Oslo Randomized Laparoscopic Versus Open Liver Resection for Colorectal Metastases Study

Colorectal Neoplasms Clinical Trial

— Oslo-CoMet  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01516710
• Other study ID #: 2011/1285/REK sør-øst B
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2012
• Est. completion date: December 2025

Study information

• Verified date: November 2023
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 280
• Est. completion date: December 2025
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Liver Neoplasms
• Neoplasm Metastasis
• Neoplasms
• Secondary Malignant Neoplasm of Liver

Intervention

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

Locations

Country	Name	City	State
Norway	Oslo University Hospital, Department of Gastrointestinal surgery, The National Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	Helse Sor-Ost

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Within 30 days after surgery
Secondary	5 Year Survival	5 year survival; overall; disease free; recurrence free	5 years after surgery
Secondary	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
Secondary	Immediate Oncologic Outcome	Immediate oncologic outcome is the result of surgical specimen evaluation - evaluation of tumor resection margins.	2 months after surgery
Secondary	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
Secondary	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
Secondary	Health Economy	We intend to compare overall cost of treatment for the hospital and for the health care system	1 year
Secondary	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
Secondary	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
Secondary	Anti-tumor Immunology	The aim is to evaluate immunological parameters related to anti-tumor immunity and inflammatory factors	20 years
Secondary	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
Secondary	Severity of Morbidity	Severity of complications will be assessed by the Comprehensive Complication Index and the Accordion system	30 days
Secondary	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
Secondary	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
Secondary	Readmissions	Readmissions within 30 days after surgery will be recorded, both admissions to Oslo University Hospital and to referring hospitals.	30 days
Secondary	Incidence of Incisional Hernia	CT scans will be performed to examine for incisional hernia 1 year after surgery	1 year