A nationwide cohort study on benign liver tumors and cysts in the Netherlands

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON20812

Enrollment

450

Registered

2019-12-10

Start date

2020-10-01

Completion date

Unknown

Last updated

2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid lesions Focal nodular hyperplasia Haemangioma Hepatocellular adenoma Hepatic haemangioendothelioma Cystic lesions Simple hepatic cysts Mucinous cystic neoplasm of the liver and biliary system Intraductal papillary neoplasms of the liver and bile ducts

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Change in PROs including severity of symptoms from the start compared to the end of the follow-up period. 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	—

Measure

Time frame

Change in PROs including severity of symptoms from the start compared to the end of the follow-up period. 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

Measure	Time frame
Surgical outcomes & tumor specific complications	—

Contacts

Public ContactAlicia Furumaya

Department of Surgery, Amsterdam UMC Location AMC

020 566 9111

Outcome results