NCT01463553

Brief Summary

The purpose of this study is to:

  1. 1.Evaluate the validity of using abnormal characteristics of the pneumothorax line, as evaluated from chest X-ray film, as the operative indications for video-assisted thoracic surgery (VATS) on primary spontaneous pneumothorax (PSP).
  2. 2.Through a randomized double blind controlled trial on patients whose PSP was caused by lung bullae, evaluate the effectiveness of pleurodesis in terms of the rate of recurrence of PSP and the trauma of the operation on patients.
  3. 3.Based on the findings, establish selection standards for the timing of surgery to treat PSP by VATS and establish technical specifications for performing operations on different types of lung bullae. The goal is to improve the diagnosis and treatment of PSP so as to reduce the recurrence rate of pneumothorax, reduce the trauma of operation, shorten hospital stays and postoperative recovery time, and provide better services for returning to everyday life and improving the quality of life for patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
320

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2011

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 2, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

November 13, 2013

Status Verified

November 1, 2013

Enrollment Period

2.3 years

First QC Date

October 30, 2011

Last Update Submit

November 10, 2013

Conditions

PneumothoraxPleurodesis

Keywords

primary spontaneous pneumothoraxVATSpleurodesisrecurrence rate

Outcome Measures

Primary Outcomes (1)

  • Recurrence of Primary Spontaneous Pneumothorax (PSP)

    Monitor patients for 24 months to measure recurrence rate of primary spontaneous pneumothorax

    24 months

Secondary Outcomes (1)

  • Did not recurrence

    24months

Study Arms (2)

wedge resection

NO INTERVENTION

Wedge resection and pleurodosis

EXPERIMENTAL
Procedure: VATS pleurodesis

Interventions

VATS pleurodesisPROCEDURE

Based on the findings, establish selection standards for the timing of surgery to treat PSP by VATS and establish technical specifications for performing operations on different types of lung bullae. The goal is to improve the diagnosis and treatment of PSP so as to reduce the recurrence rate of pneumothorax, reduce the trauma of operation, shorten hospital stays and postoperative recovery time, and provide better services for returning to everyday life and improving the quality of life for patients.

Wedge resection and pleurodosis

Eligibility Criteria

Age10 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • patients in whom obvious bullous forms are seen in PSP pneumothorax lines, or whose pneumothorax lines are rough and interrupted with or without thoracentesis, thoracic close drainage
  • patients whose lung compression exceeded 30% for the first incidence of pneumothorax
  • patients between the ages of 14 and 40, with normal vital signs (body temperature, breathing, blood pressure, pulse) and normal results on routine examination (routine blood test, liver and kidney functions)
  • no language barrier, such as surdimutism, aphasia
  • patients who voluntarily joined the group and signed the informed consent after reviewing the substance, significance and risks of this experiment

You may not qualify if:

  • patients who refuse VATS operation
  • patients who refuse the follow-up
  • patients with secondary spontaneous pneumothorax including that caused by emphysema, COPD, asthma, pulmonary lymphangiomyomatosis, thoracic injury and other diseases
  • patients with mental illness, low IQ, or inability to understand the informed consent
  • substance abusers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Haidian Hospital

Beijing, Beijing Municipality, 100080, China

RECRUITING

Related Publications (1)

  • 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: 25236367DERIVED

MeSH Terms

Conditions

Pneumothorax

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract Diseases

Study Officials

  • Jun Liu, associate director

    Peking University People Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuqing Huang, associate director

CONTACT

0861337735630huangyuqing555@gmail.com

Jun liu, associate director

CONTACT

08613601249585liujundaifu@yahoo.cn

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Director

Study Record Dates

First Submitted

October 30, 2011

First Posted

November 2, 2011

Study Start

July 1, 2011

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

November 13, 2013

Record last verified: 2013-11

Locations

CN(1)