MedDataX Logo

Mini Thoracoscopy vs Semirigid Thoracoscopy in Exudative Pleural Effusions

NCT ID: NCT02851927

Last Updated: 2018-12-27

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

COMPLETED

Clinical Phase

NA

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2018-09-30

Brief Summary

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

Undiagnosed pleural effusion is a diagnostic dilemma especially in exudative pleural effusions (EPE). 20-40 % are unable to be attributed to a specific diagnosis, even after thoracentesis and closed pleural biopsy. Thoracoscopy has been demonstrated to increase the diagnostic yield in undiagnosed EPE. The diagnostic yield of thoracoscopy in malignant and TB pleural effusion ranges from 91% to 94% and 93% to 100%, respectively.

Rigid thoracoscopy has traditionally been the modality of choice. The recently introduced semirigid thoracoscope provides ease of handling like a flexible bronchoscope. However, there are concerns about the diagnostic yield of semi-rigid thoracoscopy when compared with rigid thoracoscopy. According to the available literature, the yield of semirigid and rigid thoracoscopy is almost similar if adequate pleural biopsy is obtained. However there are concerns that with semi-rigid thoracoscope, there might be greater incidence of inability to obtain adequate pleural biopsy. On the other hand, the use of conventional rigid thoracoscope may be associated with greater procedure related pain.Mini-Thoracoscopy is a newer rigid thoracoscopy instrument which is smaller in diameter (5.5 mm) and may allow pleural biopsy with a smaller incision. There is scant literature on its utility. The investigators hereby propose to undertake a randomized comparison of rigid 'mini thoracoscope' vs semi rigid thoracoscope in undiagnosed pleural effusions.

Detailed Description

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

Patients meeting the inclusion criteria and giving prior consent for the study shall be randomised. The randomization sequence will be computer generated with variable block size and the assignments will be placed in opaque sealed envelopes. All patients will undergo hemogram, liver and renal function tests, coagulation profile, an electrocardiogram and Computed tomography (CT) of the chest before entering the study. Chest ultrasound will be performed in all patients to evaluate the rib spaces, amount of pleural fluid and for selection of the entry point.

Instruments The semi-rigid thoracoscope to be used is the autoclavable Olympus LTF-160 (Olympus, Tokyo, Japan) thoracoscope with 2.8 mm inner channel diameter and 7 mm outer diameter. The forceps is flexible forceps with alligator jaw with spike cusps, 2.8 mm of the outer diameter. The rigid mini thoracoscope is the Richard Wolf 5.5 mm operating endoscope with the working channel.

Thoracoscopy technique Thoracoscopy will be performed in the interventional pulmonology lab. Patients shall be fasting for solids for 8 hours and for liquids 6 hours. Patients shall be having continuous monitoring of blood pressure, pulse rate, and oxygen saturation.

Topical anesthesia will be achieved by infiltrating 2% lidocaine locally at the incision site. The procedure shall be performed under conscious sedation and analgesia using a combination of midazolam and intravenous fentanyl. An incision shall be made at the site of maximum fluid thickness as assessed by pre-procedural USG chest, with the patient in lateral decubitus position and involved side upward. After incision, the appropriately sized trocar shall be placed through the skin into the pleural space. The thoracoscope shall be inserted through the trocar. The pleural surfaces shall then be thoroughly inspected. A minimum of 6-8 pleural biopsy samples shall be obtained by semi-rigid thoracoscope and at least 4 with rigid mini-thoracoscope.

Samples shall be sent for histopathological analysis and mycobacterial cultures. At the end of the procedure, a chest tube shall be placed and removed subsequently.

All patients shall be followed up for a period of six months from the time of procedure if non-specific inflammation/ fibrinous pleuritis is the diagnosis or no definitive diagnosis is made during that time.

Statistical analysis:

Data shall be expressed as mean ± standard deviation (SD), or percentage. Differences in continuous variables between the two groups shall be compared using Student's t test (or Mann-Whitney U test); while differences in categorical data shall be compared using the chi-square test (or Fisher's exact test). A p value of less than 0.05 shall be considered statistically significant.

Conditions

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

Pleural Effusion

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

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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

Mini Thoracoscopy

Thoracoscopy procedure shall be performed using the Rigid Mini Thoracoscope

Group Type EXPERIMENTAL

Mini Thoracoscopy

Intervention Type PROCEDURE

Pleural biopsy using rigid mini thoracoscope

Semirigid Thoracoscopy

Thoracoscopy procedure shall be performed using the SemiRigid Thoracoscope

Group Type ACTIVE_COMPARATOR

SemiRigid Thoracoscopy

Intervention Type PROCEDURE

Pleural biopsy using semirigid thoracoscope

Interventions

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

Mini Thoracoscopy

Pleural biopsy using rigid mini thoracoscope

Intervention Type PROCEDURE

SemiRigid Thoracoscopy

Pleural biopsy using semirigid thoracoscope

Intervention Type PROCEDURE

Eligibility Criteria

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

Inclusion Criteria

* Age \>18 years Presence of undiagnosed exudative pleural effusion as determined by the criteria detailed by Light et al where a specific diagnosis was not obtained after initial cytological and/or microbiological examinations.

Adequate rib spaces for successful performance of thoracoscopy as judged by clinical examination Adequate pleural fluid space as judged by pre-procedural USG chest

Exclusion Criteria

1. Pregnancy
2. Coagulopathy (platelet count \< 50000/mm3, INR \> 1.5)
3. Unstable hemodynamic status ( SBP \> 180, DBP\> 100 or SBP\< 90 mm Hg / heart failure
4. Myocardial infarction or unstable angina in the last 6 wk
5. Hypoxemia not correctable with low flow oxygen (SpO2 \<90% despite low flow oxygen @ 1-2 l/min)
6. Extensive rib crowding as judged by clinical examination
7. Extensive adhesions and lack of pleural space on USG chest
8. Refusal of consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

All India Institute of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Karan Madan

Dr Karan Madan MD, DM Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Randeep Guleria, MD, DM

Role: STUDY_CHAIR

AIIMS, New Delhi

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

All India Institute of Medical Sciences

New Delhi, , India

Site Status

Countries

Review the countries where the study has at least one active or historical site.

India

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Mini vs Semirigid RCT

Identifier Type: -

Identifier Source: org_study_id