Intrapleural Minocycline After Simple Aspiration for the Prevention of Primary Spontaneous Pneumothorax

NCT00418392 | Unknown Phase 3

• 2 other identifiers: 950510DOH95-TD-I-111-012
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The estimated recurrence rate of primary spontaneous pneumothorax is 23-50% after the first episode, and the optimal treatment remains unknown. In the recently published British Thoracic Society (BTS) guidelines, simple aspiration is recommended as first line treatment for all primary pneumothoraces requiring intervention. However, the 1 year recurrence rate of this procedure was as high as 25-30%, making it inappropriate as a standard of care. Intrapleural instillation of a chemical irritant (chemical pleurodesis) is an effective way to shorten the duration of air leaks and reduce the rates of recurrent spontaneous pneumothorax in surgical and non-surgical patients. Many chemical irritants (tetracycline, talc, and minocycline) have been used to decrease the rate of recurrence in spontaneous pneumothorax. Tetracycline, which was the most commonly used irritant, is no longer available. Talc insufflation of the pleural cavity is safe and effective for primary spontaneous pneumothorax. However, it should be applied either with surgical or medical thoracoscopy. Minocycline, a derivative of tetracycline, is as effective as tetracycline in inducing pleural fibrosis in rabbits. In the previous studies, we have shown that additional minocycline pleurodesis is a safe and convenient procedure to decrease the rates of ipsilateral recurrence after thoracoscopic treatment of primary spontaneous pneumothorax. In the present study, additional minocycline pleurodesis will be randomly administered in patients with first episode of primary spontaneous pneumothorax after simple aspiration to test if it can reduce the rate of recurrence.

Conditions

Pneumothorax

Keywords

pneumothorax, aspiration, minocycline, pleurodesis

Outcome Measures

Primary Outcomes (1)

• to compare the rates of ipsilateral recurrence between the minocycline and observation groups after simple aspiration of the pneumothorax.

  12 months after treatment

Secondary Outcomes (3)

• Safety profile of minocycline pleurodesis

  12 months after treatment

• Early results, including immediate success rates, one-week success rates, complication rates, rates of hospitalization, duration of hospitalization, and the degrees of chest pain.

  7 days after treatment

• Long-term effects of minocycline pleurodesis, including degrees of residual chest pain and pulmonary function test

  12 months after treatment

Study Arms (2)

Minocycline group

EXPERIMENTAL

After successful simple aspiration, minocycline pleurodesis will be performed.

Procedure: Simple aspiration with minocycline pleurodesis

Control group

PLACEBO COMPARATOR

After successful simple aspiration, nothing will be performed.

Procedure: simple aspiration

Interventions

Simple aspiration with minocycline pleurodesis PROCEDURE

Intrapleural instillation of 300mg minocycline within 5 min after simple aspiration

Minocycline group

simple aspiration PROCEDURE

Simple aspiration for primary spontaneous pneumothorax by pigtail catheter

Control group

Eligibility Criteria

• Age: 15 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male or female.
• Age between 15 and 40 years old.
• First episode of spontaneous pneumothorax.
• Symptomatic (dyspnea or chest pain) or the rim of air is \> 2cm on CXR requiring simple aspiration
• Complete or nearly complete and persistent lung expansion immediately following manual aspiration
• Organ Function Requirements:
• Adequate hematological function (Hb \> 10 g/dl, ANC \> 1.5 x 109/L, platelets \> 100 x 109/L)
• Normal renal and hepatic functions: serum creatinine \< 1 x ULN, SGPT and SGOT\< 2.5 x ULN, alkaline phosphatase \< 5 x ULN
• Written inform consent

You may not qualify if:

• With underlying pulmonary disease (asthma, chronic obstructive pulmonary disease, bronchiectasis, etc)
• With hemothorax or tension pneumothorax requiring chest tube insertion or operation
• A history of previous pneumothorax
• A history of previous ipsilateral thoracic operation
• Allergy to tetracycline or minocycline
• Pregnant or lactating patients.
• Other serious concomitant illness or medical conditions:
• Congestive heart failure or unstable angina pectoris.
• History of myocardial infarction within 1 year prior to the study entry.
• Uncontrolled hypertension or arrhythmia.
• History of significant neurologic or psychiatric disorders, including dementia or seizure.
• Active infection requiring i.v. antibiotics.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Related Publications (5)

• Chen JS, Hsu HH, Chen RJ, Kuo SW, Huang PM, Tsai PR, Lee JM, Lee YC. Additional minocycline pleurodesis after thoracoscopic surgery for primary spontaneous pneumothorax. Am J Respir Crit Care Med. 2006 Mar 1;173(5):548-54. doi: 10.1164/rccm.200509-1414OC. Epub 2005 Dec 15.

  PMID: 16357330 BACKGROUND

• Chen JS, Hsu HH, Kuo SW, Tsai PR, Chen RJ, Lee JM, Lee YC. Effects of additional minocycline pleurodesis after thoracoscopic procedures for primary spontaneous pneumothorax. Chest. 2004 Jan;125(1):50-5. doi: 10.1378/chest.125.1.50.

  PMID: 14718420 BACKGROUND

• Light RW, O'Hara VS, Moritz TE, McElhinney AJ, Butz R, Haakenson CM, Read RC, Sassoon CS, Eastridge CE, Berger R, et al. Intrapleural tetracycline for the prevention of recurrent spontaneous pneumothorax. Results of a Department of Veterans Affairs cooperative study. JAMA. 1990 Nov 7;264(17):2224-30.

  PMID: 2214100 BACKGROUND

• Henry M, Arnold T, Harvey J; Pleural Diseases Group, Standards of Care Committee, British Thoracic Society. BTS guidelines for the management of spontaneous pneumothorax. Thorax. 2003 May;58 Suppl 2(Suppl 2):ii39-52. doi: 10.1136/thorax.58.suppl_2.ii39. No abstract available.

  PMID: 12728149 BACKGROUND

• Chen JS, Chan WK, Tsai KT, Hsu HH, Lin CY, Yuan A, Chen WJ, Lai HS, Yang PC. Simple aspiration and drainage and intrapleural minocycline pleurodesis versus simple aspiration and drainage for the initial treatment of primary spontaneous pneumothorax: an open-label, parallel-group, prospective, randomised, controlled trial. Lancet. 2013 Apr 13;381(9874):1277-82. doi: 10.1016/S0140-6736(12)62170-9. Epub 2013 Mar 12.

  PMID: 23489754 DERIVED

MeSH Terms

Conditions

Pneumothorax; cyclopia sequence

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Study Officials

• Yung-Chie Lee, MD, PhD

  National Taiwan University Hospital

  STUDY CHAIR

Central Study Contacts

Jin-Shing Chen, MD, PhD

CONTACT

886-2-23123456; chenjs@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2006
• First Posted: January 4, 2007
• Study Start: November 1, 2006
• Primary Completion: April 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 17, 2012

Record last verified: 2012-11

Locations

TW (1)