Efficacy And Safety Of Thoracoscopic Cryobiopsy In Patients With Undiagnosed Exudative Pleural Effusion

NCT04761003 | Completed

• 1 other identifier: Thoracoscopic cryobiopsy
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

To demonstrated the efficacy and safety of taking biopsy specimens from parietal pleura in undiagnosed exudative pleural effusion

Conditions

Pleura; Exudate

Outcome Measures

Primary Outcomes (3)

• efficacy which determined by the diagnostic yield

  comparing forceps biopsy and cryobiopsy as regard: efficacy which determined by the diagnostic yield.

  baseline

• efficacy which determined by the size of biopsy

  comparing forceps biopsy and cryobiopsy as regard: efficacy which determined by the size of biopsy.

  baseline

• The incidence of complications

  comparing forceps biopsy and cryobiopsy as regard: Safety which determined by the incidence of complications

  baseline

Study Arms (2)

Group I (Cryobiopsy group):

ACTIVE COMPARATOR

patients where patients will be subjected to thoracoscopic cryobiopsy.

Device: Thoracoscopy forceps

Group II (Forceps group)

ACTIVE COMPARATOR

patients where patients will be subjected to thoracoscopic forceps biopsy.

Device: Thoracoscopy forceps

Interventions

Thoracoscopy forceps DEVICE

take pleural biopsy

Also known as: Thoracoscopic cryobiopsy

Group I (Cryobiopsy group):; Group II (Forceps group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients diagnosed as exudative pleural effusion according to Light criteria .informed written consents were taken from all patients enrolled in the study

You may not qualify if:

• patients who refused participation ,patients unfit for medical thoracoscopy (MT) will be excluded from the study such as:Uncooperative patient ,Severe uncorrected hypoxemia in spite of continuous oxygen administration, because it's necessary to keep oxygen saturation above 90 % during procedure ,patients who could not tolerate the lateral decubitus position for a period long adequate to do the thoracoscopy, unstable cardiovascular or hemodynamic condition, uncorrected Coagulation defects and small pleural space

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, Egypt

Location

Related Publications (7)

• Light RW. Pleural diseases. Curr Opin Pulm Med. 2003 Jul;9(4):251-3. doi: 10.1097/00063198-200307000-00001. No abstract available.

  PMID: 12806235 RESULT

• Noppen M. The utility of thoracoscopy in the diagnosis and management of pleural disease. Semin Respir Crit Care Med. 2010 Dec;31(6):751-9. doi: 10.1055/s-0030-1269835. Epub 2011 Jan 6.

  PMID: 21213207 RESULT

• Porcel JM. Pleural fluid biomarkers: beyond the Light criteria. Clin Chest Med. 2013 Mar;34(1):27-37. doi: 10.1016/j.ccm.2012.11.002. Epub 2013 Jan 17.

  PMID: 23411054 RESULT

• Tousheed SZ, Manjunath PH, Chandrasekar S, Murali Mohan BV, Kumar H, Hibare KR, Ramanjaneya R. Cryobiopsy of the Pleura: An Improved Diagnostic Tool. J Bronchology Interv Pulmonol. 2018 Jan;25(1):37-41. doi: 10.1097/LBR.0000000000000444.

  PMID: 29261578 RESULT

• Bonniot JP, Homasson JP, Roden SL, Angebault ML, Renault PC. Pleural and lung cryobiopsies during thoracoscopy. Chest. 1989 Mar;95(3):492-3. doi: 10.1378/chest.95.3.492.

  PMID: 2920573 RESULT

• Hetzel J, Hetzel M, Hasel C, Moeller P, Babiak A. Old meets modern: the use of traditional cryoprobes in the age of molecular biology. Respiration. 2008;76(2):193-7. doi: 10.1159/000135934. Epub 2008 Jun 26.

  PMID: 18708736 RESULT

• Porcel JM, Light RW. Diagnostic approach to pleural effusion in adults. Am Fam Physician. 2006 Apr 1;73(7):1211-20.

  PMID: 16623208 RESULT

Study Officials

• Raed E ALI, MD

  Mansoura University

  STUDY CHAIR

• Ahmed E Mansour, MD

  Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: A full medical history was obtained. Medical history, clinical examination and local chest examination for signs of pleural effusion, Radiological data include chest X-ray, chest computed tomography (CT), and chest ultrasound (US) for localization of a better entry site. Thoracoscopy procedure the procedure was performed in the lateral decubitus position with the affected side upward under conscious sedation. Local anesthesia consisting of 2% lignocaine was administered to the skin, subcutaneous tissue, muscle, and parietal pleura. The appearance of the parietal and visceral pleural was assessed and recorded. Pleural biopsies were obtained using rigid forceps and cryoprobe during rigid medical thoracoscopy Complications during thoracoscopy were recorded as bleeding and surgical emphysema. Samples were directly fixed in 10% formalin solution Biopsies obtained were examined pathologically with stress on size and quality of the sample.

Study Record Dates

• First Submitted: February 14, 2021
• First Posted: February 18, 2021
• Study Start: January 1, 2021
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: March 15, 2021

Record last verified: 2021-03

Locations

EG (1)