Assessment of changes in symptoms and quality of life after surgical treatment of patients with symptomatic pineal cyst – a prospective observational cohort study
ISRCTN | ISRCTN51545574 |
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DOI | https://doi.org/10.1186/ISRCTN51545574 |
IRAS number | 292313 |
Secondary identifying numbers | IRAS292313 |
- Submission date
- 17/03/2025
- Registration date
- 17/03/2025
- Last edited
- 17/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English Summary
Background and study aims:
A pineal cyst is a non-cancerous fluid-filled lump in the pineal gland in the brain. PCs are common and only some are thought to cause symptoms. Until only quite recently, it had been the understanding of the medical community that PCs don’t cause symptoms. However, several studies published since 2015 have shown that the majority of patients with symptoms (headaches; visual disturbances; balance and hearing problems; memory, speech and other cognitive impairment etc) improve following surgical removal of the cyst. These are early studies, based on a review of clinical records of a relatively small number of patients. As helpful as these studies are, a higher level of clinical evidence is required to reduce the uncertainty about the role of surgery in the management of symptoms of patients with symptomatic pineal cysts (SPCs). The aim of this study is to collect comprehensive and beforehand agreed information about the symptoms and quality of life of patients with SPCs before and after surgery to remove the PC. Comparing the information about symptoms and quality of life from before and after surgery will not only help our understanding of the value of surgery in SPCs but will also help calculate the probability of each symptom improving following surgery.
Who can participate?
Patients aged over 18 years with SPCs
What does the study involve?
Participants will be asked to fill in a questionnaire before the operation, asking about their overall quality of life as well as about specific symptoms. Three months and 12 months after surgery, patients will be asked to fill in a new questionnaire to monitor their progress.
What are the possible benefits and risks of participating?
There will be no direct benefit to patients as a result of participation in the study. However, it is hoped that the detailed information about symptoms and quality of life will help us better understand your symptoms and related quality of life as well as patients with symptomatic pineal cysts in general.
There are no real disadvantages in taking part in the study as it does not influence the course of treatment.
Where is the study run from?
The Cambridge University Hospital (UK)
When is the study starting and how long is it expected to run for?
July 2021 to May 2024
Who is funding the study?
The study is organised by a research group from the Departments of Neurosurgery, National Institute for Health Research and the Cambridge Clinical Trials Unit. The study is run by highly experienced medical scientists who do all the work related to this study on a voluntary (unpaid) basis.
Who is the main contact?
Mr Thomas Santarius, maria.harrington@addenbrookes.nhs.uk
Contact information
Public, Scientific, Principal Investigator
Department of Neurosurgery
Addenbrooke's Hospital
University of Cambridge
Cambridge
CB2 0QQ
United Kingdom
0000-0002-1416-9566 | |
Phone | +44 (0)1223 805000 |
ts381@cam.ac.uk |
Study information
Study design | Single-centre observational cohort study |
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Primary study design | Observational |
Secondary study design | Cohort study |
Study setting(s) | Hospital |
Study type | Quality of life, Safety, Efficacy |
Participant information sheet | https://cam-pc.org/ |
Scientific title | Cambridge prospective cohort study of surgical treatment of patients with symptomatic pineal cyst |
Study acronym | CamProS-PC |
Study hypothesis | The shortage of high-quality evidence to inform the management of patients with pineal cysts with symptoms in the absence of ventriculomegaly (nhSPC) underlies the lack of consensus on the management of this condition. We are working towards conducting a large-scale randomised controlled trial (RCT) to assess the safety and efficacy of pineal cyst resection in the management of the nhSPC syndrome. This prospective cohort study aims to prospectively collect patient-reported outcomes from 40 patients who underwent cyst resection as treatment of nhSPC, in order to assess the feasibility of conducting a definitive RCT. |
Ethics approval(s) |
Approved 09/07/2021, HRA and Health and Care Research Wales (HCRW) (HRA, 2 Redman Place, Stratford Cross, London, E20 1JQ, United Kingdom; +44 (0)20 7104 8000; contact@hra.nhs.uk), ref: 21/NI/0120 |
Condition | Pineal cyst with symptoms without hydrocephalus |
Intervention | Pineal cyst resection Participants will be asked to fill in a questionnaire before the operation, asking about their overall quality of life as well as about specific symptoms. Three months and 12 months after surgery, patients will be asked to fill in a new questionnaire to monitor their progress. |
Intervention type | Procedure/Surgery |
Primary outcome measure | Quality of life improvement by 20 points in the Role Functioning scale score of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire – C30 (EORTC QLQ-C30) at 12 months postoperatively as compared to preoperatively |
Secondary outcome measures | 1. The effect of surgery on all other domains of the EORTC-QLQ-C30 questionnaire at 3 months, 12 months and every subsequent year postoperatively compared to the preoperative level: Global quality of life (QL2), Physical functioning (PF2), Emotional functioning (EF), Cognitive functioning (CF), Social functioning (SF), Fatigue (FA), Nausea and Vomiting (NV), Pain (PA), Dyspnoea (DY), Insomnia (SL), Appetite loss (AP), Constipation (CO), Diarrhoea (DI), Financial difficulties (FI). 2. The rate of symptom improvement at 3 months, 12 months, and every subsequent year. Specifically, the symptoms assessed are the following: overall, headache, dizziness/balance, hearing/tinnitus, vision, memory, concentration, and sleep. The assessment scale consisted of six levels: much worse, worse, no change, better, much better, I no longer have this symptom. 3. The safety of the intervention assessed by prospectively collecting complications immediately after the operation, at 3 months, 12 months and every subsequent year postoperatively. |
Overall study start date | 01/07/2021 |
Overall study end date | 31/05/2024 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 40 |
Total final enrolment | 40 |
Participant inclusion criteria | 1. Age >18 years 2. Presence of a pineal cyst (PC) of size >10 mm 3. Presence of severe symptoms consistent with the syndrome of nhSPC, defined as ≥6/10 on an established severity scale 4. Minimum of 6 months of conservative treatment without improvement |
Participant exclusion criteria | 1. Radiological evidence of ventriculomegaly 2. Other diagnosis of CNS pathology, including neoplasm, vascular (ischemic or haemorrhagic), traumatic, or hydrocephalus 3. History of intracranial neurosurgical intervention |
Recruitment start date | 01/01/2019 |
Recruitment end date | 31/05/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Sponsor information
Hospital/treatment centre
Hills Road
Cambridge
CB2 0QQ
England
United Kingdom
Phone | +44 (0)1223 805000 |
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cuh.research@nhs.net | |
Website | http://www.cuh.org.uk |
https://ror.org/04v54gj93 |
University/education
The Old Schools
Trinity lane
Cambridge
CB2 1TN
England
United Kingdom
Phone | +44 (0)1223 337733 |
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croenquiries@admin.cam.ac.uk | |
Website | http://www.cam.ac.uk |
https://ror.org/013meh722 |
Funders
Funder type
Other
No information available
Results and Publications
Intention to publish date | 01/05/2025 |
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Individual participant data (IPD) Intention to share | Yes |
IPD sharing plan summary | Published as a supplement to the results publication |
Publication and dissemination plan | Planned publication in peer-reviewed journal |
IPD sharing plan | The datasets generated in the current study will be published as a supplement to the results publication |
Editorial Notes
17/03/2025: Study's existence confirmed by the HRA.