Clinical trial NCT06998420: Developing a Clinical Prediction Model for Adverse Outcomes in Percutaneous Trigeminal Ganglion Balloon Compression
Official title: Construction of a Clinical Prediction Model for Poor Prognosis Following Percutaneous Balloon Compression of the Trigeminal Ganglion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trigeminal Neuralgia (TN)
Keywords: Trigeminal neuralgia
PCGG
poor prognosis
Clinical Prediction Model
Lead sponsor: Affiliated Hospital of Nantong University
Sponsor class: OTHER
First posted: 2025-05-31
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent PCGG surgery at the Pain Department of Affiliated Hospital of Nantong University between 2022 and 2024 and were willing to participate in postoperative follow-up were selected as the study subjects.

Brief summary: This clinical study aims to investigate adverse outcomes following percutaneous balloon compression (PBC) of the trigeminal ganglion, establish a predictive model, and assess the probability of postoperative complications.The main question it aims to answer is:

1. What factors are associated with adverse postoperative outcomes?
2. What is the occurrence probability of different types of adverse outcomes? The study will record patients' demographic and clinical characteristics, laboratory test results, and conduct follow-ups at 3, 6, and 12 months postoperatively.


Eligibility criteria: Inclusion criteria:

1. Diagnosed with primary trigeminal neuralgia and underwent PBCG at the Pain Department of Affiliated Hospital of Nantong University
2. Age ≥18 years
3. Willing to complete postoperative follow-up

Exclusion criteria:

1. Secondary trigeminal neuralgia (e.g., tumor compression, multiple sclerosis)
2. Previous interventional treatments for trigeminal neuralgia
3. Incomplete follow-up data
4. General anesthesia contraindications or significant dysfunction of major organs (cardiac, pulmonary, hepatic, renal) or severe neurological impairment

Primary outcomes:
measure: Pain recurrence (BNI≥Ⅲ)
timeFrame: Follow-up timepoints: 3, 6, and 12 months postoperatively (final determination based on preliminary observation endpoints)
measure: Severe sensory impairment (facial numbness with BNI sensory score ≥ Grade III)
timeFrame: 3 months, 6 months, and 12 months postoperatively (determined based on prior observation endpoints).
measure: Masticatory dysfunction (bite force reduction ≥50% or subjective weakness)
timeFrame: 3 months, 6 months, and 12 months postoperatively (determined based on prior observation endpoints).
Secondary outcomes:
measure: Mild sensory abnormalities (BNI sensory score Grade II)
timeFrame: 3 months, 6 months, and 12 months postoperatively (determined based on prior observation endpoints).
measure: Diplopia or hearing loss (rare complications to be recorded)
timeFrame: 3 months, 6 months, and 12 months postoperatively (determined based on prior observation endpoints).
measure: Postoperative infection (puncture site/intracranial)
timeFrame: 3 months, 6 months, and 12 months postoperatively (determined based on prior observation endpoints).
measure: Psychological status (change in HADS score)
timeFrame: 3 months, 6 months, and 12 months postoperatively (determined based on prior observation endpoints).
Other outcomes:
Locations:
city: NanTong
country: China
facility: The Affiliated Hospital of Nantong University
state: Jiangsu
Study officials:
References: