Neoplasms

Symptoms and General Pathology

All Conditions

Digestive System Diseases

Neoplasm Metastasis

Colorectal Neoplasms

Liver Neoplasms

Neoplastic Processes

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Liver Diseases

Hematinics

All Drugs and Chemicals

Liver Extracts

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.

Spots Global Cancer Trial Database for Oslo Randomized Laparoscopic Versus Open Liver Resection for Colorectal Metastases Study

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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