Physical frailty and nutritional malassimilation are often observed after pancreaticoduodenectomy for pancreatic cancer. But long-term data concerning the course of micronutrient status is still ...missing. Micronutrient status after pylorus preserving pancreaticoduodenectomy with a follow-up of 12 months was evaluated using data of a randomized controlled trial. 47 patients were randomized with respect to the physiotherapy regimen they received (intensified physiotherapy: n = 22; standard physiotherapy: n = 25). Nutritional status was recorded preoperatively and postoperatively after one week, 3, 6 and 12 months. BMI, body fat measurement and albumin, lipid, iron and bone metabolism parameters, vitamins A, B1 B6 and B12, homocysteine, folic acid, and trace elements were measured. Laboratory values were analyzed descriptively. Differences between the groups were analyzed using the t-test in SPSS. For vitamin D, B1, B6 and iron a deficiency over time could be demonstrated with 50% of all patients or more being below normal range. The other laboratory values were in low normal range after 3 months and later. Significant differences between groups were found in cholesterol, HDL and selenium levels (corrected p-values < 0.033 in all cases). Vitamin D and iron should be supplemented postoperatively in the long term, and vitamin B1 and B6 substitution should be considered in symptomatic patients. Levels of malnutrition induced fatigue should be comparable between both groups. However, the role of nutritional status on other health-related aspects such as quality of life should be the focus of further studies.Trial Registration Number in the German Registry for Clinical Studies: DRKS00006786; Date of Registration: 01.10.2014.
Patients have significantly lower QoL scores after pancreatic resection due to cancer in the physical and psychological domains compared to healthy controls or other cancer patients. Intensified ...physiotherapy or physical training can increase QoL by reducing fatigue levels and improving physical functioning. However, data on the long-term effects of intensive or supervised physiotherapy is lacking. The aim of this exploratory study is the assessment of QoL in the intervention group, using various QoL questionnaires in their validated German translations and gather data on its feasibility in the context of chemotherapy with a follow-up of 12 months (and develop concepts to improve QoL after pancreatic cancer resection).
Fifty-six patients (mean age: 66.4 ± 9.9 years) were randomized in this study to intervention (cohort A, n = 28) or control group (cohort B, n = 28). Intervention of intensified physiotherapy program consisted of endurance and muscle force exercises using cycle ergometer. In the control group physiotherapy was limited to the duration of the hospital stay and was scheduled for 20 min on 5 days per week. The clinical visits took place 2 days preoperatively, 1 week, 3 months, 6 months and 12 months postoperatively. Both groups attended the follow-up program. QoL was evaluated using the Short Physical Performance Battery (SPPB), Short Form-8 Health Survey (SF-8) and the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and pancreatic cancer-specific module QLQ-PAN26 questionnaires. The course of QoL was evaluated using a repeated measures ANOVA and a per protocol design.
Of the initial 56 randomized patients, 34 finished the 12 months follow-up period. There were no adverse events due to the intervention and 80% of patients in the intervention group where adherent. There was no significant influence on physical performance as measured by SPPB and SF-8 questionnaire. However, after 6 months patients in the intervention group regained their prior physical condition, whereas the control group did not. Intensive physiotherapy significantly influenced various factors of QoL measured with the C30 questionnaire positively, such as physical functioning (p = 0.018), role functioning (p = 0.036), and appetite loss (p = 0.037), even after 6 months. No negative effects in patients undergoing chemotherapy compared to those without chemotherapy was observed.
This first randomized controlled study with a 12-month follow-up shows that supervised physiotherapy or prescribed home-based exercise after pancreatic cancer resection is safe and feasible and should be proposed and started as soon as possible to improve certain aspects of QoL.
German Clinical Trials Register (No: DRKS00006786 ); Date of registration: 01/10/2014.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Auscultation is a fundamental diagnostic technique that provides valuable diagnostic information about different parts of the body. With the increasing prevalence of digital stethoscopes and ...telehealth applications, there is a growing trend towards digitizing the capture of bodily sounds, thereby enabling subsequent analysis using machine learning algorithms. This study introduces the SonicGuard sensor, which is a multichannel acoustic sensor designed for long-term recordings of bodily sounds. We conducted a series of qualification tests, with a specific focus on bowel sounds ranging from controlled experimental environments to phantom measurements and real patient recordings. These tests demonstrate the effectiveness of the proposed sensor setup. The results show that the SonicGuard sensor is comparable to commercially available digital stethoscopes, which are considered the gold standard in the field. This development opens up possibilities for collecting and analyzing bodily sound datasets using machine learning techniques in the future.
Factors for overall survival after pancreatic ductal adenocarcinoma (PDAC) seem to be nodal status, chemotherapy administration, UICC staging, and resection margin. However, there is no consensus on ...the definition for tumor free resection margin. Therefore, univariate OS as well as multivariate long-term survival using cancer center data was analyzed with regards to two different resection margin definitions. Ninety-five patients met inclusion criteria (pancreatic head PDAC, R0/R1, no 30 days mortality). OS was analyzed in univariate analysis with respect to R-status, CRM (circumferential resection margin; positive: ≤1mm; negative: >1mm), nodal status, and chemotherapy administration. Long-term survival >36 months was modelled using multivariate logistic regression instead of Cox regression because the distribution function of the dependent data violated the requirements for the application of this test. Significant differences in OS were found regarding the R status (Median OS and 95%CI for R0: 29.8 months, 22.3-37.4; R1: 15.9 months, 9.2-22.7; p = 0.005), nodal status (pN0 = 34.7, 10.4-59.0; pN1 = 17.1, 11.5-22.8; p = 0.003), and chemotherapy (with CTx: 26.7, 20.4-33.0; without CTx: 9.7, 5.2-14.1; p < .001). OS according to CRM status differed on a clinically relevant level by about 12 months (CRM positive: 17.2 months, 11.5-23.0; CRM negative: 29.8 months, 18.6-41.1; p = 0.126). A multivariate model containing chemotherapy, nodal status, and CRM explained long-term survival (p = 0.008; correct prediction >70%). Chemotherapy, nodal status and resection margin according to UICC R status are univariate factors for OS after PDAC. In contrast, long-term survival seems to depend on wider resection margins than those used in UICC R classification. Therefore, standardized histopathological reporting (including resection margin size) should be agreed upon.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
The prognostic effect of resection margin status following pancreatoduodenectomy for pancreatic ductal adenocarcinoma (PDAC) remains controversial, even with the implementation of standardized ...pathological assessment. We therefore investigated the impact of resection margin (RM) status and RM distance in curative resected PDAC on overall survival (OS), disease-free survival (DFS) and recurrence.
108 patients were retrieved from a prospectively maintained database of a certified pancreatic cancer center. Distribution and relationships between circumferential resection margin (CRM) involvement (CRM≤1mm; CRM>1mm; CRM≥2mm) and their prognostic impact on OS and DFS were assessed using Kaplan-Meier statistics and the Log-Rank test. Multivariate logistic regression was used explain the development of a recurrence 12 months after surgery.
63 out of 108 patients had medial RM and 32 posterior RM involvement. There was no significant difference in OS and DFS between CRM≤1mm and CRM>1mm resections. Clearance at the medial margin of ≥2mm had an impact on OS and DFS, (RM≥2mm vs. RM<2mm: median OS 29.8 vs 16.8 months, median DFS 19.6 vs. 10.3 months). Multivariate analysis demonstrated that age, medial RM ≥2mm, lymph node status and chemotherapy were prognostic factors for OS and DFS. Posterior RM had no influence on OS or DFS.
Not all RM seem to have the same impact on OS and DFS, and a clearance of 1mm for definition of a negative RM (i.e. CRM>1mm) seems not sufficient. Future studies should include more patients to stratify for potential confounders we could not account for.
This study was registered with the German Clinical Trials Registry (reference number DRKS0017425).
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
The distribution of time-to-event outcomes is usually right-skewed. While for symmetric and moderately skewed data the mean and median are appropriate location measures, the mode is preferable for ...heavily skewed data as it better represents the center of the distribution. Mode regression has been introduced for uncensored data to model the relationship between covariates and the mode of the outcome. Starting from nonparametric kernel density based mode regression, we examine the use of inverse probability of censoring weights to extend mode regression to handle right-censored data. We add a semiparametric predictor to add further flexibility to the model and we construct a pseudo Akaike’s information criterion to select the bandwidth and smoothing parameters. We use simulations to evaluate the performance of our proposed approach. We demonstrate the benefit of adding mode regression to one’s toolbox for analyzing survival data on a pancreatic cancer data set from a prospectively maintained cancer registry.
Introduction
Thyroid diseases are very common and rarely life‐threatening. One of the main therapeutic goals is an improvement in quality of life, making it important to measure in clinical and ...research settings. The aim of this systematic review is to provide an overview of the currently available thyroid‐specific quality of life questionnaires with regard to their validation quality in order to make recommendations for clinical use with a special focus on German questionnaires.
Methods
A systematic literature search was performed in Pubmed, Google Scholar and the Cochrane Library. A total of 904 studies were identified. After excluding duplicates, non‐English‐ or German‐language texts, full texts that were not freely available and studies with irrelevant content, 64 studies reporting on 16 different questionnaires were included in the analysis.
Results
Four questionnaires concerned benign thyroid diseases (ThyPRO, ThyPRO‐39, Thy‐R‐HRQoL and Thy‐D‐QOL), six malignant thyroid diseases (THYCA‐QoL, ThyCa‐HRLQOL, EORTC‐Thy34, MADSI‐Thy, QOL‐Thyroid and ThyCAT), and six endocrine orbitopathy (GO‐QOL, GO‐QLS, TED‐QOL, STED‐QOL, TAO‐QoL and Ox‐TED). Only five questionnaires were at least developed, if not validated, in German, and five were developed in more than two languages.
Conclusions
ThyPRO and the ThyPRO‐39 are the best‐evaluated questionnaires for benign thyroid diseases. Alternatively, in hypothyroid patients, the adequately validated Thy‐D‐QoL can be used. For malignant thyroid diseases, the choice should be made individually, as all six questionnaires (THYCA‐QoL, ThyCA‐HRQOL, EORTC‐Thy34, MDASI‐Thy, QOL‐Thyroid and ThyCAT) have different strengths and weaknesses. The GO‐QOL is the best‐validated questionnaire in endocrine orbitopathy. However, the TED‐QOL is also suitable as a short‐screening questionnaire for these patients.
The aim of this systematic review was to provide an overview of currently available thyroid‐specific Qol questionnaires with focus on the quality of the validation studies and on the clinical applicability of the questionnaires and the identification of gaps regarding specific research needs. In this systematic review, a total of 16 questionnaires could be identified. For different benign thyroid diseases, the Thy‐PRO and its short version ThyPRO‐39 are well established, whereas for malignant thyroid diseases and for endocrine orbitopathy there is still some work to be done to establish a clinically usable, and rigorously validated questionnaire.
Background: Recurrent laryngeal nerve (RLN) palsy is one possible complication during thyroid surgery. Intraoperative neuromonitoring and visualization of the nerve during surgery are standard ...procedures to reduce the risk of RLN palsy. This study aims to investigate new factors for RLN palsy and review ones that are already known in the literature to help surgeons prepare for the procedure. Methods: A retrospective study design was used to analyze the data of 1147 patients from a certified center for thyroid surgery. All patients underwent either total thyroidectomy or hemithyroidectomy from 2016 to 2020. The acquired information was analyzed descriptively. A logistic regression was used to analyze the independent variables of interest with the binary variable RLN palsy (yes/no). For the second aim of this study, a multiple logistic regression was applied to analyze the combined significant known and new risk factors. Results: Surgery indication for Graves’ disease (OR 14.34, p < 0.001), thyroid cancer (OR 2.39, p = 0.012), and recurrent goiter (OR 5.57, p < 0.001) increased the risk for RLN palsy significantly compared to nodular goiter in hemithyroidectomy. The duration of surgery correlated positively with a higher risk for RLN palsy (OR 1.009, p = 0.005). For gender, BMI, resection weight, left or right nerve at risk, and surgeon experience, no significant differences were found. Conclusion: Operations for Graves’ disease, thyroid cancer, and recurrent goiter have the highest risk for RLN palsy and surgeons should be alerted. The longer the operation, the higher the risk of RLN palsy. The correlation between surgery method (hemithyroidectomy vs. thyroidectomy) and RLN palsy should be carefully considered due to possible bias.
We present a case report of a 73-year-old male patient with a complete clinical response following neoadjuvant radiochemotherapy of mid-rectal adenocarcinoma. The patient was initially diagnosed with ...stage IIIB microsatellite stable mid-rectal adenocarcinoma in February 2017. During restaging in June 2017, which included rectoscopy, endosonography, computed tomography and magnetic resonance imaging, a complete clinical response was observed. After appropriate consultation, a watch-and-wait strategy was chosen. During stringent follow-up every 3 months for the first 3 years and thereafter every 6 months, no recurrence or regrowth was observed. After the fifth year of complete clinical response, we recommended an annual follow-up. As of November 2023, the patient has no signs of recurrence or late toxicity after radiochemotherapy. The omission of resection in patients with locally advanced rectal cancer and the establishment of a watch-and-wait strategy are currently under discussion as possible treatment courses in patients with complete clinical response. Long-term data on watch-and-wait strategies for patients with a complete clinical response in locally advanced rectal cancer are rare. A clear national and international accepted standardization of follow-up programs for patients managed by a watch-and-wait strategy in the long-term is missing. Here, we report the case of a patient who had undergone a follow-up program for more than five years and discuss the current literature. Our case report and literature review highlights that a watch-and-wait strategy does not seem to increase the risk of systemic disease or compromise survival outcomes in selected locally advanced rectal cancer patients. Thus, our case contributes to the growing body of knowledge on personalized and precision medicine for rectal cancer.