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Outcomes after Pancreatectomy with Routine Pasireotide Use.

ABSTRACT: BACKGROUND:Morbidity 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 DESIGN:A 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. RESULTS:During 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. CONCLUSIONS:At 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.

SUBMITTER: Kunstman JW

PROVIDER: S-EPMC7592191 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

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Outcomes after Pancreatectomy with Routine Pasireotide Use.

Kunstman John W JW Goldman Debra A DA Gönen Mithat M Balachandran Vinod P VP D'Angelica Michael I MI Kingham T Peter TP Jarnagin William R WR Allen Peter J PJ

Journal of the American College of Surgeons 20181107 2

<h4>Background</h4>Morbidity 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.<h4>Study desig ...[more]

PMID: 30414453

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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.

Dataset Information

Outcomes after Pancreatectomy with Routine Pasireotide Use.

Publications

Outcomes after Pancreatectomy with Routine Pasireotide Use.

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