NCT06267365招募中不适用
Predictive Biomarker for Endoscopic Therapy in Chronic Pancreatitis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change from Baseline in Brief Pain Inventory (BPI) Score at Month 3 Post-Operation
研究概览
简要总结
This is an observational prospective study to develop predictive biomarkers for pain response in participants with chronic pancreatitis scheduled for endoscopic therapy. Participants will undergo baseline assessments including electroencephalography (EEG), quantitative sensory testing (QST), and psychosocial questionnaires. Response to endoscopic therapy will be assessed at approximately 3, 6, 12 and 18 months post-procedure using questionnaires.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults older than 18 years;
- •Cambridge III or IV criteria for Chronic Pancreatitis (CP); or M-ANNHEIM criteria for definitive chronic pancreatitis;
- •scheduled for endoscopic therapy for ductal obstruction (may include lithotripsy, pancreatic duct dilation, or stone extraction to facilitate successful stenting) as part of routine clinical care based on multidisciplinary review;
- •pain present for ≥ 3 days per week for ≥ 3 months;
- •average pain over the last week ≥ 4 on a 11-point numeric rating scale (NRS).
排除标准
- •chronic pain syndrome other than CP;
- •episode of acute pancreatitis within 2 months of enrollment;
- •endoscopic therapy including Endoscopic retrograde cholangiopancreatography (ERCP), Endoscopic ultrasound (EUS) Guided Celiac Plexus Block or pancreatic surgery < 6 months prior to enrollment;
- •active illicit drug use (excludes marijuana use);
- •American Society of Anesthesiologists classification > 3;
- •immune-mediated pancreatitis or associated pancreatic neoplasms
- •Major neurological disease such as stroke, uncontrolled epilepsy, dementia
- •Diagnosis of schizophrenia
- •Chronic benzodiazepine use. Use of short acting benzodiazepine on as needed basis is acceptable if participant is able to hold benzodiazepine prior to EEG recording.
- •Pregnancy
结局指标
主要结局
Change from Baseline in Brief Pain Inventory (BPI) Score at Month 3 Post-Operation
时间窗: Baseline, Month 3 Post-Operation
BPI is a 9-item assessment of pain. Each item is rated on a Likert scale from 0 (No Pain) to 10 (Pain as bad as you can imagine). The total score is the sum of responses and ranges from 0-90; higher scores indicate greater pain.
次要结局
- Change from Baseline in BPI Score at Month 12 Post-Operation(Baseline, Month 12 Post-Operation)
- Change from Baseline in BPI Score at Month 18 Post-Operation(Baseline, Month 18 Post-Operation)
- Change from Baseline in Patient Reported Outcome System (PROMIS) - Physical Function - Short Form 6b Score at Month 3 Post-Operation(Baseline, Month 3 Post-Operation)
- Change from Baseline in PROMIS - Physical Function - Short Form 6b Score at Month 6 Post-Operation(Baseline, Month 6 Post-Operation)
- Number of Participants who use Opioids at Month 3(Month 3)
- Change from Baseline in PROMIS - Depression - Short Form 4a Score at Month 6 Post-Procedure(Baseline, Month 6 Post-Procedure)
- Change from Baseline in PROMIS - Depression - Short Form 4a Score at Month 12 Post-Procedure(Baseline, Month 12 Post-Procedure)
- Change from Baseline in PROMIS - Depression - Short Form 4a Score at Month 18 Post-Procedure(Baseline, Month 18 Post-Procedure)
- Change from Baseline in PROMIS - Anxiety- Short Form 4a Score at Month 3 Post-Procedure(Baseline, Month 3 Post-Procedure)
- Change from Baseline in BPI Score at Month 6 Post-Operation(Baseline, Month 6 Post-Operation)
- Change from Baseline in PROMIS - Physical Function - Short Form 6b Score at Month 12 Post-Operation(Baseline, Month 12 Post-Operation)
- Number of Participants who use Opioids at Baseline(Baseline)
- Change from Baseline in PROMIS - Physical Function - Short Form 6b Score at Month 18 Post-Operation(Baseline, Month 18 Post-Operation)
- Number of Participants who use Opioids at Month 18(Month 18)
- Change from Baseline in PROMIS - Depression - Short Form 4a Score at Month 3 Post-Procedure(Baseline, Month 3 Post-Procedure)
- Number of Participants who use Opioids at Month 6(Month 6)
- Number of Participants who use Opioids at Month 12(Month 12)
- Change from Baseline in PROMIS - Anxiety- Short Form 4a Score at Month 6 Post-Procedure(Baseline, Month 6 Post-Procedure)
- Change from Baseline in PROMIS - Anxiety- Short Form 4a Score at Month 12 Post-Procedure(Baseline, Month 12 Post-Procedure)
- Change from Baseline in PROMIS - Anxiety- Short Form 4a Score at Month 18 Post-Procedure(Baseline, Month 18 Post-Procedure)
- Change from Baseline in PROMIS - Neuropathic Pain Quality 5a Score at Month 3 Post-Procedure(Baseline, Month 3 Post-Procedure)
- Change from Baseline in PROMIS - Neuropathic Pain Quality 5a Score at Month 6 Post-Procedure(Baseline, Month 6 Post-Procedure)
- Change from Baseline in PROMIS - Neuropathic Pain Quality 5a Score at Month 12 Post-Procedure(Baseline, Month 12 Post-Procedure)
- Change from Baseline in PROMIS - Neuropathic Pain Quality 5a Score at Month 18 Post-Procedure(Baseline, Month 18 Post-Procedure)
- Change from Baseline in PROMIS - Sleep Disturbance - Short Form 6a Score at Month 3 Post-Procedure(Baseline, Month 3 Post-Procedure)
- Change from Baseline in PROMIS - Sleep Disturbance - Short Form 6a Score at Month 6 Post-Procedure(Baseline, Month 6 Post-Procedure)
- Change from Baseline in PROMIS - Sleep Disturbance - Short Form 6a Score at Month 12 Post-Procedure(Baseline, Month 12 Post-Procedure)
- Change from Baseline in PROMIS - Sleep Disturbance - Short Form 6a Score at Month 18 Post-Procedure(Baseline, Month 18 Post-Procedure)
- Change from Baseline in PROMIS - Fatigue - Short Form 6a Score at Month 3 Post-Procedure(Baseline, Month 3 Post-Procedure)
- Change from Baseline in PROMIS - Fatigue - Short Form 6a Score at Month 6 Post-Procedure(Baseline, Month 6 Post-Procedure)
- Change from Baseline in PROMIS - Fatigue - Short Form 6a Score at Month 12 Post-Procedure(Baseline, Month 12 Post-Procedure)
- Change from Baseline in PROMIS - Fatigue - Short Form 6a Score at Month 18 Post-Procedure(Baseline, Month 18 Post-Procedure)
- Change from Baseline in Pain Catastrophizing Scale (PCS) Score at Month 3 Post-Procedure(Baseline, Month 3 Post-Procedure)
- Change from Baseline in PCS Score at Month 6 Post-Procedure(Baseline, Month 6 Post-Procedure)
- Change from Baseline in PCS Score at Month 12 Post-Procedure(Baseline, Month 12 Post-Procedure)
- Change from Baseline in PCS Score at Month 18 Post-Procedure(Baseline, Month 18 Post-Procedure)
- Change from Baseline in Sleep Duration at Month 3 Post-Procedure(Baseline, Month 3 Post-Procedure)
- Change from Baseline in Sleep Duration at Month 6 Post-Procedure(Baseline, Month 6 Post-Procedure)
- Change from Baseline in Sleep Duration at Month 12 Post-Procedure(Baseline, Month 12 Post-Procedure)
- Change from Baseline in Sleep Duration at Month 18 Post-Procedure(Baseline, Month 18 Post-Procedure)
- Change from Baseline in Tobacco, Alcohol, Prescription medications, and other Substance (TAPS) Score at Month 3 Post-Procedure(Baseline, Month 3 Post-Procedure)
- Change from Baseline in TAPS Score at Month 6 Post-Procedure(Baseline, Month 6 Post-Procedure)
- Change from Baseline in TAPS Score at Month 12 Post-Procedure(Baseline, Month 12 Post-Procedure)
- Change from Baseline in TAPS Score at Month 18 Post-Procedure(Baseline, Month 18 Post-Procedure)
- Change from Baseline in Patient Global Impression of Change (PGIC) Score at Month 3 Post-Procedure(Baseline, Month 3 Post-Procedure)
- Change from Baseline in PGIC Score at Month 6 Post-Procedure(Baseline, Month 6 Post-Procedure)
- Change from Baseline in PGIC Score at Month 12 Post-Procedure(Baseline, Month 12 Post-Procedure)
- Change from Baseline in PGIC Score at Month 18 Post-Procedure(Baseline, Month 18 Post-Procedure)
- Change from Baseline in Patient Health Questionnaire-2 (PHQ-2) Score at Month 3 Post-Procedure(Baseline, Month 3 Post-Procedure)
- Change from Baseline in PHQ-2 Score at Month 6 Post-Procedure(Baseline, Month 6 Post-Procedure)
- Change from Baseline in PHQ-2 Score at Month 12 Post-Procedure(Baseline, Month 12 Post-Procedure)
- Change from Baseline in PHQ-2 Score at Month 18 Post-Procedure(Baseline, Month 18 Post-Procedure)
- Change from Baseline in Generalized Anxiety Disorder 2 (GAD-2) Score at Month 3 Post-Procedure(Baseline, Month 3 Post-Procedure)
- Change from Baseline in GAD-2 Score at Month 6 Post-Procedure(Baseline, Month 6 Post-Procedure)
- Change from Baseline in GAD-2 Score at Month 12 Post-Procedure(Baseline, Month 12 Post-Procedure)
- Change from Baseline in GAD-2 Score at Month 18 Post-Procedure(Baseline, Month 18 Post-Procedure)
- Change from Baseline in Pain, Enjoyment of Life and General Activity (PEG) Scale at Month 3 Post-Procedure(Baseline, Month 3 Post-Procedure)
- Change from Baseline in PEG Scale at Month 6 Post-Procedure(Baseline, Month 6 Post-Procedure)
- Change from Baseline in PEG Scale at Month 12 Post-Procedure(Baseline, Month 12 Post-Procedure)
- Change from Baseline in PEG Scale at Month 18 Post-Procedure(Baseline, Month 18 Post-Procedure)
研究者
研究点 (1)
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