Comparison of Talc Slurry Versus Talc Insufflation: A Study on Effectiveness, Safety, and Hospital Outcomes in Pleurodesis

NCT07167992 | Not Yet Recruiting

• 1 other identifier: IRB/2025/1559/SIMS
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Pleural effusion is characterized by the accumulation of fluid in the pleural space, which typically contains about 10-20 mL of pleural fluid that is crucial for the movement of the lungs against the chest wall. This fluid closely resembles plasma but has a lower protein concentration, usually less than 1.5 gm/dL. It primarily originates from pleural capillaries and the interstitial spaces of the lung, and is reabsorbed through the lymphatic vessels in the parietal pleura, either via small openings known as stomas or through a process called transcytosis (1, 2). When the balance between fluid production and reabsorption is disrupted-often due to various pathogenic mechanisms-it can lead to pleural effusion. In such cases, effective management is essential. This study aims to conduct a thorough comparison of the two talc administration methods-TS and TI-using sterilized, large-particle, asbestos-free talc powder. By examining key outcome measures such as pleurodesis success rates, procedural morbidity, and length of hospital stay, the goal is to provide clinicians with evidence-based guidance to facilitate informed decision-making in the management of pleural effusions.

Conditions

Pneumothorax Spontaneous Secondary; Pleural Effusion, Malignant; Pleurodesis; Pneumothorax Spontaneous Primary

Keywords

Talc slurry; Talc Insufflation; Pleurodesis; malignant pleural effusions; recurrent pneumothorax

Outcome Measures

Primary Outcomes (1)

• Success of Pleurodesis

  The success rate of pleurodesis is defined as the percentage of patients who achieve complete resolution of pleural effusion or pneumothorax within a specified time frame of 01 months post-procedure. Success is assessed through follow-up chest radiographs, with criteria for success including the absence of fluid reaccumulation or lung collapse during this period. Clinical improvement in symptoms such as dyspnea may also be considered as supplementary evidence of a successful outcome.

  01 months post-procedure

Secondary Outcomes (1)

• Procedural Morbidity of pleurodesis

  30 days

Study Arms (2)

Talc Slurry Group

EXPERIMENTAL

patient undergoing pleurodesis by talc slurry method are included in this group

Procedure: Pleurodesis

Talc Insufflation Group

EXPERIMENTAL

patient undergoing pleurodesis by talc insufflation method are included in this group

Procedure: pleurodesis

Interventions

pleurodesis PROCEDURE

Talc slurry pleurodesis is a chemical technique for managing recurrent pleural effusions and pneumothoraces. The procedure involves instilling a suspension of talc (4-5 grams) in sterile saline (50-100 mL) into the pleural space via a chest tube. This induces an inflammatory reaction, leading to fibrosis and fusion of pleural surfaces. The technique demonstrates 70-90% success rates in malignant pleural effusions and pneumothoraces, with efficacy comparable to talc poudrage. While generally safe, potential complications include pain, fever, and rarely, pneumonitis or empyema. Use of large-particle, asbestos-free talc and standardized protocols has improved its safety profile.

Talc Slurry Group

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients aged 12 years and older.
• Diagnosed with malignant pleural effusions or pneumothoraces.
• ECOG performance status of 0-2.
• Life expectancy of at least 3 months.
• Ability to provide informed consent.
• No contraindications to general anesthesia or conscious sedation.

You may not qualify if:

• Patients younger than 12 years old
• Female patients who are pregnant or lactating
• Patients with encysted or septated pleural effusions and pneumothoraces
• Patients presenting with respiratory failure
• Patients complaining of dyspnea in spite of complete evacuation of pleural effusion or pneumothorax.
• Patients with evident chest infection with clinical or laboratory signs suggestive of parapneumonic effusions.

Sponsors & Collaborators

• University of Health Sciences Lahore: lead

Study Sites (1)

Services Institute of Medical Sciences (SIMS), Services Hospital Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Pneumothorax; Pleural Effusion, Malignant

Interventions

Pleurodesis

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Muhammad Shoaib Nabi, Professor of Thoracic Surgery

  Services institute of Medical Sciences (SIMS), Services Hospital Lahore

  STUDY CHAIR

Central Study Contacts

Zeeshan Sarwar

CONTACT

+92 3214347410; zeeshan.sarwar195@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study will be a randomized controlled trial (RCT) to ensure robust comparisons between talc slurry (TS) and talc insufflation (TI) in managing pleural effusions or pneumothoraces. To reduce bias, the study will be single-blind, where patients will be unaware of the procedure type, while clinicians will know the intervention. This design minimizes performance and response biases without compromising the feasibility of the procedures.

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: September 11, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): March 30, 2027
• Last Updated: January 6, 2026

Record last verified: 2026-01

Locations

PA (1)