Pancreatic Quantitative Sensory Testing (P-QST) to Predict Treatment Response for Pain in Chronic Pancreatitis

Обзор

Abdominal pain in chronic pancreatitis (CP) affects up to 90% of patients during the course of their disease, and response to currently available therapies is suboptimal and unpredictable. The proposed clinical trial will evaluate the predictive capability of Pancreatic Quantitative Sensory Testing (P-QST) - a novel assessment of neurosensory phenotyping- for improvement in pain in patients with CP who are undergoing medically-indicated invasive treatment with endoscopic therapy or surgery.

Подробное описание

P-QST has been shown to be able to phenotype patients with CP into nociceptive patterns according to degree of central sensitization. As a tool to identify baseline nociceptive pattern in patients with painful CP, P-QST will be performed at baseline prior to planned invasive treatment with endoscopic therapy or decompressive surgery. We will evaluate the ability of P-QST to predict response to invasive treatment for painful CP, and to develop a predictive model for individualized prediction of treatment response.

Patients will undergo pre-procedure P-QST testing before undergoing scheduled invasive treatment as directed by their treating gastroenterologist. The date of first endoscopic therapy or surgery will be used to calculate follow-up timepoints, which will be scheduled at 3, 6, and 12 months after the first endotherapy session or surgery. At each follow-up time point, patients will answer questions about their pain. In addition, patients will complete patient reported outcome tools (HADS, PCS instruments) and the Patient Global Impression of Change. Serum and urine samples will be obtained at baseline and at 6-month follow-up timepoints.

Вмешательства

• Диагностический тест Quantitative Sensory Test 1
  Subject will give pain rating (on Visual Analogue Scale (VAS) 0-10) of single as well as multiple stimulation with round-tip non-invasive pin-prick device. Difference is recorded as Temporal Summation Score.
• Диагностический тест Quantitative Sensory Test 2
  Subject will state when they first detect pain and pain detection threshold in response to pressure administration with pressure algometer. Pressure threshold recorded in kilopascals(kP). Stimulation will be repeated in pancreatic and control dermatomes. Subject will then state pain tolerance threshold at same locations. Sensitization will be characterized by ratio of pancreatic vs. control dermatome scores.
• Диагностический тест Quantitative Sensory Test 3
  Subject will apply dominant hand to ice-chilled water bath (36F) for up to 2 minutes. Pain score (VAS 0-10) will be assessed each 10 seconds. Pain tolerance threshold (in kP) will be assessed with algometer on non-dominant thigh before and after water bath to determine change in threshold. Difference in pain tolerance recorded as Conditioned Pain Modulation Score.

Первичные конечные точки

• Average Pain Score [Срок оценки: six months post procedure]

Вторичные конечные точки (12)

• Change from baseline in Seven Day Pain Diary Score [Срок оценки: 3 months after intervention.]
• Change from baseline in Seven Day Pain Diary Score [Срок оценки: 6 months after intervention.]
• Change from baseline in Seven Day Pain Diary Score [Срок оценки: 12 months after intervention.]
• Change from baseline in Single-question NRS score [Срок оценки: at 3 months after intervention]
• Change from baseline in Single-question NRS score [Срок оценки: at 12 months.]
• Number of patients using prescription opioids for pain control at time of assessment [Срок оценки: 3 months]
• Number of patients using prescription opioids for pain control at time of assessment [Срок оценки: 6 months]
• Number of patients using prescription opioids for pain control at time of assessment [Срок оценки: 12 months]
• Mean reported daily opioid dose for patients using prescription opioids at time of assessment [Срок оценки: 3 months]
• Mean reported daily opioid dose for patients using prescription opioids at time of assessment [Срок оценки: 6 months]
• Mean reported daily opioid dose for patients using prescription opioids at time of assessment [Срок оценки: 12 months]
• Pain relief of ≥30% [Срок оценки: 3 months]

Критерии участия

Критерии включения

• Adult patients ≥ 18 years of age with definite CP undergoing decompressive invasive treatments (endoscopic therapy or surgery) to relieve main pancreatic duct obstruction due to stones and/or stricture for management of pain.

• Endoscopic therapy: Endoscopic Retrograde Cholangiopancreatography (ERCP) with pancreatic duct stone removal, stent placement, and/or stricture dilation, ± intraductal lithotripsy or Extracorporeal Shock Wave Lithotripsy (ESWL).
• Surgery: drainage procedures (Frey and Puestow operations)

Критерии исключения

• Patients with chronic pain from conditions other than CP
• Patients < 18 years of age
• Patients who have had endoscopic therapy within the past 12 months
• Patients who have undergone prior pancreatic surgery
• Patients who have resective surgical procedure planned (eg. Whipple procedure, Total Pancreatectomy)
• Patients with peripheral sensory deficits
• Patients with known pregnancy at the time of study screening\*\*

• Note: Women who become pregnant during the course of the study can no longer participate in P-QST testing.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

США · 3 центра

• Indiana University Medical Center — Indianapolis
• Johns Hopkins Medical Institutions — Baltimore
• University of Pittsburgh Medical Center — Pittsburgh

Публикации

• Phillips AE, Afghani E, Akshintala VS, Benos PY, Das R, Drewes AM, Easler J, Faghih M, Gabbert C, Halappa V, Khashab MA, Olesen SS, Saloman JL, Sholosh B, Slivka A, Wang T, Yadav D, Singh VK. Pancreatic quantitative sensory testing to predict treatment response of endoscopic therapy or surgery for painful chronic pancreatitis with pancreatic duct obstruction: study protocol for an observational cl PMID 38514147

Идентификаторы

NCT: NCT04996628 · STUDY21050169 · R01DK127042

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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