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Pancreatic Endotherapy for Refractory Chronic Pancreatitis (PERCePT)

Primary Purpose

Pancreatic Duct Stone, Pancreatic Duct Stricture, Pancreatic Duct Dilatation

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EUS + SHAM
EUS + Pancreatic Endotherapy
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Duct Stone focused on measuring pancreas, pancreatic duct, ductal stone, duct stricture, ERCP, pancreatic duct obstruction, duct calcification

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oregon Health & Science UniversityRecruiting
  • Medical University of South CarolinaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

EUS + SHAM

EUS + Pancreatic Endotherapy

Arm Description

All subjects will undergo anesthesia administered sedation and endoscopic ultrasound (EUS). The endoscopist will assess the pancreas for parenchymal and ductal features of chronic pancreatitis and confirm the absence of exclusion criteria (such as the presence of an occult pancreatobiliary malignancy).

If randomized to ERCP with pancreatic endotherapy, the endoscopist will proceed with this intervention immediately following the completion of EUS and treatment allocation (during the same anesthesia). 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. Overall technical success will be defined by the ability to insert at least one pancreatic stent across the dominant main pancreatic duct obstruction. Technical success for pancreatic stone treatment will be defined by the ability to remove all fluoroscopically visible main pancreatic duct stones.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.
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.
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
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).
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.
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).
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.

Full Information

First Posted
December 6, 2019
Last Updated
August 2, 2022
Sponsor
Oregon Health and Science University
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT04232670
Brief Title
Pancreatic Endotherapy for Refractory Chronic Pancreatitis
Acronym
PERCePT
Official Title
Pancreatic Endotherapy for Refractory Chronic Pancreatitis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 9, 2020 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Duct Stone, Pancreatic Duct Stricture, Pancreatic Duct Dilatation
Keywords
pancreas, pancreatic duct, ductal stone, duct stricture, ERCP, pancreatic duct obstruction, duct calcification

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
In addition to the participant and the investigator assessing outcomes, study coordinators involved in collecting outcomes data will be masked to the treatment assignment.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EUS + SHAM
Arm Type
Sham Comparator
Arm Description
All subjects will undergo anesthesia administered sedation and endoscopic ultrasound (EUS). The endoscopist will assess the pancreas for parenchymal and ductal features of chronic pancreatitis and confirm the absence of exclusion criteria (such as the presence of an occult pancreatobiliary malignancy).
Arm Title
EUS + Pancreatic Endotherapy
Arm Type
Experimental
Arm Description
If randomized to ERCP with pancreatic endotherapy, the endoscopist will proceed with this intervention immediately following the completion of EUS and treatment allocation (during the same anesthesia). 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. Overall technical success will be defined by the ability to insert at least one pancreatic stent across the dominant main pancreatic duct obstruction. Technical success for pancreatic stone treatment will be defined by the ability to remove all fluoroscopically visible main pancreatic duct stones.
Intervention Type
Procedure
Intervention Name(s)
EUS + SHAM
Intervention Description
Endoscopic Ultrasound
Intervention Type
Procedure
Intervention Name(s)
EUS + Pancreatic Endotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Average daily pain: Numeric Rating Scale (NRS)
Description
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.
Time Frame
Day -14 to Day 90
Secondary Outcome Measure Information:
Title
Change from baseline in pain severity and functional impairment
Description
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
Time Frame
Baseline to Day 90
Title
Quality of Life: Using the PROMIS 29 instrument
Description
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.
Time Frame
Baseline to Day 90
Title
Opioid Misuse
Description
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.
Time Frame
Baseline to Day 90
Title
Pain Catastrophizing
Description
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
Time Frame
Baseline to Day 90
Title
Mechanical pain threshold
Description
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).
Time Frame
Baseline to Day 90
Title
Pain tolerance: Quantitative Sensory Testing
Description
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.
Time Frame
Baseline to Day 90
Title
Pain wind up
Description
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).
Time Frame
Baseline to Day 90
Title
Conditioned pain modulation
Description
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.
Time Frame
Baseline to Day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gregory Cote, MD, MS
Phone
503-494-5255
Email
coteg@ohsu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Cote, MD, MS
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97035
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Czarinna Posadas
Phone
503-494-2278
Email
posadasc@ohsu.edu
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haley Nitchie, MHA
Email
nitchie@musc.edu
First Name & Middle Initial & Last Name & Degree
Badih J Elmunzer, MD, MS

12. IPD Sharing Statement

Plan to Share IPD
No

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Pancreatic Endotherapy for Refractory Chronic Pancreatitis

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