Oslo Randomized Laparoscopic Versus Open Liver Resection for Colorectal Metastases Study

Not Applicable

Active, not recruiting

Conditions: Secondary Malignant Neoplasm of Liver
Colorectal Neoplasms

Interventions: Procedure: Open liver resection
Procedure: Laparoscopic liver resection

Registration Number: NCT01516710

Lead Sponsor: Oslo University Hospital

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

Recruitment & Eligibility

Status: ACTIVE_NOT_RECRUITING

Sex: All

Target Recruitment: 280

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Open liver resection	Open liver resection	Patients will be operated with open liver resection
Laparoscopic liver resection	Laparoscopic liver resection	Patients will be operated with laparoscopic liver resection

Primary Outcome Measures

Name	Time	Method
30 Days Perioperative Morbidity	Within 30 days after surgery	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

Secondary Outcome Measures

Name	Time	Method
5 Year Survival	5 years after surgery	5 year survival * overall * disease free * recurrence free
Recurrence Pattern	5 years	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.
Postoperative Quality of Life	Up to 2 years	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
Health Economy	1 year	We intend to compare overall cost of treatment for the hospital and for the health care system
Molecular Biology	20 years	The aim is to perform molecular characterization of biological samples harvested perioperatively and during follow-up, and to correlate results with clinical end points.
Severity of Morbidity	30 days	Severity of complications will be assessed by the Comprehensive Complication Index and the Accordion system
Number of Patients That Complete Adjuvant Oncologic Treatment	1 year	Time from operation to initiation of oncologic treatment, and the total number of courses given will be recorded and compared between the groups.
Immediate Oncologic Outcome	2 months after surgery	Immediate oncologic outcome is the result of surgical specimen evaluation - evaluation of tumor resection margins.
Readmissions	30 days	Readmissions within 30 days after surgery will be recorded, both admissions to Oslo University Hospital and to referring hospitals.
Incidence of Incisional Hernia	1 year	CT scans will be performed to examine for incisional hernia 1 year after surgery
Surgical Trauma and Activation of the Immune System	72 hours	Evaluation of surgical trauma caused by open and laparoscopic resection by means of analyzing complement and cytokine activation at set perioperative time points.
Severity of Postoperative Pain	4 months	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.
Imaging	5 years	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.
Anti-tumor Immunology	20 years	The aim is to evaluate immunological parameters related to anti-tumor immunity and inflammatory factors
Level of Adhesions	2 years	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.