A Comparative Study of Patients Undergoing Surgery for Pituitary Neuroendocrine Tumors Detected by Different Ways

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-85
SponsorBeijing Tiantan Hospital

About this trial

This multicenter cohort study is based on the National Brain Tumor Registry of China (NBTRC). It will compare patients who underwent surgery for Pituitary Neuroendocrine Tumors (PitNETs) detected through health screening versus those diagnosed via outpatient consultations. The study will evaluate differences between the two groups in surgical metrics, patient-centered outcomes, and healthcare utilization.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with PitNETs who underwent surgical resection at Beijing Tiantan Hospital from September 1, 2011, to November 30, 2019, together with those recorded in the NBTRC who underwent surgery from December 1, 2019, to December 31, 2021.

Disqualifiers

The department (health screening or outpatient clinics) where the definitive diagnosis confirmed was missing or unclear

PitNETs was recurrent or synchronous brain tumors of any histology existed

Admission was via the emergency department

Maximum tumor diameter on preoperative MRI were unavailable

Trial population

Patients with PitNETs who underwent surgical resection at Beijing Tiantan Hospital from September 1, 2011, to November 30, 2019, together with those recorded in the NBTRC who underwent surgery from December 1, 2019, to December 31, 2021.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

5,000 Participants
are grouped into 2 trial groups
Group A: Clinical group
Group B: Screening group

Trial outcomes

Primary outcomes

1

Preoperative maximum tumor diameter

Maximum tumor diameter in millimeters, measured on preoperative Magnetic Resonance Imaging (MRI), defined as the largest dimension of the tumor.

Time frame
Within 3 months before surgery
2

Extent of resection

Gross total resection (GTR) versus non-GTR, assessed by intraoperative findings combined with MRI performed within 72 hours after surgery.

Time frame
Within 72 hours after surgery
3

Preoperative symptom phenotype

Presence or absence of preoperative symptoms (including visual decline, headache, hyperpituitarism, hypopituitarism, diplopia, cerebrospinal fluid leak, nonspecific symptoms, and other symptoms) reported by the patient at hospital admission, reflecting symptoms experienced during the preoperative period.

Time frame
At hospital admission
4

Time interval from symptom onset to surgery

Time in months from the date of symptom onset to the date of surgery, calculated from patient-reported history documented in medical records.

Time frame
At hospital admission

Secondary outcomes

1

Length of hospital stay

Number of days from admission to discharge, calculated from medical records.

Time frame
At hospital discharge
2

Operation duration

Total time of surgery, measured from the start to the end of the procedure, extracted from surgical records.

Time frame
At the end of surgery
3

Total hospitalization costs

Total inpatient expenses in Chinese Yuan (CNY) during the index admission, including all medical services, medications, imaging, laboratory tests, and surgical fees, extracted from hospital billing records.

Time frame
At hospital discharge

Other outcomes

Sponsors and contacts

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