Recruiting

Observational Study

Sponsor:

University of Pittsburgh

Code:

NCT04996628

Conditions

Chronic Pancreatitis

Chronic Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Quantitative Sensory Test 1

Quantitative Sensory Test 2

Quantitative Sensory Test 3

Study Details

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.

Conditions

Chronic Pancreatitis

Chronic Pain

Study ID

NCT04996628

Start date

Jan 4, 2022

Status verified date

Dec, 2025

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

150 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Pancreatic Quantitative Sensory Testing (P-QST)

Definite Chronic Pancreatitis patients undergoing decompressive invasive treatments (endoscopic therapy or surgery) to relieve main pancreatic duct obstruction due to stones and/or stricture for management of pain will undergo P-QST prior to clinically-indicated invasive treatment.

Interventions

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.

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.

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.

Primary outcome measure

  • Average Pain Score [ Time Frame: six months post procedure ]

Central Contacts and Locations

Central contacts

Anna Evans Phillips, MD, MS

412-647-2345evansac3@upmc.edu

Apsara Mishra

apm179@pitt.edu

Locations

Indiana University Medical Center

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Suzette Schmidt, RN

317-278-0691suschmid@iu.edu

Principal Investigator:

Jeffrey Easler, MD

Johns Hopkins Medical Institutions

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Mahya Faghih, MD

410-614-6708mfaghih2@jhu.edu

Principal Investigator:

(Site) Vikesh K Singh, MD, MSc

University of Pittsburgh Medical Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Anna E Phillips, MD, MS

412-647-2345evansac3@upmc.edu

Principal Investigator:

Anna E Phillips, MD, MS

More Information

Sponsor

University of Pittsburgh

Last update posted

Dec 22, 2025

Last verified

Dec, 2025

Keywords

  • Chronic Pain
  • Chronic Pancreatitis
  • Recurrent Acute Pancreatitis
  • Chronic Abdominal Pain
  • ERCP
  • Pancreatic Surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2025-12-22.