NCT03850977

Brief Summary

To evaluate pulmonary function in chronic pancreatitis compared with healthy volunteers and patients with cirrhosis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 22, 2019

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

5.1 years

First QC Date

February 20, 2019

Last Update Submit

November 15, 2023

Conditions

Chronic PancreatitisRespiratory InsufficiencyCirrhosis, LiverLung Function DecreasedHealthy

Outcome Measures

Primary Outcomes (2)

  • Diffusion capacity of the lung for carbon monoxide

    Lung diffusion capacity

    Three years

  • Alveolar volume

    Alveolar volume

    Three years

Study Arms (1)

Patients and controls

Patients diagnosed with chronic pancreatitis or cirrhosis and healthy controls

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

We plan to include patients with chronic pancreatitis, cirrhosis and healthy controls

You may qualify if:

  • Patients with chronic pancreatitis or cirrhosis
  • Healthy controls

You may not qualify if:

  • Lack of informed consent
  • Known chronic lung disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gastrounit, Copenhagen University Hospital Hvidovre

Hvidovre, Capital Region Denmark, 2650, Denmark

Location

MeSH Terms

Conditions

Pancreatitis, ChronicRespiratory InsufficiencyLiver Cirrhosis

Condition Hierarchy (Ancestors)

PancreatitisPancreatic DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration DisordersRespiratory Tract DiseasesLiver DiseasesFibrosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician, PhD

Study Record Dates

First Submitted

February 20, 2019

First Posted

February 22, 2019

Study Start

September 1, 2018

Primary Completion

October 1, 2023

Study Completion

October 1, 2023

Last Updated

November 18, 2023

Record last verified: 2023-11

Locations

DK(1)