Randomized Study Comparing Pleural Drainage by Videothoracoscopy to Medical Drainage in Infectious Pleural Effusion

NCT01994499 | Completed

• 1 other identifier: 2013/009/HP
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 3

Brief Summary

Infectious pleural effusion is a classic complication of pneumonia and often require pleural drainage. There is no consensus between surgical drainage and medical drainage indication in first intention to treat an empyema. Usually surgery is proposed in second intention after failure of medical drainage. Videothoracoscopy is well accepted in diagnosis and treatment of pleural pathologies. The morbidity of this approach is very low with good results and become the gold standard in different pleural diseases. The medical drainage can be also very efficient but its results depends of the evolution of the pleural effusion. The rate of failure is estimated around 25%. Then, the aim of our study is to compare surgical drainage and medical drainage in first intention. The first end-point will be the hospital stay (day). Hospital discharge will be strict, following different objective criteria of healing allowing comparison between these two approaches of drainage. To answer this question we will randomized 50 patients in 2 years with a multicenter recruitment.

Conditions

Infectious Pleural Effusion

Outcome Measures

Primary Outcomes (1)

• Hospital Stay in days

  patients will be followed for the duration of the hopital stay, an expected average of 4 weeks

Study Arms (2)

videothoracoscopy drainage

EXPERIMENTAL

videothoracoscopy drainage of pleural effusion

Device: Videothoracoscopy drainage

Medical pleural drainage

ACTIVE COMPARATOR

Medical drainage

Drug: Medical drainage

Interventions

Videothoracoscopy drainage DEVICE

videothoracoscopy drainage of pleural effusion

videothoracoscopy drainage

Medical drainage DRUG

Medical pleural drainage

Medical pleural drainage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Infectious pleural effusion diagnosed by pleural punction with biologic features of infection: C Reactive Protein level \>5 mg/L, White cells counts \> 10000 G/L, Temperature \>38°c, effusion with a ph\<7,2 or presence of polynuclear, and radiologic features of effusion requiring drainage (\>1/5 thoracic volume)

You may not qualify if:

• prior thoracic surgery, past history of pleural effusion
• compressive effusion which should be treated in emergency
• Pregnancy
• No acceptance of the protocol by the informed patient

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (3)

University Hospital

Amiens, 80000, France

Location

University Hospital

Caen, 14000, France

Location

UH Rouen

Rouen, France

Location

Study Officials

• jean-marc baste, MD

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2013
• First Posted: November 25, 2013
• Study Start: January 24, 2014
• Primary Completion: July 12, 2019
• Study Completion: July 12, 2019
• Last Updated: November 24, 2023

Record last verified: 2023-11

Locations

FR (3)