Risk-stratified analysis of pasireotide for patients undergoing pancreatectomy.
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ABSTRACT:
SUBMITTER: Peng JS
PROVIDER: S-EPMC7369221 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundMorbidity after pancreatectomy is commonly due to leakage of exocrine secretions resulting in abscess or pancreatic fistula (PF). Previously, we authored a double-blind randomized controlled trial demonstrating that perioperative pasireotide administration lowers abscess or PF formation by >50%. Accordingly, we adopted pasireotide use as standard practice after pancreatectomy in October 2014 and hypothesized a similar PF/abscess rate reduction would be observed.Study designA prospectively maintained database was queried for all patients who underwent pancreatectomy between October 2014 and July 2017. Pasireotide was administered preoperatively and twice daily for 7 days postoperatively or until discharge. The primary end point was clinically relevant PF/abscess requiring procedural intervention, identical to the earlier trial outcomes. Logistic regression was used to compare outcomes with the placebo arm of the earlier randomized trial and to control known PF risk factors.ResultsDuring the 34-month study period, 652 patients underwent pancreatectomy (211 distal pancreatectomy, 441 pancreaticoduodenectomy). Compared with the historical placebo group (n = 148), the observational group had an increased prevalence of higher American Society of Anesthesiologists scores (69% vs 54%; p < 0.001) and high-risk cases (small duct and soft gland, 47% vs 36%; p = 0.030). The primary end point occurred in 13.3% of patients receiving pasireotide vs 20.9% in the placebo arm of the earlier trial trial (odds ratio 0.58; 95% CI 0.37 to 0.92; p = 0.020). Biliary leakage was lower in those receiving pasireotide (0.6% vs 3.4%; p = 0.014), and other morbidity was unchanged. No subpopulation was identified more likely to benefit from pasireotide.ConclusionsAt our center, adoption of pasireotide has allowed us to achieve a clinically significant abscess or pancreatic leak rate of 13.3%, approximating the effect observed in the randomized trial of pasireotide during routine surgical practice.
| S-EPMC7592191 | biostudies-literature
Project description:Circulating microRNAs (miRNAs) can be biomarkers for diagnosis and progression of several pathophysiological conditions. In a cohort undergoing total pancreatectomy with islet autotransplantation (TPIAT) from the multicenter Prospective Observational Study of TPIAT (POST), we investigated associations between a panel of circulating miRNAs (hsa-miR-375, hsa-miR-29b-3p, hsa-miR-148a-3p, hsa-miR-216a-5p, hsa-miR-320d, hsa-miR-200c, hsa-miR-125b, hsa-miR-7-5p, hsa-miR-221-3p, hsa-miR-122-5p) and patient, disease and islet-isolation characteristics. Plasma samples (n = 139) were collected before TPIAT and miRNA levels were measured by RTPCR. Disease duration, prior surgery, and pre-surgical diabetes were not associated with circulating miRNAs. Levels of hsa-miR-29b-3p (P = 0.03), hsa-miR-148a-3p (P = 0.04) and hsa-miR-221-3p (P = 0.01) were lower in those with genetic risk factors. Levels of hsa-miR-148a-3p (P = 0.04) and hsa-miR-7-5p (P = 0.04) were elevated in toxic/metabolic disease. Participants with exocrine insufficiency had lower hsa-miR-29b-3p, hsa-miR-148a-3p, hsa-miR-320d, hsa-miR-221-3p (P < 0.01) and hsa-miR-375, hsa-miR-200c-3p, and hsa-miR-125b-5p (P < 0.05). Four miRNAs were associated with fasting C-peptide before TPIAT (hsa-miR-29b-3p, r = 0.18; hsa-miR-148a-3p, r = 0.21; hsa-miR-320d, r = 0.19; and hsa-miR-221-3p, r = 0.21; all P < 0.05), while hsa-miR-29b-3p was inversely associated with post-isolation islet equivalents/kg and islet number/kg (r = -0.20, P = 0.02). Also, hsa-miR-200c (r = 0.18, P = 0.03) and hsa-miR-221-3p (r = 0.19, P = 0.03) were associated with islet graft tissue volume. Further investigation is needed to determine the predictive potential of these miRNAs for assessing islet autotransplant outcomes.
| S-EPMC8718159 | biostudies-literature
Project description:BACKGROUND:First postoperative day drain fluid amylase (DFA1) <5000 U/L is commonly used for early drain removal. We manage patients with risk-stratified pancreatectomy care pathways determined preoperatively by risk for postoperative pancreatic fistula. We hypothesized that preoperative risk stratification would yield unique DFA1/DFA3 cutoffs for safe early drain removal. METHODS:Patients with DFA1/DFA3 values after pancreaticoduodenectomy or distal pancreatectomy were identified. Patients were risk stratified as "low-risk pancreaticoduodenectomy," "high-risk pancreaticoduodenectomy," or "distal pancreatectomy." Receiver operator characteristic analyses yielded clinically relevant sensitivity thresholds for International Study Group on Pancreatic Surgery grade B/C postoperative pancreatic fistulas. RESULTS:From October 2016 to April 2018, 174 patients were preoperatively stratified as low-risk pancreaticoduodenectomy (n = 78, 45%), high-risk pancreaticoduodenectomy (n = 51, 29%), and distal pancreatectomy (n = 45, 26%). B/C postoperative pancreatic fistulas developed in 3% (n = 2) of low-risk pancreaticoduodenectomies, 37% (n = 19) of high-risk pancreaticoduodenectomies, and 24% (n = 11) of distal pancreatectomies (low- vs high-risk pancreaticoduodenectomy P < .001, low-risk pancreaticoduodenectomy versus distal pancreatectomy P = .004, high-risk pancreaticoduodenectomy versus distal pancreatectomy P = .25). B/C postoperative pancreatic fistulas occurred in 16% (n = 21) pancreaticoduodenectomy patients (high- + low-risk pancreaticoduodenectomy), and B/C postoperative pancreatic fistulas were excluded in pancreaticoduodenectomy with 100% sensitivity if DFA1 ? 136 or DFA3 ? 93. DFA1 < 5000 excluded B/C postoperative pancreatic fistulas with only 57% sensitivity after pancreaticoduodenectomy. Exclusion of B/C postoperative pancreatic fistulas occurred with 100% sensitivity if DFA1 ? 661 or DFA3 ? 141 in low-risk pancreaticoduodenectomy patients, DFA1 ? 136 or DFA3 ? 93 in high-risk pancreaticoduodenectomy patients, and DFA1 < 49 or DFA3 < 26 in distal pancreatectomy patients. CONCLUSION:Preoperative risk stratification results in unique DFA1/DFA3 thresholds to exclude B/C postoperative pancreatic fistulas, thus allowing for safe drain removal and potential for accelerated discharge. Rather than applying generic DFA cutoffs based on national databases, we propose institution-specific DFA1 and DFA3 values tailored to 3 replicable postoperative pancreatic fistula-risk pathways.
| S-EPMC7288221 | biostudies-literature
Project description:Total pancreatectomy with islet cell autotransplantation (TPIAT) is a surgical treatment modality used for the management of painful chronic pancreatitis when medical and endoscopic therapies fail. Total pancreatectomy (TP) results in a number of clinical implications. However, the glucose-responsive insulin secretion can be preserved by combining TP with islet cell autotransplant (IAT). Despite the known clinical implications of TPIAT, the systemic molecular effects of TPIAT remains poorly investigated. Therefore, we performed the first hypothesis-generating study of the urinary proteome before and after TPIAT. The RAW- and processed data from the analysis can be found in this repository. Twenty-two chronic pancreatitis patients eligible for TPIAT were prospectively enrolled in the study at the University of Minnesota Medical Center between September 2011 and February 2014. Urine was collected within the week pre-TPIAT and 12-18 months post-TPIAT, resulting in 44 paired samples. The paired experimental design allowed us to subtract interpersonal differences. The unique set of urine samples were prepared for bottom-up label-free quantitative proteomics using the in-house developed ‘MStern’ protocol for the 96-well plate compatible processing of the urine samples. The samples were analyzed by LC-MS/MS and 2477 proteins were identified (FDR<0.01%). Five samples were found to have less than 30% of the cumulated list of proteins (<743 proteins) and so these samples and their respective matching sample were thus removed from the analysis. This resulted in a complete dataset with 17 matched pre- and post-TPIAT sample pairs. The final list of recommended included pairs for future analysis are indicated in the PX_TPIAT_Metadata.csv file. Note that extended clinical information only was available for the included samples. Furthermore, the information is only listed for the pre-TPIAT sample but applies to both the pre- and post-TPIAT participant sample. The data allows for studying the systemic molecular impact of the TPIAT procedure.
2022-08-19 | PXD028570 | Pride
Project description:BACKGROUND:Postoperative pancreatic fistula is associated with adverse events, increased duration of stay and hospital costs. We developed perioperative care pathways stratified by postoperative pancreatic fistula risk with the aims of minimizing variations in care, improving quality, and decreasing costs. STUDY DESIGN:Three unique risk-stratified pancreatectomy clinical pathways-low-risk pancreatoduodenectomy, high-risk pancreatoduodenectomy, and distal pancreatectomy were developed and implemented. Consecutive patients treated after implementation of the risk-stratified pancreatectomy clinical pathways were compared with patients treated immediately prior. Duration of stay, rates of perioperative adverse effects, discharge disposition, and hospital readmission, as well as the associated costs of care, were evaluated. RESULTS:The median hospital stay after pancreatectomy decreased from 10 to 6 days after implementation of the risk-stratified pancreatectomy clinical pathways (P < .001), and the median cost of index hospitalization decreased by 22%. Decreased changes in median hospital stay and costs of hospitalization were observed in association with low-risk pancreatoduodenectomy (P < .05) and distal pancreatectomy (P < .05), but not high-risk pancreatoduodenectomy. The rates of 90-day adverse events, grade B/C postoperative pancreatic fistula, discharge to a facility other than home, or readmission did not change after implementation. CONCLUSION:Implementation of risk-stratified pancreatectomy clinical pathways decreased median stay and cost of index hospitalization after pancreatectomy without unfavorably affecting rates of perioperative adverse events or readmission, or discharge disposition. Outcomes were most favorably improved for low-risk pancreatoduodenectomy and distal pancreatectomy. Additional work is necessary to decrease the rate of postoperative pancreatic fistula, minimize variability, and improve outcomes after high-risk pancreatoduodenectomy.
| S-EPMC7265789 | biostudies-literature
Project description:BackgroundThe use of epidural analgesia (EA) in pancreatic surgery remains under debate. This study compares patients treated with EA versus non-EA after open pancreatectomy in a tertiary referral center.MethodsAll patients undergoing open pancreatectomy from 2013 to 2017 were retrospectively reviewed. (Non-)EA was terminated on postoperative day (POD) 3 or earlier if required.ResultsIn total, 190 (72.5%) patients received EA and 72 (27.5%) patients received non-EA (mostly intravenous morphine). EA was terminated prematurely in 32.6% of patients and non-EA in 10.5% of patients. Compared with non-EA patients, EA patients had significantly lower pain scores on POD 0 (1.10 (0-3.00) versus 3.00 (1.67-5.00), P?<?0.001) and POD 1 (2.00 (0.50-3.41) versus 3.00 (2.00-3.80), P?=?0.001), though significantly higher pain scores on POD 3 (3.00 (2.00-4.00) versus 2.33 (1.50-4.00), P?<?0.001) and POD 4 (2.50 (1.50-3.67) versus 2.00 (0.50-3.00), P?=?0.007). EA patients required more vasoactive medication perioperatively and had higher cumulative fluid balances on POD 1-3. Postoperative complications were similar between groups.ConclusionsIn our cohort, patients with EA experienced significantly lower pain scores in the first PODs compared with non-EA, yet higher pain scores after EA had been terminated. Although EA patients required more vasoactive medication and fluid therapy, the complication rate was similar.
| S-EPMC6877489 | biostudies-literature
Project description:OBJECTIVE:The aim of this study is to examine, by a prospective randomized controlled trial, the influence of liberal (LIB) vs restricted (RES) perioperative fluid administration on morbidity following pancreatectomy. SUMMARY OF BACKGROUND DATA:Randomized controlled trials in patients undergoing major intra-abdominal surgery have challenged the historical use of LIB fluid administration, suggesting that a more restricted regimen may be associated with fewer postoperative complications. METHODS:Patients scheduled to undergo pancreatic resection were consented for randomization to a LIB (n = 164) or RES (n = 166) perioperative fluid regimen. Sample size was designed with 80% power to decrease Grade 3 complications from 35% to 21%. RESULTS:Between July 2009 and July 2015, we randomized 330 patients undergoing pancreaticoduodenectomy (PD, n = 218), central (n = 16), or distal pancreatectomy (DP, n = 96). Patients were equally distributed for all demographic and intraoperative characteristics. Intraoperatively, LIB patients received crystalloid 12?mL/kg/h and RES patients 6?mL/kg/h. Cumulative crystalloid given (median, range, mL) days 0 to 3 was LIB: 12,252 (6600 to 21,365), RES 7808 (2700 to 16,274) P < 0.0001. Sixty-day mortality was 2 of 330 (0.6%). Median operative time for PD was 227?minutes (105 to 462) and DP 150 (44 to 323). Grade 3 complications occurred in 20% of LIB and 27% of RES patients (P = 0.6). Median length of stay was 7 and 5 days for PD and DP, respectively, in both arms. CONCLUSIONS:In a high volume institution, major perioperative complications from pancreatic resection were not significantly influenced by fluid regimens that differed approximately 1.6-fold.
| S-EPMC5017901 | biostudies-literature
Project description:BackgroundPancreatic cancer is the third leading cause of cancer-related deaths, and although pancreatectomy is currently the only curative treatment, it is associated with significant morbidity.ObjectiveThe objective of this study was to evaluate the utility of wearable telemonitoring technologies to predict treatment outcomes using patient activity metrics and machine learning.MethodsIn this prospective, single-center, single-cohort study, patients scheduled for pancreatectomy were provided with a wearable telemonitoring device to be worn prior to surgery. Patient clinical data were collected and all patients were evaluated using the American College of Surgeons National Surgical Quality Improvement Program surgical risk calculator (ACS-NSQIP SRC). Machine learning models were developed to predict whether patients would have a textbook outcome and compared with the ACS-NSQIP SRC using area under the receiver operating characteristic (AUROC) curves.ResultsBetween February 2019 and February 2020, 48 patients completed the study. Patient activity metrics were collected over an average of 27.8 days before surgery. Patients took an average of 4162.1 (SD 4052.6) steps per day and had an average heart rate of 75.6 (SD 14.8) beats per minute. Twenty-eight (58%) patients had a textbook outcome after pancreatectomy. The group of 20 (42%) patients who did not have a textbook outcome included 14 patients with severe complications and 11 patients requiring readmission. The ACS-NSQIP SRC had an AUROC curve of 0.6333 to predict failure to achieve a textbook outcome, while our model combining patient clinical characteristics and patient activity data achieved the highest performance with an AUROC curve of 0.7875.ConclusionsMachine learning models outperformed ACS-NSQIP SRC estimates in predicting textbook outcomes after pancreatectomy. The highest performance was observed when machine learning models incorporated patient clinical characteristics and activity metrics.
| S-EPMC8074869 | biostudies-literature
Project description:BackgroundSurgical factors, including resection of Gerota's fascia, R0-resection, and lymph node yield, may be associated with survival after distal pancreatectomy (DP) for pancreatic ductal adenocarcinoma (PDAC), but evidence from large multicenter studies is lacking. This study aimed to identify predictors for overall survival after DP for PDAC, especially those related to surgical technique.Patients and methodsData from an international retrospective cohort including patients from 11 European countries and the USA who underwent DP for PDAC (2007-2015) were analyzed. Cox proportional hazard analyses were performed and included Gerota's fascia resection, R0 resection, lymph node ratio, extended resection, and a minimally invasive approach.ResultsOverall, 1200 patients from 34 centers with median follow-up of 15 months [interquartile range (IQR) 5-31 months] and median survival period of 30 months [95% confidence interval (CI), 27-33 months] were included. Gerota's fascia resection [hazard ratio (HR) 0.74; p?=?0.019], R0 resection (HR 0.70; p?=?0.006), and decreased lymph node ratio (HR 0.28; p?<?0.001) were associated with improved overall survival, whereas extended resection (HR 1.75; p?<?0.001) was associated with worse overall survival. A minimally invasive approach did not improve survival as compared with an open approach (HR 1.14; p?=?0.350). Adjuvant chemotherapy (HR 0.67; p?=?0.003) was also associated with improved overall survival.ConclusionsThis international cohort identified Gerota's fascia resection, R0 resection, and decreased lymph node ratio as factors associated with improved overall survival during DP for PDAC. Surgeons should strive for R0 resection and adequate lymphadenectomy and could also consider Gerota's fascia resection in their routine surgical approach.
| S-EPMC7801299 | biostudies-literature
Project description:BackgroundThe purpose of this study is to evaluate and redefine patients at high risk for increased resource utilization and complications after total joint arthroplasty (TJA), so interventions may focus on patients standing to receive the most benefit.Material and methodsThis is a retrospective study of 787 patients undergoing primary unilateral TJA from September 1, 2020, to September 31, 2021. Patients were deemed to be at "high risk" based on criteria derived from published literature and triaged to an enhanced preoperative education program. Patients that were discharged to a skilled nursing facility, had a length of stay ≥ 2 days, returned to the emergency department, or readmitted within 30 days were classified as having a composite outcome. A univariate analysis compared patients who did and did not experience the composite outcome, and multivariate regression was performed to evaluate predictors of this endpoint.ResultsDifferences in rates of 5 of the 28 risk factors were present between patients who did and did not experience composite outcomes. After controlling for other factors, African American race, planned discharge to skilled nursing facility, mental health conditions or drug use, cardiac, and neurologic conditions were predictive of the composite outcome. Patients who were reclassified as "high risk" with 1 or more of these characteristics, experienced longer length of stay and lower rates of home discharge than the rest of the population.ConclusionThis study presents a profile of high-risk TJA patients that can be incorporated into clinical practice for risk stratification and targeted intervention.
| S-EPMC9237280 | biostudies-literature