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Pasireotide does not improve efficacy of aspiration sclerotherapy in patients with large hepatic cysts, a randomized controlled trial.

ABSTRACT: OBJECTIVES:We tested whether complementary use of the somatostatin analogue pasireotide would augment efficacy of aspiration sclerotherapy of hepatic cysts. METHODS:We conducted a double-blind, placebo-controlled trial in patients who underwent aspiration sclerotherapy of a large (>5 cm) symptomatic hepatic cyst. Patients were randomized to either intramuscular injections of pasireotide 60 mg long-acting release (n = 17) or placebo (sodium chloride 0.9 %, n = 17). Injections were administered 2 weeks before and 2 weeks after aspiration sclerotherapy. The primary endpoint was proportional cyst diameter reduction (%) from baseline to 6 weeks. Secondary outcomes included long-term cyst reduction at 26 weeks, patient-reported outcomes including the polycystic liver disease-questionnaire (PLD-Q) and safety. RESULTS:Thirty-four patients (32 females; 53.6 ± 7.8 years) were randomized between pasireotide or placebo. Pasireotide did not improve efficacy of aspiration sclerotherapy at 6 weeks compared to controls (23.6 % [IQR 12.6-30.0] vs. 21.8 % [9.6-31.8]; p = 0.96). Long-term cyst diameter reduction was similar in both groups (49.1 % [27.0-73.6] and 45.6 % [29.6-59.6]; p = 0.90). Mean PLD-Q scores improved significantly in both groups (p < 0.01) without differences between arms (p = 0.92). CONCLUSIONS:In patients with large symptomatic hepatic cysts, complementary pasireotide to aspiration sclerotherapy did not improve cyst reduction or clinical response. KEY POINTS:• Complementary pasireotide treatment does not improve efficacy of aspiration sclerotherapy. • Cyst fluid reaccumulation after aspiration sclerotherapy is a transient phenomenon. • Aspiration sclerotherapy strongly reduces symptoms and normalizes quality of life.

SUBMITTER: Wijnands TFM

PROVIDER: S-EPMC5938297 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature

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Pasireotide does not improve efficacy of aspiration sclerotherapy in patients with large hepatic cysts, a randomized controlled trial.

Wijnands Titus F M TFM Gevers Tom J G TJG Lantinga Marten A MA Te Morsche René H RH Schultze Kool Leo J LJ Drenth Joost P H JPH

European radiology 20180109 6

<h4>Objectives</h4>We tested whether complementary use of the somatostatin analogue pasireotide would augment efficacy of aspiration sclerotherapy of hepatic cysts.<h4>Methods</h4>We conducted a double-blind, placebo-controlled trial in patients who underwent aspiration sclerotherapy of a large (>5 cm) symptomatic hepatic cyst. Patients were randomized to either intramuscular injections of pasireotide 60 mg long-acting release (n = 17) or placebo (sodium chloride 0.9 %, n = 17). Injections were ...[more]

PMID: 29318424

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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:OBJECTIVE:To 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. METHODS:We 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). RESULTS:We 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). CONCLUSION:Cyst 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: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.

Project description:Few randomized controlled trials (RCTs) report interventions targeting improvement of frailty status as an outcome.This RCT enrolled 117 older adults (65-79?years of age) in Toufen, Taiwan who scored 3-6 on The Chinese Canadian Study of Health and Aging Clinical Frailty Scale Telephone Version and then score ?1 on the Cardiovascular Health Study Phenotypic Classification of Frailty (CHS_PCF). With a two by two factorial design, subjects were randomly assigned to interventions (Exercise and nutrition, EN, n?=?55 or problem solving therapy, PST, n?=?57) or controls (non-EN, n?=?62 or non-PST, n?=?60). Educational booklets were provided to all. EN group subjects received nutrition consultation and a thrice-weekly exercise-training program while PST group subjects received 6 sessions in 3?month. Subjects were followed at 3, 6, and 12?months. Primary outcome was improvement of the CHS_PCF by at least one category (from pre-frail to robust, or from frail to pre-frail or robust) from baseline assessments. One hundred and one completed final assessments. Intention-to-treat analysis with the generalized estimating equation model was applied with adjustment for time and treatment-by-time interactions.Mean age was 71.4?±?3.7?years, with 59% females. Baseline characteristic were generally comparable between groups. EN group subjects had a higher improvement rate on the primary outcome than non-EN group subjects (45% vs 27%, adjusted p?=?0.008) at 3?months, but not 6 or 12?months. They also had more increase of serum 25(OH) vitamin D level (4.9?±?7.7 vs 1.2?±?5.4, p?=?0.006) and lower percentage of osteopenia (74% vs 89% p?=?0.042) at 12?months. PST group subjects had better improvement (2.7?±?6.1 vs 0.2?±?6.7, p?=?0.035, 6-month) and less deterioration (-3.5?±?9.7 vs -7.1?±?8.7, p?=?0.036, 12-month) of dominant leg extension power than non-PST subjects. Some secondary outcomes were also improved in control groups (non-EN or non-PST). No adverse effects were reported.The three-month EN intervention resulted in short-term (3-month) frailty status improvement and long-term effect on bone mineral density and serum vitamin D (12-month) among Taiwanese community-dwelling elders. The effect of PST was less pronounced.ClinicalTrials.gov: EC0970301

Project description:OBJECTIVE:To evaluate the effect of oral gabapentin in conjunction with usual oral pain management regimens of lorazepam, ibuprofen, oxycodone, and acetaminophen for surgical abortion on pain 5 minutes postprocedure. METHODS:This was a randomized, double-blind, placebo-controlled trial of patients from 6 0/7-14 6/7 weeks of gestation scheduled to undergo surgical abortion at the Duke Family Planning Clinic. Participants were administered 600 mg of oral gabapentin compared with placebo with usual oral pain management. Pain score was assessed using a 100-mm visual analog scale, with the primary outcome being pain score 5 minutes after the procedure. The effect of gabapentin was assessed using a linear regression model controlling for baseline pain. We also measured pain perception 24 hours after the procedure. Secondary outcome measures included anxiety, side effects, and usage of opiate pain medication in the 24-hour postoperative period. RESULTS:Out of 113 women screened for this study; 96 women were recruited, enrolled, and randomized to study treatment arm from August 2016 to June 2018. Pain at 5 minutes after the procedure was similar between the gabapentin and placebo groups ((Equation is included in full-text article.)=3.40; 95% CI -8.20 to 15.0; P=.56). Gabapentin and placebo were well tolerated, with no statistically significant difference in side effects or anxiety levels. Although prescription of opioids after the procedure was not standardized among patients, 73% of women received a short-term prescription for oxycodone. A lower percentage of women in the gabapentin group self-reported taking opioids in the 24 hours postprocedure (18% vs 47%; odds ratio 0.26; 95% CI 0.09-0.75). CONCLUSION:The addition of gabapentin to usual oral pain management regimens with paracervical block did not reduce postoperative pain for patients undergoing outpatient surgical abortion. Although the addition of gabapentin was well tolerated and reduced oral opiate use 24 hours postprocedure, it did not affect the experience of pain during and immediately after the procedure. CLINICAL TRIAL REGISTRATION:ClinicalTrials.gov, NCT02725710.

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Pasireotide does not improve efficacy of aspiration sclerotherapy in patients with large hepatic cysts, a randomized controlled trial.

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Pasireotide does not improve efficacy of aspiration sclerotherapy in patients with large hepatic cysts, a randomized controlled trial.

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