Pancreatic Endotherapy for Refractory Chronic Pancreatitis

Pancreatic Duct Stone Clinical Trial

— PERCePT  

Official title:

Pancreatic Endotherapy for Refractory Chronic Pancreatitis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04232670
• Other study ID #: Pro00087299
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 9, 2020
• Est. completion date: July 2025

Study information

• Verified date: November 2023
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate whether endoscopic ultrasound (EUS) only versus EUS + endoscopic retrograde cholangiopancreatography (ERCP) with pancreatic endotherapy reduces pain in the treatment of chronic pancreatitis with pancreatic duct obstruction.

Description:

This is a single center, pilot, sham-controlled clinical trial of ERCP with pancreatic endotherapy for pain secondary to chronic calcific pancreatitis with main pancreatic duct obstruction. Potential subjects will undergo a comprehensive baseline assessment including Quantitative Sensory Testing, to ensure enrollment criteria are met and baseline covariates are measured. Eligible subjects will complete a 14-day run-in period. If eligibility criteria persist, subjects will be randomized to diagnostic endoscopic ultrasound (EUS) + sham pancreatic endotherapy or diagnostic EUS + ERCP with pancreatic endotherapy as defined in the study protocol. Subjects will be followed by a blinded physician for the next 90 days, at which time the pilot trial outcomes will be measured. Regardless of outcomes, all subjects will be followed longitudinally for 12 months after randomization.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 14
• Est. completion date: July 2025
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• Age = 18 years

• Main pancreatic duct obstruction, defined by the presence of one or both of the following features:

• Main pancreatic duct calcification with upstream main duct dilation =6mm.

• Main pancreatic duct stricture, defined by the presence of main pancreatic duct narrowing with upstream main duct dilation =6mm.

• Baseline average abdominal pain score =4 during the run-in period, based on Ecological Momentary Assessment 11-point Numeric Rating Scale

• Ability to provide written, informed consent

Exclusion Criteria

• Symptoms attributable to a pancreatic pseudocyst or walled off necrosis

• Clinical suspicion of pancreatobiliary malignancy*

• Low probability of follow-up to complete study objectives

• Pregnancy or incarceration

• Medical comorbidities that contraindicate the performance of ERCP

• Previous pancreatic endotherapy

• Current Opioid Misuse Measure score =9

• Does not have access to a mobile phone * Pancreatobiliary malignancy

Related Conditions & MeSH terms

• Constriction, Pathologic
• Pancreatic Duct Dilatation
• Pancreatic Duct Stone
• Pancreatic Duct Stricture
• Pancreatitis
• Pancreatitis, Chronic

Intervention

Procedure:
• EUS + SHAM
Endoscopic Ultrasound
• EUS + Pancreatic Endotherapy
Pancreatic endotherapy may include any or all of the following maneuvers: pancreatic endoscopic sphincterotomy, stricture dilation using a bougie or hydrostatic balloon catheter, pancreatic stone extraction with or without mechanical or electrohydraulic lithotripsy, extracorporeal shock wave lithotripsy, and stent placement.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average daily pain: Numeric Rating Scale (NRS)	The average daily pain from the electronic diaries during the 14-day period preceding the 90-day assessment, compared to the average daily pain reported during the 14-day run-in. Clinical improvement will be defined by the change in the average pain score between these two intervals, and without the need for increased opioids or additional interventions/procedures. The investigators will employ the standardized 11-point Numeric Rating Scale (NRS) to capture average daily pain with the empirically-supported anchors of 0=No Pain and 10=Worst Pain Imaginable.	Day -14 to Day 90
Secondary	Change from baseline in pain severity and functional impairment	At 90-days, change from baseline in functional impairment due to pain will be examined.; The instrument used is Brief Pain Inventory (BPI),; Measures pain at its worst, least, average, and at time of evaluation; Measures patient perception of effectiveness of current pain medications; Measures functional impairment due to pain	Baseline to Day 90
Secondary	Quality of Life: Using the PROMIS 29 instrument	Using the PROMIS 29 instrument, quality of life will be assessed through this questionnaire evaluating anxiety, depression, fatigue, pain interference, physical function, sleep disturbance, ability to participate in social roles and activities, and a single pain intensity item.	Baseline to Day 90
Secondary	Opioid Misuse	Using the instrument titled Current Opioid Misuse Measure (COMM), this will be evaluated by patient self-reported measures of risk for aberrant medication-related behavior in patients prescribed opioids for chronic pain.	Baseline to Day 90
Secondary	Pain Catastrophizing	The instrument titled Pain Catastrophizing Scale (PCS) used to assess pain catastrophizing will do the following: Measure of negative cognitive-set brought to bear during painful experiences; Predict functional impairment due to pain and pain-related depression	Baseline to Day 90
Secondary	Mechanical pain threshold	Using Quantitative Sensory Testing, assess the mechanical pain threshold using the IITC Life Sciences Digital Anesthesiometer applied to the distal phalange of the digiti minimi of the left hand (increased at rate of 10grams/sec; pressure recorded in grams).	Baseline to Day 90
Secondary	Pain tolerance: Quantitative Sensory Testing	Using Quantitative Sensory Testing, assess thermal pain tolerance using 5 trials of cutaneous heat stimuli via the thermode of the Medoc TSA-II Neurosensory Analyzer.	Baseline to Day 90
Secondary	Pain wind up	Using Quantitative Sensory Testing, assess thermal wind-up pain (3 trials) with the thermode delivering 20 brief suprathreshold thermal pulses at the rate of 1 pulse per 1.5 secs thereby selectively stimulating C-fibers (during the 3 trials of 30sec of repeated heat stimulation, subjects will indicate their level of pain severity using a dynamic visual analogue scale).	Baseline to Day 90
Secondary	Conditioned pain modulation	Using Quantitative Sensory Testing, assess conditioned pain modulation (3 trials) using mechanical pain thresholds assessed via the IITC Life Sciences Digital Anesthesiometer applied to the right trapezus (increased at rate of 10grams/sec; pressure recorded in grams) with and without simultaneous stimulation via the ATS thermode.	Baseline to Day 90