The association between proton pump inhibitor use and the risk of adverse kidney outcomes: a systematic review and meta-analysis.

Background: Existing epidemiological studies illustrate that proton pump inhibitors (PPIs) may be related to adverse kidney outcomes. To date, no comprehensive meta-analysis has been conducted to evaluate and quantify this association. Methods: We performed a systematic review and meta-analysis of studies to assess the association between PPI use and the risk of adverse kidney outcomes. We searched MEDLINE, Embase, SCOPUS, Web of Science, CINAHL, Cochrane Library and grey literature with no language restrictions (through 31 October 2016). Adverse kidney outcomes were acute interstitial nephritis (AIN), acute kidney injury (AKI), chronic kidney disease (CKD) and end-stage renal disease (ESRD). The risk ratios (RRs) and confidence intervals (CIs) were pooled using a random effects model. The strength of evidence (SOE) for each outcome was assessed using the Grading of Recommended Assessment, Development and Evaluation system. Results: Of 2037 identified studies, four cohort and five case-control studies with ∼2.6 million patients were included. Of these, 534 003 (20.2%) were PPI users. Compared with non-PPI users, PPI users experienced a significantly higher risk of AKI [RR 1.44 (95% CI 1.08-1.91); P = 0.013; SOE, low] and CKD [RR 1.36 (95% CI 1.07-1.72); P = 0.012; SOE, low]. Moreover, PPIs increased the risk of AIN [RR 3.61 (95% CI 2.37-5.51); P < 0.001; SOE, insufficient] and ESRD [RR 1.42 (95% CI 1.28-1.58); P < 0.001; SOE, insufficient]. Conclusion: PPI usage was associated with adverse kidney outcomes; however, these findings were based on observational studies and low-quality evidence. Additional rigorous studies are needed for further clarification.

Routine or selective carotid artery shunting for carotid endarterectomy (and different methods of monitoring in selective shunting).

BACKGROUND: Temporary interruption of cerebral blood flow during carotid endarterectomy can be avoided by using a shunt across the clamped section of the carotid artery. This may improve outcome. This is an update of a Cochrane review originally published in 1996 and previously updated in 2009. OBJECTIVES: To assess the effect of routine versus selective or no shunting during carotid endarterectomy, and to assess the best method for selecting people for shunting. SEARCH METHODS: We searched the Cochrane Stroke Group Trials Register (last searched August 2013), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, 2013, Issue 8), MEDLINE (1966 to August 2013), EMBASE (1980 to August 2013) and Index to Scientific and Technical Proceedings (1980 to August 2013). We handsearched journals and conference proceedings, checked reference lists, and contacted experts in the field. SELECTION CRITERIA: Randomised and quasi-randomised trials of routine shunting compared with no shunting or selective shunting, and trials that compared different shunting policies in people undergoing carotid endarterectomy. DATA COLLECTION AND ANALYSIS: Three review authors independently performed the searches and applied the inclusion criteria. For this update, we identified two new relevant randomised controlled trials. MAIN RESULTS: We included six trials involving 1270 participants in the review: three trials involving 686 participants compared routine shunting with no shunting, one trial involving 200 participants compared routine shunting with selective shunting, one trial involving 253 participants compared selective shunting with and without near-infrared refractory spectroscopy monitoring, and the other trial involving 131 participants compared shunting with a combination of electroencephalographic and carotid pressure measurement with shunting by carotid pressure measurement alone. In general, reporting of methodology in the included studies was poor. For most studies, the blinding of outcome assessors and the report of prespecified outcomes were unclear. For routine versus no shunting, there was no significant difference in the rate of all stroke, ipsilateral stroke or death up to 30 days after surgery, although data were limited. No significant difference was found between the groups in terms of postoperative neurological deficit between selective shunting with and without near-infrared refractory spectroscopy monitoring, However, this analysis was inadequately powered to reliably detect the effect. There was no significant difference between the risk of ipsilateral stroke in participants selected for shunting with the combination of electroencephalographic and carotid pressure assessment compared with pressure assessment alone, although again the data were limited. AUTHORS' CONCLUSIONS: This review concluded that the data available were too limited to either support or refute the use of routine or selective shunting in carotid endarterectomy. Large scale randomised trials of routine shunting versus selective shunting are required. No method of monitoring in selective shunting has been shown to produce better outcomes.

Local versus general anaesthesia for carotid endarterectomy.

BACKGROUND: Carotid endarterectomy may significantly reduce the risk of stroke in people with recently symptomatic, severe carotid artery stenosis. However, there are significant perioperative risks that may be reduced by performing the operation under local rather than general anaesthetic. This is an update of a Cochrane Review first published in 1996, and previously updated in 2004 and 2008. OBJECTIVES: To determine whether carotid endarterectomy under local anaesthetic: (1) reduces the risk of perioperative stroke and death compared with general anaesthetic; (2) reduces the complication rate (other than stroke) following carotid endarterectomy; and (3) is acceptable to patients and surgeons. SEARCH METHODS: We searched the Cochrane Stroke Group Trials Register (September 2013), MEDLINE (1966 to September 2013), EMBASE (1980 to September 2013) and Index to Scientific and Technical Proceedings (ISTP) (1980 to September 2013). We also handsearched relevant journals, and searched the reference lists of articles identified. SELECTION CRITERIA: Randomised trials comparing the use of local anaesthetic to general anaesthetic for carotid endarterectomy were considered for inclusion. DATA COLLECTION AND ANALYSIS: Three review authors independently assessed trial quality and extracted data. We calculated a pooled Peto odds ratio (OR) and corresponding 95% confidence interval (CI) for the following outcomes that occurred within 30 days of surgery: stroke, death, stroke or death, myocardial infarction, local haemorrhage, cranial nerve injuries, and shunted arteries. MAIN RESULTS: We included 14 randomised trials involving 4596 operations, of which 3526 were from the single largest trial (GALA). In general, reporting of methodology in the included studies was poor. All studies were unable to blind patients and surgical teams to randomised treatment allocation and for most studies the blinding of outcome assessors was unclear. There was no statistically significant difference in the incidence of stroke within 30 days of surgery between the local anaesthesia group and the general anaesthesia group. The incidence of strokes in the local anaesthesia group was 3.2% compared to 3.5% in the general anaesthesia group (Peto OR 0.92, 95% CI 0.67 to 1.28). There was no statistically significant difference in the proportion of patients who had a stroke or died within 30 days of surgery. In the local anaesthesia group 3.6% of patients had a stroke or died compared to 4.2% of patients in the general anaesthesia group (Peto OR 0.85, 95% CI 0.63 to 1.16). There was a non-significant trend towards lower operative mortality with local anaesthetic. In the local anaesthesia group 0.9% of patients died within 30 days of surgery compared to 1.5% of patients in the general anaesthesia group (Peto OR 0.62, 95% CI 0.36 to 1.07). However, neither the GALA trial or the pooled analysis were adequately powered to reliably detect an effect on mortality. AUTHORS' CONCLUSIONS: The proportion of patients who had a stroke or died within 30 days of surgery did not differ significantly between the two types of anaesthetic techniques used during carotid endarterectomy. This systematic review provides evidence to suggest that patients and surgeons can choose either anaesthetic technique, depending on the clinical situation and their own preferences.

Predictors for kidney stones recurrence following extracorporeal shock wave lithotripsy (ESWL) or percutaneous nephrolithotomy (PCNL).

BACKGROUND: Stone recurrence after extracorporeal shock wave lithotripsy (ESWL) or percutaneous nephrolithotomy (PCNL) are common. Predictors for kidney stones vary among populations and areas. OBJECTIVE: To determine predictors for kidney stones recurrence after ESWL or PCNL. MATERIAL AND METHOD: A retrospective cohort study was conducted at a university hospital. The study cohort was patients aged more than 18 years, diagnosed with kidney stones, who were treated with ESWL or PCNL between 2006 and 2009. Medical files were reviewed for clinical profiles, stone characteristics, composition, type of treatment, presence of stone after treatment, stone reappearance, and related laboratory data. Predictors were determined by a multivariable poisson regression and presented as incidence rate ratios (IRRs) with 95% confidence interval. RESULTS: From a cohort of 252 patients, 240 who had at least one follow-up and with complete plain kidney ureters and bladder (KUB) film or intravenous pyelogram (IVP) were included in analysis. At three years, the total incidence rate of recurrence was 46 per 1,000 person-months. After a multivariable poisson regression clustering by type of stone composition, independent predictors for stone recurrence were age < or = 50 years (adjusted IRR = 1.3, 95% CI = 1.2-1.4, p < 0.001), ESWL treatment (adjusted IRR = 2.1, 95% CI = 2.1-2.2, p < 0.001), stones located in lower calyx as compared to renal pelvis (adjusted IRR = 8.7, 95% CI = 2.9-25.9, p = 0.001), multiple stones (adjusted IRR = 5.9, 95% CI = 4.8-7.5, p < 0.001), and stone size larger than 20 mm (adjusted IRR = 1.4, 95% CI = 1.2-1.6, p < 0.001). CONCLUSION: After stone removals, patients with these predictors should closely be followed up for regular clinical evaluations.

Use of serotonin reuptake inhibitor antidepressants and the risk of bleeding complications in patients on anticoagulant or antiplatelet agents: a systematic review and meta-analysis.

BACKGROUND: Serotonin reuptake inhibitor (SRI) antidepressants are implicated in increasing the risk of bleeding among users; however, the comparative increase in bleeding risk with concurrent antithrombotic therapy (anticoagulant or antiplatelet) remains unclear. As such, we performed a systematic review and meta-analysis of all available evidence to evaluate the effects of SRI and the risk of bleeding complications among patients receiving antithrombotic therapy. METHODS: We searched Medline, Embase, PubMed, PsycINFO, Cochrane Library, Web of Science, Scopus, CINAHL, and grey literature (Google Scholar and preprint reports) up to 26 November, 2020, with no language restrictions (updated on 31 July 2021). The primary outcome of interest was major bleeding. Secondary outcomes included intracranial haemorrhage, gastrointestinal bleeding, and any bleeding events. We used a random-effects model meta-analysis to estimate the odds ratios (ORs) and 95% confidence intervals (CIs). RESULTS: We did not identify any randomised studies but found 32 non-randomized studies (cohort or case-control) with 1,848,285 patients that fulfilled the study selection criteria and were included in the meta-analysis. Among individuals receiving anticoagulants (13 studies), SRI users experienced a statistically higher risk of major bleeding compared to non-SRI users: pooled OR was 1.39 (95% CI, 1.23-1.58; p < .001; moderate heterogeneity). Among individuals receiving antiplatelet therapy (2 studies), SRI users were associated with an increased risk of major bleeding: pooled OR was 1.45 (95% CI, 1.17-1.80; p = .001; low heterogeneity). For secondary outcomes, the use of SRI among individuals treated with antithrombotic therapy revealed a higher risk of gastrointestinal bleeding or any bleeding events, whereas only anticoagulant use was illustrated an increased risk of intracranial haemorrhage. CONCLUSIONS: The use of SRI antidepressants among patients treated with antithrombotic therapy (either anticoagulant or antiplatelet) is associated with a higher risk of bleeding complications, suggesting that caution is warranted in co-prescription. PROSPERO REGISTRATION: CRD42018083917KEY MESSAGESIn this meta-analysis of 32 non-randomized studies, SRI users were associated with the risk of bleeding complications compared to non-SRI users, with concurrent antithrombotic use (either anticoagulant or antiplatelet).The risk was consistently elevated across types of bleeding events (major bleeding, gastrointestinal bleeding, or any bleeding events), whereas only anticoagulant use was associated with intracranial haemorrhage.To promote the rational use of medicines, our findings suggest that the risk-benefit ratio must account for the clear efficacy of SRI against safety concerns in terms of bleeding risks.

External Validation of the Individualized Prediction of Breast Cancer Survival (IPBS) Model for Estimating Survival after Surgery for Patients with Breast Cancer in Northern Thailand.

The individualized prediction of breast cancer survival (IPBS) model was recently developed. Although the model showed acceptable performance during derivation, its external performance remained unknown. This study aimed to validate the IPBS model using the data of breast cancer patients in Northern Thailand. An external validation study was conducted based on female patients with breast cancer who underwent surgery at Maharaj Nakorn Chiang Mai hospital from 2005 to 2015. Data on IPBS predictors were collected. The endpoints were 5-year overall survival (OS) and disease-free survival (DFS). The model performance was evaluated in terms of discrimination and calibration. Missing data were handled with multiple imputation. Of all 3581 eligible patients, 1868 were included. The 5-year OS and DFS were 85.2% and 81.9%. The IPBS model showed acceptable discrimination: C-statistics 0.706 to 0.728 for OS and 0.675 to 0.689 for DFS at 5 years. However, the IPBS model minimally overestimated both OS and DFS predictions. These overestimations were corrected after model recalibration. In this external validation study, the IPBS model exhibited good discriminative ability. Although it may provide minimal overestimation, recalibrating the model to the local context is a practical solution to improve the model calibration.

Prognostic factors for success in treating kidney stones by extracorporeal shock wave lithotripsy.

BACKGROUND: Extracorporeal shock wave lithotripsy (ESWL) is widely used worldwide to treat kidney stone because it is without invasive and can be done on an outpatient basis. However, not all patients are treated successfully. The success of kidney stone treatment by ESWL depends on several factors. OBJECTIVE: To investigate prognostic factors for the successful treatment of kidney stones by ESWL. MATERIAL AND METHOD: A prospective cohort study was made of 394 patients with kidney stone who underwent ESWL using Storz SLX-20 Lithotripter at Chiang Mai University Hospital between June 2008 and October 2009. All patients were followed up for three months after treatment to evaluate treatment success. Success was defined as the presence of clinically insignificant residual fragments less than or equal to 4 mm or complete clearance of the stones. Data were analyzed using exponential risk regression to determine the prognostic factors of ESWL treatment success. RESULTS: The ESWL treatment success rate was 81.2%. The stone free (SF) rate was 56.4%. The clinically insignificant residual fragment (CIRF) rate was 24.8%. The median number of ESWL treatment sessions was two (IQR = 2-4). Multivariable exponential risk regression analysis demonstrated that the statistically significant prognostic factors for ESWL treatment were stone size < 15 mm (IRR = 1.52, 95% CI = 1.13-2.05, p = 0.005), stone location (renal pelvis had a higher success rate than lower calyx; IRR = 1.32, 95% CI = 1.01-1.72, p = 0.028) and a single stone (IRR = 1.35, 95% CI = 1.02-1.79, p = 0.035). CONCLUSION: Stone size, stone location, and stone number were prognostic factors in determining the success of ESWL treatment.

Kidney stones recurrence and regrowth after extracorporeal shock wave lithotripsy and percutaneous nephrolithotomy.

OBJECTIVE: To estimate and compare the incidence rate of kidney stone recurrence and regrowth after ESWL with PCNL at one, two, and three years. MATERIAL AND METHOD: A retrospective cohort study was performed The study recruited patients aged more than 18 years, diagnosed with kidney stones and treated by ESWL or PCNL between January 2006 and August 2010 at the urological unit of a university hospital located in the northern part of Thailand. Data were retrieved from medical records and analyzed using exact probability test or student's t-test. Poisson regression was used to compare the recurrence rate and the regrowth rate between ESWL and PCNL. RESULTS: During three years of follow-up, the overall stones recurrence and regrowth were 15.5% and 25.1% in ESWL group and 12.6% and 16% in PCNL group, repectively. At one, two and three years after treatment, stones recurrence rate in the ESWL group were 13.1, 7.5 and 7.3 per 1,000 patient-months while in the PCNL group were 11.3, 6.1 and 5.4 per 1,000 patient-months. After ESWL stones regrowth rates were 29.1, 12.3 and 11.9 per 1,000 patient-months, whereas after PCNL were 11.3, 6.9 and 6.9 per 1,000 patient-months, respectively. In comparison to PCNL, the relative recurrence rate after ESWL presented as incidence rate ratio (IRR) were 1.1 (95% CI; 0.4-3.2, p = 0.762), 1.2 (95% CI; 0.6-2.6, p = 0.517) and 1.4 (95% CI; 0.8-2.5, p = 0.271) at 1, 2 and 3 years, respectively. For regrowth, the IRRs were 2.6 (95% CI; 1.1-6.5, p = 0.012), 1.8 (95% CI; 0.9-3.4, p = 0.048), and 1.7 (95%CI; 1.1-2.9, p = 0.017) at 1, 2 and 3 years, respectively. CONCLUSION: Patients after ESWL had a higher trend ofrecurrent rates and statistically significant higher regrowth rates, in comparison with those after PCNL.

COVID-19 Public Stigma Scale (COVID-PSS): development, validation, psychometric analysis and interpretation.

OBJECTIVE: Amid the COVID-19 pandemic, social stigma towards COVID-19 infection has become a major component of public discourse and social phenomena. As such, we aimed to develop and validate the COVID-19 Public Stigma Scale (COVID-PSS). DESIGN AND SETTING: National-based survey cross-sectional study during the lockdown in Thailand. PARTICIPANTS: We invited the 4004 adult public to complete a set of measurement tools, including the COVID-PSS, global fear of COVID-19, perceived risk of COVID-19 infection, Bogardus Social Distance Scale, Pain Intensity Scale and Insomnia Severity Index. METHODS: Factor structure dimensionality was constructed and reaffirmed with model fit by exploratory and confirmatory factor analyses and non-parametric item response theory (IRT) analysis. Psychometric properties for validity and reliability were tested. An anchor-based approach was performed for classifying the proper cut-off scores. RESULTS: After factor analysis, IRT analysis and test for model fit, we created the final 10-item COVID-PSS with a three-factor structure: stereotype, prejudice and fear. Face and content validity were established through the public and experts' perspectives. The COVID-PSS was significantly correlated (Spearman rank, 95% CI) with the global fear of COVID-19 (0.68, 95% CI 0.66 to 0.70), perceived risk of COVID-19 infection (0.79, 95% CI 0.77 to 0.80) and the Bogardus Social Distance Scale (0.50, 95% CI 0.48 to 0.53), indicating good convergent validity. The correlation statistics between the COVID-PSS and the Pain Intensity Scale and Insomnia Severity Index were <0.2, supporting the discriminant validity. The reliability of the COVID-PSS was satisfactory, with good internal consistency (Cronbach's α of 0.85, 95% CI 0.84 to 0.86) and test-retest reproducibility (intraclass correlation of 0.94, 95% CI 0.86 to 0.96). The proposed cut-off scores were as follows: no/minimal (≤18), moderate (19-25) and high (≥26) public stigma towards COVID-19 infection. CONCLUSIONS: The COVID-PSS is practical and suitable for measuring stigma towards COVID-19 in a public health survey. However, cross-cultural adaptation may be needed.

Effects of angiotensin-converting enzyme inhibitors or angiotensin receptor blockers on all-cause mortality, cardiovascular death, and cardiovascular events among peritoneal dialysis patients: A protocol for systematic review.

BACKGROUND: Based on the International Society for peritoneal dialysis (PD) recommendations, blockade of renin-angiotensin systems with an angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARB) improves residual kidney function in PD patients. However, the long-term effectiveness of ACEI/ARB use in PD patients has not been fully elucidated. We, therefore, intend to perform a systematic review and meta-analysis to summarize the effects of ACEI/ARB use on long-term mortality, cardiovascular outcomes, and adverse events among PD patients. METHODS: This systematic review will include both randomized controlled trials and non-randomized studies in adult PD patients. We also plan to incorporate data from our cohort study in Thai PD population into this review. We will search PubMed, Medline, EMBASE, Cochrane Library, Web of Science, Scopus, CINAHL, and grey literature from inception to February 29, 2019, with no language restrictions. The process of study screening, selection, data extraction, risk of bias assessment, and grading the strength of evidence will be performed independently by a pair of reviewers. Any discrepancy will be resolved through a team discussion and/or consultation with the third reviewer. The pooled effects estimate and 95% confidence intervals will be estimated using DerSimonian-Laird random-effects models. Heterogeneity will be assessed by the Cochran Q test, I index and tau-squared statistics. The funnel plots along with the Begg and Egger test and trim and fill method will be performed to investigate any evidence of publication bias. Preplanned subgroup analyses and random-effects univariate meta-regressions will be performed to quantify the potential sources of heterogeneity based on studies- and patient-characteristics. RESULTS: This will be the first systematic review and meta-analysis to summarize the long-term effectiveness of renin-angiotensin system inhibitors in PD populations. CONCLUSION: In summary, this systematic review and meta-analysis will summarize the effectiveness of ACEI/ARB on long-term mortality, cardiovascular outcomes, and adverse events among adult PD patients by integrated all available evidences. ETHICS AND DISSEMINATION: Based on the existing published data, an ethical approval is not required. The findings will be disseminated through scientific meetings and publications in peer-reviewed journals.PROSPERO registration number: CRD42019129492.

Age as a prognostic factor of 30-day mortality in hemorrhagic stroke patients: A Thai large tertiary care referral center.

OBJECTIVE: The aim of the present study was to identify incidences and prognostic factors for 30-day mortality of hemorrhagic strokes (HS) and divide them into intracerebral hemorrhage (ICH) and subarachnoid hemorrhage (SAH). METHODS: This retrospective cohort study was conducted using medical records of patients who underwent surgery due to HS, between January 2013 and April 2017, at Chiang Mai University Hospital, a large tertiary referral center, in Northern Thailand. 30-day mortality was followed after surgery. Prognostic factors included patients' characteristics, and clinical date related to early death, were determined. Data analysis was performed using Cox's proportional hazards model. RESULTS: 460 patients were enrolled. The 30-day mortality rate was 8.8% and 12.3%, in ICH and SAH patients, respectively. Multivariable analyses demonstrated that the prognostic factors of early mortality in ICH patients were age 65-70 years (Adjusted HR 3.10 (95%CI 1.14-8.41)), >70 years (Adj.HR 2.64 (95%CI 1.09-6.36)) and hypertension (HT) (Adj.HR 2.98 (95%CI 1.25-7.12)). In SAH patients, prognostic factors were HT (Adj.HR 7.32 (95%CI 2.12-25.29)), and atrial fibrillation (AF) (Adj.HR 5.48 (95% CI 1.57-19.09)). CONCLUSIONS: Ages over 65 years and HT were an important predictor of 30-day mortality in a subgroup of ICH patients, whereas HT and AF were significant prognostic factors in SAH. To reduce early death, management for stroke cases needed to take into account the specifics for older age patients with HT, and AF.

Low-pressure pneumoperitoneum versus standard pneumoperitoneum in laparoscopic cholecystectomy, a prospective randomized clinical trial.

BACKGROUND: Post-laparoscopic pain syndrome is well recognized and characterized by abdominal and particularly shoulder tip pain; it occurs frequently following laparoscopic cholecystectomy. The etiology of post-laparoscopic pain can be classified into three aspects: visceral, incision, and shoulder. The origin of shoulder pain is only partly understood, but it is commonly assumed that the cause is overstretching of the diaphragmatic muscle fibers owing to a high rate of insufflations. This study aimed to compare the frequency and intensity of shoulder tip pain between low-pressure (7 mmHg) and standard-pressure (14 mmHg) in a prospective randomized clinical trial. METHODS: One hundred and forty consecutive patients undergoing elective laparoscopic cholecystectomy were randomized prospectively to either high- or low-pressure pneumoperitoneum and blinded by research nurses who assessed the patients during the postoperative period. The statistical analysis included sex, mean age, weight, American Society of Anesthesiologists (ASA) grade, operative time, complication rate, duration of surgery, conversion rate, postoperative pain by using visual analogue scale, number of analgesic injections, incidence and severity of shoulder tip pain, and postoperative hospital stay. p < 0.05 was considered indicative of significance. RESULTS: The characteristics of the patients were similar in the two groups except for the predominance of males in the standard-pressure group (controls). The procedure was successful in 68 of 70 patients in the low-pressure group compared with in 70 patients in the standard group. Operative time, number of analgesic injections, visual analogue score, and length of postoperative days were similar in both groups. Incidence of shoulder tip pain was higher in the standard-pressure group, but not statistically significantly so (27.9% versus 44.3%) (p = 0.100). CONCLUSIONS: Low-pressure pneumoperitoneum tended to be better than standard-pressure pneumoperitoneum in terms of lower incidence of shoulder tip pain, but this difference did not reach statistical significance following elective laparoscopic cholecystectomy.

Phyllodes tumor of the breast: diagnosis, management and outcome during a 10-year experience.

BACKGROUND: Phyllodes tumor is a very rare tumor of the breast, incidence being 0.3-0.9% of all breast tumors. Phyllodes tumors are classified into three grades: benign, borderline or malignant. The aim of this study was to investigate patient characteristics, imaging characteristic findings, surgical treatment and outcome of phyllodes tumor. MATERIALS AND METHODS: This is a retrospective review of phyllodes tumor patients who had undergone surgical management between 1 January 2006 and 31 December 2015 in Head, Neck and Breast Unit, Department of Surgery, Chiang Mai University Hospital. RESULTS: A total of 188 phyllodes tumor patients were included in this study. The average age of the patients was 35.6 years. The majority of the tumors were of lobulated shape. Tumor morphology from imaging: lobulated shaped tumor 112 cases, oval-shape 37 cases, round shape 8 cases and irregular 5 cases. Surgical management is the standard procedure for treatment of phyllodes tumors. A wide local excision was performed in 147 cases, mastectomy in 20 cases (modified radical mastectomy in 2 cases) and wide excision followed by mastectomy 21 cases. The final pathological diagnoses of the phyllodes tumors were: benign 118 cases (62%), borderline 33 cases (18%) and malignant in 37 cases (20%). The margin did not affect recurrence in all types. CONCLUSION: The most frequent is a benign phyllodes tumor. Surgical treatment to remove the tumor with a free margin is acceptable with no recurrence difference from a wider margin. However, younger age and malignant phyllodes tumor are the two highest risk factors for recurrence.

Interleukin-8 associated with chemosensitivity and poor chemotherapeutic response to gastric cancer.

BACKGROUND: Gastric cancer (GC) patients have been found to have developed chemotherapy resistance that has resulted in a lowering of their overall survival rates. Interleukin-6 (IL-6) and interleukin-8 (IL-8) could be responsible as the predictive biomarkers in monitoring drug resistance. We have developed a protocol to monitor drug treatment by testing ex vivo chemosensitivity and cytokine levels of primary gastric cultures obtained from endoscopic biopsies. METHODS: We studied 49 patients with distal GC who underwent primary surgical resection between June 2014 and December 2016 in the northern endemic region of Thailand. The clinical and pathological data of patients were recorded, and the cancer sub-type was classified. The correlation of cytokine IL-6 and IL-8 protein expression levels and chemotherapy sensitivity in primary gastric cultures was investigated. Endoscopic biopsies were collected before and/or after chemotherapy treatment followed by FOLFOXIV regimen (oxaliplatin + 5-FU/leucovorin). The 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT) assay was performed to examine ex vivo chemosensitivity to cisplatin, oxaliplatin, 5-fluorouracil (5-FU) and irinotecan. Enzyme-linked immunosorbent assay (ELISA) was performed to investigate cytokine levels. RESULTS: Ex vivo drug treatment of 49 primary gastric cultures from naive patients revealed a significant correlation between basal levels of IL-8 and chemosensitivity to cisplatin (P=0.001) and oxaliplatin (P=0.001). IL-8 protein expression levels were significantly decreased in the early phase after cisplatin and oxaliplatin treatments leading to an increase in cell sensitivity to drug treatments. Among 49 patients, 11 patients were classified as partial or poor responders after drug interventions, in which case, second endoscopic biopsies were performed for determination of chemosensitivity and cytokine levels. The results demonstrated significant decreases in sensitivity to cisplatin (P=0.049) and oxaliplatin (P=0.014), meanwhile IL-8 protein expression levels were significantly increased by P=0.0423 in both drug treatments. There was no correlation of IL-6 and drug resistance when treatments of the primary gastric cultures involved each of the four chemotherapeutic drugs (P=0.0663). CONCLUSIONS: Upregulation of IL-8 after drug intervention might be useful as predictive biomarker in monitoring drug resistance in GC patients; however, this needs to be confirmed among a larger number of patients and with control groups that are properly age-paired. The established primary gastric culture could serve as a valuable tool for chemotherapy screening, while the repeated usage of platinum drugs may result in drug resistance via upregulation of IL-8 levels.

Comparative Effectiveness of Local Application of Chlorhexidine Gluconate, Mupirocin Ointment, and Normal Saline for the Prevention of Peritoneal Dialysis-related Infections (COSMO-PD Trial): a multicenter randomized, double-blind, controlled protocol.

BACKGROUND: Current international guidelines recommend the use of a daily topical exit-site antimicrobial to prevent peritoneal dialysis (PD)-related infections. Although nonantibiotic-based therapies are appealing because they may limit antimicrobial resistance, no controlled trials have been conducted to compare topical antimicrobial agents with usual exit-site care for the prevention of PD-related infections among the Thai PD population. We propose a controlled three-arm trial to examine the efficacy and safety of a daily chlorhexidine gluconate-impregnated patch versus mupirocin ointment versus usual exit-site care with normal saline for the prevention of PD-related infections. METHODS/DESIGNS: This study is a randomized, double-blind, multicenter, active-controlled, clinical trial. Adult patients aged 18 years or older who have end-stage kidney disease and are undergoing PD will be enrolled at three PD Centers in Thailand. A total of 354 PD patients will be randomly assigned to either the 2% chlorhexidine gluconate-impregnated patch, mupirocin ointment, or usual exit-site care with normal saline dressing according to a computer-generated random allocation sequence. Participants will be followed until discontinuation of PD or completion of 24 months. The primary study outcomes are time to first PD-related infection (exit-site/tunnel infection or peritonitis) event and the overall difference in PD-related infection rates between study arms. Secondary study outcomes will include (i) the rate of infection-related catheter removal and PD technique failure, (ii) rate of nasal and exit-site Staphylococcus aureus colonization, (iii) healthcare costs, and (iv) skin reactions and adverse events. We plan to conduct a cost-utility analysis alongside the trial from the perspectives of patients and society. A Markov simulation model will be used to estimate the total cost and health outcome in terms of quality-adjusted life years (QALYs) over a 20-year time horizon. An incremental cost-effectiveness ratio in Thai Baht and U.S. dollars per QALYs gained will be illustrated. A series of probabilistic sensitivity analyses will be conducted to assess the robustness of the cost-utility analysis findings. DISCUSSION: The results from this study will provide new clinical and cost-effectiveness evidence to support the best strategy for the prevention of PD-related infections among the Thai PD population. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02547103. Registered on September 11, 2015.

Adult-to-Adult Living Donor Liver Transplantation: Postoperative Outcomes and Quality of Life in Liver Donors: First Report in Thailand.

BACKGROUND: Deceased donor liver transplantation is a rare procedure in Northern Thailand because of cultural issues. Living donor liver transplantation (LDLT) can decrease waiting list mortality for the patients who have end-stage liver disease. In Thailand, our center is the only active adult-to-adult LDLT program. This study is the first report of outcomes and health-related quality of life in liver donors. OBJECTIVES: The aim of this study was to evaluate the postoperative outcomes and health related quality of life in living liver transplant donors at the Transplant Center in Thailand. MATERIALS AND METHODS: All patients undergoing liver resection for adult-to-adult LDLT at our center between March 2010 and July 2018 were evaluated in a cross-sectional study. The effect of donor demographics, operative details, postoperative complications (Clavien-Dindo classification), hospitalization, and health related quality of life was evaluated through health-related quality of life questionnaires (short-form survey, SF-36) RESULTS: A total of 14 donor patients were included in this study with an age range from 26 to 51 years (mean 39.86 years, standard deviation [SD] = 8.59 years). The patients were 71.43% female and 28.57% male. The majority of patients had primary and secondary education (57.14%) and were married (64.29%). After hepatectomy, there was no mortality in the evaluated donors. The Clavien-Dindo classification of postoperative complications were as follows: Grade I (none), Grade II (50%), Grade IIIa (7.14%), and Grade IIIb (7.14%). The serum levels of total protein and albumin were decreased on postoperative day 5. The hospital stays averaged 11.5 days (SD = 4.9 days) and ranged from 5 to 22 days. After considering each aspect of the donors' postoperative quality of life, the highest mean score was related to physical composite scores in physical roles with a mean of 96.42 (SD = 13.36) and physical function with a mean of 95.35 (SD = 13.36). Moreover, the mental composite scores in social function was the highest mean of 91.96 (SD = 12.60) and role emotion was a mean of 90.47 (SD = 27.51). CONCLUSIONS: Living donor hepatectomy was safe, with an acceptable morbidity, and recognized as a safe procedure with an excellent long-term health quality of life.

Prospective performance of the Prostate Health Index in prostate cancer detection in the first prostate biopsy of men with a total prostatic specific antigen of 4-10 ng/mL and negative digital rectal examination.

BACKGROUND: The disadvantage of using total serum prostatic specific antigen (PSA) test for detection of prostate cancer is that it has a low specificity. The low specificity of total PSA (tPSA) test leads to unnecessary prostate biopsies. In this prospective study, we assessed the serum tPSA, free PSA, p2PSA, and the Prostate Health Index (PHI) in the detection of prostate cancer in men with a tPSA of 4-10 ng/mL and a negative digital rectal examination (DRE). MATERIALS AND METHODS: 101 male outpatients with a serum PSA of 4-10 ng/mL and nonsuspicious DRE for prostate cancer who underwent first transrectal ultrasound with a prostate biopsy were recruited. A blood sample to enable tPSA, free PSA, and p2PSA levels to be calculated was drawn before the prostate biopsy. The diagnosis and detection of high-grade cancer are correlated with the blood sample. RESULTS: Sixteen patients were positive for prostate cancer. All had significantly higher serum 2pPSA and PHI levels than patients with no cancer. A PHI level at 90% sensitivity (cutoff of 34.14) demonstrated a higher area under the receiver operating characteristic curve and more specificity in diagnosis and detection of high-grade prostate cancer than other tests. CONCLUSIONS: The PHI in men with a PSA level of 4-10 ng/mL with negative DRE increased specificity in the detection of prostate cancer. This test is useful in discriminating between patients with or without cancer and also enables the detection of high-grade cancer avoiding unnecessary biopsies.

A Clinical Risk Prediction Tool for Peritonitis-Associated Treatment Failure in Peritoneal Dialysis Patients.

A tool to predict peritonitis-associated treatment failure among peritoneal dialysis (PD) patients has not yet been established. We conducted a multicentre, retrospective cohort study among 1,025 PD patients between 2006 and 2016 in Thailand to develop and internally validate such a tool. Treatment failure was defined as either a requirement for catheter removal, a switch to haemodialysis, or peritonitis-associated mortality. Prediction model performances were analysed using discrimination (C-statistics) and calibration (Hosmer-Lemeshow test) tests. Predictors were weighted to calculate a risk score. In total, 435 patients with 855 episodes of peritonitis were identified; 215 (25.2%) episodes resulted in treatment failure. A total risk score of 11.5 was developed including, diabetes, systolic blood pressure <90 mmHg, and dialysate leukocyte count >1,000/mm3 and >100/mm3 on days 3-4 and day 5, respectively. The discrimination (C-statistic = 0.92; 95%CI, 0.89-0.94) and calibration (P > 0.05) indicated an excellent performance. No significant difference was observed in the internal validation cohort. The rate of treatment failure in the different groups was 3.0% (low-risk, <1.5 points), 54.4% (moderate-risk, 1.5-9 points), and 89.5% (high-risk, >9 points). A simplified risk-scoring scheme to predict treatment failure may be useful for clinical decision making regarding PD patients with peritonitis. External validation studies are needed.

Guy's Stone Score (GSS) Based on Intravenous Pyelogram (IVP) Findings Predicting Upper Pole Access Percutaneous Nephrolithotomy (PCNL) Outcomes.

Objective. To predict the success rate and complications following percutaneous nephrolithotomy via the upper pole using the Guy's Stone Score (GSS) based on the findings of a preoperative intravenous pyelogram (IVP). Patients and Methods. Two hundred and twenty-seven renal operations, which were carried out using PCNL via the upper pole, were classified according to the GSS assigned. Any complications were classified according to the Clavien classification. The success rates and incidence of any complications were compared between each GSS. Results. The immediate success rates were 87.50% of GSS1, 71.43% of GSS2, 53.62% of GSS3, and 38.46% of GSS4, P < 0.01. There were statistically significant differences between the groups in stone size, overall immediate success rate, operative time, number of access tracts, and frequency of tubeless PCNL. Major complications (a Clavien score of 3-5) were significantly higher in the cases with a higher GSS. Conclusion. A GSS based on an IVP is a simple and reliable tool in predicting the success rate and possible complications following upper pole access PCNL.

Correlation of Helicobacter pylori and interleukin-8 mRNA expression in high risk gastric cancer population prediction.

AIM: To evaluate (1) the association of the Helicobacter pylori (H. pylori) test and interleukin-8 (IL-8) mRNA expression alone and the severity of gastric cancer (GC); (2) the association of both tests were added to patients' characteristics to identifli Thai suspected patients of gastric cancer who would receive the most benefit; and (3) diagnostic value of levels of IL-8 mRNA expression for gastric cancer. METHODS: A cross-sectional analytical study was completed with 220 patients with 86 GC patients who underwent endoscopy with gastric surgery divided into non-metastasis and metastasis groups, and 134 patients with benign lesions who underwent endoscopic examination, at the Gastrointestinal Surgery and Endoscopy Unit, Chiang Mai University Hospital between 2006 and 2010. Of 220 patients, 86 cases of diagnosed gastric adenocarcinoma were in an advanced stage and 134 cases were non-cancer patients. RESULTS: The IL-8 mRNA expression showed predominant association with advanced GC when compared to H. pylori infection alone [OR (95%CI); 0.86 (0.49-1.53) vs 5.44 (3.08-9.62)] when including the patients' characteristics the highest of the area under the receiver operating characteristic curves (AuROC) of the model were males older than 40 years of age [AuROC (95%CI); 0.81 (0.75-0.86)]. However, preliminary testing for diagnostic indices of four cut-off points of IL-8 mRNA expression to predict the severity of GC cases found an increasing suboptimal trend from the likelihood ratio of positive to differentiate the severity in the GC group. The IL-8 mRNA expression showed a predominant association with GC when compared to H. pylori infection, especially in males older than 40 years of age who may benefit most from this test. CONCLUSION: The future research of IL-8 mRNA expression to predict severity in the gastric cancer group should be warranted.