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Status unknownNCT02558608Updated Oct 16, 2015

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

A Phase 3 interventional study of DIPL and WR in Pneumothorax, sponsored by Chinese Medical Association. Status unknown at 1 site in China. Open to participants aged 10 Years to 50 Years. Per ClinicalTrials.gov, last updated 2015-10-16.

Sponsored by Chinese Medical Association · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
260
Allocation
Randomized
Ages
10 Years to 50 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Pneumothorax

Keywords

  • Prime Spontaneous Pneumothorax
  • recurrence
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In context

Pneumothorax

178 studies on the registry are indexed under Pneumothorax; 42 are open to participants now.

This study's planned enrollment of 260 is above the median of 100 across 115 interventional studies indexed under Pneumothorax.

Browse Pneumothorax studies →

Lead sponsor

Chinese Medical Association is the lead sponsor of 39 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
10 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
260 participants (estimated)

Study arms

  • Experimental
    WR AND DIPL

    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

  • Active comparator
    WR

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

    Procedure: WR · Procedure: thoracoscopic surgery

Interventions

  • ProcedureDIPL

    dissection of the inferior pulmonary ligament

  • ProcedureWR

    wedge resection of the lung bleb

  • Procedurethoracoscopic surgery

    surgery performed by video assisted thoracoscopy

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What researchers measure

Primary outcomes

  1. recurrence rate

    the 3- year recurrence rate of pneumothorax after surgery.

    Time frame: 3 years

Secondary outcomes

  1. pulmonary reexpansion rate

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

    Time frame: 1 day and 4 days

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Study locations

1 of 1 sites recruiting
  • Beijing Haidian Hospital
    Beijing, Beijing 100086, China
    Recruiting
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References and documents

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. doi: 10.1378/chest.119.2.590. PubMed 11171742 ↗
  • 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. PubMed 18455414 ↗
  • 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. PubMed 22785214 ↗
  • 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. PubMed 25236367 ↗
  • 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. PubMed 10921718 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 16, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02558608
Lead sponsor
Chinese Medical Association
Responsible party
Jian Cui (Principal Investigator, Beijing Haidian Hospital) — Principal investigator
First posted
Sep 24, 2015
Start date
Jun 2015
Primary completion
Dec 2018 (estimated)
Completion
Apr 2020 (estimated)
Last update
Oct 16, 2015

Study contacts

Jian Cui, director
Contact
cuijiandoctor@sina.com
+861082693152
Jian Cui, director
study director · Beijing Haidian Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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