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

NCT ID: NCT05012150

Last Updated: 2025-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-05

Study Completion Date

2026-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Pancreatitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

American Society for Gastrointestinal Endoscopy

OTHER

Sponsor Role collaborator

Ohio State University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mitchell Ramsey

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020H0410

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Enhanced Recovery in Acute Pancreatitis
NCT02813876 COMPLETED PHASE2