Oslo Randomized Laparoscopic Versus Open Liver Resection for Colorectal Metastases Study

Oslo University Hospital280 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

280

Conditions

Secondary Malignant Neoplasm of Liver Colorectal Neoplasms

Interventions

Open liver resectionPROCEDURE

Patients will be operated with open liver resection for colorectal metastasis

Laparoscopic liver resectionPROCEDURE

Patients will be operated with laparoscopic liver resection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Oslo University Hospital, Department of Gastrointestinal surgery, The National Hospital

Oslo, Norway

Outcomes

Primary Outcomes

30 Days 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

Time frame: Within 30 days after surgery

Secondary Outcomes

5 Year Survival

5 year survival * overall * disease free * recurrence free

Time frame: 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.

Time frame: 5 years

Immediate Oncologic Outcome

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

Time frame: 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

Time frame: 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.

Data from ClinicalTrials.gov

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