NCT00018525

Brief Summary

The main objectives of this study are to see if a type of lung surgery, known as lung reduction surgery, in addition to standard medical treatment improves the quality of life, lung function, and reduces the high mortality associated with severe emphysema when compared to standard medical treatment alone. Another goal of this study is to better identify the patients most likely to benefit from this surgical treatment. The information obtained in this study is important because lung reduction surgery is being done in several centers around the country but its long term benefits, if any, over standard medical treatment, are not known.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Oct 2000

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2000

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2001

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 5, 2001

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2002

Completed
Last Updated

January 21, 2009

Status Verified

December 1, 2004

First QC Date

July 3, 2001

Last Update Submit

January 20, 2009

Conditions

Emphysema

Interventions

Lung Volume Reduction SurgeryPROCEDURE

Eligibility Criteria

AgeUp to 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
1. Post-bronchodilator FEV I \< 40% and \> 15% of predicted 2. TLC \> 120% of predicted\* 3. Carbon monoxide diffusing capacity by the single breath technique (DLCOSB) \< 50% of predicted 4. PaCO2 \< 55 mmHg 5. Age 75 years or younger * TLC will be determined by body plethysmography using slow inspiratory effort to determine thoracic gas lume because of the overestimation of lung volumes by high frequency panting in patients with COPD.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Veterans Affairs Medical Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Emphysema

Interventions

Pneumonectomy

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Procedures, OperativePulmonary Surgical ProceduresThoracic Surgical Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
FED

Study Record Dates

First Submitted

July 3, 2001

First Posted

July 5, 2001

Study Start

October 1, 2000

Study Completion

September 1, 2002

Last Updated

January 21, 2009

Record last verified: 2004-12

Locations

US(1)