Chronic PancreatitisRespPancNCT03850977
Is There an Association Between Chronic Pancreatitis and Pulmonary Function
An observational study of Chronic Pancreatitis and Respiratory Insufficiency, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
Trial summary
To evaluate pulmonary function in chronic pancreatitis compared with healthy volunteers and patients with cirrhosis. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pancreatitis, Respiratory Insufficiency, Cirrhosis, Liver
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2018to 1 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: We plan to include patients with chronic pancreatitis, cirrhosis and healthy controls
Who may be able to join
- Patients with chronic pancreatitis or cirrhosis
- Healthy controls
Who cannot join
- Lack of informed consent
- Known chronic lung disease
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Gastrounit, Copenhagen University Hospital Hvidovre
Hvidovre, Capital Region Denmark, 2650
About this study
Official title: Association Between Chronic Pancreatitis and Respiratory Dysfunction: A Prospective Cohort Study?
To evaluate pulmonary function in chronic pancreatitis compared with healthy volunteers and patients with cirrhosis.
- Conditions
- Chronic Pancreatitis, Respiratory Insufficiency, Cirrhosis, Liver, Lung Function Decreased, Healthy
- Medical subject headings
- Pancreatitis, Chronic, Respiratory Insufficiency, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients and controls | Patients diagnosed with chronic pancreatitis or cirrhosis and healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diffusion capacity of the lung for carbon monoxide
Lung diffusion capacity
Measured: Three years
Alveolar volume
Alveolar volume
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2019
- Study start1 Sep 2018
- Primary completion1 Oct 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Hvidovre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lise Gluud, Copenhagen University Hospital, Hvidovre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03850977
- Sponsor's protocol ID
- H-18016860
- Acronym
- RespPanc
- Status last verified
- Nov 2023
- First submitted
- 20 Feb 2019
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Chronic Pancreatitis and Respiratory Dysfunction: A Prospective Cohort Study?
- ClinicalTrials.gov ID
- NCT03850977
- Acronym / sponsor ID
- RespPanc / H-18016860
- Conditions
- Chronic Pancreatitis, Respiratory Insufficiency, Cirrhosis, Liver, Lung Function Decreased, Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, HvidovreUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 22 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate pulmonary function in chronic pancreatitis compared with healthy volunteers and patients with cirrhosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients and controls | – | –Patients diagnosed with chronic pancreatitis or cirrhosis and healthy controls |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We plan to include patients with chronic pancreatitis, cirrhosis and healthy controls
Key inclusion criteria (2 listed)
- Patients with chronic pancreatitis or cirrhosis
- Healthy controls
Key exclusion criteria (2 listed)
- Lack of informed consent
- Known chronic lung disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diffusion capacity of the lung for carbon monoxide
Time frame: Three years
Lung diffusion capacity
Alveolar volume
Time frame: Three years
Alveolar volume
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pancreatitis and Respiratory Insufficiency, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diffusion capacity of the lung for carbon monoxide (time frame: Three years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.