A nationwide cohort study on benign liver tumors and cysts in the Netherlands
Recruiting
- Conditions
- Solid lesionsFocal nodular hyperplasiaHaemangiomaHepatocellular adenomaHepatic haemangioendotheliomaCystic lesionsSimple hepatic cystsMucinous cystic neoplasm of the liver and biliary system Intraductal papillary neoplasms of the liver and bile ducts
- Registration Number
- NL-OMON20812
- Lead Sponsor
- /a
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 450
Inclusion Criteria
Adult patients (>18 years old) presenting with a common and/or clinically relevant BLTC at participating centers are eligible for inclusion. Clinically relevant BLTCs are defined as all BLTCs potentially eligible for either surgical intervention or follow-up.
Exclusion Criteria
- Age < 18 years
- Unable to fill in questionnaires
- Unable to comprehend the Dutch language sufficiently
- Severe quality of life impairment by alternate pathology
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in PROs including severity of symptoms from the start compared to the end of the follow-up period.<br>PROs: anxiety, fatigue, ability to participate and pain interference using computerized adaptive testing through the Dutch-Flemish Patient-Reported Outcomes Measurement Information System (PROMIS), numerical rating scales for pain (current and most, least, and average pain over a week) and two general health and quality of life questions
- Secondary Outcome Measures
Name Time Method Surgical outcomes & tumor specific complications