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

NCT02558608 | Unknown Phase 3 DMC

• 1 other identifier: FPL001
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumothorax

Keywords

Prime Spontaneous Pneumothorax; recurrence

Outcome Measures

Primary Outcomes (1)

• recurrence rate

  the 3- year recurrence rate of pneumothorax after surgery.

  3 years

Secondary Outcomes (1)

• pulmonary reexpansion rate

  1 day and 4 days

Study Arms (2)

WR AND DIPL

EXPERIMENTAL

patients undergo wedge resection and dissection the inferior pulmonary ligament by thoracoscopic surgery or video assisted thoracoscopic surgery

Procedure: DIPL; Procedure: WR; Procedure: thoracoscopic surgery

WR

ACTIVE COMPARATOR

patients undergo wedge resection by thoracoscopic surgery or video assisted thoracoscopic surgery without dissection the inferior pulmonary ligament

Procedure: WR; Procedure: thoracoscopic surgery

Interventions

DIPL PROCEDURE

dissection of the inferior pulmonary ligament

WR AND DIPL

WR PROCEDURE

wedge resection of the lung bleb

WR; WR AND DIPL

thoracoscopic surgery PROCEDURE

surgery performed by video assisted thoracoscopy

WR; WR AND DIPL

Eligibility Criteria

• Age: 10 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese Medical Association: lead

Study Sites (1)

Beijing Haidian Hospital

Beijing, Beijing Municipality, 100086, China

RECRUITING

Related 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. doi: 10.1378/chest.119.2.590.

  PMID: 11171742 BACKGROUND

• 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.

  PMID: 18455414 BACKGROUND

• 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.

  PMID: 22785214 BACKGROUND

• 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.

  PMID: 25236367 BACKGROUND

• 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.

  PMID: 10921718 BACKGROUND

MeSH Terms

Conditions

Pneumothorax; Recurrence

Interventions

Thoracoscopy

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Officials

• Jian Cui, director

  Beijing Haidian Hospital

  STUDY DIRECTOR

Central Study Contacts

Jian Cui, director

CONTACT

+861082693152; cuijiandoctor@sina.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 13, 2015
• First Posted: September 24, 2015
• Study Start: June 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: April 1, 2020
• Last Updated: October 16, 2015

Record last verified: 2015-10

Locations

CN (1)