Sarcopenia, low muscle strength, cognitive functions, and quality of life in parkinsonian syndromes.

OBJECTIVES: Parkinsonian syndromes are disabling neurodegenerative diseases resulting in reduced muscle function/performance and sarcopenia, but clinical manifestations could be systemic, including deterioration of cognitive function. As studies have reported an association between muscle dysfunction and cognitive decline yet no information on these syndromes is available, we investigated the relationship between sarcopenia, its components, and cognitive function, fatigue, and quality of life (QoL). METHODS: Consecutive patients affected by parkinsonian syndromes were assessed for the presence of sarcopenia using the European Working Group on Sarcopenia in Older People-2 algorithm: low strength (handgrip strength: <27 kg [men]; <16 kg [women]) and low appendicular skeletal muscle index by impedance (<7.0 kg/m2 [men]; <6.0 kg/m2 [women]). Cognitive function was evaluated using the Montreal Cognitive Assessment, the Mini Mental State Examination and the Frontal Assessment Battery. Fatigue and QoL were assessed using the 16-item Parkinson's Disease Fatigue Scale and the 39-item Parkinson's Disease Questionnaire, respectively. RESULTS: In total, 314 patients were included: 198 presented with low strength (63.0% probable sarcopenia); 68 (21.7%) of these were diagnosed with sarcopenia. After adjusting for multiple confounders, we observed a significant effect (poorer score) of both low strength only and sarcopenia on Montreal Cognitive Assessment, Mini Mental State Examination, and QoL. Only reduced muscle strength had a relevant impact on the outcomes considered. CONCLUSIONS: Sarcopenia is associated with worse cognitive functions and QoL in patients with parkinsonian syndromes, with muscle dysfunction playing a major role. The prognostic impact of sarcopenia and its components should be addressed in prospective studies.

Comparing GBA1-Parkinson's disease and idiopathic Parkinson's disease: α-Synuclein oligomers and synaptic density as biomarkers in the skin biopsy.

The main genetic risk factors for Parkinson's disease (PD) are presently represented by variants in GBA1 gene encoding for the ß-glucocerebrosidase (GCase). Searching for a peripheral biomarker that can be used for selecting and monitoring patients in clinical trials targeting GBA1-associated PD (GBA1-PD) is a current challenge. We previously demonstrated that α-synuclein oligomers expressed as proximity ligation assay (PLA) score in synaptic terminals of skin biopsy are a reliable biomarker for distinguishing idiopathic PD (iPD) from healthy controls (HC). This cross-sectional study investigates an unexplored cohort of GBA1-PD (n = 27) compared to 28 HC, and 36 iPD cases to (i) analyze α-synuclein oligomers and quantify them throughout PLA score, (ii) investigate GCase expression in brain and synaptic terminals targeting the sweat gland, (iii) unravel indicators that could differentiate patients with specific GBA1 mutations. PLA score discriminates GBA1-PD from HC with sensitivity = 88.9% (95% CI 70.84-97.65), specificity = 88.5% (95% CI 69.85-97.55), and PPV = 88.9% (95% CI 73.24-95.90), AUC value = 0.927 (95% CI 0.859-0.996). No difference was found between GBA1-PD patients and iPD, suggesting a common pathological pathway based on α-synuclein oligomers. GCase score did not differ in GBA1-PD, iPD, and HC in the synaptic terminals, whereas a positive correlation was found between PLA score and GCase score. Moreover, a significant increase in synaptic density was observed in GBA1-PD compared to iPD and HC (P < 0.0001). Employing ROC curve to discriminate GBA1-PD from iPD, we found an AUC value for synaptic density = 0.855 (95% CI 0.749-0.961) with sensitivity = 85.2% (95% CI 66.27%-95.81%), specificity = 77.1% (95% CI 59.86%-89.58%), and PPV = 74.19% (60.53%-84.35%). The highest synaptic density values were observed in p.N409S patients. This work points out to the value of both PLA score and synaptic density in distinguishing GBA1-PD from iPD and to their potential to stratify and monitor patients in the context of new pathway-specific therapeutic options.

The era of 3D-reconstruction techniques in a medical setting: Earlier experience with video using botulinum toxin for complex ventral incisional hernia.

INTRODUCTION AND IMPORTANCE: Incisional hernias occur in about 15 % of all patients that undergo abdominal surgery. Treatment of giant incisional ventral hernias (GIH) results in a surgical challenge associated with postoperative morbidities, risk of hernia recurrence, and costs. In recent years the use of both botulinum toxin (BT) to overcome abdominal cavity leakage and improved preoperative imaging studies by 3D-reconstruction has improved outcomes after these complex procedures. CASE PRESENTATION: We describe a case of 3D-reconstruction technique before and after the use of botulinum toxin for complex ventral incisional hernia. No intraoperative complications or technical failures of the system were recorded. The operative time was 180 min, and the length of hospital stay was five days. DISCUSSION: In this preliminary study we showed our experience with the use of 3D-reconstruction of abdominal wall following preoperative BT preparation for elective surgical repair of recurrent complex incisional hernias. CONCLUSION: The use of 3D-recostruction provides important information for a correct pre-surgical planning.

Cost-effectiveness of robotic vs laparoscopic distal pancreatectomy. Results from the national prospective trial ROBOCOSTES.

INTRODUCTION: Although several studies report that the robotic approach is more costly than laparoscopy, the cost-effectiveness of robotic distal pancreatectomy (RDP) over laparoscopic distal pancreatectomy (LDP) is still an issue. This study evaluates the cost-effectiveness of the RDP and LDP approaches across several Spanish centres. METHODS: This study is an observational, multicenter, national prospective study (ROBOCOSTES). For one year from 2022, all consecutive patients undergoing minimally invasive distal pancreatectomy were included, and clinical, QALY, and cost data were prospectively collected. The primary aim was to analyze the cost-effectiveness between RDP and LDP. RESULTS: During the study period, 80 procedures from 14 Spanish centres were analyzed. LDP had a shorter operative time than the RDP approach (192.2 min vs 241.3 min, p = 0.004). RDP showed a lower conversion rate (19.5% vs 2.5%, p = 0.006) and a lower splenectomy rate (60% vs 26.5%, p = 0.004). A statistically significant difference was reported for the Comprehensive Complication Index between the two study groups, favouring the robotic approach (12.7 vs 6.1, p = 0.022). RDP was associated with increased operative costs of 1600 euros (p < 0.031), while overall cost expenses resulted in being 1070.92 Euros higher than the LDP but without a statistically significant difference (p = 0.064). The mean QALYs at 90 days after surgery for RDP (0.9534) were higher than those of LDP (0.8882) (p = 0.030). At a willingness-to-pay threshold of 20,000 and 30,000 euros, there was a 62.64% and 71.30% probability that RDP was more cost-effective than LDP, respectively. CONCLUSIONS: The RDP procedure in the Spanish healthcare system appears more cost-effective than the LDP.

Fully laparoscopic distal splenic pancreatectomy with prophylactic hyperthermic intraperitoneal chemotherapy (with video).

Peritoneal involvement represents one of the major difficulties that arise during the treatment of pancreatic adenocarcinoma. In fact, currently, there is a growing interest in the administration of intraoperative hyperthermic intraperitoneal chemotherapy (HIPEC) as an adjunct to surgical pancreatic resection, both with prophylactic or therapeutic intent. With this video, we report a case of pancreatic body adenocarcinoma treated with fully laparoscopic distal splenic pancreatectomy with intraoperative HIPEC with gemcitabine, administered initially with a prophylactic intent, based on a preliminary negative peritoneal washing cytology result. In our case, the association of HIPEC and surgical resection did not affect the postoperative recovery, and after 15 months of follow-up, the patient remains alive and has no signs of disease recurrence.

Same-day post-therapy imaging with a new generation whole-body digital SPECT/CT in assessing treatment response to [177Lu]Lu-PSMA-617 in metastatic castration-resistant prostate cancer.

PURPOSE: Lutetium-177 [177Lu]Lu-PSMA-617 radioligand therapy (RLT) represents a significant advancement for metastatic castration-resistant prostate cancer (mCRPC), demonstrating improvements in radiographic progression free survival (rPFS) and overall survival (OS) with a low rate of associated side effects. Currently, most post-therapy SPECT/CT is conducted at 24 h after infusion. This study examines the clinical utility of a next-generation multi-detector Cadmium-Zinc-Telluride (CZT) SPECT/CT system (StarGuide) in same-day post-infusion assessment and early treatment response to [177Lu]Lu-PSMA-617. METHODS: In this retrospective study, 68 men with progressive mCRPC treated with [177Lu]Lu-PSMA-617 at our center from June 2022 to June 2023 were evaluated. Digital whole-body SPECT/CT imaging was performed after [177Lu]Lu-PSMA-617infusion (mean ± SD: 1.8 ± 0.6 h, range 1.1-4.9 h). Quantitative analysis of [177Lu]Lu-PSMA-617 positive lesions was performed in patients who underwent at least 2 post-therapy SPECT/CT, using liver parenchyma uptake as reference. Metrics including [177Lu]Lu-PSMA-617 positive total tumor volume (Lu-TTV), SUVmax and SUVmean were calculated. These quantitative metrics on post-infusion SPECT/CT images after cycles 1, 2 and 3 were correlated with overall survival (OS), prostate specific antigen-progression free survival (PSA-PFS) as defined by prostate cancer working group 3 (PCWG3), and PSA decrease over 50% (PSA50) response rates. RESULTS: 56 patients (means age 76.2 ± 8.1 years, range: 60-93) who underwent at least 2 post-therapy SPECT/CT were included in the image analysis. The whole-body SPECT/CT scans (~ 12 min per scan) were well tolerated, with 221 same-day scans performed (89%). At a median of 10-months follow-up, 33 (58.9%) patients achieved PSA50 after [177Lu]Lu-PSMA-617 treatment and median PSA-PFS was 5.0 months (range: 1.0-15 months) while median OS was not reached. Quantitative analysis of SPECT/CT images showed that 37 patients (66%) had > 30% reduction in Lu-TTV, associated with significantly improved overall survival (median not reached vs. 6 months, P = 0.008) and PSA-PFS (median 6 months vs. 1 months, P < 0.001). However, changes in SUVmax or SUVmean did not correlate with PSA-PFS or OS. CONCLUSION: We successfully implemented same-day post-therapy SPECT/CT after [177Lu]Lu-PSMA-617 infusions. Quantitation of 1-2 h post-therapy SPECT/CT images is a promising method for assessing treatment response. However, the approach is currently limited by its suboptimal detection of small tumor lesions and the necessity of incorporating a third-cycle SPECT/CT to mitigate the effects of any potential treatment-related flare-up. Further investigation in a larger patient cohort and prospective validation is essential to confirm these findings and to explore the role of SPECT/CT as a potential adjunct to PSMA PET/CT in managing mCRPC.

Light and shadow of watch-and-wait strategy in rectal cancer: oncological result, clinical outcomes, and cost-effectiveness analysis.

BACKGROUND: The watch-and-wait (WW) strategy is a potential option for patients with rectal cancer who obtain a complete clinic response after neoadjuvant therapy. The aim of this study is to analyze the long-term oncological outcomes and perform a cost-effectiveness analysis in patients undergoing this strategy for rectal cancer. MATERIAL AND METHODS: The data of patients treated with the WW strategy were prospectively collected from January 2015 to January 2020. A control group was created, matched 1:1 from a pool of 480 patients undergoing total mesorectal excision. An independent company carried out the financial analysis. Clinical and oncological outcomes were analyzed in both groups. Outcome parameters included surgical and follow-up costs, quality-adjusted life years (QALYs), and the incremental cost per QALY gained or the incremental cost-effectiveness ratio (ICER). RESULTS: Forty patients were included in the WW group, with 40 patients in the surgical group. During a median follow-up period of 36 months, metastasis-free survival (MFS) and overall survival (OS) were similar in the two groups. In the WW group, nine (22%) local regrowths were detected in the first 2 years. The permanent stoma rate was slightly higher after salvage surgery in the WW group compared to the surgical group (48.5% vs 20%, p < 0.01). The cost-effectiveness analysis was slightly better for the WW group, especially for low rectal cancer compared to medium-high rectal cancer (ICER = - 108,642.1 vs ICER = - 42,423). CONCLUSIONS: The WW strategy in locally advanced rectal cancer offers similar oncological outcomes with respect to the surgical group and excellent results in quality of life and cost outcomes, especially for low rectal cancer. Nonetheless, the complex surgical field during salvage surgery can lead to a high permanent stoma rate; therefore, the careful selection of patients is mandatory.

New era of robotic surgery: first case in Spain of right hemicolectomy on Hugo RAS surgical platform.

We describe the first robot-assisted right hemicolectomy performed in Spain using the new Hugo RAS (robotic-assisted surgery) (Medtronic, Minneapolis, Minnesota, USA). No conversion was registered, and no intraoperative complications or technical failures of the system were recorded. The operative time was 200 min, the docking time was 5 min and the length of the hospital stay was 8 days. We conclude that a right hemicolectomy using the Hugo RAS system is safe and feasible. Our earlier experience provides important skills for those who are starting to use this new robotic system.

Can 3D imaging modeling recognize functional tissue and predict liver failure? A retrospective study based on 3D modelling of the major hepatectomies after hepatic modulation.

BACKGROUND: Thanks to the introduction of radiomics, 3d reconstruction can be able to analyse tissues and recognise true hypertrophy from non-functioning tissue in patients treated with major hepatectomies with hepatic modulation.The aim of this study is to evaluate the performance of 3D Imaging Modelling in predict liver failure. METHODS: Patients submitted to major hepatectomies after hepatic modulation at Sanchinarro University Hospital from May 2015 to October 2019 were analysed. Three-dimensional reconstruction was realised before and after surgical treatment. The volumetry of Future Liver Remnant was calculated, distinguishing in Functional Future Liver Remnant (FRFx) i.e. true hypertrophy tissue and Anatomic Future Liver Remnant (FRL) i.e. hypertrophy plus no functional tissue (oedema/congestion) These volumes were analysed in patients with and without post hepatic liver failure. RESULTS: Twenty-four procedures were realised (11 ALPPS and 13 PVE followed by major hepatectomy). Post hepatic liver failure grade B and C occurred in 6 patients. The ROC curve showed a better AUC for FRFxV (74%) with respect to FRLV (54%) in prediction PHLF > B. The increase of anatomical FRL (iFRL) was superior in the ALPPS group (120%) with respect to the PVE group (73%) (p = 0,041), while the increase of functional FRFX (iFRFx) was 35% in the ALLPS group and 46% in the PVE group (p > 0,05), showing no difference in the two groups. CONCLUSION: The 3D reconstruction model can allow optimal surgical planning, and through the use of specific algorithms, can contribute to differential functioning liver parenchyma of the FLR.

Robot-assisted cholecystectomy with the new HUGO™ robotic-assisted system: first worldwide report with system description, docking settings, and video.

Robotic surgery has gained worldwide acceptance in the past decade, and several studies have shown that this technique is safe and feasible. The innovation of this system is the open surgical console with an HD-3D display, a system tower, and four independent arm carts. We describe the first robot-assisted cholecystectomy performed with the new Hugo RAS (robotic-assisted surgery) system (Medtronic, Minneapolis, MN, USA) in Spain. The procedure was completed without conversion. No intraoperative complication or technical failure of the system was recorded. The operative time was 70 min. The docking time was 3 min. Hospital length of stay was 1 days. This case report shows the safety and feasibility of cholecystectomy with the Hugo RAS system and provides relevant data that may be of help to early adopters of this surgical platform.

Pancreatic head resection with segmental duodenectomy for the treatment of benign and malign pancreatic diseases. Case series experience of a single center.

INTRODUCTION AND IMPORTANCE: Duodenum-preserving pancreatic resections (DPPHR) is a reasonable surgical option for benign or low-grade malignant tumours of the pancreatic head. Several techniques have been proposed, with or without common biliary duct preservation. CASE PRESENTATION: We report for the first time two cases of pancreas divisum treated with this technique and we illustrate two other cases of pancreatic disease in which this procedure was realized from January 2015 to January 2020 in the HM Sanchinarro University Hospital. CLINICAL DISCUSSION: Pancreatic head resection with pancreatic parenchyma sparing, and duodenal preservation has been commonly accepted in the treatment of benign pancreatic head disease. CONCLUSION: This technique offers a wide application in the treatment of pancreatic and duodenal benign disease, including pancreatic malformation such as pancreas divisum and duodenal tumour that require segmental resection, in order to assure complete pancreatic head resection and to avoid duodenal and biliary duct ischemia.

Robot-assisted Nissen fundoplication with the new HUGO™ Robotic assisted system: First worldwide report with system description, docking settings and video.

BACKGROUND: Robotic surgery has gained worldwide acceptance over the past decade, with several studies showing that this technique is safe and feasible. METHODS: We describe the first robot-assisted Nissen fundoplication for hiatal hernia performed with the new Hugo™ RAS (Robotic assisted surgery) system (Medtronic, Minneapolis, MN, USA) in Spain. The innovation of this system is the open surgical console with a 3D-HD display, a system tower and four independent arm carts. RESULTS: The surgical procedures were completed without conversion. No intraoperative complications or technical failures of the system were recorded. The operative time was 97 min, the docking time was 3 min, and the length of hospital stay was three days. CONCLUSIONS: This case report shows the safety and feasibility of Nissen fundoplication for hiatal hernia with the Hugo™ RAS system and provides relevant data that may assist early adopters of this surgical platform.

SPECT at the speed of PET: a feasibility study of CZT-based whole-body SPECT/CT in the post 177Lu-DOTATATE and 177Lu-PSMA617 setting.

PURPOSE: To evaluate the feasibility of using the StarGuide (General Electric Healthcare, Haifa, Israel), a new generation multi-detector cadmium-zinc-telluride (CZT)-based SPECT/CT, for whole-body imaging in the setting of post-therapy imaging of 177Lu-labeled radiopharmaceuticals. METHODS: Thirty-one patients (34-89 years old; mean ± SD, 65.5 ± 12.1) who were treated with either 177Lu-DOTATATE (n=17) or 177Lu-PSMA617 (n=14) as part of standard of care were scanned post-therapy with the StarGuide; some were also scanned with the standard GE Discovery 670 Pro SPECT/CT. All patients had either 64Cu-DOTATATE or 18F-DCFPyL PET/CT prior to first cycle of therapy for eligibility check. The detection/targeting rate (lesion uptake greater than blood pool uptake) of large lesions meeting RECIST 1.1 size criteria on post-therapy StarGuide SPECT/CT was evaluated and compared to the standard design GE Discovery 670 Pro SPECT/CT (when available) and pre-therapy PET by two nuclear medicine physicians with consensus read. RESULTS: This retrospective analysis identified a total of 50 post-therapy scans performed with the new imaging protocol from November 2021 to August 2022. The StarGuide system acquired vertex to mid-thighs post-therapy SPECT/CT scans with 4 bed positions, 3 min/bed and a total scan time of 12 min. In comparison, the standard GE Discovery 670 Pro SPECT/CT system typically acquires images in 2 bed positions covering the chest, abdomen, and pelvis with a total scan time of 32 min. The pre-therapy 64Cu-DOTATATE PET takes 20 min with 4 bed positions on GE Discovery MI PET/CT, and 18F-DCFPyL PET takes 8-10 min with 4-5 bed positions on GE Discovery MI PET/CT. This preliminary evaluation showed that the post-therapy scans acquired with faster scanning time using StarGuide system had comparable detection/targeting rate compared to the Discovery 670 Pro SPECT/CT system and detected large lesions defined by RECIST criteria on the pre-therapy PET scans. CONCLUSION: Fast acquisition of whole-body post-therapy SPECT/CT is feasible with the new StarGuide system. Short scanning time improves the patients' clinical experience and compliance which may lead to increased adoption of post-therapy SPECT. This opens the possibility to offer imaged-based treatment response assessment and personalized dosimetry to patients referred for targeted radionuclide therapies.

Closed hyperthermic intraperitoneal chemotherapy with CO2 recirculation system compared with the open Coliseum technique in peritoneal malignity treatment.

BACKGROUND: Cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) for peritoneal carcinomatosis can be performed in two ways: first, the standard open abdominal technique (Open HIPEC); or second, the closed technique. In recent years, a new technique has been introduced to perform closed HIPEC; the Peritoneal Recirculation System (PRS-1.0 Combat) with CO2 recirculation technology (PRS Closed HIPEC). The objective of this study is to present our experience with the PRS Closed HIPEC by comparing the intraoperative, postoperative and oncological results with the standard Open HIPEC technique (the Coliseum technique). METHODS: Data on patients undergoing CRS and HIPEC at the Sanchinarro University Hospital, Madrid from October 2012 to June 2021 were collected in a prospective database. The inclusion criteria were patients with primary or recurrent peritoneal metastases in gastrointestinal malignancies or ovarian cancer. The presence of an unresectable peritoneal carcinomatosis, the coexistence of another oncological disease, unresectable and distant metastases were the exclusion criteria. RESULTS: From October 2014 to June 2021, 84 patients underwent CRS and HIPEC at the Sanchinarro University Hospital, Madrid with curative intent. Since the introduction of the PRS Closed HIPEC technique in 2016, 65 patients have been treated. Before the introduction of PRS Closed HIPEC, 19 cases were performed using the Coliseum technique (the Open HIPEC group). The intraoperative results were similar in the two groups. Complete cytoreduction was achieved in all cases in the Open HIPEC group and in 98% in the PRS Closed HIPEC group. The rate of major complications was similar between the groups. Median Overall Survival (OS) resulted better in the Closed HIPEC group (67 months) with respecto to the Open group (43 months) (p < 0,001). Median Disease-Free Survival (DFS) was 15 months in the Open HIPEC group and 40 months in the PRS Closed HIPEC group (p < 0.001). CONCLUSION: The Peritoneal Recirculation System with CO2 recirculation technology (PRS Closed HIPEC) is a reproducible and safe technique and may represent a valid alternative for the administration of HIPEC.

Onset and mortality of Parkinson's disease in relation to type II diabetes.

OBJECTIVES: There is growing evidence that Parkinson's disease and diabetes are partially related diseases; however, the association between the two, and the impact of specific treatments, are still unclear. We evaluated the effect of T2D and antidiabetic treatment on age at PD onset and on all-cause mortality. RESEARCH DESIGN AND METHODS: The standardized rate of T2D was calculated for PD patients using the direct method and compared with subjects with essential tremor (ET) and the general Italian population. Age at onset and survival were also compared between patients without T2D (PD-noT2D), patients who developed T2D before PD onset (PD-preT2D) and patients who developed T2D after PD onset (PD-postT2D). RESULTS: We designed a retrospective and prospective study. The T2D standardized ratio of PD (N = 8380) and ET (N = 1032) patients was 3.8% and 6.1%, respectively, while in the Italian general population, the overall prevalence was 5.3%. In PD-preT2D patients, on antidiabetic treatment, the onset of PD was associated with a + 6.2 year delay (p < 0.001) while no difference was observed in PD-postT2D. Occurrence of T2D before PD onset negatively affected prognosis (adjusted hazard ratio = 1.64 [95% CI 1.33-2.02]; p < 0.001), while no effect on survival was found in PD-postT2D subjects (hazard ratio = 0.86, [95% CI 0.53-1.39]; p = 0.54). CONCLUSIONS: T2D, treated with any antidiabetic therapy before PD, is associated with a delay in its onset. Duration of diabetes increases mortality in PD-preT2D, but not in PD-postT2D. These findings prompt further studies on antidiabetic drugs as a potential disease-modifying therapy for PD.

Image-mode performance characterisation of a positron emission tomography subsystem designed for Biology-guided radiotherapy (BgRT).

OBJECTIVES: In this study, we characterise the imaging-mode performance of the positron emission tomography (PET) subsystem of the RefleXion X1 machine using the NEMA NU-2 2018 standard. METHODS: The X1 machine consists of two symmetrically opposing 900 arcs of PET detectors incorporated into the architecture of a ring-gantry linear accelerator rotating up to 60 RPM. PET emissions from a tumour are detected by the PET detectors and used to guide the delivery of radiation beam. Imaging performance of the PET subsystem on X1 machine was evaluated based on sensitivity of the PET detectors, spatial resolution, count-loss performance, image quality, and daily system performance check. RESULTS: PET subsystem sensitivity was measured as 0.183 and 0.161 cps/kBq at the center and off-center positions, respectively. Spatial resolution: average FWHM values of 4.3, 5.1, and 6.7 mm for the point sources at 1, 10, and 20 cm off center, respectively were recorded. For count loss, max NECR: 2.63 kcps, max true coincidence rate: 5.56 kcps, and scatter fraction: 39.8%. The 10 mm sphere was not visible. Image-quality contrast values were: 29.6%, 64.9%, 66.5%, 81.8%, 81.2%, and background variability: 14.8%, 12.4%, 10.3%, 8.8%, 8.3%, for the 13, 17, 22, 28, 37 mm sphere sizes, respectively. CONCLUSIONS: When operating in an imaging mode, the spatial resolution and image contrast of the X1 PET subsystem were comparable to those of typical diagnostic imaging systems for large spheres, while the sensitivity and count rate were lower due to the significantly smaller PET detector area in the X1 system. Clinical efficacy when used in BgRT remains to be validated. ADVANCES IN KNOWLEDGE: This is the first performance evaluation of the PET subsystem on the novel BgRT machine. The dual arcs rotating PET subsystem on RefleXion X1 machine performance is comparable to those of the typical diagnostic PET system based on the spatial resolution and image contrast for larger spheres.

Radiofrequency-assisted transection of the pancreas versus stapler in distal pancreatectomy: study protocol for a multicentric randomised clinical trial (TRANSPAIRE).

INTRODUCTION: To date, no pancreatic stump closure technique has been shown to be superior to any other in distal pancreatectomy. Although several studies have shown a trend towards better results in transection using a radiofrequency device (radiofrequency-assisted transection (RFT)), no randomised trial for this purpose has been performed to date. Therefore, we designed a randomised clinical trial, with the hypothesis that this technique used in distal pancreatectomies is superior in reducing clinically relevant postoperative pancreatic fistula (CR-POPF) than mechanical closures. METHODS AND ANALYSIS: TRANSPAIRE is a multicentre randomised controlled trial conducted in seven Spanish pancreatic centres that includes 112 patients undergoing elective distal pancreatectomy for any indication who will be randomly assigned to RFT or classic stapler transections (control group) in a ratio of 1:1. The primary outcome is the CR-POPF percentage. Sample size is calculated with the following assumptions: 5% one-sided significance level (α), 80% power (1-ß), expected POPF in control group of 32%, expected POPF in RFT group of 10% and a clinically relevant difference of 22%. Secondary outcomes include postoperative results, complications, radiological evaluation of the pancreatic stump, metabolomic profile of postoperative peritoneal fluid, survival and quality of life. Follow-ups will be carried out in the external consultation at 1, 6 and 12 months postoperatively. ETHICS AND DISSEMINATION: TRANSPAIRE has been approved by the CEIM-PSMAR Ethics Committee. This project is being carried out in accordance with national and international guidelines, the basic principles of protection of human rights and dignity established in the Declaration of Helsinki (64th General Assembly, Fortaleza, Brazil, October 2013), and in accordance with regulations in studies with biological samples, Law 14/2007 on Biomedical Research will be followed. We have defined a dissemination strategy, whose main objective is the participation of stakeholders and the transfer of knowledge to support the exploitation of activities. REGISTRATION DETAILS: ClinicalTrials.gov Registry (NCT04402346).

Giant fibrovascular polyps of the esophagus. Trans oral versus surgical approach. Case report and systematic literature review.

INTRODUCTION: Giant fibrovascular esophageal polyp is a rare benign intraluminal tumour. The aim of this study is to perform a review of the most recent literature in order to describe and analyse the current range of possible diagnostics and treatment strategies. CASE REPORT: We present two cases of giant fibrovascular esophageal polyp treated with a combined minimally invasive transluminal approach at Sanchinarro University Hospital. Further, we perform a literature review. CONCLUSION: We present two cases of grant fibrovascular polyp submitted to minimally invasive transluminal approach. Furthermore, 54 original articles reporting 59 cases have been analysed. In the surgical group, an esophagotomy and polyp resection were performed in 31 (91 %) patients and a total esophagectomy in two patients (5,8 %). Severe morbidity occurred in two patients (5,8 %.) The median hospital stay was 9.25 days. A total of two (5,8 %) cases of recurrence have been registered. In the minimally invasive transluminal approach group, 27 patients had a polyp resection performed completely by endoscopy/transoral. There were no complications but there was one case of recurrence. CONCLUSION: The transluminal approach is safe and should be considered also in the treatment of large esophageal polyps.

89Zr-panitumumab Combined With 18F-FDG PET Improves Detection and Staging of Head and Neck Squamous Cell Carcinoma.

PURPOSE: Determine the safety and specificity of a tumor-targeted radiotracer (89Zr-pan) in combination with 18F-FDG PET/CT to improve diagnostic accuracy in head and neck squamous cell carcinoma (HNSCC). EXPERIMENTAL DESIGN: Adult patients with biopsy-proven HNSCC scheduled for standard-of-care surgery were enrolled in a clinical trial and underwent systemic administration of 89Zirconium-panitumumab and panitumumab-IRDye800 followed by preoperative 89Zr-pan PET/CT and intraoperative fluorescence imaging. The sensitivity, specificity, and AUC were evaluated. RESULTS: A total of fourteen patients were enrolled and completed the study. Four patients (28.5%) had areas of high 18F-FDG uptake outside the head and neck region with maximum standardized uptake values (SUVmax) greater than 2.0 that were not detected on 89Zr-pan PET/CT. These four patients with incidental findings underwent further workup and had no evidence of cancer on biopsy or clinical follow-up. Forty-eight lesions (primary tumor, LNs, incidental findings) with SUVmax ranging 2.0-23.6 were visualized on 18F-FDG PET/CT; 34 lesions on 89Zr-pan PET/CT with SUVmax ranging 0.9-10.5. The combined ability of 18F-FDG PET/CT and 89Zr-pan PET/CT to detect HNSCC in the whole body was improved with higher specificity of 96.3% [confidence interval (CI), 89.2%-100%] compared to 18F-FDG PET/CT alone with specificity of 74.1% (CI, 74.1%-90.6%). One possibly related grade 1 adverse event of prolonged QTc (460 ms) was reported but resolved in follow-up. CONCLUSIONS: 89Zr-pan PET/CT imaging is safe and may be valuable in discriminating incidental findings identified on 18F-FDG PET/CT from true positive lesions and in localizing metastatic LNs.