Nutritional and Metabolic Diseases

Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Rare Diseases

Overweight

Obesity

Neoplasm Metastasis

Fatty Liver

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Visceral Steatosis

Hematinics

All Drugs and Chemicals

Liver Extracts

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

Neoplastic Processes

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

Laparoscopic 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
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 open liver resection