Clinical trial NCT06099054: Ultrasound-guided Pigtail Catheter Versus Intercostal Tube Drainage of Non-traumatic Exudative Pleural Effusion
Official title: Ultrasound-guided Pigtail Catheter Versus Intercostal Tube Drainage of Non-traumatic Exudative Pleural Effusion
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pleural Effusion
Keywords: pigtail versus intercostal tube
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-10-25
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomised to either group:

Group I (Intervention group): in which pleural effusion will be drained using pigtail catheter under US guidance.

Group II (Control group): in which pleural effusion will be drained using ICT
Primary purpose: TREATMENT

Brief summary: Primary Aims:

To compare the performance of pigtail catheter to that of ICT in drainage of pleural effusion of medical aetiology regarding:

1. Various complications(mainly wound pain) that result from either therapeutic approach.
2. Success of complete drainage.
3. Compare the duration needed for complete drainage.

Secondary Aims:

To evaluate both techniques in terms of:

1. Degree of patient's mobility that either technique permits.
2. Percentage of patients that can be managed on outpatient settings by either approach

Detailed description: The pleural cavity is a space between the visceral and parietal pleura that contains a subtle amount of serous fluid (10 to 20ml) this fluid act as a lubricant to the pleural surface for proper gliding during respiration . Accumulation of abnormal amount of pleural fluid occurs under various pathological disorders, each of which manifests with a different physical and biochemical characteristics of the effused pleural fluid, it may be serous,pus,blood,or chyle.

Long standing undrained accumulated pleural fluid can lead to serious complications: like lung collapse leading to respiratory failure, fibrosis or scarring of the pleural membranes and underlying lung tissue, empyema, septic shock and even death in severe circumstance .

So we always seek to drain accumulated pleural fluid; Chest tubes connected to underwater seal have largely replaced open thoracotomy and rib resection in draining exudative pleural effusion and are now considered the standard method . However Intercostal tube drainage poses risks and hazards: large size of the tube that make it more painful more tissue destructive with more injury to intercostal arteries and nerves, the incisional insertion is also painful and results in more tissue dissection, moreover the tube is heavy as it need water seal to work so causing patient discomfort and increase liability of slippage.

Recently pigtail catheter has been employed to drain accumulated pleural fluid .pigtail catheter has many advantages: it has small caliber , which makes it less painful, less tissue destruction, less Injurious to intercostal nerves and vessels, Additionally it has a suction power with unidirectional valve which abolishes the need for underwater seal; thus avoiding the heavy weight of bottles and decreasing the risk of accidental slippage, inserted with trocar under ultrasonographic guidance decreasing liability of lung injury.

Previous studies compared pigtail versus chest tube in drainage of pleural effusion show .A total of 92 patients were included in the study, 57 (61.9%) patients in pigtail group and 35 (31.8%) in ICD group. Causes of pleural effusion included were pneumonia, malignancy,TB. the study had revealed that pigtail catheter had higher success rate less painful with no significant difference at mean duration of drainage..At other study data collected retrospectively from 60 patient aged more than 18 year 30 patients had an intercostal chest tube and 30 patients had pigtail catheters found that no statistically significant difference between pigtail and ICT at success rate and duration of drainage but pigtail found less painful with less incidence of complication regarding pneumothorax and catheter kinking and slippage .

However these studies have some limations first study was observational study not randomised, second study was retrospective with small sample size. Both studies have no clear definitions of outcomes , not focus on complications mainly wound pain as primary outcome and didn't answer the question of recurrence or drainage failure of pleural effusion after pigtail catheter drainage.

Eligibility criteria: Inclusion Criteria:

1. Age \> 18 years.
2. Non-traumatic non-iatrogenic exudative pleural effusion necessitating drainage.
3. Loculated pleural effusion where positive colour doppler sign is preserved

Exclusion Criteria:

1. Traumatic or iatrogenic pleural effusion.
2. Transudative pleural effusion (subjected to treatment of the underlying cause and diuretic therapy).
3. Exudative pleural effusion amenable for medical treatment
4. Large-volume, easily accessible, free non-loculated empyema.
5. Pleural infections with loculated pleural effusion but showing negative colour doppler sign.
6. Malignant pleural effusion with potentially inexpnasible underlying lung (thick pleural peel, central airway obstruction), life expectancy \< 1 month or asymptomatic.
7. Patients with uncorrected bleeding tendency (INR \> 1.5, Platelet count \< 50.000/mm3).
8. Inability or refusal to sign written consent.

Primary outcomes:
measure: 1) Degree of Pain/discomfort elicited by the Intervention:
timeFrame: 10 day
measure: 2) Adverse outcomes complicating either line of intervention
timeFrame: through study completion, an average of 1 year
measure: 3) Success of Complete Drainage
timeFrame: through study completion, an average of 1 year
measure: 4) Duration needed for Complete Drainage:
timeFrame: 15 day
Secondary outcomes:
measure: 5) Degree of Patient's Mobility:
timeFrame: 0ne week
measure: 6) Duration of Hospital stay.
timeFrame: "through study completion, an average of 1 year
measure: 7) Number of Patients Managed on Outpatient Settings.
timeFrame: "through study completion, an average of 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Assiut Univeristy
name: Hossam El-din Galal, Prof.Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut Univeristy
name: Hamdy Mohammad Ibrahim, lecturer
role: STUDY_DIRECTOR
affiliation: Assiut Univeristy
name: Sara Mohammed Hashem, lecturer
role: STUDY_DIRECTOR
References:
citation: Chubb SP, Williams RA. Biochemical Analysis of Pleural Fluid and Ascites. Clin Biochem Rev. 2018 May;39(2):39-50.
citation: Karkhanis VS, Joshi JM. Pleural effusion: diagnosis, treatment, and management. Open Access Emerg Med. 2012 Jun 22;4:31-52. doi: 10.2147/OAEM.S29942. eCollection 2012.
citation: Broaddus VC, Light RW. Pleural effusion. In:Broaddus VC, Ernst JD, King TE, et al, eds. Murray and Nadel's Textbook of Respiratory Medicine. 7th ed. Philadelphia, PA: Elsevier; 2022:chapater108
citation: Monaghan SF, Swan KG. Tube thoracostomy: the struggle to the "standard of care". Ann Thorac Surg. 2008 Dec;86(6):2019-22. doi: 10.1016/j.athoracsur.2008.08.006.
citation: Munnell ER. Thoracic drainage. Ann Thorac Surg. 1997 May;63(5):1497-502. doi: 10.1016/s0003-4975(97)00082-9.
citation: Liu YH, Lin YC, Liang SJ, Tu CY, Chen CH, Chen HJ, Chen W, Shih CM, Hsu WH. Ultrasound-guided pigtail catheters for drainage of various pleural diseases. Am J Emerg Med. 2010 Oct;28(8):915-21. doi: 10.1016/j.ajem.2009.04.041. Epub 2010 Feb 25.
citation: Gammie JS, Banks MC, Fuhrman CR, Pham SM, Griffith BP, Keenan RJ, Luketich JD. The pigtail catheter for pleural drainage: a less invasive alternative to tube thoracostomy. JSLS. 1999 Jan-Mar;3(1):57-61.
citation: Khare R*, Anand K, Agrawal P, Yadav A. Comparative analysis of pigtail catheter versus intercostal tube drainage for pleural effusion: a tertiary centre study. Khare R et al. Int Surg J. 2023 Jan;10(1):105-109
citation: Mathis G. Pleura. In: Mathis G, ed. Chest sonography. 3rd ed. Heidelberg: Springer-Verlag, 2011;30-32
citation: Yang PC, Luh KT, Chang DB, Wu HD, Yu CJ, Kuo SH. Value of sonography in determining the nature of pleural effusion: analysis of 320 cases. AJR Am J Roentgenol. 1992 Jul;159(1):29-33. doi: 10.2214/ajr.159.1.1609716.
citation: Reuß J., "Sonographic imaging of the pleura: Nearly 30 years experience," European Journal of Ultrasound, vol. 3, no. 2, pp. 125-139, 1996.
citation: SELDINGER SI. Catheter replacement of the needle in percutaneous arteriography; a new technique. Acta Radiol (Stockh). 1953 May;39(5):368-76. doi: 10.3109/00016925309136722. No abstract available.
citation: Laws D, Neville E, Duffy J; Pleural Diseases Group, Standards of Care Committee, British Thoracic Society. BTS guidelines for the insertion of a chest drain. Thorax. 2003 May;58 Suppl 2(Suppl 2):ii53-9. doi: 10.1136/thorax.58.suppl_2.ii53. No abstract available.
citation: Fox V, Gould D, Davies N, Owen S. Patients' experiences of having an underwater seal chest drain: a replication study. J Clin Nurs. 1999 Nov;8(6):684-92. doi: 10.1046/j.1365-2702.1999.00307.x.