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
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

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

Study website

Contact information

Dr Thomas Santarius
Public, Scientific, Principal Investigator

Department of Neurosurgery
Addenbrooke's Hospital
University of Cambridge
Cambridge
CB2 0QQ
United Kingdom

ORCiD logoORCID ID 0000-0002-1416-9566
Phone +44 (0)1223 805000
Email ts381@cam.ac.uk

Study information

Study designSingle-centre observational cohort study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typeQuality of life, Safety, Efficacy
Participant information sheet https://cam-pc.org/
Scientific titleCambridge prospective cohort study of surgical treatment of patients with symptomatic pineal cyst
Study acronymCamProS-PC
Study hypothesisThe 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

ConditionPineal cyst with symptoms without hydrocephalus
InterventionPineal 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 typeProcedure/Surgery
Primary outcome measureQuality 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 measures1. 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 date01/07/2021
Overall study end date31/05/2024

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants40
Total final enrolment40
Participant inclusion criteria1. 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 criteria1. 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 date01/01/2019
Recruitment end date31/05/2023

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Cambridge University Hospitals NHS Foundation Trust
Cambridge Biomedical Campus
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Sponsor information

Cambridge University Hospitals NHS Foundation Trust
Hospital/treatment centre

Hills Road
Cambridge
CB2 0QQ
England
United Kingdom

Phone +44 (0)1223 805000
Email cuh.research@nhs.net
Website http://www.cuh.org.uk
ROR logo "ROR" https://ror.org/04v54gj93
University of Cambridge
University/education

The Old Schools
Trinity lane
Cambridge
CB2 1TN
England
United Kingdom

Phone +44 (0)1223 337733
Email croenquiries@admin.cam.ac.uk
Website http://www.cam.ac.uk
ROR logo "ROR" https://ror.org/013meh722

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date01/05/2025
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryPublished as a supplement to the results publication
Publication and dissemination planPlanned publication in peer-reviewed journal
IPD sharing planThe 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.