First Local Anaesthesia Thoracoscopy for Pleural Effusion Diagnosis.

NCT06946498 | Recruiting

• 1 other identifier: FLAT1STIPNKUA
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Non randomized study with two groups. The study group includes patients with suspected malignant pleural effusion, in whom the investigation of pleural effusion begins directly with pleural biopsy by Local Anesthesia Thoracoscopy (LAT). The Control Group includes patients who come to the same hospital and are treated with the Standard of Care (SOC) strategies were used. Efficacy of LAT, Sensitivity, Hospitalization, time to diagnosis and general safety and comfort of the groups' subjects will be assessed.

Conditions

Suspected Malignant Lung Neoplasm; Pleural Effusion; Pleural Effusion, Malignant; Mesothelioma, Malignant

Keywords

Malignant Pleural Effusion; Local Anesthesia Thoracoscopy; Medical Thoracoscopy; Lung cancer; Mesothelioma; Lymphocytic Exudate

Outcome Measures

Primary Outcomes (2)

• Time to Diagnosis

  Time to diagnosis is defined as the period between the first thoracentesis ,showing a lymphocytic exudate, of a newly discovered pleural effusion in a patient without prior signs of pleural disease to the time of multi-disciplinary team final diagnosis involving a pathology report of biopsy samples.

  From enrollment to final diagnosis of MDT, assesed up to 12 months

• Hospitalization time

  The time from the patient's admission in the hospital with diagnosis of unexplained lymphocytic pleural effusion until discharge with or without final diagnosis.

  From enrollment to hospital discharge, assesed up to 3 months

Secondary Outcomes (3)

• Patient's discomfort/pain

  Day 1: immediately post-procedure. Day 2: 24hours post-procedure. Day 3 up to Day of tube removal: Every 24 hours. Time frame ends on removal of chest tube or patient dishcarge, assesment up to 2 weeks

• Complications

  Day 1: immediately post-procedure. Day 2: 24hours post-procedure. Day 3 up to Day of tube removal: Every 24 hours. Time frame ends on removal of chest tube or patient dishcarge, assesment up to 3 months.

• Rate of Non Specific Pleuritis

  Assesment up to 12 months

Study Arms (2)

LAT Group

EXPERIMENTAL

The study group includes patients in whom the investigation of pleural effusion begins directly with pleural biopsy by Local Anesthesia Thoracoscopy (LAT) under conscious sedation. In these patients, imaging with chest CT and/or thoracic ultrasound has been performed and lymphocytic exudate is confirmed in fluid aspiration.

Procedure: Local Anesthesia Thoracoscopy; Device: Pleuroscopy with Rigid Thoracoscope and Forceps biopsies

Control Group

NO INTERVENTION

The Control Group includes patients admitted with undiagnosed pleural lymphocytic exudate, who undergo Standard of Care (SOC) diagnostic strategies according to BTS guideline including among others, 3 samples for cytological examination (40-60 ml each), chest tube drainage, microbiological and immunological studies. If the diagnosis is not established and there is still indication for pleural biopsy patients are referred either for surgical biopsy or LAT.

Interventions

Local Anesthesia Thoracoscopy PROCEDURE

The patient is placed in a lateral decubitus, with the affected hemithorax upwards. Ensuring a venous line and full monitoring of vital functions. Mild sedation is given and a dose of Ceftriaxone is given 30 minutes before. Local anesthesia is injected in layers, starting from the skin and working up to the intercostal muscles, intercostal nerve, and periosteum of the rib. Development of pneumothorax is done using a 16-gauge Boutin needle. 15 spontaneous breaths are sufficient to create a pneumothorax, and entry of rigid thoracoscope into the hemithorax through a 11-13 mm Trocar. Multiple biopsies from the parietal pleura are taken and pleurodesis is made according to operator judgment. A chest drain 20-22 G is placed and sutured. A chest X-ray is performed 2-8 hours later after the patient is transferred to the ward. Chest drain is removed after 24h if fluid production is \<250ml and lung re-expansion.

LAT Group

Pleuroscopy with Rigid Thoracoscope and Forceps biopsies DEVICE

A video thoracoscope with an external light source, outer diameter 10 mm (Karl Storz), is inserted into the pleural cavity through a uniportal incision (1 - 1.5 cm) and complete inspection of the pleural cavity is performed. Parietal pleural biopsies are taken with a rigid 40 mm forceps (Karl Storz).

LAT Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undiagnosed pleural effusion with the character of a lymphocytic exudate

You may not qualify if:

• Empyema
• Transudate pleural effusion.
• Central airway obstruction by tumor.
• Existence of extensive adhesions that do not allow the development of iatrogenic pneumothorax and the safe entry of the thoracoscope.
• Uncontrollable cough.
• Acute respiratory failure and/or Hypercapnia.
• Performance Status: 5

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead
• Sotiria Thoracic Diseases Hospital of Athens: collaborator

Study Sites (1)

Sotiria General Hospital of Thoracic Diseases

Athens, Attica, 11527, Greece

RECRUITING

Related Publications (12)

• Ferguson J, Tsim S, Kelly C, Alexander L, Shad S, Neilly M, Tate M, Zahra B, Saleh M, Cowell G, Banks E, Grundy S, Corcoran J, Downer N, Stanton A, Evison M, Rahman NM, Maskell N, Blyth KG. Staging by Thoracoscopy in potentially radically treatable Lung Cancer associated with Minimal Pleural Effusion (STRATIFY): protocol of a prospective, multicentre, observational study. BMJ Open Respir Res. 2023 Nov 23;10(1):e001771. doi: 10.1136/bmjresp-2023-001771.

  PMID: 37996118 BACKGROUND

• Wan YY, Zhai CC, Lin XS, Yao ZH, Liu QH, Zhu L, Li DZ, Li XL, Wang N, Lin DJ. Safety and complications of medical thoracoscopy in the management of pleural diseases. BMC Pulm Med. 2019 Jul 10;19(1):125. doi: 10.1186/s12890-019-0888-5.

  PMID: 31291926 BACKGROUND

• Shaikh F, Lentz RJ, Feller-Kopman D, Maldonado F. Medical thoracoscopy in the diagnosis of pleural disease: a guide for the clinician. Expert Rev Respir Med. 2020 Oct;14(10):987-1000. doi: 10.1080/17476348.2020.1788940. Epub 2020 Jul 12.

  PMID: 32588676 BACKGROUND

• Gong L, Huang G, Huang Y, Liu D, Tang X. Medical Thoracoscopy for the Management of Exudative Pleural Effusion: A Retrospective Study. Risk Manag Healthc Policy. 2020 Dec 4;13:2845-2855. doi: 10.2147/RMHP.S287758. eCollection 2020.

  PMID: 33324122 BACKGROUND

• Murthy V, Bessich JL. Medical thoracoscopy and its evolving role in the diagnosis and treatment of pleural disease. J Thorac Dis. 2017 Sep;9(Suppl 10):S1011-S1021. doi: 10.21037/jtd.2017.06.37.

  PMID: 29214061 BACKGROUND

• Xu LL, Yang Y, Wang Z, Wang XJ, Tong ZH, Shi HZ. Malignant pleural mesothelioma: diagnostic value of medical thoracoscopy and long-term prognostic analysis. BMC Pulm Med. 2018 Apr 3;18(1):56. doi: 10.1186/s12890-018-0619-3.

  PMID: 29615010 BACKGROUND

• Li D, Jackson K, Panchal R, Aujayeb A. Local Anaesthetic Thoracoscopy for Pleural Effusion-A Narrative Review. Healthcare (Basel). 2022 Oct 9;10(10):1978. doi: 10.3390/healthcare10101978.

  PMID: 36292425 BACKGROUND

• Arnold DT, De Fonseka D, Perry S, Morley A, Harvey JE, Medford A, Brett M, Maskell NA. Investigating unilateral pleural effusions: the role of cytology. Eur Respir J. 2018 Nov 8;52(5):1801254. doi: 10.1183/13993003.01254-2018. Print 2018 Nov.

  PMID: 30262573 BACKGROUND

• Kiani A, Abedini A, Karimi M, Samadi K, Sheikhy K, Farzanegan B, Pour Abdollah M, Jamaati H, Jabardarjani HR, Masjedi MR. Diagnostic Yield of Medical Thoracoscopy in Undiagnosed Pleural Effusion. Tanaffos. 2015;14(4):227-31.

  PMID: 27114723 BACKGROUND

• Wu YB, Xu LL, Wang XJ, Wang Z, Zhang J, Tong ZH, Shi HZ. Diagnostic value of medical thoracoscopy in malignant pleural effusion. BMC Pulm Med. 2017 Aug 4;17(1):109. doi: 10.1186/s12890-017-0451-1.

  PMID: 28778184 BACKGROUND

• Kassirian S, Hinton SN, Cuninghame S, Chaudhary R, Iansavitchene A, Amjadi K, Dhaliwal I, Zeman-Pocrnich C, Mitchell MA. Diagnostic sensitivity of pleural fluid cytology in malignant pleural effusions: systematic review and meta-analysis. Thorax. 2023 Jan;78(1):32-40. doi: 10.1136/thoraxjnl-2021-217959. Epub 2022 Feb 2.

  PMID: 35110369 BACKGROUND

• Tsim S, Paterson S, Cartwright D, Fong CJ, Alexander L, Kelly C, Holme J, Evison M, Blyth KG. Baseline predictors of negative and incomplete pleural cytology in patients with suspected pleural malignancy - Data supporting 'Direct to LAT' in selected groups. Lung Cancer. 2019 Jul;133:123-129. doi: 10.1016/j.lungcan.2019.05.017. Epub 2019 May 16.

  PMID: 31200818 BACKGROUND

MeSH Terms

Conditions

Pleural Effusion; Pleural Effusion, Malignant; Mesothelioma, Malignant; Lung Neoplasms; Mesothelioma

Interventions

Thoracoscopy

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases; Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Mesothelial; Lung 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

• Grigorios Stratakos, Professor

  National and Kapodistrian University of Athens

  STUDY DIRECTOR

Central Study Contacts

Nektarios ANAGNOSTOPOULOS, Ass. professor

CONTACT

+306946869480; aris.anag@yahoo.gr

Michail Kon/nos Tsatsis, MD, MSc, PhDc

CONTACT

+306979234105; tsatsis.mihail@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Interventional Pulmonology

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: April 27, 2025
• Study Start: May 23, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)