Minimally Invasive or Open Surgery for Lung Cancer: Pain, Quality of Life and Economy. (PLEACE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Odense University Hospital
Sponsor:
Information provided by (Responsible Party):
Peter B Licht, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01278888
First received: January 14, 2011
Last updated: January 2, 2014
Last verified: January 2014
  Purpose

Is thoracoscopic surgery better than traditional open surgery for lung cancer?

Video assisted thoracoscopic surgery for lung cancer (VATS) is presumed to be less traumatic than traditional open surgery for lung cancer but this has never been documented in a randomized trial. Some surgeons hesitate to use VATS because it is technically more demanding, others question if the two methods are oncologically equal. Regardless, VATS has been implemented as a routine method for lung cancer surgery several places around the world including Odense University Hospital. The investigators have launched the first randomized controlled trial in the world comparing the two surgical methods to investigate any differences in length of hospitalization, postoperative pain, life quality within the first year, and health economical aspects.

The investigators include patients with stage I and II lung cancer, and randomize between VATS and open surgery in a design where both the patient and doctors doing general rounds in the ward are blinded until discharge because the dressing on the surgical wound is identical, regardless of the surgical method. The surgeon cannot influence clinical decisions including time to discharge, which is decided by other specialist surgeons. Pain evaluation is performed 6 times daily using the VAS-score, life quality is evaluated continuously during the first 12 months using EQ5D and EORTC QLQC-30 questionnaires, and the consumption of analgetics in both groups are monitored via the national prescription database.

Parallel to this trial a similar clinical study, which is also the first of its kind in the world, has been launched for patients with lung cancers not eligible for VATS. They are randomized between the two traditional open surgical methods (anterolateral and posterolateral thoracotomy) - this is also blinded to both patient and doctors doing rounds until discharge from hospital, and endpoint are similar in the two studies.

250 patients will be asked to participate in each study - so far, 91 patients has been randomized and patient accrual is beginning soon at Skejby University Hospital,Denmark in collaboration with surgeons from department of thoracic surgery.


Condition Intervention
Nonsmall Cell Lung Cancer Cellular Diagnosis
Procedure: Anterolateral thoracotomy
Procedure: Posterolateral thoracotomy
Procedure: VATS
Procedure: Anterolateral Thoracotomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Minimally Invasive or Open Surgery for Lung Cancer: Pain, Quality of Life and Economy.

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Postoperative pain [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Aim is to asses the development of acute and chronic pain after lobectomy.


Secondary Outcome Measures:
  • Quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Three questionnaires are used. EQ5D, QLQC-30 and WPAI.

  • Economy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    An economical evaluation will be done. Including in-hospital expences, use of sociale-security, readmissions to hospital, use of family practioner, use of and duration of prescription analgetics, wether or not patients are able to return to work, the effect this type of surgery has on the patients quality of life, including a QALY evaluation and cost utility analysis.


Estimated Enrollment: 500
Study Start Date: September 2008
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PLEACE 1
Anterolateral vs. posterolateral thoracotomy
Procedure: Anterolateral thoracotomy
Standard anterolateral thoracotomy
Other Name: ALT
Procedure: Posterolateral thoracotomy
Standard muscle sparing posterolateral thoracotomy
Other Name: PLT
Active Comparator: PLEACE 2
Video assisted thoracic surgery (VATS) vs. anterolateral thoracotomy
Procedure: VATS
Standard video assisted thoracic surgery, no use of rib-spreader.
Other Name: VATS
Procedure: Anterolateral Thoracotomy
Standard anterolateral thoracotomy
Other Name: ALT

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eligible for surgery for lunge cancer.
  • Elective surgery (surgery planed > 2 days)
  • Accepts randomization
  • Age 18 or above.

Exclusion Criteria:

  • Previous thoracic surgery
  • Planned segment resection or pneumonectomy.
  • Any type of chronic pain, requiring daily use of analgetics
  • pregnant
  • Breast feeding
  • T3, T4 tumors or cerebral tumors.
  • contraindications to NSAID
  • Chemo- and/or radiotherapy in connection to present admission.
  • Major surgery planned in connection to this admission.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01278888

Contacts
Contact: Morten Bendixen, MD + 45 65 41 24 25 mbe@dadlnet.dk
Contact: Peter B Licht, Professor + 45 65 41 24 25 peter.licht@rsyd.dk

Locations
Denmark
Odense University Hospital Recruiting
Odense, Southern Denmark, Denmark, 5000
Contact: Susanne Petersen, Nurse    + 45 65 41 24 25    susanne.petersen@rsyd.dk   
Principal Investigator: Morten Bendixen, MD         
Sponsors and Collaborators
Peter B Licht
Investigators
Study Director: Peter B Licht, Professor Dept. Cardithoracic and Vascular Surgery
Principal Investigator: Morten Bendixen, MD Dept. Cardiothoracic and Vascular Surgery
  More Information

Additional Information:
No publications provided

Responsible Party: Peter B Licht, Professor, MD, pHd., Odense University Hospital
ClinicalTrials.gov Identifier: NCT01278888     History of Changes
Other Study ID Numbers: s-20080085
Study First Received: January 14, 2011
Last Updated: January 2, 2014
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Odense University Hospital:
Lung cancer
Pain
Quality of life
Economy

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 11, 2014