Oslo Randomized Laparoscopic Versus Open Liver Resection for Colorectal Metastases Study

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 Title of Study: “Prospective Randomized Study of Laparoscopic Versus Open Liver Resection for Colorectal Metastases”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: April 2016

Detailed Description

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

Interventions

  • Procedure: Open liver resection
    • Patients will be operated with open liver resection for colorectal metastasis
  • Procedure: Laparoscopic liver resection
    • Patients will be operated with laparoscopic liver resection

Arms, Groups and Cohorts

  • Active Comparator: Open liver resection
    • Patients will be operated with open liver resection
  • Active Comparator: Laparoscopic liver resection
    • Patients will be operated with laparoscopic liver resection

Clinical Trial Outcome Measures

Primary Measures

  • Perioperative morbidity
    • Time Frame: 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 Measures

  • 5 year survival
    • Time Frame: 5 years after surgery
    • 5 year survival overall disease free recurrence free
  • Recurrence pattern
    • Time Frame: 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.
  • Immediate oncologic outcome
    • Time Frame: 2 months after surgery
    • Immediate oncologic outcome is the result of surgical specimen evaluation – evaluation of tumor resection margins.
  • Postoperative quality of life
    • Time Frame: 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
  • Surgical trauma and activation of the immune system
    • Time Frame: 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.
  • Health economy
    • Time Frame: 1 year
    • We intend to compare overall cost of treatment for the hospital and for the health care system
  • Severity of postoperative pain
    • Time Frame: 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.
  • Molecular biology
    • Time Frame: 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.
  • Anti-tumor immunology
    • Time Frame: 20 years
    • The aim is to evaluate immunological parameters related to anti-tumor immunity and inflammatory factors
  • Imaging
    • Time Frame: 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.
  • Severity of morbidity
    • Time Frame: 30 days
    • Severity of complications will be assessed by the Comprehensive Complication Index and the Accordion system
  • Level of adhesions
    • Time Frame: 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.
  • Number of patients that complete adjuvant oncologic treatment
    • Time Frame: 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.
  • Readmissions
    • Time Frame: 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
    • Time Frame: 1 year
    • CT scans will be performed to examine for incisional hernia 1 year after surgery

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Oslo University Hospital
  • Collaborator
    • Helse Sor-Ost
  • Provider of Information About this Clinical Study
    • Principal Investigator: Åsmund Avdem Fretland, MD – Oslo University Hospital
  • Overall Official(s)
    • Bjørn Edwin, MD, PhD, Study Chair, Oslo University Hospital – The Interventional Centre
    • Bjorn Edwin, MD, PhD, Principal Investigator, Oslo University Hospital – The Interventional Centre

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