Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Hemorrhage

Liver Neoplasms

Pneumoperitoneum

Peritoneal Diseases

Gastrointestinal Diseases

Hematinics

All Drugs and Chemicals

Liver Extracts

Laparoscopic liver resection performed in standard (14mmHg) pneumoperitoneum pressure

Laparoscopic liver resection performed in low (10mmHg) pneumoperitoneum pressure

Performing surgery in 14mmHg pneumoperitoneum pressure

Pneumoperitoneum 14mmHg

Performing surgery in 10mmHg pneumoperitoneum pressure

Pneumoperitoneum 10mmHg

Wacław Hołówko, MD, PhD

Wacław Hołówko

Commonly the pressure of about 14 mmHg is applied during laparoscopic liver resection (LLR) with moderate neuromuscular blockade. Lowering the pneumoperitoneum pressure combined with deep neuromuscular blockade may sustain optimal operating space with providing better short-term postoperative results. It has been proved in randomized controlled trials in colorectal or bariatric patients, however there is lack of similar data for laparoscopic liver resection. Doubts about lowering the pneumoperitoneum pressure too hasty are supported by apprehension of worse bleeding control during liver parenchyma transection and its impact on postoperative results.

The aim of the trial is to assess the impact of standard (14 mmHg; arm 1) versus low (10 mmHg; arm 2) pneumoperitoneum pressure on intraoperative blood loss, what will be the primary outcome. As secondary endpoints following outcomes will be measured: quality of operating space, intraoperative adverse events, quality of recovery, postoperative renal function, 30-day postoperative complications rate, length of hospital stay. The investigators assume that lower pneumoperitoneum provides non-inferior blood loss control during laparoscopic liver resection with better postoperative results.

After signing the informed consent patients will be randomized into 2 groups. Randomization will be conducted by investigators via drawing a sealed envelope with computer-generated intervention code at the Department just before patient transfer to the operating theatre. There will be two study arms with 1:1 fashion

For both trial arms additional routine elements of perioperative anesthesia care will be defined:

* low central vein pressure, aimed for 5 ± 2 mmHg with restrictive fluid therapy
* ventilation in a volume-controlled mode without intraoperative high positive end-expiratory pressure (PEEP)
* invasive arterial blood pressure monitoring with maintaining mean arterial pressure ≥ 60 mmHg
* maintaining hemoglobin concentration \> 8g/dl
* maintaining normothermia and normoglycemia
* maintaining oxygenation \>94%, in case of hypercapnia with respiratory acidosis, the respiratory rate and tidal volume will be stepwise increased

The surgeon will be blinded to the study arm and level of pneumoperitoneum pressure.

The blood loss during liver parenchyma transection and total procedure blood loss will be reported based on the amount of sucked outside intraperitoneal fluids after liver transection and after procedure without volume inserted for intraperitoneal irrigation. The estimated blood loss will be measured in milliliters. Patients who are converted to open surgery are excluded from the analysis of the primary end-point.

During the procedure, the surgeon will be asked regularly to rate the quality of operating space in accordance to the Leiden Surgical Rating Scale. In case of inadequate operating space, pneumoperitoneum pressure may be increased by 2 mmHg (with maximum of 16 mmHg in arm 1. and 12 mmHg in arm 2.). Intraoperative adverse events will be assessed in accordance to ClassIntra classification. Quality of recovery (QoR) will be measured on postoperative day 1, 3 and 5 with patient reported QoR-40 questionnaire, 30-day postoperative complication rate will be assessed in accordance to Clavien-Dindo classification. Length of hospital stay will be counted from the date of surgery to the discharge day. All patients will be followed up by researchers who are blinded to the intraoperative grouping.

Intraoperative Blood Loss Under Standard Versus Low Pneumoperitoneum Pressure During Laparoscopic Liver Resection.

Intraoperative Blood Loss Under Standard Versus Low Pneumoperitoneum Pressure During Laparoscopic Liver Resection: Study Protocol for a Randomized Controlled Trial

Expressed in accordance to Leiden scale (L-SRS) and the rate of need for increase of pneumoperitoneum pressure

Score 1-5 (where 1 means extremely poor conditions; 5- optimal conditions)

From multiple measurements, value submitted for analysis will be the lowest reported during the surgery.

Expressed in accordance to ClassIntra scale

Grades 0-V (where 0 means no deviation; V- intraoperative death of the patient)

Expressed in accordance to questionaire QoR-40

40 questions with 1-5 points each (total score minimum 40 points; maximum 200 points)

Expressed in accordance to Clavien-Dindo classification in 30-day postoperative period

Jagiellonian University

Regional Oncology Center, Białystok, Poland

Medical University of Warsaw

Principal Investigator

Gastrointestinal Neoplasms

Digestive System Neoplasms

Liver Diseases

Liver tumors are resected with minimally invasive approach, laparoscopically.

Laparoscopic liver resection

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.

National Polish Registry of Minimally Invasive Liver Surgery

Complications in the postoperative period classified by type and their severity according to the Clavien-Dindo grading system

Ludwik Rydygier Memorial Hospital, Cracow, Poland

Medical University of Lublin

Nicolaus Copernicus university Collegium Medicum, Bydgoszcz, Poland

Medical University of Łódź

Neoplasm Metastasis

Neoplastic Processes

Liver resection performed by laparoscopic approach

Liver resection performed by open approach

The investigators perform an anatomical liver resections or wedge resections depending on tumour's location and tumour's characteristics

Liver resection

Ricardo Robles Campos, MD; PHD

This study evaluates the feasibility of laparoscopic surgery in patients diagnosed with colorectal liver metastases. Half of participants will be operated on by laparoscopic approach and the results obtained will be compared with the results from the other half of patients operated on by open approach.

The safety and efficacy of liver surgery in the treatment of colorectal liver metastases are well established for the open approach. It allows good results in terms of complications, disease free survival and overall survival, and for these reasons it has become the gold standard technique in the treatment of colorectal liver metastases.

On the contrary, the role of laparoscopic liver resection in this context is not so clear nowadays. Generally, laparoscopic surgery offers some advantages such as less pain, shorter hospital stay and better aesthetic results. But the use of laparoscopic approach in liver surgery is still discussing: two international consensus conferences have been held and no strong conclusions have been made. Furthermore for colorectal liver metastases no randomized trials, comparing both techniques, have been published until now.

To assess the feasibility of laparoscopic liver resection for colorectal metastases, the investigators propose this trial in which the patients suitable for laparoscopic approach are randomized to open or laparoscopic group

Open vs Laparoscopic Liver Surgery for Colorectal Liver Metastases

Prospective and Randomized Study Comparing Open vs Laparoscopic Liver Surgery for Colorectal Liver Metastases

Number of blood transfusions required during surgical operation

Days between surgical operation and hospital discharge

Days between surgical operation and the beginning of adjuvant chemotherapy

Hospital Universitario Virgen de la Arrixaca

MD, PHD

Laparoscopic liver resection (LLR) has gained acceptance as an effective treatment for colorectal liver metastases (CRLM) in selected patients, providing similar oncologic outcomes compared to open liver resection (OLR). A single-center retrospective analysis of a prospectively maintained database was performed. The primary aim of this study was to determine prognostic factors for the survival outcomes associated with LLR for CRLM.

LLR was defined as pure LLR, including conversions to OLR. In case of missing data, additional details were retrieved from the individual patient file. Data on patient demographics, timing of diagnosis, neoadjuvant chemotherapy (NAC), tumor characteristics (both primary tumor and CRLM), histopathology, molecular characteristics, operative technique (including classification into anatomically major/technically major/minor LR), intra- and postoperative course, adjuvant chemotherapy (AC) as well as oncological outcomes (OS and DFS) were gathered and analyzed. Postoperative complications were graded according to the Clavien-Dindo classification. Complications were classified as major in case of Clavien-Dindo ≥ 3A.

Prognostic Factors and Oncological Outcomes in Laparoscopic Liver Resection for CRLM

Laparoscopic Liver Resection for Colorectal Liver Metastases: Retrospective Analysis of Prognostic Factors and Oncological Outcomes in a Single-center Cohort

Overall and disease-free survival (Kaplan-Meier method)

Univariate Cox proportional-hazards regression analysis

General Hospital Groeninge

Dr Mathieu D'Hondt, Principal Investigator

Nutritional and Metabolic Diseases

Rare Diseases

Overweight

Obesity

Fatty Liver

Visceral Steatosis

Non-obese or obese patients that underwent an open liver resection for all indications

Non-obese or obese patients that underwent a minimally invasive liver resection for all indications

A liver resection performed by minimally invasive (keyhole) surgery

Minimally invasive liver resection

Despite the worldwide increase of both obesity and use of minimally invasive liver surgery(MILS), evidence regarding the safety and eventual benefits of MILS in obese patients is scarce. The aim of this study is therefore to compare the outcomes of non-obese and obese patients(BMI 18.5-29.9 and BMI≥30, respectively) undergoing MILS and OLS, and to assess trends in MILS use among obese patients. In this retrospective cohort study, patients operated at 20 hospitals in eight countries(2009-2019) will be included and the characteristics and outcomes of non-obese and obese patients will be compared. Thereafter, the outcomes of MILS and OLS were compared in both groups after propensity-score matching(PSM). Changes in the adoption of MILS during the study period will be investigated.

Impact of Minimally Invasive and Open Liver Surgery in Different BMI-classes

Indications, Trends, and Perioperative Outcomes of Minimally Invasive and Open Liver Surgery in Non-obese and Obese Patients: an International Multicentre Propensity Score Matched Retrospective Cohort Study of 9963 Patients.

The data of this study will be available from the corresponding author, Professor Mohammed Abu Hilal, upon reasonable request. The data are not publicly available since this could compromise the privacy of research participants.

Severe complications (Clavien-Dindo grade 3a or higher) related to the surgical procedure

Overall complications related to the surgical procedure

The length of hospital stay for the surgical procedure

Proportion of patients in whom a microscopically radical resection of both the primary colorectal carcinoma and the liver metastases was performed.

Proportion of patients in whom a microscopically radical resection was performed

Intra-operative conversion to an open or hand-assisted procedure in the minimally invasive group

Occurrence of post-hepatectomy liver failure (ISGLS definition and classification)

Occurrence of bile leak (ISGLS definition and classification)

Intraoperative red blood cell transfusion

Amsterdam UMC location University of Amsterdam, Amsterdam, the Netherlands

The Queen Elizabeth Hospital

Umberto I Mauriziano Hospital, Turin, Italy

Oslo University Hospital and Institute of Medicine, University of Oslo, Oslo, Norway

Padua University Hospital, Padua, Italy

IRCCS San Raffaele Hospital, Milan, Italy

Hospital Doctor Josep Trueta de Girona, Girona, Catalonia, Spain

Clinica Universidad de Navarra, Pamplona, Spain

Institut Mutualiste Montsouris, Université Paris Descartes, Paris, France

Groeninge Hospital, Kortrijk, Belgium

University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom

Riuniti Hospital, Polytechnic University of Marche, Ancona, Italy

University of Verona, Verona, Italy

Virginia Mason Medical Center, Seattle, USA

University of California San Francisco, California, USA

Moscow Clinical Research Centre, Moscow, Russia

Università Cattolica del Sacro Cuore-IRCCS, Rome, Italy

Antoine Béclère Hospital, Paris, France

IRCCS Azienda Ospedaliero-Universitaria di Bologna

University of Modena and Reggio Emilia, Modena, Italy

Fondazione Poliambulanza Istituto Ospedaliero

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Patients will be operated with open liver resection

Patients will be operated with laparoscopic liver resection

Patients will be operated with open liver resection for colorectal metastasis

Open liver resection

Bjørn Edwin, MD, PhD

Bjorn Edwin, MD, PhD

The purpose of the study is to compare outcomes of laparoscopic versus open liver resection for colorectal metastases in a prospective and randomized study. The study will include all non-anatomic liver resections in our institution.

The primary end point is that the use of laparoscopic technique significantly can reduce the frequency of complications to liver resection. Secondary end points are 5-year survival, immediate surgical outcomes, quality of life and degree of impairment of the immune system.

Full protocol is published open access in Trialsjournal:

http://www.trialsjournal.com/content/16/1/73

Oslo Randomized Laparoscopic Versus Open Liver Resection for Colorectal Metastases Study

Prospective Randomized Study of Laparoscopic Versus Open Liver Resection for Colorectal Metastases

Not decided yet but results will be public no matter the outcome of the trial

This study aims to compare major intraoperative and postoperative parameters in patients randomized to either laparoscopic or open liver resection. Pre- and perioperative events relevant for surgical outcomes will be registered. The following intraoperative parameters will be compared: operative time, blood loss, blood transfusion, while intraoperative incidents will be classified according to the Satava classification. Morbidity within the first 30 days is the primary outcome (morbidity, yes/no), and will be classified and analysed according to the validated classification for postoperative morbidity as described by Dindo et al, by the Accordion system and by the Comprehensive Complication Index

5 year survival

* overall
* disease free
* recurrence free

Pattern of recurrence in liver and extrahepatic. Studied by postoperative CT every 4 months for 2 years and every 6 months for the following 3 years. Local recurrence and new tumors will be recorded.

Immediate oncologic outcome is the result of surgical specimen evaluation - evaluation of tumor resection margins.

Evaluation of postoperative quality of life at baseline, 1 month, 4 months and 2 years using the SF-36 and the EORTC qlq-30 lmc-21 forms

Evaluation of surgical trauma caused by open and laparoscopic resection by means of analyzing complement and cytokine activation at set perioperative time points.

We intend to compare overall cost of treatment for the hospital and for the health care system

To compare pain the first 5 postoperative days, at 1 month and 4 months. Patients in the open group will be randomized to receiving either a patient controlled analgesic pump containing opioids, or a patient controlled epidural analgesic pump. In laparoscopic group all patients will receive a PCA.

The aim is to perform molecular characterization of biological samples harvested perioperatively and during follow-up, and to correlate results with clinical end points.

The aim is to evaluate immunological parameters related to anti-tumor immunity and inflammatory factors

The aim is to evaluate two new imaging methods, CT perfusion of liver and LIME-PET, in order to optimize the preoperative identification of colorectal liver metastases.

Severity of complications will be assessed by the Comprehensive Complication Index and the Accordion system

Level of adhesions will be recorded during repeated liver resection in patients formerly randomized to open or laparoscopic liver resection. a modified version of the peritoneal adhesion index will be used for scoring.

Time from operation to initiation of oncologic treatment, and the total number of courses given will be recorded and compared between the groups.

Readmissions within 30 days after surgery will be recorded, both admissions to Oslo University Hospital and to referring hospitals.

CT scans will be performed to examine for incisional hernia 1 year after surgery

Helse Sor-Ost

Oslo University Hospital

Adverse events were systematically collected using the Accordion system

Patients will be operated with open liver resection

Open liver resection: Patients will be operated with open liver resection for colorectal metastasis

Open Liver Resection

Patients will be operated with laparoscopic liver resection

Laparoscopic liver resection: Patients will be operated with laparoscopic liver resection

Laparoscopic Liver Resection

Total

Age, Continuous

Sex: Female, Male

Norway

Region of Enrollment

A total of 280 patients were enrolled. Only 273 underwent surgery, and only these could reach the primary endpoint of 30 days morbidity. This is why there is a difference between baseline and analyzed for the primary endpoint.

Dr. Aasmund A. Fretland

30 Days Perioperative Morbidity

5 Year Survival

Recurrence Pattern

Immediate Oncologic Outcome

Postoperative Quality of Life

Surgical Trauma and Activation of the Immune System

Health Economy

Severity of Postoperative Pain

Molecular Biology

Anti-tumor Immunology

Imaging

Severity of Morbidity

Level of Adhesions

Number of Patients That Complete Adjuvant Oncologic Treatment

Readmissions

Incidence of Incisional Hernia

Overall Study

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

participants will be performed with laparoscopic hepatectomy using laparoscopic instruments

participants will be performed with open hepatectomy using laparotomic instruments

Xiujun Cai, MD

Renan Jin, MS

The purpose of this study is to investigate the clinical value of laparoscopic liver resection in the treatment of hepatocellular carcinoma by assessing its Surgical and oncologic outcomes comparing with open liver resection.

Laparoscopic Versus Open Liver Resection in the Treatment of Hepatocellular Carcinoma

A Randomized Controlled Trial of Laparoscopic Versus Open Liver Resection in the Treatment of Hepatocellular Carcinoma

Regulatory T cells and associated cytokines in peripheral blood will be tested 1day before operation,5 days, 3,6 months and 1,3,5 years after operation

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Intraoperative Blood Loss Under Standard Versus Low Pneumoperitoneum Pressure During Laparoscopic Liver Resection.	NCT06060899	Liver Tumor	Pneumoperitoneu... Pneumoperitoneu...	18 Years - 80 Years	Medical University of Warsaw
National Polish Registry of Minimally Invasive Liver Surgery	NCT05516394	Liver Tumor	Laparoscopic li...	18 Years -	Medical University of Warsaw
Open vs Laparoscopic Liver Surgery for Colorectal Liver Metastases	NCT02727179	Colorectal Live... Laparoscopic Li...	Liver resection	18 Years -	Hospital Universitario Virgen de la Arrixaca
Prognostic Factors and Oncological Outcomes in Laparoscopic Liver Resection for CRLM	NCT05036265	Colorectal Canc... Liver Metastase... Surgery		-	General Hospital Groeninge
Impact of Minimally Invasive and Open Liver Surgery in Different BMI-classes	NCT05475054	Liver Cancer Liver Metastase... Obesity	Minimally invas...	18 Years -	Fondazione Poliambulanza Istituto Ospedaliero
Oslo Randomized Laparoscopic Versus Open Liver Resection for Colorectal Metastases Study	NCT01516710	Secondary Malig... Colorectal Neop...	Open liver rese... Laparoscopic li...	18 Years -	Oslo University Hospital
Impact of Minimally Invasive and Open Liver Surgery in Different BMI-classes	NCT05475054	Liver Cancer Liver Metastase... Obesity	Minimally invas...	18 Years -	Fondazione Poliambulanza Istituto Ospedaliero
Laparoscopic Versus Open Liver Resection in the Treatment of Hepatocellular Carcinoma	NCT01768741	Hepatocellular ...	Laparoscopic li... Open liver rese...	18 Years - 70 Years	Sir Run Run Shaw Hospital

Spots Global Cancer Trial Database for laparoscopic liver resection