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

Primary Purpose

Pneumothorax

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
DIPL
WR
thoracoscopic surgery
Sponsored by
Chinese Medical Association
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumothorax focused on measuring Prime Spontaneous Pneumothorax, recurrence

Eligibility Criteria

10 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing Haidian HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

WR AND DIPL

WR

Arm Description

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

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

Outcomes

Primary Outcome Measures

recurrence rate
the 3- year recurrence rate of pneumothorax after surgery.

Secondary Outcome Measures

pulmonary reexpansion rate
the proportion of pulmonary reexpansion on the first and fourth day after operation.

Full Information

First Posted
September 13, 2015
Last Updated
October 14, 2015
Sponsor
Chinese Medical Association
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1. Study Identification

Unique Protocol Identification Number
NCT02558608
Brief Title
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

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
April 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Medical Association

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumothorax
Keywords
Prime Spontaneous Pneumothorax, recurrence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
260 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
WR AND DIPL
Arm Type
Experimental
Arm Description
patients undergo wedge resection and dissection the inferior pulmonary ligament by thoracoscopic surgery or video assisted thoracoscopic surgery
Arm Title
WR
Arm Type
Active Comparator
Arm Description
patients undergo wedge resection by thoracoscopic surgery or video assisted thoracoscopic surgery without dissection the inferior pulmonary ligament
Intervention Type
Procedure
Intervention Name(s)
DIPL
Intervention Description
dissection of the inferior pulmonary ligament
Intervention Type
Procedure
Intervention Name(s)
WR
Intervention Description
wedge resection of the lung bleb
Intervention Type
Procedure
Intervention Name(s)
thoracoscopic surgery
Intervention Description
surgery performed by video assisted thoracoscopy
Primary Outcome Measure Information:
Title
recurrence rate
Description
the 3- year recurrence rate of pneumothorax after surgery.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
pulmonary reexpansion rate
Description
the proportion of pulmonary reexpansion on the first and fourth day after operation.
Time Frame
1 day and 4 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jian Cui, director
Phone
+861082693152
Email
cuijiandoctor@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jian Cui, director
Organizational Affiliation
Beijing Haidian Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Beijing Haidian Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100086
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian Cui, Director
Phone
+861082693152
Email
cuijiandoctor@sina.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
11171742
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.
Results Reference
background
PubMed Identifier
18455414
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.
Results Reference
background
PubMed Identifier
22785214
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.
Results Reference
background
PubMed Identifier
25236367
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.
Results Reference
background
PubMed Identifier
10921718
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.
Results Reference
background

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

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