Liver TumorPL-MILSNCT05516394
National Polish Registry of Minimally Invasive Liver Surgery
An observational study of Liver Tumor, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
After the two consensus meetings on laparoscopic liver resection in Louisville (2008) and in Morioka (2014) minimally invasive approach for liver resection was finally widely established in liver surgery practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Tumor
- What is being tested?
- Laparoscopic liver resection
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jul 2020to 31 Dec 2025
- How long will I take part?
- 3 Years
- 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: Patients who underwent laparoscopic liver resection in Poland
Who may be able to join
- age >18 years
- underwent laparoscopic liver resection
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Department of General, Transplant and Liver Surgery, Medical University of Warsaw
Warsaw
Wacław Hołówko, 0048667667044, waclaw.holowko@wum.edu.pl
About this study
After the two consensus meetings on laparoscopic liver resection in Louisville (2008) and in Morioka (2014) minimally invasive approach for liver resection was finally widely established in liver surgery practice. Successively more countries follow laparoscopic liver pioneers and apply laparoscopic liver surgery for everyday practice.
Primary aim of the study is to assess the evolution and diffusion of minimally invasive liver surgery in Poland. Secondly, it will allow to assess the actual short- and long-term results of laparoscopic liver resections and compare it to the international benchmark values.
Read more
The National Polish Registry of Minimally Invasive Liver Surgery will include data about all cases of laparoscopic liver resections performed in Poland since the first case in 2010. All surgical departments, where laparoscopic liverresection is regularly performed, will be invited. Data of demography, previous medical history, preoperative assessment, intraoperative and postoperative period, histopathological findings and long-term follow-up will be included in the registry.
This study will be the first national report about diffusion of minimally invasive surgery in Poland.
- Conditions
- Liver Tumor
- Being tested
- Laparoscopic liver resection
- Keywords
- laparoscopic liver resection, short-term results, long-term results
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic liver resectionProcedure or surgery
Liver tumors are resected with minimally invasive approach, laparoscopically.
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications
Complications in the postoperative period classified by type and their severity according to the Clavien-Dindo grading system
Measured: 90 days
Secondary outcomes (4)
Patient survival
Measured: 5 years
Postoperative hospital stay
Measured: 1 year
Number of patients scheduled for reoperation after laparoscopic liver resection
Measured: 30 days
Number of patients readmitted to hospital after discharge
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start1 Jul 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver TumorStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Collaborators
- Jagiellonian University, Ludwik Rydygier Memorial Hospital, Cracow, Poland, Regional Oncology Center, Białystok, Poland, Medical University of Lublin, Nicolaus Copernicus university Collegium Medicum, Bydgoszcz, Poland, Medical University of Łódź
- Responsible party
- Principal investigator, Wacław Hołówko, Medical University of Warsaw
- Investigators
- Wacław Hołówko, Principal investigator, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05516394
- Sponsor's protocol ID
- AKBE/71/2020
- Acronym
- PL-MILS
- Status last verified
- Aug 2022
- First submitted
- 1 Aug 2022
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Holowko W, Serednicki W, Bartkowiak M, Wysocki M, Domurat M, Mielko J, Pierscinski S, Hogendorf P, Masior L, Kalinowski P, Wierdak M, Fraczek M, Tarasik A, Wroblewski T, Budzynski A, Pedziwiatr M, Grat M. Early adoption of laparoscopic liver surgery in Poland: a national retrospective cohort study. Int J Surg. 2024 Jan 1;110(1):361-371. doi: 10.1097/JS9.0000000000000840.
PubMed 37816169
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Polish Registry of Minimally Invasive Liver Surgery
- ClinicalTrials.gov ID
- NCT05516394
- Acronym / sponsor ID
- PL-MILS / AKBE/71/2020
- Conditions
- Liver Tumor
- Keywords
- laparoscopic liver resection, short-term results, long-term results
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Collaborators
- Jagiellonian University, Ludwik Rydygier Memorial Hospital, Cracow, Poland, Regional Oncology Center, Białystok, Poland, Medical University of Lublin, Nicolaus Copernicus university Collegium Medicum, Bydgoszcz, Poland, Medical University of Łódź
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 25 Aug 2022 (actual)
- 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.
After the two consensus meetings on laparoscopic liver resection in Louisville (2008) and in Morioka (2014) minimally invasive approach for liver resection was finally widely established in liver surgery practice. Successively more countries follow laparoscopic liver pioneers and apply laparoscopic liver surgery for everyday practice.
Primary aim of the study is to assess the evolution and diffusion of minimally invasive liver surgery in Poland. Secondly, it will allow to assess the actual short- and long-term results of laparoscopic liver resections and compare it to the international benchmark values.
The National Polish Registry of Minimally Invasive Liver Surgery will include data about all cases of laparoscopic liver resections performed in Poland since the first case in 2010. All surgical departments, where laparoscopic liverresection is regularly performed, will be invited. Data of demography, previous medical history, preoperative assessment, intraoperative and postoperative period, histopathological findings and long-term follow-up will be included in the registry.
This study will be the first national report about diffusion of minimally invasive surgery in Poland.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent laparoscopic liver resection in Poland
Key inclusion criteria (2 listed)
- age >18 years
- underwent laparoscopic liver resection
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic liver resectionLiver tumors are resected with minimally invasive approach, laparoscopically. | Procedure or surgery | – |
Primary outcome
Postoperative complications
Time frame: 90 days
Complications in the postoperative period classified by type and their severity according to the Clavien-Dindo grading system
4 secondary outcomes
Patient survival
Time frame: 5 years
Postoperative hospital stay
Time frame: 1 year
Number of patients scheduled for reoperation after laparoscopic liver resection
Time frame: 30 days
Number of patients readmitted to hospital after discharge
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
- Derived from this study: PubMed 37816169Holowko W, Serednicki W, Bartkowiak M, Wysocki M, Domurat M, Mielko J, Pierscinski S, Hogendorf P, Masior L, Kalinowski P, Wierdak M, Fraczek M, Tarasik A, Wroblewski T, Budzynski A, Pedziwiatr M, Grat M. Early adoption of laparoscopic liver surgery in Poland: a national retrospective cohort study. Int J Surg. 2024 Jan 1;110(1):361-371. doi: 10.1097/JS9.0000000000000840.
- Individual participant dataSharing planned: Undecided
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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.
Wacław Hołówko principal investigator
Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Tumor, run by Medical University of Warsaw at 1 site in Poland.
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 2 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wacław Hołówko (0048667667044, waclaw.holowko@wum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative complications (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05516394, which also lists 1 linked publication.
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 25 Aug 2022.