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

Pneumothorax Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02558608
• Other study ID #: FPL001
• Status: Recruiting
• Phase: Phase 3
• First received: September 13, 2015
• Last updated: October 14, 2015
• Start date: June 2015
• Est. completion date: April 2020

Study information

• Verified date: October 2015
• Source: Chinese Medical Association
• Contact: Jian Cui, director
• Phone: +861082693152
• Email: cuijiandoctor[@]sina.com
• Is FDA regulated: No
• Health authority: China: Beijing Municipal Health Bureau
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: April 2020
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 50 Years

Eligibility

Inclusion Criteria:

1. The patients diagnosis pneumothorax with chest radiograph or computed tomography (CT)

2. The clinical and final pathological diagnosis for patient is PSP.

3. The patients with stable vital signs, no contraindication for operation and no communication barriers.

4. The patients,after informed of test content, significance and risk, who voluntarily enroll and sign informed consent.

Exclusion Criteria:

1. The patients who refuse to do a video assisted thoracic surgery.

2. The patients with pneumothorax with specific causes such as pulmonary hamartoangiomyomatosis, catamenial pneumothorax, and pneumothorax secondary to chronic obstructive pulmonary disease.

3. The patients who were older than 50 years

4. The patients with familial history of pneumothorax.

5. The patients with mental disorders, low Intelligence Quotient, can not objectively reflect the indicators of observation.

6. The patients who refuse to follow-up.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pneumothorax
• Recurrence

Intervention

Procedure:
• DIPL
dissection of the inferior pulmonary ligament
• WR
wedge resection of the lung bleb
• thoracoscopic surgery
surgery performed by video assisted thoracoscopy

Locations

Country	Name	City	State
China	Beijing Haidian Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Medical Association

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurrence rate	the 3- year recurrence rate of pneumothorax after surgery.	3 years	No
Secondary	pulmonary reexpansion rate	the proportion of pulmonary reexpansion on the first and fourth day after operation.	1 day and 4 days	No