Assessment of changes in symptoms and quality of life after surgical treatment of patients with symptomatic pineal cyst – a prospective observational cohort study

Cambridge prospective cohort study of surgical treatment of patients with symptomatic pineal cyst

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN51545574

Enrollment

Registered

2025-03-17

Start date

2019-01-01

Completion date

Unknown

Last updated

2025-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pineal cyst with symptoms without hydrocephalus Nutritional, Metabolic, Endocrine

Interventions

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 mo

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

England, United Kingdom

Contacts

Public ContactThomas Santarius

ts381@cam.ac.uk+44 (0)1223 805000

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026