Oslo Randomized Laparoscopic Versus Open Liver Resection for Colorectal Metastases Study

NCT01516710 | Unknown Results

• 1 other identifier: 2011/1285/REK sør-øst B
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

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.

Conditions

Secondary Malignant Neoplasm of Liver; Colorectal Neoplasms

Keywords

Open liver resection; Laparoscopic liver resection; Colorectal cancer liver metastases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• 5 Year Survival

  5 years after surgery

• Recurrence Pattern

  5 years

• Immediate Oncologic Outcome

  2 months after surgery

• Postoperative Quality of Life

  Up to 2 years

• Surgical Trauma and Activation of the Immune System

  72 hours

Study Arms (2)

Open liver resection

ACTIVE COMPARATOR

Patients will be operated with open liver resection

Procedure: Open liver resection

Laparoscopic liver resection

ACTIVE COMPARATOR

Patients will be operated with laparoscopic liver resection

Procedure: Laparoscopic liver resection

Interventions

Open liver resection PROCEDURE

Patients will be operated with open liver resection for colorectal metastasis

Also known as: Open liver resection using standard technique:, Ligasure, CUSA, Thunderbeat, Autosonix, SonoSurg, Ultrasound

Open liver resection

Laparoscopic liver resection PROCEDURE

Patients will be operated with laparoscopic liver resection

Also known as: Laparoscopic liver resection using standardized technique:, Ligasure, CUSA, Thunderbeat, Autosonix, SonoSurg, Laparoscopic ultrasound

Laparoscopic liver resection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients eligible for radical liver resection without formal liver resection or without assistance of radiofrequency ablation

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead
• Helse Sor-Ost: collaborator

Study Sites (1)

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

Oslo, 0424, Norway

Location

Related Publications (3)

• Aghayan DL, Kazaryan AM, Dagenborg VJ, Rosok BI, Fagerland MW, Waaler Bjornelv GM, Kristiansen R, Flatmark K, Fretland AA, Edwin B; OSLO-COMET Survival Study Collaborators. Long-Term Oncologic Outcomes After Laparoscopic Versus Open Resection for Colorectal Liver Metastases : A Randomized Trial. Ann Intern Med. 2021 Feb;174(2):175-182. doi: 10.7326/M20-4011. Epub 2020 Nov 17.

  PMID: 33197213 DERIVED

• Fretland AA, Dagenborg VJ, Waaler Bjornelv GM, Aghayan DL, Kazaryan AM, Barkhatov L, Kristiansen R, Fagerland MW, Edwin B, Andersen MH. Quality of life from a randomized trial of laparoscopic or open liver resection for colorectal liver metastases. Br J Surg. 2019 Sep;106(10):1372-1380. doi: 10.1002/bjs.11227. Epub 2019 Jul 19.

  PMID: 31322735 DERIVED

• Fretland AA, Kazaryan AM, Bjornbeth BA, Flatmark K, Andersen MH, Tonnessen TI, Bjornelv GM, Fagerland MW, Kristiansen R, Oyri K, Edwin B. Open versus laparoscopic liver resection for colorectal liver metastases (the Oslo-CoMet Study): study protocol for a randomized controlled trial. Trials. 2015 Mar 4;16:73. doi: 10.1186/s13063-015-0577-5.

  PMID: 25872027 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Results Point of Contact

• Title: Dr. Aasmund A. Fretland
• Organization: Oslo University Hospital

aafret@ous-hf.no

004723070100

Study Officials

• Bjørn Edwin, MD, PhD

  Oslo University Hospital - The Interventional Centre

  STUDY CHAIR

• Bjorn Edwin, MD, PhD

  Oslo University Hospital - The Interventional Centre

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 13, 2012
• First Posted: January 25, 2012
• Study Start: January 1, 2012
• Primary Completion: April 1, 2016
• Study Completion: December 1, 2025
• Last Updated: May 10, 2024
• Results First Posted: May 10, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share

Locations

NO (1)