National Polish Registry of Minimally Invasive Liver Surgery

Liver Tumor Clinical Trial

— PL-MILS  

Official title:

National Polish Registry of Minimally Invasive Liver Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05516394
• Other study ID #: AKBE/71/2020
• Status: Recruiting
• Start date: July 1, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: August 2022
• Source: Medical University of Warsaw
• Contact: Waclaw Holówko
• Phone: 0048667667044
• Email: waclaw.holowko[@]wum.edu.pl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age >18 years

• underwent laparoscopic liver resection

Related Conditions & MeSH terms

• Liver Neoplasms
• Liver Tumor

Intervention

Procedure:
• Laparoscopic liver resection
Liver tumors are resected with minimally invasive approach, laparoscopically.

Locations

Country	Name	City	State
Poland	Department of General, Transplant and Liver Surgery, Medical University of Warsaw	Warsaw

Sponsors (7)

Lead Sponsor	Collaborator
Medical University of Warsaw	Jagiellonian University, Ludwik Rydygier Memorial Hospital, Cracow, Poland, Medical University of Lódz, Medical University of Lublin, Nicolaus Copernicus university Collegium Medicum, Bydgoszcz, Poland, Regional Oncology Center, Bialystok, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative complications	Complications in the postoperative period classified by type and their severity according to the Clavien-Dindo grading system	90 days
Secondary	Patient survival		5 years
Secondary	Postoperative hospital stay		1 year
Secondary	Number of patients scheduled for reoperation after laparoscopic liver resection		30 days
Secondary	Number of patients readmitted to hospital after discharge		30 days