Prevalence of Colon Cancer in Pyogenic Liver Abscess | NCT02032914

Studies
Prevalence of Colon Cancer in Pyogenic Liver Abscess

NCT02032914

Sponsor

Inje University

Status

Completed

Last Update Posted

Mar 1, 2016Estimated

Enrollment

62Actual

Phase

Not provided

Conditions

Cryptogenic Pyogenic Liver Abscess

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Feb 2016Actual

Completion Date

Feb 2016Actual

First Submitted Date

Jan 8, 2014

First Submission Date that Met QC Criteria

Jan 8, 2014

First Posted Date

Jan 10, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 26, 2016

Last Update Posted Date

Mar 1, 2016Estimated

Name	Class
Pusan National University Yangsan Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. Thus, our group will find the prevalence of colonic neoplasm in the group of cryptogenic pyogenic liver abscess by colonoscopic examination.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

62Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Colonoscopic examination group		The patients diagnosed with cryptogenic pyogenic liver abscess

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The prevalence of colonic neoplasm		within 6 weeks after diagnosis of pyogenic liver abscess

Secondary Outcomes

Measure	Description	Time Frame
Prevalence of colon polyp		Within 6 weeks at diagnosis of pyogenic liver abscess
Prevalence of colonic diverticulitis		Within 6 weeks at diagnosis of pyogenic liver abscess

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pyogenic liver abscess radiologically and bacteriologically diagnosed

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The patients diagnosed as pyogenic liver abscess, the cause of which is not found at initial evaluation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tae Oh Kim, M.D.	Inje University Haeundae Paik Hosptial	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pusan National Unversity Yangsan Hospital		Yangsan	Gyeongsangnam-do		South Korea
Inje University Haeundae Paik Hospital

Condition Browse Module

MeSH Terms

ID	Term
D046290	Liver Abscess, Pyogenic
D003110	Colonic Neoplasms

Ancestor Terms

ID	Term
D008100	Liver Abscess
D018784	Abdominal Abscess
D000038	Abscess
D013492	Suppuration

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Browse Branches

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