Clinical trial NCT02558608: Effect of Dissecting of The Inferior Pulmonary Ligament on Postoperative Pulmonary Reexpansion and Recurrence
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pneumothorax
Keywords: Prime Spontaneous Pneumothorax
recurrence
Lead sponsor: Chinese Medical Association
Sponsor class: NETWORK
First posted: 2015-09-24
Enrollment: 260
Sex: ALL
Minimum age (years): 10
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: recurrence rate
timeFrame: 3 years
Secondary outcomes:
measure: pulmonary reexpansion rate
timeFrame: 1 day and 4 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Haidian Hospital
state: Beijing
Study officials:
affiliation: Beijing Haidian Hospital
name: Jian Cui, director
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1378/chest.119.2.590.
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.
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.
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.
citation: Hatz RA, Kaps MF, Meimarakis G, Loehe F, Muller C, Furst 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. doi: 10.1016/s0003-4975(00)01411-9.