bluuebunny/crossref_metadata_2025_split huggingface dataset:
Carbon tattooing for targeted lymph node biopsy after primary systemic therapy in breast cancer: prospective multicentre TATTOO trial
Authors: Hartmann S , Kühn T , de Boniface J , Stachs A , Winckelmann A , Frisell J , Wiklander-Bråkenhielm I , Stubert J , Gerber B , Reimer T 
Published: January 2021

Abstract

Background
Several techniques for targeted lymph node biopsy in patients with node-positive breast cancer receiving primary systemic therapy are in use, each with their inherent advantages and disadvantages. The aim of the TATTOO trial was to evaluate the feasibility and accuracy of carbon tattooing of positive lymph nodes as a method for targeted lymph node biopsy avoiding radiation exposure, high costs, and preoperative localization procedures.

Methods
Patients with initially cT1–4c cN1–3 cM0 invasive breast cancer were included in this prospective multicentre trial. Before initiation of primary systemic therapy, a carbon suspension was injected into the most suspicious axillary lymph node. Targeted lymph node biopsy was performed in all patients after completion of primary systemic therapy. Additional sentinel lymph node biopsy was done in those with axillary downstaging, and completion axillary lymph node dissection in patients still presenting with suspicious lymph nodes.

Results
A total of 118 patients were included and 110 were eligible for data analysis. The detection rate for the targeted lymph node was 93.6 per cent (103 of 110), and the sentinel lymph node was identical to the targeted lymph node in 60 per cent. The false-negative rate for the combination of targeted and sentinel node lymph node biopsy (targeted axillary dissection) was 9 per cent.

Conclusion
Targeted axillary dissection after carbon tattooing is associated with a high detection rate, an acceptable false-negative rate, and appears feasible for clinical use even in healthcare settings with limited resources.
PAM-50 predicts local recurrence after breast cancer surgery in postmenopausal patients with ER+/HER2– disease: results from 1204 patients in the randomized ABCSG-8 trial
Authors: Fitzal F , Filipits M , Fesl C , Rudas M , Greil R , Balic M , Moinfar F , Herz W , Dubsky P , Bartsch R , Ferree S , Schaper C , Gnant M ,   the Austrian Breast and Colorectal Cancer Study Group (ABCSG)
Published: January 2021

Abstract

Background
The aim of this study was to investigate whether the PAM-50-based 46-gene assay carries prognostic value for risk of local recurrence of breast cancer.

Methods
The Austrian Breast and Colorectal Cancer Study Group (ABCSG) 8 RCT compared 5 years of tamoxifen with tamoxifen for 2 years followed by anastrozole for 3 years in postmenopausal women with endocrine receptor-positive breast cancer. This study included patients from the trial who had breast-conserving surgery for whom tumour blocks were available for PAM-50 analysis.

Results
Tumour blocks from 1204 patients who had breast-conserving surgery were available for the PAM-50 analysis, and 1034 of these received radiotherapy. After a median follow-up of 10.8 years, 23 local events had been observed, corresponding to an overall local recurrence risk of 2.2 per cent. Univariable competing-risk analysis demonstrated that patients at low risk according to PAM-50 analysis (risk-of-recurrence (ROR) score less than 57) had a significantly lower incidence of local recurrence than those in the high-risk group at 5 years (0.1 (95 per cent c.i. 0 to 0.7) versus 2.2 (0.9 to 4.6) per cent respectively; subhazard ratio (SHR) 17.18, 95 per cent c.i. 2.06 to 142.88; P = 0.009) and 10 years (0.9 (0.4 to 2.0) versus 3.8 (1.9 to 6.6) per cent; SHR 4.76, 1.72 to 13.17; P = 0.003). Multivariable analyses that included ROR score, age, tumour size, nodal status, type of surgery, tumor grade, and trial-specific endocrine therapy confirmed that ROR score was an independent prognostic factor for risk of local recurrence. Analysis of the women randomized to radiotherapy or control after breast conservation showed that PAM-50 was not predictive of radiotherapy effect.

Conclusion
PAM-50 can be used as a prognostic tool for local recurrence risk in postmenopausal women with hormone receptor-positive breast cancer treated with endocrine therapy. The test was not predictive for the benefit of radiotherapy.
Staging laparoscopy for pancreatic cancer using intraoperative ultrasonography and fluorescence imaging: the SLING trial
Authors: Oba A , Inoue Y , Ono Y , Ishizuka N , Arakaki M , Sato T , Mise Y , Ito H , Saiura A , Takahashi Y 
Published: January 2021

This prospective trial revealed the additional diagnostic value of staging laparoscopy with contrast-enhanced intraoperative ultrasonography and indocyanine green-fluorescence imaging, detecting radiologically occult liver metastases and other occult metastases effectively for patients with high-risk resectable or borderline resectable pancreatic cancer. The 2-year survival rate of patients without occult metastasis was significantly better than that of patients with occult metastasis. These favourable results for patients without occult metastasis indicate that an enhanced screening strategy and modern multidisciplinary treatment may improve the outcome even of patients affected by high-risk advanced pancreatic cancer.
State-of-the-art staging worth the effort
Neoadjuvant chemoradiotherapy or chemotherapy alone for oesophageal cancer: population-based cohort study
Authors: Kamarajah S K , Phillips A W , Ferri L , Hofstetter W L , Markar S R 
Published: January 2021

Abstract

Background
Although both neoadjuvant chemoradiotherapy (nCRT) and chemotherapy (nCT) are used as neoadjuvant treatment for oesophageal cancer, it is unknown whether one provides a survival advantage over the other, particularly with respect to histological subtype. This study aimed to compare prognosis after nCRT and nCT in patients undergoing oesophagectomy for oesophageal adenocarcinoma (OAC) or squamous cell carcinoma (OSCC).

Methods
Data from the National Cancer Database (2006–2015) were used to identify patients with OAC and OSCC. Propensity score matching and Cox multivariable analyses were used to account for treatment selection biases.

Results
The study included 11 167 patients with OAC (nCRT 9972, 89.3 per cent; nCT 1195, 10.7 per cent) and 2367 with OSCC (nCRT 2155, 91.0 per cent; nCT 212, 9.0 per cent). In the matched OAC cohort, nCRT provided higher rates of complete pathological response (35.1 versus 21.0 per cent; P &lt; 0.001) and margin-negative resections (90.1 versus 85.9 per cent; P &lt; 0.001). However, patients who had nCRT had similar survival to those who received nCT (hazard ratio (HR) 1.04, 95 per cent c.i. 0.95 to 1.14). Five-year survival rates for patients who had nCRT and nCT were 36 and 37 per cent respectively (P = 0.123). For OSCC, nCRT had higher rates of complete pathological response (50.9 versus 30.4 per cent; P &lt; 0.001) and margin-negative resections (92.8 versus 82.4 per cent; P &lt; 0.001). A statistically significant overall survival benefit was evident for nCRT (HR 0.78, 0.62 to 0.97). Five-year survival rates for patients who had nCRT and nCT were 45.0 and 38.0 per cent respectively (P = 0.026).

Conclusion
Despite pathological benefits, including primary tumour response to nCRT, there was no prognostic benefit of nCRT compared with nCT for OAC suggesting that these two modalities are equally acceptable. However, for OSCC, nCRT followed by surgery appears to remain the optimal treatment approach.
Systemic versus Oral and Systemic Antibiotic Prophylaxis (SOAP) study in colorectal surgery: prospective randomized multicentre trial
Authors: Papp G , Saftics Gy , Szabó B E , Baracs J , Vereczkei A , Kollár D , Oláh A , Mészáros P , Dubóczki Zs , Bursics A 
Published: January 2021

Abstract

Background
There is no consensus regarding the role of mechanical bowel preparation (MBP) and oral antibiotic prophylaxis (OABP) in reducing postoperative complications in colorectal surgery. The aim of this study was to examine the effect of OABP given in addition to MBP in the setting of a prospective randomized trial.

Methods
Patients awaiting elective colorectal surgery in four Hungarian colorectal centres were included in this multicentre, prospective, randomized, assessor-blinded study. Patients were randomized to receive MBP with or without OABP (OABP+ and OABP– groups respectively). The primary endpoints were surgical-site infection (SSI) and postoperative ileus. Secondary endpoints were anastomotic leak, mortality, and hospital readmission within 30 days.

Results
Of 839 patients assessed for eligibility between November 2016 and June 2018, 600 were randomized and 529 were analysed. Trial participation was discontinued owing to adverse events in seven patients in the OABP+ group (2.3 per cent). SSI occurred in eight patients (3.2 per cent) in the OABP+ and 27 (9.8 per cent) in the OABP– group (P = 0.001). The incidence of postoperative ileus did not differ between groups. Anastomotic leakage occurred in four patients (1.6 per cent) in the OABP+ and 13 (4.7 per cent) in the OABP– (P = 0.02) group. There were no differences in hospital readmission (12 (4.7 per cent) versus 10 (3.6 per cent); P = 0.25) or mortality (3 (1.2 per cent) versus 4 (1.4 per cent); P = 0.39).

Conclusion
OABP given with MBP reduced the rate of SSI and AL after colorectal surgery with anastomosis, therefore routine use of OABP is recommended.
Use of powered air-purifying respirators during surgical interventions
Authors: Hardy N , Dalli J , Khan M F , McCaul C , O’Keeffe D , Traynor O , Jerry J , Brady D , Cahill R A 
Published: January 2021

This clinical study confirms user acceptability of PAPR during surgery both at operating room team level as well as by groups of surgeons, anaesthesiologists and nursing level. While some care is needed in the use of this equipment, surgery can be performed safely with satisfactory user experience.
Therefore PAPR is useable for surgery but scope exists for improvement.
Fetal surgery
Authors: Sampat K , Losty P D 
Published: January 2021

Abstract
Fetal medicine is a super-specialty enterprise and a technology-driven field. The growth and interest in fetal surgery can be largely attributed to advances in fetal imaging and bespoke instruments for in utero intervention. Previously fatal fetal conditions are now being treated using open surgery, minimally invasive procedures, and percutaneous fetal technologies. Several fetal conditions, including myelomeningocele and twin-to-twin transfusion syndrome, have been tested rigorously in RCTs. However, as the specialty of fetal surgery grows, a robust evidence base with long-term follow-up is obligatory for every procedure. This article offers an overview of fetal surgery and antenatal intervention. As more cutting edge therapies come into clinical practice, growing public opinion and medical ethics will play a significant role in the future of this multidisciplinary specialty.
Conventional transarterial chemoembolization combined with systemic therapy versus systemic therapy alone as second-line treatment for unresectable colorectal liver metastases: randomized clinical trial
Authors: Liu Y , Chang W , Zhou B , Wei Y , Tang W , Liang F , Chen Y , Yan Z , Lv M , Ren L , Xu J 
Published: January 2021

Abstract

Background
The combination of conventional transarterial chemoembolization (cTACE) and systemic therapy has the potential to treat chemotherapy-refractory unresectable colorectal liver metastases (CRLMs). This study aimed to compare survival after this combined treatment versus systemic chemotherapy alone.

Methods
This single-centre RCT included patients with unresectable CRLMs that progressed after first-line treatment. Patients were randomized on a 1 : 1 basis to either systemic chemotherapy with or without cTACE, without further stratification. The primary outcome was progression-free survival (PFS). Secondary outcomes were overall response rate, disease control rate, conversion rate to liver resection, overall survival, and adverse events.

Results
Of 180 patients recruited, 168 were randomized. Eighty-five patients in arm A received systemic chemotherapy plus cTACE and 83 in arm B received systemic chemotherapy alone. Median PFS was longer in arm A than B (6.7 versus 3.8 months; hazard ratio (HR) 0.67, 95 per cent c.i. 0.49 to 0.91; P = 0.009), but did not translate into prolonged median overall survival (18.4 versus 14.8 months; HR = 0.92, 0.62 to 1.36; P = 0.669). Overall response rates (20 versus 22 per cent; P = 0.788) and conversion rate to liver resection (18 versus 16 per cent; P = 0.730) were no different between arms A and B. The disease control rate was higher in arm A than arm B (67 versus 51 per cent; P = 0.030). No adverse event higher than grade 3 according to the Common Terminology Criteria for Adverse Events was observed during treatment.

Conclusion
Systemic chemotherapy plus cTACE is a safe option as second-line treatment for unresectable colorectal liver metastases, with a modest effect on PFS. Registration number: NCT03783559 (http://www.clinicaltrials.gov).
Should all gallbladders be examined routinely or selectively by microscopy after cholecystectomy? Population-based Dutch study over a decade
Authors: Corten B J G A , de Savornin Lohman E A J , Leclercq W K G , Roumen R M H , Verhoeven R , van Zwam P H , de Reuver P R , Dejong C H C , Slooter G D 
Published: January 2021

The need for routine histopathological examination of gallbladders after cholecystectomy is debated. This study suggests that selective histopathological examination of the gallbladder may be considered oncologically safe.
While the necessity of a routine histopathologic examination of gallbladders after cholecystectomy is debated. This study suggests that a selective histopathologic examination of the gallbladder may be considered as oncologically safe.
Percutaneous tibial nerve stimulation in patients with severe low anterior resection syndrome: randomized clinical trial
Authors: Marinello F G , Jiménez L M , Talavera E , Fraccalvieri D , Alberti P , Ostiz F , Frago R , Blanco A , Pellino G , Espín-Basany E 
Published: January 2021

Abstract

Background
Treatment of low anterior resection syndrome (LARS) is challenging. Percutaneous tibial nerve stimulation (PTNS) can improve select bowel disorders. An RCT was conducted to assess the efficacy of PTNS compared with sham stimulation in patients with severe LARS.

Method
This was a multicentre, double-blind RCT. Patients with major LARS score were allocated to receive PTNS or sham therapy (needle placement simulation without nerve stimulation). The study included 16 sessions of 30 min once a week for 12 consecutive weeks, followed by four additional sessions once a fortnight for the following 4 weeks. The primary endpoint was efficacy of PTNS defined by the LARS score 12 months after treatment. Secondary endpoints included faecal incontinence, quality of life (QoL), and sexual function.

Results
Between September 2016 and July 2018, 46 eligible patients were assigned randomly in a 1 : 1 ratio to PTNS or sham therapy. Baseline characteristics were similar. LARS scores were reduced in both groups, but only patients who received PTNS maintained the effect in the long term (mean(s.d.) score 36.4(3.9) at baseline versus 30.7(11.5) at 12 months; P = 0.018; effect size –5.4, 95 per cent c.i. –9.8 to –1.0), with a mean reduction of 15.7 per cent at 12-month follow-up. The faecal incontinence score was improved after 12 months in the PTNS group (mean(s.d.) score 15.4(5.2) at baseline versus 12.5(6.4) at 12 months; P = 0.018). No major changes in QoL and sexual function were observed in either group. There was no therapy-associated morbidity. Three patients discontinued the study, but none owing to study-related issues.

Conclusion
PTNS has positive effects in some patients with major LARS, especially in those with faecal incontinence. Registration number: NCT02517853 (http://www.clinicaltrials.gov).
Genomic Epidemiology of MRSA During Incarceration at a Large Inner-City Jail
Authors: Popovich Kyle J , Thiede Stephanie N , Zawitz Chad , Aroutcheva Alla , Payne Darjai , Janda William , Schoeny Michael , Green Stefan J , Snitkin Evan S , Weinstein Robert A 
Published: January 2021

Abstract

Background
Congregate settings, such as jails, may be a location where colonized detainees transmit methicillin-resistant Staphylococcus aureus (MRSA). We examined MRSA acquisition during incarceration and characterized the genomic epidemiology of MRSA entering the jail and isolated during incarceration.

Methods
Males incarcerated at the Cook County Jail were enrolled within 72 h of intake and MRSA surveillance cultures collected. Detainees in jail at Day 30 were re-cultured to determine MRSA acquisition. A survey was administered to identify acquisition predictors. Genomic sequencing of surveillance and clinical isolates was integrated with epidemiologic and jail location data to track MRSA transmission pathways.

Results
800 males were enrolled; 19% MRSA colonized at intake. Of 184 who reached Day 30 visit, 12 acquired MRSA. Heroin use before entering (OR 3.67, P = .05) and sharing personal items during incarceration (OR = 4.92, P = .01) were predictors of acquisition. Sequenced clinical USA300 isolates (n = 112) were more genetically similar than diverse intake USA300 strains (P &lt; .001), suggesting jail transmission. Four acquired colonization isolates were within 20 single-nucleotide variant (SNVs) of other isolates; 4 were within 20 SNVs of an intake isolate, 2 for an acquisition isolate, and 1 for a clinical isolate. Individuals with genetically similar isolates were more likely to have had overlapping stays in the same buildings.

Conclusion
There was a high MRSA burden entering jail. Genomic analysis of acquisition and clinical isolates suggests potential spread of incoming strains and networks of spread during incarceration, with spread often occurring among detainees housed in similar locations. Sharing personal items during incarceration is associated with MRSA acquisition and could be a focus for intervention.
Relative Effectiveness of the Cell-derived Inactivated Quadrivalent Influenza Vaccine Versus Egg-derived Inactivated Quadrivalent Influenza Vaccines in Preventing Influenza-related Medical Encounters During the 2018–2019 Influenza Season in the United States
Authors: Boikos Constantina , Fischer Lauren , O’Brien Dan , Vasey Joe , Sylvester Gregg C , Mansi James A 
Published: January 2021

Abstract

Background
The cell-propagated inactivated quadrivalent influenza vaccine (ccIIV4) may offer improved protection in seasons where egg-derived influenza viruses undergo mutations that affect antigenicity. This study estimated the relative vaccine effectiveness (rVE) of ccIIV4 versus egg-derived inactivated quadrivalent influenza vaccine (eIIV4) in preventing influenza-related medical encounters in the 2018–2019 US season.

Methods
A dataset linking primary care electronic medical records with medical claims data was used to conduct a retrospective cohort study among individuals ≥ 4 years old vaccinated with ccIIV4 or eIIV4 during the 2018–2019 season. Adjusted odds ratios (ORs) were derived from a doubly robust inverse probability of treatment-weighted approach adjusting for age, sex, race, ethnicity, geographic region, vaccination week, and health status. rVE was estimated by (1 – OR) × 100 and presented with 95% confidence intervals (CI).

Results
Following the application of inclusion/exclusion criteria, the study cohort included 2 125 430 ccIIV4 and 8 000 903 eIIV4 recipients. Adjusted analyses demonstrated a greater reduction in influenza-related medical encounters with ccIIV4 versus eIIV4, with the following rVE: overall, 7.6% (95% CI, 6.5–8.6); age 4–17 years, 3.9% (95% CI, .9–7.0); 18–64 years, 6.5% (95% CI, 5.2–7.9); 18–49 years, 7.5% (95% CI, 5.7–9.3); 50–64 years, 5.6% (95% CI, 3.6–7.6); and ≥65 years, –2.2% (95% CI, –5.4 to .9).

Conclusions
Adjusted analyses demonstrated statistically significantly greater reduction in influenza-related medical encounters in individuals vaccinated with ccIIV4 versus eIIV4 in the 2018–2019 US influenza season. These results support ccIIV4 as a potentially more effective public health measure against influenza than an egg-based equivalent.
Venous Thromboembolism and Major Bleeding in Patients With Coronavirus Disease 2019 (COVID-19): A Nationwide, Population-Based Cohort Study
Authors: Dalager-Pedersen Michael , Lund Lars Christian , Mariager Theis , Winther Rannva , Hellfritzsch Maja , Larsen Torben Bjerregaard , Thomsen Reimar Wernich , Johansen Nanna Borup , Søgaard Ole Schmeltz , Nielsen Stig Lønberg , Omland Lars Haukali , Lundbo Lene Fogt , Israelsen Simone Bastrup , Harboe Zitta Barrella , Pottegård Anton , Nielsen Henrik , Bodilsen Jacob 
Published: January 2021

Abstract

Background
Venous thromboembolism (VTE) is a potentially fatal complication of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, and thromboprophylaxis should be balanced against risk of bleeding. This study examined risks of VTE and major bleeding in hospitalized and community-managed SARS-CoV-2 patients compared with control populations.

Methods
Using nationwide population-based registries, 30-day risks of VTE and major bleeding in SARS-CoV-2 positive patients were compared with those of SARS-CoV-2 test-negative patients and with an external cohort of influenza patients. Medical records of all COVID-19 patients at 6 departments of infectious diseases in Denmark were reviewed in detail.

Results
The overall 30-day risk of VTE was 0.4% (40/9460) among SARS-CoV-2 patients (16% hospitalized), 0.3% (649/226 510) among SARS-CoV-2 negative subjects (12% hospitalized), and 1.0% (158/16 281) among influenza patients (59% hospitalized). VTE risks were higher and comparable in hospitalized SARS-CoV-2 positive (1.5%), SARS-CoV-2 negative (1.8%), and influenza patients (1.5%). Diagnosis of major bleeding was registered in 0.5% (47/9460) of all SARS-CoV-2 positive individuals and in 2.3% of those hospitalized. Medical record review of 582 hospitalized SARS-CoV-2 patients observed VTE in 4% (19/450) and major bleeding in 0.4% (2/450) of ward patients, of whom 31% received thromboprophylaxis. Among intensive care patients (100% received thromboprophylaxis), risks were 7% (9/132) for VTE and 11% (15/132) for major bleeding.

Conclusions
Among people with SARS-CoV-2 infection in a population-based setting, VTE risks were low to moderate and were not substantially increased compared with SARS-CoV-2 test-negative and influenza patients. Risk of severe bleeding was low for ward patients, but mirrored VTE risk in the intensive care setting.