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"Paracentesis - adverse effects"
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Palliative long-term abdominal drains vs. large volume paracentesis for refractory ascites secondary to cirrhosis: protocol for a definitive randomised controlled trial (REDUCe2 study)
2025
Background
Ascites remains the most common complication of cirrhosis and a frequent reason for hospitalisation in advanced chronic liver disease (ACLD). Ascites is associated with significant symptom burden, caregiver workload and poor health-related quality of life (HRQoL). Once refractory to treatment, median survival is poor. Many with refractory ascites (RA) will neither receive a transjugular intrahepatic portosystemic shunt (TIPS) nor a liver transplant. Palliative care remains underutilised and evidence-based interventions focused on improving HRQoL are clearly needed. The standard of care for RA is repeated hospital ascites drainage with large volume paracentesis (LVP). Our earlier feasibility randomised controlled trial (RCT) (REDUCe) showed acceptability of palliative tunnelled long-term abdominal drains (LTADs), as well as preliminary evidence of safety and efficacy. The current REDUCe2 trial is a definitive national study designed to assess the impact of palliative LTADs on HRQoL in patients with RA due to ACLD.
Methods/design
The REDUCe2 study is a pragmatic, multicentre, open-label, mixed-methods, superiority RCT being conducted in England, Scotland and Wales. Patients with RA secondary to ACLD who are ineligible for a liver transplant or TIPS will be randomised 1:1 to receive a LTAD or continue the current standard of care (LVP). Fortnightly home research visits will be conducted for 12 weeks in both arms. The primary outcome will be liver specific HRQoL assessed at 12 weeks using the Short Form Liver Disease Quality of Life questionnaire (SFLDQoL). Secondary outcomes include assessment of symptom burden (Ascites Questionnaire), health utilities (EQ-5D-5L tool), caregiver workload (Caregiver Roles and Responsibilities Scale—CRRS questionnaire), safety (including infection, acute kidney injury and other clinical outcomes), health resource utilisation and acceptability of the intervention by patients, caregivers and healthcare professionals. We aim to recruit a total of 310 patients (155 in each arm).
Discussion
Effective palliative care provision remains an unmet need in ACLD. The REDUCe2 study, the largest palliative interventional trial in the UK, aims to address this inequity for this vulnerable and underserved cohort. It has the potential to generate high quality evidence to optimise and enhance palliative care in RA.
Trial registration
ISRCTN26993825, date registered: 15/08/2022.
Journal Article
Midodrine Versus Albumin in the Prevention of Paracentesis-Induced Circulatory Dysfunction in Cirrhotics: A Randomized Pilot Study
by
Sharma, Navneet
,
Mahi, Sushil K.
,
Nain, Chander K.
in
Adult
,
Ascites - etiology
,
Ascites - therapy
2008
Intravenous albumin has been used to prevent paracentesis-induced circulatory dysfunction (PICD) in cirrhotics; however, its use is costly and controversial. Splanchnic arterial vasodilatation is primarily responsible for PICD. There are no reports of use of midodrine in the prevention of PICD. In this pilot study, we evaluated midodrine and albumin in the prevention of PICD.
Forty patients with cirrhosis underwent therapeutic paracentesis with midodrine or albumin in a randomized controlled trial at a tertiary center. Effective arterial blood volume was assessed by plasma renin activity.
Plasma renin activity at baseline and at 6 days after paracentesis did not differ in the two groups (43.18 +/- 10.73 to 45.90 +/- 8.59 ng/mL/h, P= 0.273 in the albumin group and 44.44 +/- 8.44 to 41.39 +/- 10.21 ng/mL/h, P= 0.115 in the midodrine group). Two patients had an increase in plasma renin activity of more than 50% from baseline in the albumin group, and none in the midodrine group. A significant increase in 24-h urine volume and urine sodium excretion was noted in the midodrine group. Midodrine therapy was cheaper than albumin therapy.
The study suggests that midodrine may be as effective as albumin in preventing PICD in cirrhotics, but at a fraction of the cost, and can be administered orally. Midodrine also resulted in an increase in 24-h urine volume and sodium excretion.
Journal Article
A randomised controlled trial of the reciprocating syringe in arthrocentesis
2006
Objective: To evaluate the outcomes of arthrocentesis with the new highly controllable, one handed reciprocating procedure syringe compared with a conventional syringe. Methods: 100 arthrocentesis procedures were randomised between the reciprocating syringe and the conventional syringe. Outcome measures included patient pain, procedure duration, operator satisfaction, synovial fluid volume, cell counts, and complications. Results: 50 arthrocentesis procedures with the conventional syringe resulted in a mean (SD) procedure time of 3.39 (1.88) minutes, a mean VAPS (patient pain) score of 5.35 (3.15), and a mean VASS (operator satisfaction) score of 4.88 (1.92); 30 of the 50 subjects experienced moderate to severe pain (VAPS score 5 or greater) during arthrocentesis. In contrast, the reciprocating syringe resulted in a reduced procedure time of 1.94 (1.14) minutes (p<0.001), a reduced VAPS (patient pain) score of 2.54 (1.60) (p<0.001), and an increased VASS (operator satisfaction) score of 8.91 (0.79) (p<0.001). Only five of the 50 of subjects experienced moderate to severe pain with the reciprocating syringe. Synovial cell counts were similar between the two syringes (p>0.05), but there was a trend toward greater volume (greater synovial fluid yield) and fewer red blood cells with the reciprocating syringe. Conclusions: Arthrocentesis with a conventional syringe results in moderate to severe pain in 60% of subjects. The reciprocating syringe prevents significant pain, reduces procedure time, and improves physician performance of arthrocentesis. The reciprocating syringe is superior to the conventional syringe in arthrocentesis.
Journal Article
Management of refractory ascites
2023
The development of refractory ascites in approximately 10% of patients with decompensated cirrhosis heralds the progression to a more advanced stage of cirrhosis. Its pathogenesis is related to significant hemodynamic changes, initiated by portal hypertension, but ultimately leading to renal hypoperfusion and avid sodium retention. Inflammation can also contribute to the pathogenesis of refractory ascites by causing portal microthrombi, perpetuating the portal hypertension. Many complications accompany the development of refractory ascites, but renal dysfunction is most common. Management starts with continuation of sodium restriction, which needs frequent reviews for adherence; and regular large volume paracentesis of 5 L or more with albumin infusions to prevent the development of paracentesisinduced circulatory dysfunction. Albumin infusions independent of paracentesis may have a role in the management of these patients. The insertion of a covered, smaller diameter, transjugular intrahepatic porto-systemic stent shunt (TIPS) in the appropriate patients with reasonable liver reserve can bring about improvement in quality of life and improved survival after ascites clearance. Devices such as an automated low-flow ascites pump may be available in the future for ascites treatment. Patients with refractory ascites should be referred for liver transplant, as their prognosis is poor. In patients with refractory ascites and concomitant chronic kidney disease of more than stage 3b, assessment should be referred for dual liver-kidney transplants. In patients with very advanced cirrhosis not suitable for any definitive treatment for ascites control, palliative care should be involved to improve the quality of life of these patients.
Journal Article
Outcomes following nurse-led day-case paracentesis
by
Umar, Rabiat
,
Wilkes, Emilie
,
Yousuff, Mahir
in
Abdomen
,
Advanced chronic liver disease
,
Alcohol use
2026
•About 10% of patients with cirrhosis and ascites require therapeutic paracentesis (TP).•Nurse-led day-case services are being established due to rising demand for TP.•Nurse-led services have similar morbidity risks to physician-led services.•The cumulative yearly mortality rates of TP are demonstrated.
Therapeutic paracentesis (TP) is a key symptom-relieving intervention in refractory ascites. In response to rising demand, Nottingham University Hospitals NHS Trust was among the first UK centres to introduce a nurse-led, day-case TP service. This study evaluates the complications and mortality associated with this service.
Retrospective analysis was undertaken on patients with decompensated cirrhosis who underwent nurse-led day-case TP between 1 January 2017 and 31 December 2021. Clinical and outcome data were systematically collected.
A total of 2,530 TP procedures were performed on 340 patients. Minor (self-limiting) complications occurred in 54 cases (2.1%). In 22 cases (0.9%), patients were admitted to hospital within 7 days of TP – the reasons for admission were bacterial peritonitis (n = 11), abdominal pain (n = 3), and leakage of ascitic fluid (n = 7) or bleeding (n = 1) from the puncture site. There were no cases of abdominal visceral perforation or in-hospital deaths among those admitted.
About 290 patients were included in 1-year survival analysis. About 177 (61%) were alive 1 year after their first TP. The median time from first TP to death was 125 days (IQR 43–210). The 30- and 90-day mortality rates after TP were 21.0% and 33.1%, respectively. Older age (p < 0.001), hepatocellular carcinoma (p < 0.001) and ongoing alcohol use (p < 0.001) were independently associated with 1-year mortality.
Nurse-led, day-case TP is an effective and safe approach for managing refractory ascites in decompensated cirrhosis. Mortality remains high, particularly in patients with hepatocellular carcinoma and ongoing alcohol use.
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Journal Article
Thoracentesis outcomes: a 12-year experience
2015
Background Despite a lack of evidence in the literature, several assumptions exist about the safety of thoracentesis in clinical guidelines and practice patterns. We aimed to evaluate specific demographic and clinical factors that have been commonly associated with complications such as iatrogenic pneumothorax, re-expansion pulmonary oedema (REPE) and bleeding. Methods We performed a cohort study of inpatients who underwent thoracenteses at Cedars-Sinai Medical Center (CSMC) from August 2001 to October 2013. Data were collected prospectively including information on volume of fluid removed, procedure side, whether the patient was on positive pressure ventilation, number of needle passes and supine positioning. Iatrogenic pneumothorax, REPE and bleeding were tracked for 24 h after the procedure or until a clinical question was reconciled. Demographic and clinical characteristics were obtained through query of electronic medical records. Results CSMC performed 9320 inpatient thoracenteses on 4618 patients during the study period. There were 57 (0.61%) iatrogenic pneumothoraces, 10 (0.01%) incidents of REPE and 17 (0.18%) bleeding episodes. Iatrogenic pneumothorax was significantly associated with removal of >1500 mL fluid (p<0.0001), unilateral procedures (p=0.001) and more than one needle pass through the skin (p=0.001). For every 1 mL of fluid removed there was a 0.18% increased risk of REPE (95% CI 0.09% to 0.26%). There were no significant associations between bleeding and demographic or clinical variables including International Normalised Ratio, partial thromboplastin time and platelet counts. Conclusions Our series of thoracenteses had a very low complication rate. Current clinical guidelines and practice patterns may not reflect evidence-based best practices.
Journal Article
Iatrogenic vascular complications of non-vascular percutaneous abdominal procedures
2024
PurposeThe purpose of this paper is to compile and present all of the reported vascular complications that resulted from common non-vascular abdominal procedures in the literature. Non-vascular procedures include, though are not limited to, percutaneous abscess/fluid collection drainage (PAD), percutaneous nephrostomy (PN), paracentesis, percutaneous transhepatic cholangiography (PTC)/percutaneous biliary drainage (PBD), percutaneous biliary stone removal, and percutaneous radiologic gastrostomy (PG)/percutaneous radiologic gastrojejunostomy (PG-J). By gathering this information, radiologists performing these procedures can be aware of the associated vascular injuries, as well as take steps to minimize risks.MethodsA literature review was conducted using the PubMed database to catalog relevant articles, published in the year 2000 onward, in which an iatrogenic vascular complication occurred from the following non-vascular abdominal procedures: PAD, PN, paracentesis, PTC/PBD, percutaneous biliary stone removal, and PG/PG-J. Biopsy and tumor ablation were deferred from this article.Results214 studies met criteria for analysis. 28 patients died as a result of vascular complications from the analyzed non-vascular abdominal procedures. Vascular complications from paracentesis were responsible for 19 patient deaths, followed by four deaths from PTC/PBD, three from biliary stone removal, and two from PG.ConclusionDespite non-vascular percutaneous abdominal procedures being minimally invasive, vascular complications still can arise and be quite serious, even resulting in death. Through the presentation of vascular complications associated with these procedures, interventionalists can improve patient care by understanding the steps that can be taken to minimize these risks and to reduce complication rates.
Journal Article
Safety of anterior chamber paracentesis using a 30-gauge needle integrated with a specially designed disposable pipette
2017
AimsTo investigate the safety of anterior chamber (AC) paracentesis using a 30-gauge needle integrated with a specially designed disposable pipette.MethodsIn this retrospective observational case-series study, AC paracentesis was performed on 301 eyes of 301 patients between September 2009 and August 2016 at the Department of Ophthalmology, Kyoto Prefectural University of Medicine and the Baptist Eye Institute, Kyoto, Japan. AC paracentesis was performed with the patient placed in the supine position using a 30-gauge needle integrated with a disposable pipette with one hand, and the safety post procedure was then evaluated.ResultsThe indications for AC paracentesis were virus detection (ie, corneal endotheliitis, anterior infectious uveitis, cytomegalovirus retinitis and acute retinal necrosis) in 264 eyes, bacterial detection (ie, endophthalmitis) in 8 eyes and malignancy (ie, primary intraocular lymphoma, leukaemia and retinoblastoma) in 29 eyes. No serious complications such as infection, hyphema, lens trauma or severe inflammation including hypopyon and AC fibrin formation were observed.ConclusionsOur findings show that AC paracentesis with a disposable pipette is safe with no severe complications.
Journal Article
Pleural procedures and patient safety: a national BTS audit of practice
2015
The BTS pleural procedures audit collected data over a 2-month period in June and July 2011. In contrast with the 2010 audit, which focussed simply on chest drain insertions, data on all pleural aspirations and local anaesthetic thoracoscopy (LAT) was also collected. Ninety hospitals submitted data, covering a patient population of 33 million. Twenty-one per cent of centres ran a specialist pleural disease clinic, 71% had a nominated chest drain safety lead, and 20% had thoracic surgery on site. Additionally, one-third of centres had a physician-led LAT service.
Journal Article
Construction and validation of a nomogram predictive model for safety-related influencing factors in unilateral paracentesis kyphoplasty for spinal compression fractures
2026
Background
To explore the influencing factors on the safety of unilateral puncture kyphoplasty in the treatment of spinal compression fractures, and to construct and verify the nomogram prediction model.
Methods
Relevant information about patients who received safe unilateral puncture kyphoplasty for the treatment of spinal compression fractures in our hospital from January 2022 to October 2023 was collected retrospectively. Independent predictive variables included in the Nomogram model were determined and modeled through univariate analysis and multivariate logistic analysis, for internal validation and evaluation of model accuracy, discrimination and calibration.
Results
A total of 240 patients was enrolled and randomly divided into a training set (
n
= 168) and a validation set (
n
= 72) at a 7:3 ratio. The rates of ineffective treatment in training set and validation set were 18.45% and 16.67%. Age, cone leading edge height loss rate, sagittal Cobb angle of vertebral body, pedicle width, pedicle height, preoperative hemoglobin level and preoperative blood calcium level were significantly associated with ineffective treatment of spinal compression fractures (all
P
< 0.05). The receiver operating characteristic curves showed that the area under the curves for suboptimal treatment predicted by the nomogram model was 0.871 (95% CI 0.769–0.972) and 0.787 (95% CI 0.578–0.996), respectively.
Conclusions
The constructed nomogram demonstrated acceptable predictive ability for the safety of unilateral paracentesis kyphoplasty in the treatment of spinal compression fractures. This model shows promising potential for clinical application, though the generalizability requires further external validation.
Journal Article