Benign liver tumors and cysts carry a significant burden on the quality of life in some cases. Apart from impairing symptoms, psychological burden might provide sufficient ground for surgical intervention. There is a variable approach to them…
ID
Source
Brief title
Condition
- Hepatic and biliary neoplasms benign
Health condition
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
Research involving
Sponsors and support
Intervention
- Other intervention
Outcome measures
Primary outcome
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 outcome
Surgical outcomes & tumor specific complications
Background summary
Benign liver tumours and cysts (BLTCs) comprise a heterogeneous group of cystic and solid lesions, including hepatic hemangioma, focal nodular hyperplasia and hepatocellular adenoma. Some BLTCs, for example (large) hepatocellular adenoma, are at risk of complications. Incidence of malignant degeneration or hemorrhage is low in most other BLTCs. Nevertheless, the diagnosis BLTC may carry a substantial burden and patients may be symptomatic, necessitating treatment. The indications for interventions remain matter of debate. The primary study aim is to investigate patient reported outcomes (PROs) of patients with BLTCs, with special regard to the influence of invasive treatment as compared to the natural course of the disease.
Study objective
Benign liver tumors and cysts carry a significant burden on the quality of life in some cases. Apart from impairing symptoms, psychological burden might provide sufficient ground for surgical intervention. There is a variable approach to them throughout the country, but surgical outcomes are comparable.
Study design
Questionnaire biannually, or if (minimally invasive) intervention occurs at 3, 6 and 12 months postoperatively. Study period October 2021-October 2026, minimal follow-up 2 years
Intervention
N/a
Alicia Furumaya
020 566 9111
Alicia Furumaya
Department of Surgery, Amsterdam UMC Location AMC
020 566 9111
Age
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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8231 |
| Other | METc AMC & METc UMCG : AMC:W19_134 # 19.167 UMCG: 201900292 (2019-269) |