Feasibility and Safety of Laparoscopic D2 Gastrectomy in Combination with Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) in Patients with Gastric Cancer at High Risk of Recurrence-The PIPAC-OPC4 Study.

BACKGROUND: Patients with gastric adenocarcinoma (GAC) are at high risk of peritoneal recurrence despite perioperative chemotherapy and radical resection. This study evaluated feasibility and safety of laparoscopic D2 gastrectomy in combination with pressurized intraperitoneal aerosol chemotherapy (PIPAC). METHODS: This was a prospective, controlled bi-institutional study in patients with GAC at high risk of recurrence treated with PIPAC with cisplatin and doxorubicin (PIPAC C/D) after laparoscopic D2 gastrectomy. High risk was defined as a poorly cohesive subtype with predominance of signet-ring cells, clinical stage ≥ T3 and/or ≥ N2, or positive peritoneal cytology. Peritoneal lavage fluid was collected before and after resection. Cisplatin (10.5 mg/m2) and doxorubicin (2.1 mg/m2) were aerosolized after anastomosis (flow 0.5-0.8 ml/s, maximum pressure 300 PSI). Treatment was feasible and safe if ≤ 20% had Dindo-Clavien ≥ 3b surgical complications or CTCAE ≥ 4 medical adverse events within 30 days. Secondary outcomes were length of stay (LOS), peritoneal lavage cytology, and completion of postoperative systemic chemotherapy. RESULTS: Twenty-one patients were treated with a D2 gastrectomy and PIPAC C/D. The median age was 61 years (range 24-76), there were eleven female patients, and 20 patients had preoperative chemotherapy. There was no mortality. Two patients had grade 3b complications that were potentially related to PIPAC C/D (one anastomotic leakage, and one late duodenal blow-out). One patient had severe neutropenia, and nine patients had moderate pain. The LOS was 6 days (4-26). One patient had positive peritoneal lavage cytology before resection, and none were positive after. Fifteen patients had postoperative chemotherapy. CONCLUSIONS: Laparoscopic D2 gastrectomy in combination with PIPAC C/D is feasible and safe.

Treatment of Peritoneal Metastasis with Pressurized Intraperitoneal Aerosol Chemotherapy: Results from the Prospective PIPAC-OPC2 Study.

BACKGROUND: Pressurized Intraperitoneal Aerosol chemotherapy (PIPAC) is a local treatment for peritoneal metastasis (PM). Prospective data are scarce and evaluation of treatment response remains difficult. This study evaluated the use of the Peritoneal Regression Grading score (PRGS) and its prognostic value. PATIENTS AND METHODS: This was a prospective, controlled phase II trial in patients with PM from gastrointestinal, gynaecological, hepatopancreatobiliary, primary peritoneal, or unknown primary cancer. Patients in performance status 0-1, with a non-obstructed gastrointestinal tract, and a maximum of one extraperitoneal metastasis were eligible. Colorectal or appendiceal PM had PIPAC with oxaliplatin, other primaries had PIPAC with cisplatin and doxorubicin. Biopsies were taken at each PIPAC and evaluated using the PRGS. Quality-of-life questionnaires were reported at baseline and after three PIPACs. RESULTS: One hundred ten patients were treated with 336 PIPACs (median 3, range 1-12). One hundred patients had prior palliative chemotherapy and 45 patients received bidirectional treatment. Complete or major histological response to treatment (PRGS 1-2) was observed in 38 patients (61%) who had three PIPACs, which was the only independent prognostic factor in a multivariate analysis. The median overall survival (mOS) from PIPAC 1 was 10 months, while patients with PM from gastric, colorectal, and pancreatic cancer had a mOS of 7.4, 16.7, and 8.2 months, respectively. Global health scores were significantly reduced, but patients were less fatigued, nauseated, constipated, and had better appetite after three PIPACs. CONCLUSIONS: PIPAC with oxaliplatin or cisplatin and doxorubicin was able to induce a major or complete histological response during three PIPACs, which may provide significant prognostic information, both at baseline and after treatment.

Intraoperative ultrasound imaging in the surgical treatment of congenital hyperinsulinism: prospective, blinded study.

BACKGROUND: In congenital hyperinsulinism (CHI), preoperative prediction of the histological subtype (focal, diffuse, or atypical) relies on genetics and 6-[18F]fluoro-l-3,4-dihydroxyphenylalanine (18F-DOPA) PET-CT. The scan also guides the localization of a potential focal lesion along with perioperative frozen sections. Intraoperative decision-making is still challenging. This study aimed to describe the characteristics and potential clinical impact of intraoperative ultrasound imaging (IOUS) during CHI surgery. METHODS: This was a prospective, observational study undertaken at an expert centre over a 2-year interval. IOUS was performed blinded to preoperative diagnostic test results (genetics and 18F-DOPA PET-CT), followed by unblinding and continued IOUS during pancreatic resection. Characteristics and clinical impact were assessed using predefined criteria. RESULTS: Eighteen consecutive, surgically treated patients with CHI, with a median age of 5.5 months, were included (focal 12, diffuse 3, atypical 3). Focal lesions presented as predominantly hypoechoic, oval lesions with demarcated or blurred margins. Patients with diffuse and atypical disease had varying echogenicity featuring stranding and non-shadowing hyperechoic foci in three of six, whereas these characteristics were absent from those with focal lesions. The blinded IOUS-based subclassification was correct in 17 of 18 patients; one diffuse lesion was misclassified as focal. IOUS had an impact on the surgical approach in most patients with focal lesions (9 of 12), and in those with diffuse (2 of 3) and atypical (2 of 3) disease when the resection site was close to the bile or pancreatic duct. CONCLUSION: Uniform IOUS characteristics made all focal lesions identifiable. IOUS had a clinical impact in 13 of 18 patients by being a useful real-time supplementary modality in terms of localizing focal lesions, reducing the need for frozen sections, and preserving healthy tissue and delicate structures.

Value of regular endosonography and [18F]fluorodeoxyglucose PET-CT after surgery for gastro-oesophageal junction, stomach or pancreatic cancer.

BACKGROUND: Most patients undergo follow-up after surgery for cancers of the gastro-oesophageal junction, stomach or pancreas, but data to support which modalities to use and the frequency of investigation are limited. METHODS: Patients in the EUFURO study were randomized to either visits to the outpatient clinic at 3, 6, 9, 12, 18, and 24 months after surgery (standard), or to the addition of [18F]fluorodeoxyglucose (FDG) PET-CT and endoscopic ultrasonography (EUS) with guided fine-needle aspiration biopsy to clinical assessments (intervention). Data from the intervention arm were used to analyse the diagnostic performance of endosonography or [18F]FDG PET-CT in detecting recurrences. RESULTS: During the scheduled follow-up, 42 of 89 patients developed recurrence; PET-CT and EUS in combination detected 38 of these recurrences. EUS detected 23 of the 42 patients with recurrent disease during follow-up and correctly diagnosed 17 of 19 locoregional recurrences. EUS was able to detect isolated locoregional recurrence in 11 of 13 patients. In five patients, EUS was false-positive for isolated locoregional recurrence owing to missed distant metastases. PET-CT detected locoregional recurrence in only 12 of 19 patients, and isolated locoregional recurrence in only 7 of 13. False-positive PET-CT results in 23 patients led to a total of 44 futile procedures. CONCLUSION: Accuracy in detecting recurrences by concomitant use of PET-CT and EUS was high (90 per cent). PET-CT had moderate to high sensitivity for overall recurrence detection, but low specificity. EUS was superior to PET-CT in the detection of locoregional and isolated locoregional recurrences.

Ecological succession in the vaginal microbiota during pregnancy and birth.

The mother's vaginal microbiota represents the first microbes to which a child is exposed when delivered vaginally. However, little is known about the composition and development of the vaginal microbiota during pregnancy and birth. Here, we analyzed the vaginal microbiota of 57 women in pregnancy week 24, 36 and at birth after rupture of membranes but before delivery, and further compared the composition with that of the gut and airways of the 1-week-old child. The vaginal community structure had dramatic changes in bacterial diversity and taxonomic distribution, yet carried an individual-specific signature. The relative abundance of most bacterial taxa increased stepwise from week 24 of pregnancy until birth, with a gradual decline of Lactobacillus. Mother-to-child vertical transfer, as suggested by sharing, was modest, with the strongest transfer being for Clostridiales followed by Lactobacillales and Enterobacteriales. In conclusion, late gestation is associated with an increase in maternal vaginal microbiota diversity, and vaginal bacteria at birth only modestly predict the composition of the neonatal microbiota.

Pressurized intraperitoneal aerosol chemotherapy (PIPAC) of peritoneal metastasis from gastric cancer: a descriptive cohort study.

Pressurized intraperitoneal aerosol chemotherapy (PIPAC) represents a novel approach to deliver intraperitoneal chemotherapy. We report our experience with PIPAC in patients with peritoneal metastasis (PM) from gastric cancer (GC). Data from GC patients (n = 20) included in the prospective PIPAC-OPC1 and PIPAC-OPC2 studies are reported. All patients had received prior systemic chemotherapy. The mean peritoneal cancer index (PCI) was 10.5 (range 0-39) and nine patients had diffuse GC. PIPAC with cisplatin 7.5 mg/m2 and doxorubicin 1.5 mg/m2 were administered at 4-6-week intervals. Outcome criteria were objective tumour response, survival and adverse events. Twenty patients had 52 PIPAC procedures with a median follow-up of 10.4 months (3.3-26.5). Median survival from the time of PM diagnosis and after the first PIPAC procedure was 11.5 months and 4.7 months, respectively. Fourteen patients had repeated PIPAC (> 2), and the objective tumour response according to the histological peritoneal regression grading score (PRGS) was observed in 36%, whereas 36% had stable disease. Ten patients completed the three prescheduled sessions (per protocol group) and 40% of those displayed an objective tumour response, while 20% had stable disease. Only minor postoperative complications were noted, and none were considered causally related to the PIPAC treatment. PIPAC with low-dose cisplatin and doxorubicin can induce a quantifiable objective tumour response in selected patients with PM from GC. Survival data are encouraging and warrant further clinical studies.

The role of home visits by a nurse to improve palliation in patients treated with self-expandable metallic stents due to incurable esophageal cancer.

Self-expandable metallic stent (SEMS) is a preferred option to relieve dysphagia and to palliate patients with incurable esophageal or gastro-esophageal junction (GEJ) cancer. Health Related Quality of Life (QoL) represents a clinically relevant outcome measure in research focused on palliation of patients with advanced GI cancer. In this context, home visits by a nurse carry the potential to offer important advantages. Eighty patients with incurable esophageal or GEJ cancer were randomized to either standard follow up or to an intervention containing regular home visits by a nurse. The primary outcome variable QoL was assessed by EORTC QLQ-C30 and OES-18 before insertion of SEMS, and at 2, 7 and 12 weeks thereafter. Secondary outcomes were; need for re-interventions, number of patients receiving palliative oncological therapy and overall survival. Sixty-six males and 13 females, with a median age of 71, were included. Self-reported overall QoL was significantly higher in the intervention group (P = 0.03). The organ specific module OES-18 revealed a significant reduction in dysphagia by the intervention (P = 0.03) as well as fewer eating disabilities (P = 0.04). No differences were observed in secondary outcomes except for overall survival, where the median survival was increased from 114 to 183 days by the active intervention (P = 0.02). Home visits by a nurse seem to play an important palliative role after placement of SEMS in patients with incurable esophageal or GEJ cancer by improving QoL and may carry the potential to increase overall survival.

Phase II randomized clinical trial of endosonography and PET/CT versus clinical assessment only for follow-up after surgery for upper gastrointestinal cancer (EUFURO study).

BACKGROUND: Upper gastrointestinal malignancies have a poor prognosis. There is no consensus on how patients should be followed after surgery. The authors hypothesized that a structured follow-up programme including endoscopic ultrasonography (EUS) and [18 F]fluorodeoxyglucose (FDG) PET/CT would detect cancer recurrences, leading to more patients being eligible for therapy. METHODS: After surgery with curative intent for adenocarcinomas in the gastro-oesophageal junction, stomach or pancreas, patients were randomized 1 : 1 to standard clinical assessment in the outpatient clinic at 3, 6, 9, 12, 18 and 24 months after operation, or clinical assessment plus imaging including [18 F]FDG PET/CT and EUS. The primary endpoint was number of patients receiving oncological treatment for recurrence. Secondary endpoints were overall and progression-free survival, survival after recurrence detection of isolated locoregional recurrences and risk factors affecting survival. RESULTS: In total, 183 patients were enrolled, including 93 who underwent standard follow-up and 90 who had follow-up plus imaging. A recurrence was detected in 84 patients within 2 years after surgery (42 in each group), including 33 of 42 patients in the imaging group who were asymptomatic. Some 25 of 42 patients in the imaging group and 14 of 42 in the standard group received chemotherapy (P = 0·028). Although survival after detection of recurrence in asymptomatic patients was significantly longer than that for symptomatic patients (P < 0·001), overall survival from date of surgery in the two treatment groups was comparable. CONCLUSION: Follow-up after surgery for upper gastrointestinal cancer with EUS and PET/CT leads to detection of more asymptomatic cancer recurrences and patients referred for treatment without prolonging overall survival. Registration number: NCT02209415 ( http://www.clinicaltrials.gov).

ANTECEDENTES: Las neoplasias del tracto digestivo superior tienen un mal pronóstico. No existe consenso sobre en qué pacientes debe indicarse un seguimiento tras la cirugía. Se estableció la hipótesis de que un programa de seguimiento estructurado en el que se incluía ecoendoscopia (endosonography, EUS) y 18F-FDG-PET/CT detecta recidivas del cáncer logrando que más pacientes sean elegibles para tratamiento. MÉTODOS: Después de cirugía con intención curativa para adenocarcinomas de la unión gastroesofágica, estómago o páncreas, los pacientes fueron aleatorizados 1:1 a evaluación clínica estándar en consultas externas a los 3, 6, 9, 12, 18, y 24 meses postoperatorios o evaluación clínica más pruebas de diagnóstico por la imagen en las que se incluían 18F-FDG-PET/CT y EUS. La variable principal fue el número de pacientes que recibieron tratamiento oncológico para la recidiva. Las variables secundarias fueron la supervivencia global y libre de progresión, supervivencia tras la recidiva, la detección de recidivas locorregionales aisladas (isolated loco-regional recurrences, ILR) y factores de riesgo que afectan a la supervivencia. RESULTADOS: En total se reclutaron 183 pacientes, incluyendo 93 pacientes sometidos a un seguimiento estándar (controles) y 90 pacientes con seguimiento y pruebas de imagen. Se detectó recidiva en 84 pacientes dentro de los primeros dos años tras la cirugía (42 pacientes en cada grupo), incluyendo 33 de 42 pacientes (78%) en el grupo con pruebas de imagen que estaban asintomáticos. Veinticinco de 42 pacientes (60%) del grupo con pruebas de imagen y 14 de 42 pacientes (33%) del grupo control recibieron quimioterapia (P = 0,03). Aunque la supervivencia tras la detección de la recidiva en pacientes asintomáticos fue significativamente más larga en comparación con los pacientes sintomáticos (P < 0,001), la supervivencia global desde la fecha de la cirugía en las dos ramas del tratamiento fue comparable. CONCLUSIÓN: El seguimiento tras la cirugía del cáncer gastrointestinal del tracto superior con EUS y PET-CT permite detectar más recidivas asintomáticas de la enfermedad y derivar a los pacientes para tratamiento sin que ello prolongue la supervivencia global.

Multicentre study of multidisciplinary team assessment of pancreatic cancer resectability and treatment allocation.

BACKGROUND: Multidisciplinary team (MDT) meetings have been adopted widely to ensure optimal treatment for patients with cancer. Agreements in tumour staging, resectability assessments and treatment allocation between different MDTs were assessed. METHODS: Of all patients referred to one hospital, 19 patients considered to have non-metastatic pancreatic cancer for evaluation were selected randomly for a multicentre study of MDT decisions in seven units across Northern Europe. Anonymized clinical information and radiological images were disseminated to the MDTs. All patients were reviewed by the MDTs for radiological T, N and M category, resectability assessment and treatment allocation. Each MDT was blinded to the decisions of other teams. Agreements were expressed as raw percentages and Krippendorff's α values, both with 95 per cent confidence intervals. RESULTS: A total of 132 evaluations in 19 patients were carried out by the seven MDTs (1 evaluation was excluded owing to technical problems). The level of agreement for T, N and M categories ranged from moderate to near perfect (46·8, 61·1 and 82·8 per cent respectively), but there was substantial variation in assessment of resectability; seven patients were considered to be resectable by one MDT but unresectable by another. The MDTs all agreed on either a curative or palliative strategy in less than half of the patients (9 of 19). Only fair agreement in treatment allocation was observed (Krippendorff's α 0·31, 95 per cent c.i. 0·16 to 0·45). There was a high level of agreement in treatment allocation where resectability assessments were concordant. CONCLUSION: Considerable disparities in MDT evaluations of patients with pancreatic cancer exist, including substantial variation in resectability assessments.

Protein and energy intake improved by in-between meals: An intervention study in hospitalized patients.

BACKGROUND/AIM: Disease related malnutrition is a major problem in hospitals. Malnutrition in hospitalized patients is caused by many factors. Among these factors are decreased appetite and early satiety, and reaching nutritional requirements in nutritional risk patients is a challenge when using ordinary energy and protein dense food. The aim of this study was to examine if total protein and energy intake in medical and surgical patients at nutritional risk could be improved by protein fortified and energy rich in-between meals. METHODS: An assortment of fortified in-between meals including 10 g of protein was developed based on patient preferences and served in the Departments of Lung Medicine and Abdominal Surgery for a period of three months. Nutrition intake was recorded before and after intervention. RESULTS: Food intake records were collected from a total of 92 patients, (46 before and 46 after intervention). The total amount of protein intake per in-between meal was increased from 2,6 g to 10,3 g. Total daily protein intake increased from 49% to 88% (p < 0.00) and total energy intake from 74% to 109% (p < 0.00) of requirements. CONCLUSION: Protein and energy intake for surgical and medical patients at in-between meals as well as total daily intake increased significantly. Recommended average level for individually measured requirements was reached.

Nurse-Assisted Percutaneous Endoscopic Gastrostomy Tube Placement Is a Safe Procedure in Adult Patients.

The percutaneous endoscopic gastrostomy (PEG) procedure is normally carried out by two doctors. Preliminary experience has suggested that this procedure may be accomplished with the same safety level using one doctor and a specially trained endoscopy nurse. The aim of the study was to assess the immediate outcome and 30 days' procedure-related morbidity following nurse-assisted percutaneous endoscopic gastrostomy (NA-PEG) in an unselected population of adult patients. Retrospective, nonconsecutive analysis of NA-PEG procedures were registered between 2008 and 2014. Demographic data, indications, and early and late procedure complications were registered. During the study period, a total of 222 nonconsecutive adult patients had a NA-PEG placement. Neurologic (56%) and malignant diseases (35%) were the major indications for the PEG placement. The NA-PEGs were performed by six specially trained endoscopy nurses. NA-PEG-related overall morbidity was 24%, and all complications were minor. No procedure-related mortality occurred. When NA-PEG was compared with standard PEG placement literature, there was no increase in the number of complications, and the types of complications were similar. Despite being performed in patients with multiple co-morbid conditions, NA-PEG was a safe procedure with no mortality and minor complications. We suggest that NA-PEG should be used on a larger scale with the intention of saving time and medical costs.

Severe peritoneal sclerosis after repeated pressurized intraperitoneal aerosol chemotherapy with oxaliplatin (PIPAC OX): report of two cases and literature survey.

Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a new laparoscopic administration of chemotherapy for peritoneal metastasis (PM). PIPAC is repeated every 5th week, and seems to stabilize or improve quality of life, and might improve survival. So far, PIPAC has been well tolerated. With this paper, we aim to highlight a potential severe adverse reaction, as we describe the first cases of severe peritoneal sclerosis (SPS) caused by PIPAC. Patients with isolated PM were included in a prospective PIPAC protocol. Following insufflation of normothermic CO2, laparoscopy was performed at an intraabdominal pressure of 12 mmHg. After peritoneal lavage and quadrant biopsies of the PM, the patients were treated with oxaliplatin 92 mg/m2 (flowrate 0.5 ml/s, maximum pressure of 200 per square inch). Treatment related toxicity was evaluated after 2 weeks. Response was evaluated histologically by the Peritoneal Regression Grading Score (PRGS) and cytologically by analysis of the lavage fluid. In a series of 24 PIPAC patients treated with oxaliplatin, two patients developed SPS. Patient one had a mucinous adenocarcinoma of the appendix with PM, the mean PRGS was reduced from 2.75 to 1.75 during the course of therapy. Patient two had an appendiceal goblet cell carcinoid with a dominating mucinous adenocarcinoma component with PM, the mean PRGS was reduced from 2.00 to 1.67. Repeated applications of PIPAC with oxaliplatin can lead to SPS.

Prospective evaluation of EUS-guided fine needle biopsy in pancreatic mass lesions.

BACKGROUND AND STUDY AIM: Due to the scarcity of specific data on endoscopic ultrasound (EUS)-guided fine-needle biopsies (SharkCore) FNB in the evaluation of pancreatic lesions, we performed a prospective study of the diagnostic performance of EUS SharkCore FNB in patients with pancreatic lesions. The aim of this study was to evaluate the diagnostic accuracy. PATIENTS AND METHODS: Single-center prospective study of 41 consecutive patients referred for EUS-FNB from October 2015 to April 2016 at our center. EUS-FNB was obtained in a predefined setting regarding the procedure and pathological evaluation. Data regarding demographics, lesion, technical parameters, and diagnostic accuracy were obtained. RESULTS: The study included 41 consecutive patients (22 males (54 %); median age 68 years). The average size of the lesions was 28 mm (median: 30 mm). A diagnostic specimen was identified in 40 (98 %) cases during microscopy with an average of 2.4 passes. The route was trans-duodenal in 20 cases (49 %). The histological diagnosis of the specimens was malignant in 29 cases (71 %), benign in 8 (20 %), suspicious in 2 (5 %), atypical in 1 (2 %) and in 1 (2 %) no material for microscopic evaluation was obtained. This led to a diagnostic accuracy of 93 %, sensitivity of 91 % and a specificity of 100 %. 2 cases (5 %) of self-limiting bleeding were observed. The diagnosis at follow up was malignant in 32 (78 %) of the patients. CONCLUSIONS: EUS-FNB of pancreatic mass lesions with the SharkCore needle produced specimens with a diagnostic accuracy of 93 %. The procedure was safe and easy to perform, and these data support the use of EUS-FNB in a routine setting.

Randomized clinical trial of laparoscopic ultrasonography before laparoscopic colorectal cancer resection.

BACKGROUND: Intraoperative ultrasonography during open surgery for colorectal cancer may be useful for the detection of unrecognized liver metastases. Laparoscopic ultrasonography (LUS) for the detection of unrecognized liver metastasis has not been studied in a randomized trial. This RCT tested the hypothesis that LUS would change the TNM stage and treatment strategy. METHODS: Patients with colorectal cancer and no known metastases were randomized (1 : 1) to laparoscopic examination (control or laparoscopy plus LUS) in three Danish centres. Neither participants nor staff were blinded to the group assignment. RESULTS: Three hundred patients were randomized, 150 in each group. After randomization, 43 patients were excluded, leaving 128 in the control group and 129 in the LUS group. Intraoperative T and N categories were not altered by LUS, but laparoscopy alone identified previously undetected M1 disease in one patient (0·8 per cent) in the control group and three (2·3 per cent) in the LUS group. In the latter group, LUS suggested that an additional six patients (4·7 per cent) had M1 disease with liver (4) or para-aortal lymph node (2) metastases. The change in treatment strategy was greater in the LUS than in the control group (7·8 (95 per cent c.i. 3·8 to 13·8) and 0·8 (0 to 4·2) per cent respectively; P = 0·010), but the suspected M1 disease was benign in half of the patients. CONCLUSION: Routine LUS during resection of colorectal cancer is not recommended. Registration number: NCT02079389 (http://www.clinicaltrials.gov).

Reproductive hormones and metabolic syndrome in 24 testicular cancer survivors and their biological brothers.

Testicular cancer survivors have impaired gonadal function and increased risk of metabolic syndrome when compared to healthy controls. However, because of the fetal etiology of testicular cancer, familial unrelated healthy men might not be an optimal control group. The objective of this study was to clarify if testicular cancer survivors have impaired gonadal function and increased risk of metabolic syndrome when compared to their biological brothers. A cross-sectional study of testicular cancer survivors (ClinicalTrials.gov number, NCT02240966) was conducted between 2014 and 2016. Of 158 testicular cancer survivors included, 24 had a biological brother who accepted to participate in the study. Serum levels of reproductive hormones and prevalence of metabolic syndrome according to International Diabetes Federation Criteria and National Cholesterol Education Program (Adult Treatment Panel III) criteria comprised the main outcome measures of the study. Median age was similar in testicular cancer survivors and their biological brothers [44 years (IQR 39-50) vs. 46 (40-53) years respectively (p = 0.1)]. In testicular cancer survivors, follow-up since treatment was 12 years (7-19). Serum levels of luteinizing hormone and follicle-stimulating hormone were elevated (p ≤ 0.001), while total testosterone, free testosterone, inhibin B and anti-Müllerian hormone were lower (p ≤ 0.001) in testicular cancer survivors than in their biological brothers. The prevalence of metabolic syndrome was similar and apart from HDL-cholesterol, which was lower in testicular cancer survivors (p = 0.01); there were no differences in the individual components of the metabolic syndrome between testicular cancer survivors and their brothers. In conclusion, gonadal function was impaired in testicular cancer survivors, while we did not detect any difference in the prevalence of metabolic syndrome between testicular cancer survivors and their biological brothers.

Common variables in European pancreatic cancer registries: The introduction of the EURECCA pancreatic cancer project.

BACKGROUND: Quality assurance of cancer care is of utmost importance to detect and avoid under and over treatment. Most cancer data are collected by different procedures in different countries, and are poorly comparable at an international level. EURECCA, acronym for European Registration of Cancer Care, is a platform aiming to harmonize cancer data collection and improve cancer care by feedback. After the prior launch of the projects on colorectal, breast and upper GI cancer, EURECCA's newest project is collecting data on pancreatic cancer in several European countries. METHODS: National cancer registries, as well as specific pancreatic cancer audits/registries, were invited to participate in EURECCA Pancreas. Participating countries were requested to share an overview of their collected data items. Of the received datasets, a shared items list was made which creates insight in similarities between different national registries and will enable data comparison on a larger scale. Additionally, first data was requested from the participating countries. RESULTS: Over 24 countries have been approached and 11 confirmed participation: Austria, Belgium, Bulgaria, Denmark, Germany, The Netherlands, Slovenia, Spain, Sweden, Ukraine and United Kingdom. The number of collected data items varied between 16 and 285. This led to a shared items list of 25 variables divided into five categories: patient characteristics, preoperative diagnostics, treatment, staging and survival. Eight countries shared their first data. CONCLUSIONS: A list of 25 shared items on pancreatic cancer coming from eleven participating registries was created, providing a basis for future prospective data collection in pancreatic cancer treatment internationally.