A Prospective, Randomized Controlled Trial for a Rapid Pleurodesis Protocol for the Management of Pleural Effusions

NCT00758316 | Completed Phase 3

• 1 other identifier: 149/2008
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Malignant pleural effusions form a significant proportion of respiratory and oncology work-load. The efficacy of thoracoscopic talc poudrage which is the current standard of care is limited by lung entrapment which prevents lung re-expansion. Thoracoscopy patients also have significant hospital length of stay because chest tube drainage must continue until the pleural space is dry to effect successful pleurodesis. Alternative management strategies such as tunnelled pleural catheters (bedside ultrasound-guided) enable outpatient management of pleural effusions but have limited pleurodesis rates and do not offer any chance of getting pleural biopsies. A prospective randomized controlled trial with two arms i.e. thoracoscopic poudrage alone (standard care) versus combined thoracoscopic poudrage and tunnelled pleural catheters. The tunnelled catheters will be inserted at the time of thoracoscopy in the endoscopy centre under ultrasound guidance. The trial is aimed to be completed within 3 years. Primary end-points will be pleurodesis success. The secondary end-points are hospital length-of-stay, complication rates, analgesia requirements, pain scores and quality-of-life scores. Based on power calculations, we aim to recruit 120 patients in each arm.

Conditions

Malignant Pleural Effusions

Keywords

Malignant; Pleural; Effusions; Thoracoscopy; Catheter

Outcome Measures

Primary Outcomes (1)

• The primary end points will be pleurodesis/pleural catheter success.

  30 days

Secondary Outcomes (4)

• Hospital length of stay

  1 year

• Complication rate/analgesia

  1 year

• Quality of life

  1 year

• Talc dose

  1 year

Study Arms (2)

1

ACTIVE COMPARATOR

Thoracoscopy with pleurodesis Patients will then undergo standard medical thoracoscopy in the endoscopy center including the use of moderate sedation, prophylactic antibiotics for 1 week and 20F chest tube insertion at the end of the procedure.

Procedure: Thoracoscopy

2

EXPERIMENTAL

Combined thoracoscopy with pleurodesis and pleurx catheter. In the combined procedure group, a PleurxTM tunnelled catheter will be inserted under ultrasound guidance. As this procedure will be done concurrently with thoracoscopy, there is no estimated increase in endoscopy time.

Other: Thoracoscopy and Pleurx

Interventions

Thoracoscopy and Pleurx OTHER

Talc poudrage and tunneled pleural catheter

Also known as: Pleuroscopy

2

Thoracoscopy PROCEDURE

Talc poudrage

Also known as: Pleuroscopy

1

Eligibility Criteria

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

You may qualify if:

• Patients aged ≥ 18 with suspected or known symptomatic malignant pleural effusions (i.e. age \>60 or smoking history \> 20 pack years or moderate effusion \>1/3 hemithorax)
• Ability and willingness to sign informed consent. See Annex 1 for patient information sheet and informed consent form.
• Absence of contraindications to thoracoscopy and tunnelled pleural catheters
• Willingness to comply with follow-up i.e. outpatient follow-up at 1 week and at 1 month for standard intervention; and additional every other day drainage in the intervention group (up to 5 times).

You may not qualify if:

• Uncorrected coagulopathy with platelet count ≤ 60 and INR ≥ 1.5.
• Uncontrolled coughing because of risk of lung puncture and air leaks
• Severe hypoxemia with a PaO2/FiO2 ratio ≤ 200 or hypercapnia with a PaCO2 ≥ 60 mmHg.
• Unstable cardiovascular status ie. hemodynamic instability requiring inotropes/vasopressors, recent myocardial infarction \< 5 days or uncontrolled arrythmias
• Uncontrolled psychiatric disorders or absence of a significant caregiver both of which will contraindicate sending the patient home with a tunnelled catheter
• Previous thoracic surgery/intervention to the affected hemothorax which may have obliterated the pleural space
• Local skin infections that prevent long term catheter placement
• Morbid obesity which will increase risks associated with moderate sedation in the endoscopy centre
• Multi-loculated effusions that will not benefit from drainage
• Suspected pregnancy

Sponsors & Collaborators

• Singapore General Hospital: lead

Study Sites (1)

Sinagpore General Hospital

Singapore, 169608, Singapore

Location

Related Publications (4)

• Shaw P, Agarwal R. Pleurodesis for malignant pleural effusions. Cochrane Database Syst Rev. 2004;(1):CD002916. doi: 10.1002/14651858.CD002916.pub2.

  PMID: 14973997 RESULT

• Dresler CM, Olak J, Herndon JE 2nd, Richards WG, Scalzetti E, Fleishman SB, Kernstine KH, Demmy T, Jablons DM, Kohman L, Daniel TM, Haasler GB, Sugarbaker DJ; Cooperative Groups Cancer and Leukemia Group B; Eastern Cooperative Oncology Group; North Central Cooperative Oncology Group; Radiation Therapy Oncology Group. Phase III intergroup study of talc poudrage vs talc slurry sclerosis for malignant pleural effusion. Chest. 2005 Mar;127(3):909-15. doi: 10.1378/chest.127.3.909.

  PMID: 15764775 RESULT

• Tremblay A, Michaud G. Single-center experience with 250 tunnelled pleural catheter insertions for malignant pleural effusion. Chest. 2006 Feb;129(2):362-368. doi: 10.1378/chest.129.2.362.

  PMID: 16478853 RESULT

• Tremblay A, Mason C, Michaud G. Use of tunnelled catheters for malignant pleural effusions in patients fit for pleurodesis. Eur Respir J. 2007 Oct;30(4):759-62. doi: 10.1183/09031936.00164706. Epub 2007 Jun 13.

  PMID: 17567670 RESULT

MeSH Terms

Conditions

Pleural Effusion, Malignant

Interventions

Thoracoscopy

Condition Hierarchy (Ancestors)

Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Pleural Effusion; Pleural Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Officials

• Devanand Anantham, FCCP

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 23, 2008
• First Posted: September 25, 2008
• Study Start: September 1, 2008
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: February 10, 2017

Record last verified: 2017-02

Locations

SG (1)