A Pilot Study in Endoscopic Therapy on Quality of Life and Pain in Chronic Pancreatitis

NCT05012150 | Active Not Recruiting

• 1 other identifier: 2020H0410
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pancreatitis

Keywords

ERCP; ESWL; quality of life; quantitative sensory testing; celiac plexus block; pancreatic duct stricture; pancreatic duct stenting; pancreatic fluid collection

Outcome Measures

Primary Outcomes (2)

• Chronic Pancreatitis-Specific Quality of Life

  Quality of life will be primarily assessed using the PANcreatitis Quality of Life Instrument (PANQOLI). Quality of life will be assessed before and after endotherapy (1, 3, 6, and 12 months). This instrument is based on a 0-87 scale with higher scores representing improved quality of life.

  12 months post-completion of endotherapy

• Feasibility of Micro-Longitudinal Daily Pain Assessment

  Pain will be assessed using daily pain diaries with the Brief Pain Inventory (BPI). These will be utilized to create short-term pain trajectories for subjects at baseline and post-procedure. This pain inventory includes 9 pain items graded on 0-10 scale with 10 being the worst pain.

  30-day post-procedure period

Secondary Outcomes (11)

• Overall Quality of Life

  12 months post-completion of endotherapy

• Change in Nociceptive Pain

  12 months post-completion of endotherapy

• Change in Neuropathic Pain

  12 months post-completion of endotherapy

• Change in Pain Catastrophizing

  12 months post-completion of endotherapy

• Change in Self-Efficacy

  12 months post-completion of endotherapy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ohio State University: lead
• American Society for Gastrointestinal Endoscopy: collaborator

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood, Urine, Stool, Saliva, and Pancreatic Fluid (juice) will be collected before and after endotherapy and stored in our Biorepository.

MeSH Terms

Conditions

Pancreatitis, Chronic

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: August 19, 2021
• Study Start: January 5, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: October 24, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available 24 months after study completion
• Access Criteria: Investigators requesting data may request access to the data by contacting the study investigators.

Locations

US (1)