aim of our study is to provide a higher level of evidence and further improve our understanding the effect of surgery on quality of life (QoL) and symptoms of patients with SPCs. So, we propose a prospective study, when we decide beforehand what clinical information is to be collected and when and how this will be recorded. It will be carried out in Cambridge with the possibility of other neurosurgical units joining in.
All adult patients diagnosed with SPCs will be offered participation. Because this is an observational study, patients will receive the same treatment as if the study was not taking place apart from being asked to fill in questionnaires. The main aim is to understand the impact of surgery on patients’ QoL and symptoms, so questionnaires will be administered before and after surgery (at 3, 12, 24 36 months after surgery). Also patients who chose not to have surgery will also be offered participation as this further will improve our understanding of this condition. We are planning to recruit 40 patients treated by surgery.
REC name
HSC REC B
REC reference
21/NI/0120
Date of REC Opinion
9 Jul 2021
REC opinion
Further Information Favourable Opinion