Effect of Dissecting of The Inferior Pulmonary Ligament on Postoperative Pulmonary Reexpansion and Recurrence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT02558608

Recruitment Status : Unknown

Verified October 2015 by Jian Cui, Beijing Haidian Hospital.
Recruitment status was: Recruiting

First Posted : September 24, 2015

Last Update Posted : October 16, 2015

Sponsor:

Information provided by (Responsible Party):

Jian Cui, Beijing Haidian Hospital

Study Description

Brief Summary:

This subject analysis of the influence of the dissociating inferior pulmonary ligament on pulmonary reexpansion and recurrence in the treatment of primary spontaneous pneumothorax by video assisted thoracic surgery. All patients are randomly divided into two groups: group A and group B. Wedge resection(WR) will be performed for all patients. Investigators dissect the inferior pulmonary ligament(DIPL) for group A. Investigators do not dissect the inferior pulmonary ligament for group B. The pulmonary reexpansion and recurrence rate are observed between the two groups.

Condition or disease	Intervention/treatment	Phase
Pneumothorax	Procedure: DIPL Procedure: WR Procedure: thoracoscopic surgery	Phase 3

Detailed Description:

Wedge resection of the lung is usually used in the treatment of primary spontaneous pneumothorax. And the pleural treatment also might be used. But part of secondary pneumothorax patients who had undergone surgical, the bullae can be found especially in the apical of lung, even if the pleural have been treated in some way.This subject provides a new way of thinking and method to solve the problem of recurrent spontaneous pneumothorax.

Study Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	260 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Effect of Dissecting of The Inferior Pulmonary Ligament on Postoperative Pulmonary Reexpansion and Recurrence After Operation by Video-assisted Thoracic Surgery in the Treatment of Primary Spontaneous Pneumothorax(PSP)
Study Start Date :	June 2015
Estimated Primary Completion Date :	December 2018
Estimated Study Completion Date :	April 2020

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Primary spontaneous pneumothorax

MedlinePlus related topics: Collapsed Lung

Genetic and Rare Diseases Information Center resources: Primary Spontaneous Pneumothorax

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: WR AND DIPL patients undergo wedge resection and dissection the inferior pulmonary ligament by thoracoscopic surgery or video assisted thoracoscopic surgery	Procedure: DIPL dissection of the inferior pulmonary ligament Procedure: WR wedge resection of the lung bleb Procedure: thoracoscopic surgery surgery performed by video assisted thoracoscopy
Active Comparator: WR patients undergo wedge resection by thoracoscopic surgery or video assisted thoracoscopic surgery without dissection the inferior pulmonary ligament	Procedure: WR wedge resection of the lung bleb Procedure: thoracoscopic surgery surgery performed by video assisted thoracoscopy

Outcome Measures

Primary Outcome Measures :

recurrence rate [ Time Frame: 3 years ]
the 3- year recurrence rate of pneumothorax after surgery.

Secondary Outcome Measures :

pulmonary reexpansion rate [ Time Frame: 1 day and 4 days ]
the proportion of pulmonary reexpansion on the first and fourth day after operation.

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	10 Years to 50 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

The patients diagnosis pneumothorax with chest radiograph or computed tomography (CT)
The clinical and final pathological diagnosis for patient is PSP.
The patients with stable vital signs, no contraindication for operation and no communication barriers.
The patients,after informed of test content, significance and risk, who voluntarily enroll and sign informed consent.

Exclusion Criteria:

The patients who refuse to do a video assisted thoracic surgery.
The patients with pneumothorax with specific causes such as pulmonary hamartoangiomyomatosis, catamenial pneumothorax, and pneumothorax secondary to chronic obstructive pulmonary disease.
The patients who were older than 50 years
The patients with familial history of pneumothorax.
The patients with mental disorders, low Intelligence Quotient, can not objectively reflect the indicators of observation.
The patients who refuse to follow-up.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02558608

Contacts

Layout table for location contacts

Contact: Jian Cui, director	+861082693152	cuijiandoctor@sina.com

Locations

Layout table for location information

China, Beijing
Beijing Haidian Hospital	Recruiting
Beijing, Beijing, China, 100086
Contact: Jian Cui, Director +861082693152 cuijiandoctor@sina.com

Sponsors and Collaborators

Chinese Medical Association

Investigators

Layout table for investigator information

Study Director:	Jian Cui, director	Beijing Haidian Hospital

More Information

Publications:

Baumann MH, Strange C, Heffner JE, Light R, Kirby TJ, Klein J, Luketich JD, Panacek EA, Sahn SA; AACP Pneumothorax Consensus Group. Management of spontaneous pneumothorax: an American College of Chest Physicians Delphi consensus statement. Chest. 2001 Feb;119(2):590-602. Review.

Gaunt A, Martin-Ucar AE, Beggs L, Beggs D, Black EA, Duffy JP. Residual apical space following surgery for pneumothorax increases the risk of recurrence. Eur J Cardiothorac Surg. 2008 Jul;34(1):169-73. doi: 10.1016/j.ejcts.2008.03.049. Epub 2008 May 1.

Casali C, Stefani A, Ligabue G, Natali P, Aramini B, Torricelli P, Morandi U. Role of blebs and bullae detected by high-resolution computed tomography and recurrent spontaneous pneumothorax. Ann Thorac Surg. 2013 Jan;95(1):249-55. doi: 10.1016/j.athoracsur.2012.05.073. Epub 2012 Jul 10.

Min X, Huang Y, Yang Y, Chen Y, Cui J, Wang C, Huang Y, Liu J, Wang J. Mechanical pleurodesis does not reduce recurrence of spontaneous pneumothorax: a randomized trial. Ann Thorac Surg. 2014 Nov;98(5):1790-6; discussion 1796. doi: 10.1016/j.athoracsur.2014.06.034. Epub 2014 Sep 16.

Hatz RA, Kaps MF, Meimarakis G, Loehe F, Müller C, Fürst H. Long-term results after video-assisted thoracoscopic surgery for first-time and recurrent spontaneous pneumothorax. Ann Thorac Surg. 2000 Jul;70(1):253-7.

Layout table for additonal information

Responsible Party:	Jian Cui, Principal Investigator, Beijing Haidian Hospital
ClinicalTrials.gov Identifier:	NCT02558608
Other Study ID Numbers:	FPL001
First Posted:	September 24, 2015 Key Record Dates
Last Update Posted:	October 16, 2015
Last Verified:	October 2015

Keywords provided by Jian Cui, Beijing Haidian Hospital:


Prime Spontaneous Pneumothorax recurrence

Additional relevant MeSH terms:

Layout table for MeSH terms

Pneumothorax Recurrence Disease Attributes	Pathologic Processes Pleural Diseases Respiratory Tract Diseases

To Top