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Predictors of treatment response following aspiration sclerotherapy of hepatic cysts: an international pooled analysis of individual patient data.

ABSTRACT: OBJECTIVES:To identify predictive variables of treatment response following aspiration sclerotherapy of large symptomatic hepatic cysts. METHODS:We collected individual patient data from two tertiary referral centres and included all patients treated with aspiration sclerotherapy of a large (>5 cm), symptomatic hepatic cyst. At six months, clinical response was defined as complete or incomplete. Secondary, suboptimal technical response was defined as lower quartile of cyst reduction. Predictive variables of clinical and technical response were analyzed by logistic regression analysis. RESULTS:We included 86 patients (58?±?10 years; female 90 %). Complete clinical response rate was 55 %. Median cyst diameter and volume reduction were 71 % (IQR 50-87 %) and 98 % (IRQ 88-100 %), respectively. Patients with complete clinical response had a significantly higher cyst reduction compared to incomplete responders (OR 1.02, 95 % CI 1.00-1.04). Aspiration of haemorrhagic cyst fluid (OR 4.39, 95 % CI 1.34-14.39) or a lower cyst reduction at one month (OR 1.06, 95 % CI 1.02-1.10) was associated with a suboptimal technical response at six months. CONCLUSION:Complete clinical response is associated with effective cyst reduction. Aspiration of haemorrhagic cyst fluid or a restricted diameter reduction at one month predicts a suboptimal technical treatment response, however, these variables did not predict symptom disappearance. KEY POINTS:• Aspiration sclerotherapy of hepatic cysts shows excellent clinical and technical efficacy. • Optimal clinical responders have a markedly higher cyst reduction. • Haemorrhagic aspirate and a strong fluid reaccumulation predict suboptimal cyst reduction.

SUBMITTER: Wijnands TF

PROVIDER: S-EPMC5209423 | biostudies-literature | 2017 Feb

REPOSITORIES: biostudies-literature

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Predictors of treatment response following aspiration sclerotherapy of hepatic cysts: an international pooled analysis of individual patient data.

Wijnands Titus F M TF Ronot Maxime M Gevers Tom J G TJ Benzimra Julie J Kool Leo J Schultze LJ Vilgrain Valérie V Drenth Joost P H JP

European radiology 20160514 2

<h4>Objectives</h4>To identify predictive variables of treatment response following aspiration sclerotherapy of large symptomatic hepatic cysts.<h4>Methods</h4>We collected individual patient data from two tertiary referral centres and included all patients treated with aspiration sclerotherapy of a large (>5 cm), symptomatic hepatic cyst. At six months, clinical response was defined as complete or incomplete. Secondary, suboptimal technical response was defined as lower quartile of cyst reducti ...[more]

PMID: 27180184

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Project description:ObjectiveTo assess whether quantitative assessment of symptom reduction is a better outcome parameter than cyst volume reduction for treatment success in patients treated by aspiration sclerotherapy.MethodsWe included patients with symptomatic, large (> 5 cm), hepatic cysts from a randomized controlled trial (NCT02048319). At baseline and 6 months after treatment, symptoms were assessed with the polycystic liver disease questionnaire (PLD-Q) and we measured cyst volume using ultrasonography. Patient-reported change in health was assessed on a 5-point Likert scale (much worse to much better) after 6 months. We tested whether PLD-Q scores and cyst volumes changed after aspiration sclerotherapy (responsiveness). Changes in PLD-Q scores and cyst volume were compared with change in health as a measure of treatment success (discriminative ability). As secondary analysis, we compared baseline characteristics between responders (improved) and non-responders (not improved).ResultsWe included 32 patients. Six months after treatment, 23 patients (72%) improved. Both PLD-Q score and cyst volume significantly decreased (median 38 to 18 points, p < 0.001, and 479 to 68 mL, p < 0.001). Larger improvement in PLD-Q score was associated with a positive change in health (p = 0.001), while larger proportional reduction in cyst volume was not significantly associated with health improvement after treatment (p = 0.136). Responders had larger baseline cyst volumes compared to non-responders (median 624 mL [IQR 343-1023] vs. 322 mL [IQR 157-423] p = 0.008).ConclusionCyst diameter reduction does not reflect treatment success in aspiration sclerotherapy from patients' perspective, while symptoms measured with the PLD-Q can be used as a reliable outcome measure.Key points• Cyst diameter reduction poorly reflects treatment success in aspiration sclerotherapy. • Symptoms measured by the polycystic liver disease questionnaire (PLD-Q) is a better outcome measure than cyst volume reduction for treatment success after aspiration sclerotherapy. • Particularly patients with larger cysts (≥ 529 mL) benefit from aspiration sclerotherapy.

Project description:Aspiration sclerotherapy is an effective therapeutic option for large symptomatic hepatic cysts. However, incomplete cyst reduction following aspiration sclerotherapy is frequently reported. Strong post-procedural cyst fluid secretion by cholangiocytes, which line the epithelium of the hepatic cyst, seems to be associated with lower reduction rates. Previous studies showed that somatostatin analogues curtail hepatic cyst fluid production. This trial will evaluate the effect of aspiration sclerotherapy combined with the somatostatin analogue pasireotide on cyst reduction. By combining treatment modalities we aim to improve cyst reduction leading to greater symptomatic relief and reduced rates of cyst recurrence.This single center, randomized, double-blind, placebo-controlled clinical trial evaluates the additional effect of pasireotide when combined with aspiration sclerotherapy in patients with a large (>5 cm) symptomatic hepatic cyst. A total of 34 participants will be randomized in a 1:1 ratio. In the active arm, patients will receive pasireotide (long-acting release, 60 mg injection) two weeks prior to and two weeks following aspiration sclerotherapy. Patients in the control arm will receive placebo injections at corresponding intervals. The primary outcome is proportional cyst diameter reduction four weeks after aspiration sclerotherapy compared to baseline measurements, obtained by ultrasonography. As secondary outcomes, proportional volume reduction, recurrence, symptomatic relief and improvement of health-related quality of life will be assessed. Furthermore, safety and tolerability of the combination of pasireotide and aspiration sclerotherapy will be evaluated.This trial aims to improve efficacy of aspiration sclerotherapy by a combined approach of two treatment modalities. We hypothesize that pasireotide will decrease fluid re-accumulation after aspiration sclerotherapy, leading to effective hepatic cyst reduction and symptomatic relief.This trial is registered with ClinicalTrials.gov (identifier: NCT02048319 ; registered on 6 January 2014) and EudraCT (identifier: 2013-003168-29; registered on 16 August 2013).

Project description:Bleomycin sclerotherapy is used in the treatment of cystic lesions; however, the histopathological changes are undefined. Present animal models of cystic diseases are not adequate for the study of sclerotherapy of hepatic cysts, primarily because the established cysts in these models are too small in size. The aim of the present study was to establish a new animal model of simple hepatic cysts, and assess the histopathological changes after bleomycin sclerotherapy. Rabbit gallbladder, with ligaturing of the cholecystic duct whilst preserving cholecystic vessels, was used as a model for simple hepatic cysts. Bleomycin (2 mg dissolved in 1 ml saline) was injected into the aspirated gallbladder, gallbladder tissue was harvested (after 1, 7, 14, 28, 42, 56 and 84 days) and histopathological changes were evaluated (n=4 per group). Additionally, control rabbit gallbladders were injected with 1 ml saline and sampled after 14 days (n=4). Histopathological changes were evaluated using hematoxylin-eosin and Masson's trichrome staining, and immunohistochemistry for CD20-, CD43- and CD68-positive cells was performed. The integrated optical density (IOD) of immunohistochemical staining and average positive stained area percentage (APSAP) of collagen were quantitatively analyzed. The results revealed gallbladders in the control group had regular epithelial cells with no visible inflammation or fibrosis. In the experimental group, epithelial cells were swollen and necrotic on the first day, and were replaced gradually by single-layer flat cells from day 56. Inflammatory infiltration was found in the submucosa, and the IOD of T cells, B cells and macrophages were highest on day 1, and these parameters declined gradually, eventually disappearing. The APSAP of collagen was highest on day 7, and gradually declined thereafter. The results suggest that histopathological changes after bleomycin sclerotherapy of a simple hepatic cyst model were characterized by sequential epithelial destruction, inflammatory cell infiltration, collagen proliferation and epithelial partial regeneration.

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Predictors of treatment response following aspiration sclerotherapy of hepatic cysts: an international pooled analysis of individual patient data.

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Predictors of treatment response following aspiration sclerotherapy of hepatic cysts: an international pooled analysis of individual patient data.

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