Comparing Different Sizes of Small-bore Chest Drains in Malignant Pleural Effusion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2024-10-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Malignant pleural effusion (MPE) is a very common medical condition, especially among patients with disseminated cancers. Chest drain insertion aims to drain the pleural fluid collection and relieve dyspnea. Small bore chest tubes are recommended as the first line therapy for draining pleural effusions. However, there is no clinical data available to inform on the size of drains for better drainage. This is a randomized study comparing the two common bores of small bore chest drains in Hong Kong, and assess for its clinical efficacy and complication risks.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pleurodesis in Small-bore Chest Tube

NCT07208409

Pleural Effusion, Malignant

NOT_YET_RECRUITING NA

The Effect of a Combined Drainage Strategy in Uniportal Upper Lung Lobectomy

NCT04461652

Carcinoma, Non-Small-Cell Lung

UNKNOWN NA

Effectiveness of Intercostal Tube Drainage Vs Pigtail Catheter Drainage Vs Ultrasound-Guided Aspiration in Management of Massive Malignant Pleural Effusion

NCT06964321

Malignant Pleural Effusion

NOT_YET_RECRUITING NA

Standard Chest Tube Compared With a Small Catheter in Treating Malignant Pleural Effusion in Patients With Cancer

NCT00042770

Metastatic Cancer Pulmonary Complications

COMPLETED PHASE3

Comparing Valve-regulated Pleural Drainage to Traditional Closed Chest Tube Drainage

NCT06410716

Lung Cancer

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Introduction: Malignant pleural effusion (MPE) is the commonest complication of lung cancer, and its associated symptoms are frequent causes of hospitalizations and morbidities in patients with disseminated cancers. Chest tube drainage is often performed for symptomatic relief. Recent clinical trials had shown that large-bore chest drains (\>14 French) caused significantly more pain than smaller drain during the insertion procedure and when the drain was in situ, which prompts the shift of preference towards smaller chest drains in guideline and clinical practice. Chest drains as small-bore as 7-8 French have been used in many local centers for drainage of MPE, though little attention has been made to the possible higher occurrence of drain blockage, kinking or dislodgement before optimal effusion drainage is achieved, which may lead to a second procedure for drain replacement. Currently, there is no data informing the efficacy and complications of ultra-small chest drains in clinical use. Therefore, it is imperative to call for further research on the optimal size of the chest drain which can achieve satisfactory drainage and at the same time, of minimal complications.

Study design: Single-center, parallel group, single blinded, randomized controlled study Study site: Department of Medicine, Queen Mary Hospital Target study participants: Subjects with symptomatic MPE requiring chest drainage

Method and analysis: This randomized controlled study to compare the efficacy of ultra-small bore chest drains (8 Fr) with standard small bore chest drain (14 French) as the reference. Primary outcome is drain success defined by nearly complete drainage of MPE on chest radiograph on day 5 of the drain. Other secondary outcomes include pain according to the visual analogue scale, dyspnea relief and complications during the procedure and post - chest drain insertion.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pleural Effusion, Malignant Lung Cancer Stage IV Chest Tubes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Seldinger chest drain 14F

Patients with seldinger chest drain 14F inserted

Group Type OTHER

Seldinger chest drain insertion

Intervention Type DEVICE

Different sizes of chest drain will be inserted with seldinger technique

Seldinger chest drain 8F

Patients with seldinger chest drain 8F inserted

Group Type ACTIVE_COMPARATOR

Seldinger chest drain insertion

Intervention Type DEVICE

Different sizes of chest drain will be inserted with seldinger technique

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Seldinger chest drain insertion

Different sizes of chest drain will be inserted with seldinger technique

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients who have cytologically/histologically proven pleural malignancy, or who have pleural effusion in the context of malignancy elsewhere
* The pleural effusion is at least moderate to massive and causes symptoms
* Ability to give informed written consent to the study

Exclusion Criteria

* Age \<18 years old
* Bleeding tendency not readily correctable (platelet \< 100 x 10\^9, INR ≥1.5 after transfusion)
* Hydropneumothorax before drain insertion
* Moderate-heavy septations in the pleural effusion (defined as a collection with more than 4 septations visible at the maximally septated area)
* Clinical emergency that an urgent chest drain is required
* Allergy to local anesthesia agents
* Blindness
* History of pleurodesis on the same side of malignant pleural effusion requiring drainage

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes