Clinical trial NCT04996628: Pancreatic Quantitative Sensory Testing (P-QST) to Predict Treatment Response for Pain in Chronic Pancreatitis
Official title: Pancreatic Quantitative Sensory Testing (P-QST) to Predict Treatment Response for Pain in Chronic Pancreatitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pancreatitis
Chronic Pain
Keywords: Chronic Pain
Chronic Pancreatitis
Recurrent Acute Pancreatitis
Chronic Abdominal Pain
ERCP
Pancreatic Surgery
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2021-08-09
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants are assessed at baseline for nociceptive pattern via P-QST and followed longitudinally for the duration of the study
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Average Pain Score
timeFrame: six months post procedure
Secondary outcomes:
measure: Change from baseline in Seven Day Pain Diary Score
timeFrame: 3 months after intervention.
measure: Change from baseline in Seven Day Pain Diary Score
timeFrame: 6 months after intervention.
measure: Change from baseline in Seven Day Pain Diary Score
timeFrame: 12 months after intervention.
measure: Change from baseline in Single-question NRS score
timeFrame: at 3 months after intervention
measure: Change from baseline in Single-question NRS score
timeFrame: at 12 months.
measure: Number of patients using prescription opioids for pain control at time of assessment
timeFrame: 3 months
measure: Number of patients using prescription opioids for pain control at time of assessment
timeFrame: 6 months
measure: Number of patients using prescription opioids for pain control at time of assessment
timeFrame: 12 months
measure: Mean reported daily opioid dose for patients using prescription opioids at time of assessment
timeFrame: 3 months
measure: Mean reported daily opioid dose for patients using prescription opioids at time of assessment
timeFrame: 6 months
measure: Mean reported daily opioid dose for patients using prescription opioids at time of assessment
timeFrame: 12 months
measure: Pain relief of ≥30%
timeFrame: 3 months
measure: Pain relief of ≥30%
timeFrame: 6 months
measure: Pain relief of ≥30%
timeFrame: 12 months
measure: Pain relief of ≥50%
timeFrame: 3 months after intervention
measure: Pain relief of ≥50%
timeFrame: 6 months after intervention
measure: Pain relief of ≥50%
timeFrame: 12 months after intervention
measure: Change from baseline on the Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale
timeFrame: Baseline, 3, 6, and 12 months
measure: Change from baseline on the Patient Reported Outcomes Measurement Information System (PROMIS) Neuropathic Pain Scale
timeFrame: Baseline, 3, 6, and 12 months
measure: Change from baseline on the Patient Reported Outcomes Measurement Information System (PROMIS) Nociceptive Pain Scale
timeFrame: Baseline, 3, 6, and 12 months
measure: Change from baseline on the Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Scale
timeFrame: Baseline, 3, 6, and 12 months
measure: Patient Global Impression of Change (PGIC) Scale
timeFrame: 3, 6, and 12 months
measure: Change from baseline on the Pain Catastrophizing Scale (PCS)
timeFrame: Baseline, 3, 6, and 12 months
measure: Change from baseline on the Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline, 3, 6, and 12 months
measure: Change from baseline on the Modified Brief Pain Inventory Short Form (mBPI-SF)
timeFrame: Baseline, 3, 6, and 12 months
measure: Change from baseline on the European Organization for the Research and Treatment of Cancer Quality(EORTC) of Life Questionnaire (QLQ) Core 30 (C30)
timeFrame: Baseline, 3, 6, and 12 months
measure: Change from baseline on the Comprehensive Pain Assessment Tool for Pancreatitis Short Form (COMPAT-SF)
timeFrame: Baseline, 3, 6, and 12 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Medical Center
state: Indiana
city: Baltimore
country: United States
facility: Johns Hopkins Medical Institutions
state: Maryland
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Anna Evans Phillips, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: