Cryptogenic Pyogenic Liver AbscessNCT02032914
Prevalence of Colon Cancer in Pyogenic Liver Abscess
An observational study of Cryptogenic Pyogenic Liver Abscess, run by Inje University at 2 sites in South Korea.
Trial summary
Although a proportion of pyogenic liver abscess may originated from colonic mucosal lesions, the prevalence of colonic neoplasm in the patients with pyogenic liver abscess are still not evaluated yet. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cryptogenic Pyogenic Liver Abscess
- How many people
- 62 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Jan 2014to Feb 2016
- How long will I take part?
- 3 Months
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients diagnosed as pyogenic liver abscess, the cause of which is not found at initial evaluation
Who may be able to join
- Pyogenic liver abscess radiologically and bacteriologically diagnosed
Who cannot join
- Amebic liver abscess
- Other causes of pyogenic liver abscess such as cholangitis, liver cancer, complication of transarterial chemoembolization or radiofrequency ablation to hepatocellular carcinoma
- Refusal to colonoscopic examination
- Inadequate general patient status to perform the colonoscopic examination
- Patient who has had the screening colonoscopic examination within 1 year and showed normal finding or had 1 or 2 colon polyp in adequate exam
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Inje University Haeundae Paik Hospital
Busan
Pusan National Unversity Yangsan Hospital
Yangsan, Gyeongsangnam-do
About this study
Official title: The Prevalence of Colonic Neoplasm in Cryptogenic Pyogenic Liver Abscess
Although a proportion of pyogenic liver abscess may originated from colonic mucosal lesions, the prevalence of colonic neoplasm in the patients with pyogenic liver abscess are still not evaluated yet. Thus, our group will find the prevalence of colonic neoplasm in the group of cryptogenic pyogenic liver abscess by colonoscopic examination.
- Conditions
- Cryptogenic Pyogenic Liver Abscess
- Keywords
- pyogenic liver abscess, colon cancer
- Medical subject headings
- Liver Abscess, Pyogenic, Colonic Neoplasms
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 |
|---|---|---|
| Colonoscopic examination group | The patients diagnosed with cryptogenic pyogenic liver abscess |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of colonic neoplasm
Measured: within 6 weeks after diagnosis of pyogenic liver abscess
Secondary outcomes (4)
Prevalence of colon polyp
Measured: Within 6 weeks at diagnosis of pyogenic liver abscess
Prevalence of colonic diverticulitis
Measured: Within 6 weeks at diagnosis of pyogenic liver abscess
Prevalence of inflammatory bowel disease
Measured: Within 6 weeks at diagnosis of pyogenic liver abscess
Prevalence of intestinal tuberculosis
Measured: Within 6 weeks at diagnosis of pyogenic liver abscess
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cryptogenic Pyogenic Liver AbscessStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 62 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Collaborators
- Pusan National University Yangsan Hospital
- Responsible party
- Principal investigator, Tae Oh Kim, Inje University
- Investigators
- Tae Oh Kim, M.D., Principal investigator, Inje University Haeundae Paik Hosptial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02032914
- Sponsor's protocol ID
- 1
- Status last verified
- Feb 2016
- First submitted
- 8 Jan 2014
- Last updated
- 1 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of Colonic Neoplasm in Cryptogenic Pyogenic Liver Abscess
- ClinicalTrials.gov ID
- NCT02032914
- Acronym / sponsor ID
- 1
- Conditions
- Cryptogenic Pyogenic Liver Abscess
- Keywords
- pyogenic liver abscess, colon cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Collaborators
- Pusan National University Yangsan Hospital
- Study start
- Jan 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 10 Jan 2014 (estimated)
- 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.
Although a proportion of pyogenic liver abscess may originated from colonic mucosal lesions, the prevalence of colonic neoplasm in the patients with pyogenic liver abscess are still not evaluated yet. Thus, our group will find the prevalence of colonic neoplasm in the group of cryptogenic pyogenic liver abscess by colonoscopic examination.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colonoscopic examination group | – | –The patients diagnosed with cryptogenic pyogenic liver abscess |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients diagnosed as pyogenic liver abscess, the cause of which is not found at initial evaluation
Key inclusion criteria (1 listed)
- Pyogenic liver abscess radiologically and bacteriologically diagnosed
Key exclusion criteria (5 listed)
- Amebic liver abscess
- Other causes of pyogenic liver abscess such as cholangitis, liver cancer, complication of transarterial chemoembolization or radiofrequency ablation to hepatocellular carcinoma
- Refusal to colonoscopic examination
- Inadequate general patient status to perform the colonoscopic examination
- Patient who has had the screening colonoscopic examination within 1 year and showed normal finding or had 1 or 2 colon polyp in adequate exam
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
The prevalence of colonic neoplasm
Time frame: within 6 weeks after diagnosis of pyogenic liver abscess
4 secondary outcomes
Prevalence of colon polyp
Time frame: Within 6 weeks at diagnosis of pyogenic liver abscess
Prevalence of colonic diverticulitis
Time frame: Within 6 weeks at diagnosis of pyogenic liver abscess
Prevalence of inflammatory bowel disease
Time frame: Within 6 weeks at diagnosis of pyogenic liver abscess
Prevalence of intestinal tuberculosis
Time frame: Within 6 weeks at diagnosis of pyogenic liver abscess
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 1 Mar 2016.
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.
Tae Oh Kim, M.D. principal investigator
Inje University Haeundae Paik Hosptial
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cryptogenic Pyogenic Liver Abscess, run by Inje University at 2 sites in South Korea.
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 1 inclusion and 5 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 1 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. 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?
The prevalence of colonic neoplasm (time frame: within 6 weeks after diagnosis of pyogenic liver abscess). 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 1 Mar 2016.