Early regression index (ERI) on MR images as response predictor in esophageal cancer treated with neoadjuvant chemo-radiotherapy: Interim analysis of the prospective ESCAPE trial.

PURPOSE: The early regression index (ERI) predicts treatment response in rectal cancer patients. Aim of current study was to prospectively assess tumor response to neoadjuvant chemo-radiotherapy (nCRT) of locally advanced esophageal cancer using ERI, based on MRI. MATERIAL AND METHODS: From January 2020 to May 2023, 30 patients with esophageal cancer were enrolled in a prospective study (ESCAPE). PET-MRI was performed: i) before nCRT (tpre); ii) at mid-radiotherapy, tmid; iii) after nCRT, 2-6 weeks before surgery (tpost); nCRT delivered 41.4 Gy/23fr with concurrent carboplatin and paclitaxel. For patients that skipped surgery, complete clinical response (cCR) was assessed if patients showed no local relapse after 18 months; patients with pathological complete response (pCR) or with cCR were considered as complete responders (pCR + cCR). GTV volumes were delineated by two observers (Vpre, Vmid, Vpost) on T2w MRI: ERI and other volume regression parameters at tmid and tpost were tested as predictors of pCR + cCR. RESULTS: Complete data of 25 patients were available at the time of the analysis: 3/25 with complete response at imaging refused surgery and 2/3 were cCR; in total, 10/25 patients showed pCR + cCR (pCR = 8/22). Both ERImid and ERIpost classified pCR + cCR patients, with ERImid showing better performance (AUC:0.78, p = 0.014): A two-variable logistic model combining ERImid and Vpre improved performances (AUC:0.93, p < 0.0001). Inter-observer variability in contouring GTV did not affect the results. CONCLUSIONS: Despite the limited numbers, interim analysis of ESCAPE study suggests ERI as a potential predictor of complete response after nCRT for esophageal cancer. Further validation on larger populations is warranted.

Self-reported prevalence of sleep disorders among medical and nursing students.

BACKGROUND: Sleep disorders are highly prevalent among university students. In particular, the symptoms of sleep disorders are more prevalent among healthcare students. AIMS: To assess the prevalence of risk factors of insomnia and sleep disorders and to examine the correlations between them among nursing and medical students. We also compared the effects of shift work during internship. METHODS: The sample was 417 healthcare students; 202 of them were nursing students, and the remaining 215 were medical students. We used a self-administered questionnaire to assess the risk factors for insomnia (i.e. age, BMI, tobacco consumption, physical activity and perceived stress, using the General Health Questionnaire-12). We also used the Sleep and Daytime Habits Questionnaire and Epworth Sleepiness Scale to assess the prevalence of sleep disorders and daytime sleepiness. RESULTS: A higher percentage of nursing students than medical students were aged 25 years or older, engaged in inadequate levels of physical activity and consumed tobacco. With the exception of tobacco consumption among nursing students, high scores on the GHQ-12 were the only risk factor associated with daytime and nighttime symptoms and poor sleep quality. There was no significant association between the symptoms of sleep disorders and shift work including night shifts. CONCLUSIONS: Since sleep disorders are highly prevalent among healthcare students, early detection and management is recommended. This will decrease the risk of harm to students and patients, due to medical mistakes.

Secondary breast angiosarcoma: A multicentre retrospective survey by the national Italian association of Breast Surgeons (ANISC).

BACKGROUND: Breast angiosarcoma is a malignant mesenchymal neoplasm, which accounts for approximately 2% of all soft tissue sarcomas. Secondary breast angiosarcoma (SBA) may be related to chronic lymphedema after a mastectomy with lymph node dissection (Stewart Treves syndrome) and previous radiotherapy for complications from breast radiation treatment. It is a very rare condition; therefore, diagnosis and management are still a challenge. METHODS: The ANISC collected SBA data by means of a survey sent to all Italian breast centres in the ANISC. The clinicopathological characteristics and the management of this disease were analysed. RESULTS: Twenty-four centres participated in this survey in which 112 cases of SBA were analysed. The median age of the women with SBA was 68.9 years and it appeared approximately 90 months after the first irradiation for breast cancer. In 92% of cases, a mastectomy was performed without axillary dissection for those patients having a high grade of SBA (74.2%). The prognosis was worse in the high-grade cases (overall survival-OS: 36 months) as compared with the low-grade cases (OS: 48 months). After a follow-up of 5 years, 50.5% of the patients were still alive. Disease-free survival (DFS) was 35 months, and there were no differences between the groups of patients with either high- or low-grade histology. CONCLUSIONS: Secondary breast angiosarcoma is a very aggressive disease associated with a short survival outcome. The surgical approach still remains an important step in the course of treatment; furthermore, an accurate histological examination is helpful in establishing the prognosis of the patient. A mastectomy is mandatory. A longer OS was observed in patients with low-grade angiosarcoma as compared to high-grade angiosarcoma (C.I. 40-57 vs. 31-41 months).

Deltoid muscle activity in patients with reverse shoulder prosthesis at 2-year follow-up.

PURPOSE: The reverse shoulder prosthesis (RSP) was developed to relieve pain and improve functional outcomes in patients with glenohumeral arthritis and deficiency of the rotator cuff. Even if clinical and functional outcomes regarding the use of the RSP were reported by literature, data concerning progressive deltoid adaptation to this non-anatomic implant are still missing. The purpose of our study was to correlate clinical and functional outcomes with deltoid fibers activity and muscle fatigability in patients with reverse shoulder prosthesis at 2 years follow-up. METHODS: Twenty patients with reverse shoulder prosthesis due to symptomatic deficient or nonfunctional rotator cuff associated with osteoarthritis were referred by Cervesi Hospital Shoulder and Elbow Surgery Unit. Exclusion criteria were: axillary nerve palsy, a nonfunctioning deltoid muscle, diabetes, previous trauma, malignancy. Furthermore patients who received the RSP for revision arthroplasty, proximal humerus fractures were excluded. All the patients underwent clinical and functional evaluation with the support of electromyography measurement focused on deltoid activity. RESULTS: RSP surgical treatment in shoulder osteoarthritis confirms his good outcome in terms of pain relief. At 2 years anterior and lateral deltoid electromyographic activity was significantly lower compared with contralateral side (p < 0.001). Posterior deltoid activity was no detectable. Range of motion at 2 years of follow-up decreased in terms of forward flexion (p = 0.045), abduction (p = 0.03) and external rotation (p < 0.001). CONCLUSIONS: Our study demonstrates that even if the patients remain pain-free, progressive deterioration of the deltoid activity is unavoidable and may lead to poor functional outcomes overtime.

Imaging of postoperative shoulder instability.

Postoperative imaging in shoulder instability is still a challenge for radiologists due to various postsurgical anatomical findings that could be considered pathologic in treated shoulder. For this reason is very important a deep knowledge about surgical procedures, anatomical changes after surgery and the appropriate diagnostic imaging modalities to work up the symptomatic postoperative shoulder. Postoperative imaging options include use conventional radiography, magnetic resonance imaging (MRI), MRI arthrography, computed tomography (CT) and CT arthrography. The purpose of our review is to explain the different surgical procedures and to describe postoperative changes detected with radiological imaging.

Can posterior capsular stretching rehabilitation protocol change scapula kinematics in asymptomatic baseball pitchers?

PURPOSE: Scapular dyskinesis is a recognized cause of shoulder pain in the throwing shoulder of baseball pitchers and athletes who participate in overhead sports. Past studies have assessed scapular kinematics using electromagnetic tracking devices and have shown a correlation between posterior shoulder tightness and forward scapular posture. The purpose of our study is to evaluate the scapular kinematics, before and after a 4-week posterior stretching protocol in asymptomatic pitchers. METHOD: Eleven asymptomatic collegiate baseball pitchers were involved in the study and divided into group A (6 pitchers) underwent 4 weeks of a regimented therapy protocol and group B (5 pitchers) did not receive any treatment. Each pitcher was tested on two separate days: at the first day of the study (S1) and after 4 weeks (S2). RESULTS: The results demonstrate that there are statistically significant differences in the kinematics of several athletes from the "treated group" (group A) between S1 and S2. It is also important to notice that variations in group A occurred in both flexextension and ab/adduction movements, strengthening the conclusion that the variation was real. CONCLUSION: The results of the study can indicate that, in order to prevent the pathologic cascade linked to these sports activities, this physical training protocol might become integral part of the normal daily exercises of baseball pitchers and overhead athletes. Level of evidence II.

Strength recovery after proximal humeral fractures treated with locking plate.

PURPOSE: The aim of this study is to understand whether the isokinetic strength could be a valid objective data of functional recovery evaluating a group of patients with proximal humeral fractures treated with open reduction and internal fixation with locking plate comparing the clinical and functional recovery (isokinetic strength) with the not involved side. METHODS: Seventy patients underwent surgery with locking plate placement for proximal humeral fractures. The strength of each patient's shoulders, both involved and not involved, was evaluated using isokinetic tests and Constant-Murley score. Finally, the study included 48 patients and the mean follow-up of 33 months. RESULTS: The functional outcome showed no significant differences between operated and not operated shoulder. CONCLUSIONS: This study shows that the assessment of the force can be supported by use of tools such as the evaluation with isokinetic machines with the advantage of having, in this way, an objective data on the functional recovery. LEVEL OF EVIDENCE: III.

Gap formation in a transosseous rotator cuff repair as a function of bone quality.

BACKGROUND: The transosseous approach has been well known for a long time as a valid repair approach. Over time, various criticisms have been raised over this technique principally classifiable in two main categories: technical difficulty and related reproducibility in an arthroscopic environment, and repair stability (in the suture-bone contact area). About cyclic performance, several authors have conceived test setups with the aim of simulating a real environment in dynamic load conditions. The aim of this study was to monitor gap formation in a cyclic test setup. METHODS: The performance (measured as gap formation) has been monitored as a function of bone density to verify the effect of the latter. The test blocks have been shaped using sawbones® test bricks (Malmo, Sweden) of different densities, and the following values have been tested: 10, 15, 20, 30 and 40pcf. FINDINGS: The comparison has been made between the two groups: traditional transosseous and new approach with an interposed device. Regarding the traditional transosseous approach in a 10-pcf environment, not even the first loading cycle was completed, the whole bone bridge was destroyed in the first loading ramp and no further loading capability was present in the repair. By increasing the block density, the surface damage in the suture-block contact decreased. INTERPRETATION: With this work, it has been demonstrated how the traditional transosseous approach is strongly influenced by the bone quality up to the point where, in certain conditions, a safe and reliable repair is not guaranteed.

Can the osteosynthesis with locking plates be a better treatment for unstable fractures of the proximal humerus?

PURPOSE: The purpose of this study is to review our experience with proximal humeral locking plates, including complications, functional outcomes, strength recovery and predictors of successful treatment. METHODS: Seventy unstable proximal humeral fractures were treated with open reduction internal fixation (ORIF) with the use of locking proximal humerus plate. At an average follow-up of 31 months, the clinical and subjective outcomes were evaluated, and complication was analysed. RESULTS: The average Constant score was 72. The mean disabilities of the arm, shoulder and hand score was 23. The average range of motion was as follows: mean range of anterior elevation and abduction 120°-150°; external rotation in abduction 64° and in adduction 44°; and internal rotation T12. CONCLUSION: On the basis of the overall functional and clinical outcome obtained, it is possible to suggest that the ORIF of the proximal humerus fractures using locking plate represents a helpful option that can lead to a good clinical and functional outcome even in the most complex fractures.

Optimal positioning of the humeral component in the reverse shoulder prosthesis.

INTRODUCTION: Total reverse shoulder arthroplasty is becoming more and more the standard therapeutic practice for glenohumeral arthropathy with massive lesions of the rotator cuff. The biomechanical principle of this prosthesis is represented by the reversion of the normal anatomy of the shoulder joint. This non-anatomical prosthesis leads to a medialization of the rotation centre of the glenohumeral joint and also to a distalization of the humeral head. All that causes a deltoid tension increasing so allowing a larger abduction of the arm. Main complications of the reverse shoulder prosthesis are due to the joint instability, the scapular notching and the wear of the polyethylene insert. PURPOSE: The main goal of the present work is to study the effect of the positioning of the humeral component on the intrinsic stability of the reverse shoulder prosthesis. In particular, through finite element method simulations, the variation of the stability ratio of the shoulder joint has been calculated for both vertical and horizontal dislocating loads depending on the humeral stem version angle. Moreover, in order to estimate the wear of the polyethylene cup, some analyses have been developed to calculate the pressures on the polyethylene insert. RESULTS: The obtained results demonstrate the dislocation of a shoulder prosthesis and the wear of the polyethylene insert can be prevented or limited by conveniently varying the version angle of the humeral component.

Motion analysis assessment of alterations in the scapulo-humeral rhythm after throwing in baseball pitchers.

PURPOSE: Throwing a baseball requires a coordinated sequence of scapula and humerus movements also called scapulo-humeral rhythm (SHR). Fatigue associated with repetitive throwing can lead to scapular dyskinesia, a recognized cause of shoulder disability in pitchers and overhead athletes. We introduce a novel device, the Xbus Kit, which can objectively assess scapular biomechanics and the effect of pitching on SHR. METHODS: SHR was studied using the Xbus Kit (Xsens Technologies B.V., NL). Thirteen collegiate baseball pitchers (aged 20 ± 2.6) were studied, evaluating SHR in forward elevation and abduction in three sessions: before throwing (S1), after 60 pitches (S2) and 24 h after a pitching session (S3). RESULTS: SHR changes were found in 85 % of pitchers (11 cases), and no changes were observed in 2 cases (15 %). We were able to subdivide pitchers into four groups, based on their response to pitching. CONCLUSION: Repetitive movement of pitching leads to SHR changes and sometimes, incomplete restoration of normal shoulder biomechanics.

Laparoscopic versus laparotomic approach to endometrial cancer.

OBJECTIVE: The aim of our study was to compare the feasibility, morbidity, long-term safety, disease-free survival, and overall survival of the laparoscopic (LPS) approach to early-stage endometrial cancer (EC) compared to the traditional laparotomic approach. METHODS: We reviewed retrospective data of patients who underwent primary surgery from 1997 to 2009. We recorded clinical parameters, surgical stage, histological type, operative and peri-operative complications, time to resumption of normal functions, conversion to laparotomy, overall survival, and disease-free survival. RESULTS: LPS, did not increase operative risk and peri-operative complications even in obese and older women. The number of pelvic lymph and aortic nodes removed was similar for the two groups. One hundred and eight patients had a follow-up of 60 months. The two groups were similar for disease-free survival and overall survival. CONCLUSIONS: Laparoscopic approach to EC provides a reduction in postoperative complications and hospital stay compared to the laparotomic approach.

Modified Phemister procedure for the surgical treatment of Rockwood types III, IV, V acute acromioclavicular joint dislocation.

Acromioclavicular (AC) joint dislocations are common in young, active patients. In case of surgical indications, Rockwood type IV, type V and selected type III dislocation, we use modified Phemister procedure. At mid-term follow-up, by an average of 35.1 months, we reassessed the records of 14 patients surgically treated for acute AC dislocation from February 2007 to November 2010. In patients with a diagnosis of grade III lesion, indication for surgery was given on the basis of the patient's functional demand. Full recovery was obtained on average 3 months after surgery. Constant Score accounted for 92.7 points, mean Disabilities of the Arm, Shoulder and Hand Score for 3.2 points, and mean Simple Shoulder Test Score for 11.4 points. X-ray findings were partial loss of reduction (9 cases), subclinic re-dislocation (2 cases), calcification (5 cases) and post-traumatic arthritis (2 cases). Modified Phemister is a reliable technique, technically easy, a low learning curve procedure and cheap with low hardware's costs.

In vitro activity of N-benzenesulfonylbenzotriazole on Trypanosoma cruzi epimastigote and trypomastigote forms.

Chagas disease is still an important health problem in Central and South America. However, the only drugs currently available for specific treatment of this disease may induce toxic side effects in the host. The aim of this work was to determine the activity of N-benzenesulfonylbenzotriazole (BSBZT) against the protozoan parasite Trypanosoma cruzi. The effects of BSBZT and benzotriazole (BZT) were compared to those of benznidazole (BZL) on epimastigote and trypomastigote forms. BSBZT was found to have an in vitro growth inhibitory dose-dependent activity against epimastigotes, with flow cytometry analysis confirming that the treated parasites presented size reduction. BSBZT showed an IC(50) of 21.56 µg/mL (81.07 µM) against epimastigotes at 72 h of incubation, whereas BZT did not affect the growth of this parasite form. Furthermore, the toxic effect of BSBZT, was stronger and appeared earlier (at 24h) in trypomastigotes than in epimastigotes, with the LC(50) of this compound being 28.40 µg/mL (106.79 µM) against trypomastigotes. The concentrations of BSBZT used in this study presented low hemolytic activity and cytotoxicity. Consequently, at concentrations near IC(50) and LC(50) (25µg/mL), BSBZT caused only 2.4% hemolysis and 15% of RAW 264.7 cell cytotoxicity. These results reveal the potential of BSBZT as a prototype in drug design for developing new anti-T. cruzi compounds.

Financial aspects of sentinel lymph node biopsy in early breast cancer.

AIM: At present, early breast cancer is treated with conservative surgery of the primary lesion (BCS) along with axillary staging by sentinel lymph node biopsy (SLNB). Although the scintigraphic method is standardized, its surgical application is different for patient compliance, work organization, costs, and diagnosis related group (DRG) reimbursements. METHODS: We compared four surgical protocols presently used in our region: (A) traditional BCS with axillary lymph node dissection (ALND); (B) BCS with SLNB and concomitant ALND for positive sentinel nodes (SN); (C) BCS and SLNB under local anaesthesia with subsequent ALND under general anaesthesia according to the SN result; (D) SLNB under local anaesthesia with subsequent BCS under local anaesthesia for negative SN, or ALND under general anaesthesia for positive SN. For each protocol, patient compliance, use of consumables, resources and time spent by various dedicated professionals, were analyzed. Furthermore, a detailed breakdown of 1-/2-day hospitalization costs was calculated using specific DRGs. RESULTS: We reported a mean costs variation that ranged from 1,634 to 2,221 Euros (protocols C and D). The number of procedures performed and the pathologists' results are the most significant variables affecting the rate of DRG reimbursements, that were the highest for protocol D and the lowest for protocol B. CONCLUSIONS: In our experience protocol C is the most suitable in terms of patient compliance, impact of surgical procedures, and work organization, and is granted by an appropriate DRG. We observed that a multidisciplinary approach enhances overall patient care and that a revaluation of DRG reimbursements is opportune.

The use of digital images to evaluate the interobserver agreement on cervical smear readings in Italian cervical cancer screening.

OBJECTIVE: The aim of this study was to measure interobserver agreement among cytologists on using a set of digital images. METHODS: A set of 90 selected Papanicolaou-stained cervical smears were digitalized and the digital images circulated among 117 readers, from laboratories spread across almost all Italian regions. Three representative fields of each smear were displayed at 20× and 40× magnification (overall six images for each case). The diagnoses made by the cytologists who provided the images were taken as target diagnoses. RESULTS: The κ values were: very low for the categories atypical squamous cells of undetermined significance (ASC-US), and atypical squamous cells - cannot exclude high-grade squamous intraepithelial lesion (ASC-H); poor for the categories atypical glandular cells (AGC), high-grade squamous intraepithelial lesion (HSIL) and invasive cancer; and fair to good for the categories negative and low-grade squamous intraepithelial lesion (LSIL). However, we found a cluster of 42 best concordant readers. The overall κ value and overall weighted κ with the target diagnosis for these 42 readers were 0.45 and 0.66, respectively. This finding is in contrast with the overall κ value and overall weighted κ for the other readers of 0.39 and 0.59, respectively. CONCLUSIONS: As this finding is an estimate of the accuracy of the readers, we can infer that it will be very important to reach this level of concordance for all the participating readers. Future effort will facilitate common experiences in order to improve the reproducibility of diagnostic criteria. Digital images could be the key to reach this aim.

The effect of self-sampled HPV testing on participation to cervical cancer screening in Italy: a randomised controlled trial (ISRCTN96071600).

BACKGROUND: In Italy, cervical cancer screening programmes actively invite women aged 25-64 years. Programmes are hindered by low participation. METHODS: A sample of non-responder women aged 35-64 years, belonging to three different programmes (in Rome, Florence and Teramo), was randomly split into four arms: two control groups received standard recall letters to perform either Pap-test (first group) or human papillomavirus (HPV) test (second group) at the clinic. A third arm was sent letters offering a self-sampler for HPV testing, to be requested by phone, whereas a fourth group was directly sent the self-samplers home. RESULTS: Compliance with standard recall was 13.9% (N619). Offering HPV test at the clinic had a nonsignificant effect on compliance (N616, relative risk (RR)=1.08; 95% CI=0.82-1.41). Self-sampler at request had the poorest performance, 8.7% (N622, RR=0.62; 95% CI=0.45-0.86), whereas direct mailing of the self-sampler registered the highest compliance: 19.6% (N616, RR=1.41; 95% CI=1.10-1.82). This effect on compliance was observed only in urban areas, Florence and Rome (N438, RR=1.69; 95% CI=1.24-2.30), but not in Abruzzo (N178, RR=0.95; 95% CI=0.61-1.50), a prevalently rural area. CONCLUSIONS: Mailing self-samplers to non-responders may increase compliance as compared with delivering standard recall letters. Nevertheless, effectiveness is context specific and the strategy costs should be carefully considered.

Age-specific patterns of unsatisfactory results for conventional Pap smears and liquid-based cytology: data from two randomised clinical trials.

OBJECTIVE: To investigate the rate of unsatisfactory cervical cell samples in liquid-based cytology (LBC) versus conventional cytology (CC) by age. DESIGN: Randomised clinical trials. SETTING: Population-based cervical cancer screening in the Netherlands and Italy. POPULATION: Asymptomatic women invited for screening enrolled in two randomised trials: Netherlands ThinPrep versus conventional cytology (NETHCON; 39 010 CC, 46 064 LBC) and New Technologies in Cervical Cancer Screening (NTCC; 22 771 CC, 22 403 LBC). METHODS: Comparison of categorical variables using Pearson's chi-square test, logistic regression and trend tests. MAIN OUTCOME MEASURES: Proportion of unsatisfactory samples, ratio of LBC versus CC, and variation by 5-year group. RESULTS: In NETHCON, a lower percentage of LBC samples were judged to be unsatisfactory compared with CC samples (0.33 versus 1.11%). There was no significant trend in unsatisfactory results by age group for conventional cytology (P(trend) = 0.54), but there was a trend towards an increasing percentage of unsatisfactory results with increasing age for LBC (P(trend) < 0.001). In NTCC, a lower percentage of LBC samples were judged to be unsatisfactory compared with conventional cytology (2.59 versus 4.10%). There was a decrease in the unsatisfactory results by age group with conventional cytology (P(trend) < 0.001) and with LBC (P(trend) = 0.01), although the latter trend arose from the 55-60-years age group (P(trend) = 0.62 when excluding this group). CONCLUSIONS: The clinical trial in which the results were collected and the cytologic method used were the most important determinants of unsatisfactory cytology. In all situations, the proportion of unsatisfactory samples was lower in LBC compared with CC. The effects of age depended on the criteria used to define unsatisfactory results.