Oslo Randomized Laparoscopic Versus Open Liver Resection for Colorectal Metastases Study

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
Full protocol is published open access in Trialsjournal: http://www.trialsjournal.com/content/16/1/73

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

Conditions
-----------------
Secondary Malignant Neoplasm of Liver, Colorectal Neoplasms

Intervention / Treatment
-----------------
* Procedure: Open liver resection
* Procedure: Laparoscopic liver resection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients eligible for radical liver resection without formal liver resection or without assistance of radiofrequency ablation Exclusion Criteria: Inability to give written informed concent Patients with tumors that can't be resected without reconstruction of vessels or bile ducts Patients with tumors that can't be resected without 1)formal liver resection 2)combination with radiofrequency ablation Patients with extrahepatic metastasis except resectable metastasis in lungs and adrenals Pre- and peroperative diagnosis of non radically treatable disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Open liver resection<br>Patients will be operated with open liver resection | Procedure: Open liver resection<br>* Patients will be operated with open liver resection for colorectal metastasis<br>* Other names: Ultrasound;|
| Active Comparator: Laparoscopic liver resection<br>Patients will be operated with laparoscopic liver resection | Procedure: Laparoscopic liver resection<br>* Patients will be operated with laparoscopic liver resection<br>* Other names: Laparoscopic ultrasound;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative morbidity | 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 | Within 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5 year survival | 5 year survival overall disease free recurrence free | 5 years after surgery | 
| Recurrence pattern | 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. | 5 years | 
| Immediate oncologic outcome | Immediate oncologic outcome is the result of surgical specimen evaluation - evaluation of tumor resection margins. | 2 months after surgery | 
| Postoperative quality of life | 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 | Up to 2 years | 
| Surgical trauma and activation of the immune system | Evaluation of surgical trauma caused by open and laparoscopic resection by means of analyzing complement and cytokine activation at set perioperative time points. | 72 hours | 
| Health economy | We intend to compare overall cost of treatment for the hospital and for the health care system | 1 year | 
| Severity of postoperative pain | 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. | 4 months | 
| Molecular biology | The aim is to perform molecular characterization of biological samples harvested perioperatively and during follow-up, and to correlate results with clinical end points. | 20 years | 
| Anti-tumor immunology | The aim is to evaluate immunological parameters related to anti-tumor immunity and inflammatory factors | 20 years | 
| Imaging | 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. | 5 years | 
| Severity of morbidity | Severity of complications will be assessed by the Comprehensive Complication Index and the Accordion system | 30 days | 
| Level of adhesions | 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. | 2 years | 
| Number of patients that complete adjuvant oncologic treatment | Time from operation to initiation of oncologic treatment, and the total number of courses given will be recorded and compared between the groups. | 1 year | 
| Readmissions | Readmissions within 30 days after surgery will be recorded, both admissions to Oslo University Hospital and to referring hospitals. | 30 days | 
| Incidence of incisional hernia | CT scans will be performed to examine for incisional hernia 1 year after surgery | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Open liver resection, Laparoscopic liver resection, Colorectal cancer liver metastases