Clinical trial NCT05012150: A Pilot Study in Endoscopic Therapy on Quality of Life and Pain in Chronic Pancreatitis
Official title: A Pilot Study in Endoscopic Therapy on Quality of Life and Pain in Chronic Pancreatitis: The EQuiPP Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Pancreatitis
Keywords: ERCP
ESWL
quality of life
quantitative sensory testing
celiac plexus block
pancreatic duct stricture
pancreatic duct stenting
pancreatic fluid collection
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: American Society for Gastrointestinal Endoscopy
First posted: 2021-08-19
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with painful chronic pancreatitis who are being referred for pancreatic endotherapy will be eligible for participation in this study. Subjects who have already had prior endotherapy or surgery, however, will be excluded.

Brief summary: This study is a prospective study designed to assess the effect of pancreatic endotherapy on quality of life, pain levels, pancreatic exocrine function, and endocrine function.

Detailed description: Pancreatic endotherapy represents a potential treatment modality for patients with painful chronic pancreatitis. While pancreatic endotherapy is commonly performed, the effect of chronic pancreatitis on patient-centered outcomes remains poorly studied. Furthermore, the effect of endotherapy on pancreatic endocrine and exocrine are largely unknown. This study therefore aims to prospective observe patients with chronic pancreatitis after endotherapy is performed to better understand how it affects patient-centered outcomes such as pain and quality of life and pancreatic function. In doing so, the study also hopes to be able to predict which patients with chronic pancreatitis will benefit from pancreatic endotherapy.

Eligibility criteria: Inclusion Criteria:

* Chronic Pancreatitis (as defined by the American Pancreatic Association Guidelines)
* Presence of Pain
* Referred for pancreatic endotherapy

Exclusion Criteria:

* Prior pancreatic endotherapy
* Prior pancreatic surgery
* Pregnant females
* Subjects unable to consent
* Imprisoned individuals

Primary outcomes:
measure: Chronic Pancreatitis-Specific Quality of Life
timeFrame: 12 months post-completion of endotherapy
measure: Feasibility of Micro-Longitudinal Daily Pain Assessment
timeFrame: 30-day post-procedure period
Secondary outcomes:
measure: Overall Quality of Life
timeFrame: 12 months post-completion of endotherapy
measure: Change in Nociceptive Pain
timeFrame: 12 months post-completion of endotherapy
measure: Change in Neuropathic Pain
timeFrame: 12 months post-completion of endotherapy
measure: Change in Pain Catastrophizing
timeFrame: 12 months post-completion of endotherapy
measure: Change in Self-Efficacy
timeFrame: 12 months post-completion of endotherapy
measure: Change in Chronic Pancreatitis-specific Pain
timeFrame: 12 months post-completion of endotherapy
measure: Quantitative Sensory Testing
timeFrame: The quantitative sensory testing will be assessed only once during the subject's baseline enrollment.
measure: Pancreatic Endocrine Function via HbA1c
timeFrame: 12 months post-completion of endotherapy
measure: Insulin Resistance
timeFrame: 12 months post-completion of endotherapy
measure: Insulin Sensitivity
timeFrame: 12 months post-completion of endotherapy
measure: Pancreatic Exocrine Function
timeFrame: 12 months post-completion of endotherapy
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
Study officials:
References: