BACKGROUND: The method of transecting the pancreatic parenchyma during pancreatic resection may influence the rate of complications, including pancreatic fistula and bleeding. The objective of this study is to compare the transection of the pancreatic parenchyma during pancreatoduodenectomy with monopolar electrocautery versus scalpel in terms of postoperative complications. METHODS: A retrospective analysis of patients with open pancreatoduodenectomy from the German DGAV StuDoQ|Pancreas registry (January 2013 to December 2021) was performed. Transection of the pancreatic parenchyma with a scalpel versus monopolar electrocautery was compared regarding postoperative pancreatic fistula B/C, post-pancreatectomy hemorrhage B/C, and major complications (Clavien-Dindo classification ≥3) rates. Multivariable analysis with adjustment for potential confounders and surgical center cluster effect was performed. RESULTS: Overall, 6,752 patients were included in the study. In 4,072 (60.3%), transection was performed with a scalpel and, in 2,680 (39.7%), with electrocautery. Transection with electrocautery was associated with higher postoperative pancreatic fistula B/C (15.4% vs 12.8%; P = .003), post-pancreatectomy hemorrhage B/C (11% vs 7.4%; P < .001), and major complications (33.4% vs 29.6%; P = .001) rates. In the multivariable analysis, after adjustment for potential confounders and surgical center, the association of the transection method with postoperative pancreatic fistula B/C (odds ratio = 1.01; 95% CI, 0.79-1.2; P = .962), post-pancreatectomy hemorrhage B/C (odds ratio = 1.23; 95% CI, 0.94-1.6; P = .127), and major complications (odds ratio = 1.09; 95% CI, 0.93-1.27; P = .297) was not significant. CONCLUSION: The study found no significant association between transection of the pancreatic parenchyma during open pancreatoduodenectomy with a scalpel compared with monopolar electrocautery regarding pancreatic fistula, postoperative bleeding, or overall major complication rates.
BACKGROUND Transplant nephrectomy (TN) has historically been associated with high morbidity and mortality rates. Our objective is to share our own experience and compare indications and surgical outcomes between early and late TN and intracapsular (ICAN) and extracapsular allograft nephrectomy (ECAN) techniques. MATERIAL AND METHODS Our study included all 69 TN procedures performed between January 2010 and February 2021. Of these, 17 TN procedures were performed within the first 60 days after transplantation (referred to as 'early'), while the remaining 52 procedures were performed later ('late'). Within the late allograft nephrectomy (AN) group, we compared the outcomes of intracapsular (ICAN) and extracapsular (ECAN) techniques. We conducted a statistical analysis using the chi-square test and the 2-sample t test. RESULTS The primary indication for early TN was surgical transplant complications (94.1%), with 58.8% of these cases requiring emergency surgery. Morbidity (major complications) occurred in 47.1% of cases, and mortality was 5.9%. In contrast, graft intolerance syndrome was the leading indication for late TN (76.9%), with elective surgery performed in 88.5% of cases. Morbidity (major complications) occurred in 11.5% of cases, and mortality was 3.8%. Within the late TN group, 82.7% of cases were treated with ICAN and 17.3% with ECAN. Blood transfusion was required during surgery in 17.3% of cases, with no significant difference between the groups. Multivariate logistic regression analysis revealed that the timing of surgery was the only statistically significant predictor of complication occurrence. CONCLUSIONS Our data suggest that TN can be performed with relatively low morbidity. However, early TN remains the only independent risk factor for developing adverse outcomes.
Kidney Transplantation , Nephrectomy , Postoperative Complications , Humans , Kidney Transplantation/methods , Kidney Transplantation/mortality , Nephrectomy/methods , Female , Male , Middle Aged , Adult , Postoperative Complications/etiology , Postoperative Complications/epidemiology , Time Factors , Retrospective Studies , Treatment Outcome , Aged
The aim of this study was to analyze the long-term results of different locoregional treatments for colorectal cancer liver metastases (CRLM), including transarterial chemoembolization (TACE), laser-induced thermotherapy (LITT) and microwave ablation (MWA). A total of 2140 patients with CRLM treated at our department between 1993 and 2020 were included in this retrospective study. The patients were divided into the following groups: LITT (573 patients; median age: 62 years), TACE + LITT (346 patients; median age: 62 years), MWA (67 patients; median age: 59 years), TACE + MWA (152 patients; median age: 65 years), and TACE (1002 patients; median age: 62 years). Median survival was 1.9 years in the LITT group and 1.7 years in the TACE + LITT group. The median survival times in the MWA group and TACE + MWA group were 3.1 years and 2.1 years, respectively. The median survival in the TACE group was 0.8 years. The 1-, 3-, and 5-year survival rates were 77%, 27%, and 9% in the LITT group and 74%, 18%, and 5% in the TACE + LITT group, respectively. The corresponding survival rates were 80%, 55%, and 33% in the MWA group, 74%, 36%, and 20% in the TACE + MWA group and 37%, 3%, and 0% in the TACE group, respectively. The long-term results of this study demonstrate the efficacy of locoregional treatments in treating patients with CRLM. The longest survival was found in the MWA group, followed by the combination therapy of TACE and MWA.
Bronchobiliary fistulas are defined as an abnormal communication between the biliary system and the bronchial tree. They are extremely rare complications of radiofrequency or microwave ablation. A 39-year-old woman with a history of neuroendocrine pancreatic carcinoma suffering from liver metastasis was treated with microwave ablation (MWA). In this case report, we present a case of intractable biliptysis from a bronchobiliary fistula secondary to an MWA. The patient was diagnosed by endoscopic retrograde cholangiopancreatograph and hepatobiliary scintigraphy. Treatment involved a right hemihepatectomy, a redo-hepaticojejunostomy, and the surgical placement of a transhepatic drain. After 6 weeks of drain placement, this could be removed. The fistula was thus successfully treated.
PURPOSE: The presence of an aberrant right hepatic artery (aRHA), arising from the superior mesenteric artery, is a common variant of the liver vascular anatomy. Considering that tumor spread occurs along vessels, the question arises, whether the presence of an aRHA influences the oncologic outcome after resection for cancer of the pancreatic head. METHODS: Patients with ductal adenocarcinoma of the pancreatic head, who underwent resection from 2011 to 2020 at the Frankfurt University Hospital, Germany, were analyzed retrospectively. Surgical records and computed tomography imaging were reviewed for the presence of aRHA. Overall and disease-free survival as well as hepatic recurrence were analyzed according to the presence of aRHA. RESULTS: aRHA was detected in 21 out of 145 patients (14.5%). The median overall survival was 26 months (95%CI 20.8-34.4), median disease-free survival was 12.1 months (95%CI 8.1-17.3). There was no significant difference in overall survival (26.1 versus 21.4 months, adjusted hazard ratio 1.31, 95%CI 0.7-2.46, p = 0.401) or disease-free survival (14.5 months versus 12 months, adjusted hazard ratio 0.98, 95%CI 0.57-1.71, p = 0.957) without and with aRHA. The hepatic recurrence rate was 24.4.% with conventional anatomy versus 30.8% with aRHA (adjusted odds ratio 1.36, 95%CI 0.3-5.38, p = 0.669). In the multivariable analysis, only lymphatic vessel invasion was an independent prognostic factor for hepatic recurrence. CONCLUSIONS: The presence of an aRHA does not seem to influence the long-term survival and hepatic recurrence after resection for ductal adenocarcinoma of the pancreatic head.
Adenocarcinoma , Hepatic Artery , Humans , Hepatic Artery/surgery , Retrospective Studies , Pancreas , Pancreatectomy
The aim of this study was to retrospectively evaluate the effects of conventional transarterial chemoembolization (cTACE) for the treatment of hepatocellular carcinoma over 20 years regarding overall survival (OS) and prognostic factors for OS. During the period from 1996 to 2016, 836 patients with HCC were treated with cTACE. Data evaluation was performed on the basis of pre- and postinterventional MRI and CT scans. Survival analysis was performed by Kaplan-Meier estimator; prognostic factors were determined by the use of Cox regression analysis. Overall, 4084 (mean 4.89 TACE sessions/patient) procedures were assessed. Median OS was 700 days (99% CI, 632.8-767.2). Depending on the indication, patients treated with a neoadjuvant intention showed the best OS (1229 days, 99% CI 983.8-1474.2) followed by curative intention (787 days, 99% CI 696.3-877.7), and then palliative intention (360 days, 99% CI 328.4-391.6). Portal vein thrombosis (HR 2.19, CI 1.63-2.96, and p < 0.01) and Child-Pugh class B or worse (HR 1.44, CI 1.11-1.86, and p < 0.001) were significantly associated with shorter OS. Patients with HCC benefit from TACE after careful patient selection. Portal vein thrombosis and Child-Pugh class B or worse are significantly unfavorable prognostic factors for patients' survival.
BACKGROUND: A structured risk assessment of patients with validated and evidence-based tools can help to identify modifiable factors before major surgeries. The Protego Maxima trial investigated the value of a new digitized risk assessment tool that combines tools which can be easily used and implemented in the clinical workflow by doctors and qualified medical staff. The hypothesis was that the structured assessment and risk-grouping is predictive of short-term surgical quality reflected by complications and overall survival. METHODS: The Protego Maxima Trial was a prospective cohort analysis of patients undergoing major surgery (visceral, thoracic, urology, vascular and gynecologic surgeries) as key inclusion criterion and the absence of an acute or acute on chronically decompensated pulmo-cardiovascular decompensation. Patients were risk-scored with the software (The Prehab App) that includes a battery of evidence-based risk assessment tools that allow a structured risk assessment. The data were grouped to predefined high and low risk groups and aggregate and individual scores. The primary outcome was to validate the predictive value of the RAI score and the TUG for overall survival in the high and low risk groups. Secondary outcomes were surgical outcomes at 90-days after surgery (overall survival, Clavien-Dindo (CD) 1-5 (all complications), and CD 3-5 (major complications)). The study was carried out in accordance with the DIN ISO 14,155, and the medical device regulation (MDR) at Frankfurt University Hospital between March 2022 and January 2023. RESULTS: In total 267 patients were included in the intention to treat analysis. The mean age was 62.1 ± 12.4 years. Patients with a RAI score > 25 and/or a timed up and go (TUG) > 8 s had a higher risk for mortality at 90 days after surgery. The low-risk group predicted beneficial outcome and the high-risk group predicted adverse outcome in the ROC analysis (Area Under the Curve Receiver Operator Characteristics: AUROC > 0.800; p = 0.01). Risk groups (high vs. low) showed significant differences for 90-day survival (99.4% vs. 95.5%; p = 0.04) and major complications (16.4% vs. 32.4%; p < 0.001). CONCLUSION: The proof-of-concept trial showed that a risk assessment with 'The Prehab App' may be viable to estimate the preoperative risk for mortality and major complications before major surgeries. The overall performance in this initial set of data indicated a certain reliability of the scoring and risk grouping, especially of the RAI score and the TUG. A larger data set will be required to proof the generalizability of the risk scoring to every subgroup and may be fostered by artificial intelligence approaches. TRIAL REGISTRATION: Ethics number: 2021-483-MDR/MPDG-zuständig monocentric; The Federal Institute for Pharmaceuticals and Medical Devices/BfArM, reference number: 94.1.04-5660-13655; Eudamed: CIV-21-07-0307311; German Clinical Trial Registry: DRKS 00026985.
PURPOSE: Hepatocellular carcinoma (HCC) arises in individuals with underlying liver disease. Diagnosing the degree of hepatic fibrosis helps to determine the severity of the underlying liver disease and may influence therapeutic decisions in HCC patients. Non-invasive fibrosis scores can be used to estimate the degree of fibrosis in liver disease patients, but most of these scores were developed in patients with viral hepatitis and without HCC. This study explored the ability of the Fibrosis-4 Index (FIB-4), the AST/Platelet Ratio Index (APRI), and the AST/ALT ratio to diagnose or exclude advanced fibrosis (METAVIR F3/4 versus F0-2) in patients with early-intermediate, potentially resectable HCC. METHODS: We retrospectively reviewed 119 patients who underwent hepatic resection for HCC at a tertiary centre (2007-2019), 75 of whom had advanced fibrosis (prevalence 63%). Histological assessment of the surgical liver specimen was used as a reference standard for the degree of fibrosis. RESULTS: Overall diagnostic performance was highest for the FIB-4 Index, with an area under the receiver operating characteristic curve (AUROC) of 0.82, compared with 0.78 for APRI, and 0.56 for the AST/ALT ratio. Using established cut-off values, FIB-4 achieved a 90% positive predictive value at the higher cut-off (3.25) and a 90% negative predictive value at the lower cut-off (1.45). CONCLUSION: The FIB-4 Index could reliably diagnose or exclude advanced fibrosis in patients with early-intermediate HCC, and may thus have a role in guiding therapeutic decisions in these patients.
Carcinoma, Hepatocellular , Liver Neoplasms , Humans , Carcinoma, Hepatocellular/diagnosis , Retrospective Studies , Liver Neoplasms/diagnosis , Liver Cirrhosis/diagnosis
BACKGROUND: Prehabilitation is of becoming of growing interest in the medical specialist societies, especially before major surgical procedures in older and frail patients. The body of evidence in steadily growing. OBJECTIVES: Are there good digital solutions for a remote prehabilitation program at home? METHODS: Narrative review of the evidence and current study activities in analogous and digital prehabilitation. RESULTS: Prehabilitation is becoming increasingly more important in the optimal preparation of patients before major surgical procedures. With the help of tailored programs patients can be improved and the risk of complications can be significantly lowered. With an optimal selection, this is not associated with a deterioration of the prognosis for patients with cancer during the intervention lasting for 3-6 weeks. There is still a lack of results and good evidence from well-designed trials for digital solutions. CONCLUSION: Prehabilitation can be safely implemented in the preparation of patients before major surgical procedures. Digital solutions are currently being developed and tested and could possibly increase the acceptance in the currently intensifying resource shortages.
Preoperative Care , Preoperative Exercise , Humans , Preoperative Care/methods , Mobile Applications
Antineoplastic Combined Chemotherapy Protocols , Deoxycytidine , Fluorouracil , Gemcitabine , Irinotecan , Leucovorin , Neoadjuvant Therapy , Oxaliplatin , Pancreatic Neoplasms , Humans , Pancreatic Neoplasms/drug therapy , Pancreatic Neoplasms/surgery , Pancreatic Neoplasms/pathology , Deoxycytidine/analogs & derivatives , Deoxycytidine/administration & dosage , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Leucovorin/administration & dosage , Leucovorin/therapeutic use , Fluorouracil/administration & dosage , Irinotecan/administration & dosage , Oxaliplatin/administration & dosage , Chemotherapy, Adjuvant , Survival Rate , Prognosis , Randomized Controlled Trials as Topic , Clinical Trials, Phase II as Topic
BACKGROUND: The purpose of this study was to compare 3-year overall survival after simultaneous portal (PVE) and hepatic vein (HVE) embolization versus PVE alone in patients undergoing liver resection for primary and secondary cancers of the liver. METHODS: In this multicentre retrospective study, all DRAGON 0 centres provided 3-year follow-up data for all patients who had PVE/HVE or PVE, and were included in DRAGON 0 between 2016 and 2019. Kaplan-Meier analysis was undertaken to assess 3-year overall and recurrence/progression-free survival. Factors affecting survival were evaluated using univariable and multivariable Cox regression analyses. RESULTS: In total, 199 patients were included from 7 centres, of whom 39 underwent PVE/HVE and 160 PVE alone. Groups differed in median age (P = 0.008). As reported previously, PVE/HVE resulted in a significantly higher resection rate than PVE alone (92 versus 68%; P = 0.007). Three-year overall survival was significantly higher in the PVE/HVE group (median survival not reached after 36 months versus 20 months after PVE; P = 0.004). Univariable and multivariable analyses identified PVE/HVE as an independent predictor of survival (univariable HR 0.46, 95% c.i. 0.27 to 0.76; P = 0.003). CONCLUSION: Overall survival after PVE/HVE is substantially longer than that after PVE alone in patients with primary and secondary liver tumours.
Embolization, Therapeutic , Hepatectomy , Hepatic Veins , Liver Neoplasms , Liver Regeneration , Portal Vein , Humans , Male , Female , Liver Neoplasms/therapy , Liver Neoplasms/mortality , Liver Neoplasms/surgery , Retrospective Studies , Embolization, Therapeutic/methods , Middle Aged , Liver Regeneration/physiology , Aged , Hepatectomy/methods , Survival Rate , Survival Analysis , Adult
Hepatocellular carcinoma (HCC) is the most common primary malignant liver tumor and a leading cause of cancer-related deaths worldwide. However, current diagnostic tools are often invasive and technically limited. In the last decade, non-invasive liquid biopsies have transformed the field of clinical oncology, showcasing the potential of various liquid-biopsy derived analytes, including extracellular vesicles (EVs), to diagnose and monitor HCC progression and metastatic spreading, serving as promising novel biomarkers. A prospective single-center cohort study including 37 HCC patients and 20 patients with non-malignant liver disease (NMLD), as a control group, was conducted. Serum EVs of both groups were analyzed before and after liver surgery. The study utilized microbead-based magnetic particle sorting and flow cytometry to detect 37 characteristic surface proteins of EVs. Furthermore, HCC patients who experienced tumor recurrence (R-HCC) within 12 months after surgery were compared to HCC patients without recurrence (NR-HCC). EVs of R-HCC patients (n = 12/20) showed significantly lower levels of CD31 compared to EVs of NR-HCC patients (p = 0.0033). EVs of NMLD-group showed significantly higher expressions of CD41b than EVs of HCC group (p = 0.0286). The study determined significant short-term changes in CD19 dynamics in EVs of the NMLD-group, with preoperative values being significantly higher than postoperative values (p = 0.0065). This finding of our pilot study suggests EVs could play a role as potential targets for the development of diagnostic and therapeutic approaches for the early and non-invasive detection of HCC recurrence. Further, more in-depth analysis of the specific EV markers are needed to corroborate their potential role as diagnostic and therapeutic targets for HCC.
Carcinoma, Hepatocellular , Extracellular Vesicles , Liver Neoplasms , Humans , Carcinoma, Hepatocellular/diagnosis , Cohort Studies , Pilot Projects , Prospective Studies , Liver Neoplasms/diagnosis , Neoplasm Recurrence, Local/diagnosis , Biomarkers
BACKGROUND: Although addition of adjuvant chemotherapy is the current standard, the prognosis of pancreatic cancers still remains poor. The NEPAFOX trial evaluated perioperative treatment with FOLFIRINOX in resectable pancreatic cancer. PATIENTS AND METHODS: This multicenter phase II trial randomized patients with resectable or borderline resectable pancreatic cancer without metastases into arm (A,) upfront surgery plus adjuvant gemcitabine, or arm (B,) perioperative FOLFIRINOX. The primary endpoint was overall survival (OS). RESULTS: Owing to poor accrual, recruitment was prematurely stopped after randomization of 40 of the planned 126 patients (A: 21, B: 19). Overall, approximately three-quarters were classified as primarily resectable (A: 16, B: 15), and the remaining patients were classified as borderline resectable (A: 5, B: 4). Of the 12 evaluable patients, 3 achieved partial response under neoadjuvant FOLFIRINOX. Of the 21 patients in arm A and 19 patients in arm B, 17 and 7 underwent curative surgery, and R0-resection was achieved in 77% and 71%, respectively. Perioperative morbidity occurred in 72% in arm A and 46% in arm B, whereas non-surgical toxicity was comparable in both arms. Median RFS/PFS was almost doubled in arm B (14.1 months) compared with arm A (8.4 months) in the population with surgical resection, whereas median OS was comparable between both arms. CONCLUSIONS: Although the analysis was only descriptive owing to small patient numbers, no safety issues regarding surgical complications were observed in the perioperative FOLFIRINOX arm. Thus, considering the small number of patients, perioperative treatment approach appears feasible and potentially effective in well-selected cohorts of patients. In pancreatic cancer, patient selection before initiation of neoadjuvant therapy appears to be critical.
Antineoplastic Combined Chemotherapy Protocols , Deoxycytidine , Fluorouracil , Gemcitabine , Irinotecan , Leucovorin , Neoadjuvant Therapy , Oxaliplatin , Pancreatic Neoplasms , Humans , Pancreatic Neoplasms/drug therapy , Pancreatic Neoplasms/pathology , Pancreatic Neoplasms/surgery , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Deoxycytidine/analogs & derivatives , Deoxycytidine/administration & dosage , Male , Female , Leucovorin/administration & dosage , Leucovorin/therapeutic use , Irinotecan/administration & dosage , Irinotecan/therapeutic use , Fluorouracil/administration & dosage , Oxaliplatin/administration & dosage , Oxaliplatin/therapeutic use , Middle Aged , Aged , Chemotherapy, Adjuvant , Survival Rate , Follow-Up Studies , Prognosis , Pancreatectomy , Adult , Adenocarcinoma/drug therapy , Adenocarcinoma/pathology , Adenocarcinoma/surgery , Adenocarcinoma/mortality
The S2k guideline "Liver Transplantation", jointly developed by the German Society of Gastroenterology, Digestive and Metabolic Diseases (DGVS) and the German Society of General and Visceral Surgery (DGAV), represents the first German-language guideline for the care of adult patients before and after liver transplantation. This guideline has been crafted through a collaborative, consensus-based approach, involving experts from various disciplines. It integrates current scientific insights and clinical experience to ensure optimal care for patients undergoing liver transplantation. Targeting health care professionals in diagnostics and therapy, patient advocates, affected individuals, and their families, the guideline aims to establish a framework for common decisions in clinical practice.
Gastroenterology , Liver Transplantation , Humans , Consensus , Germany
BACKGROUND: This animal study investigates the hypothesis of an immature liver growth following ALPPS (associating liver partition and portal vein ligation for staged hepatectomy) by measuring liver volume and function using gadoxetic acid avidity in magnetic resonance imaging (MRI) in models of ALPPS, major liver resection (LR) and portal vein ligation (PVL). METHODS: Wistar rats were randomly allocated to ALPPS, LR or PVL. In contrast-enhanced MRI scans with gadoxetic acid (Primovist®), liver volume and function of the right median lobe (=future liver remnant, FLR) and the deportalized lobes (DPL) were assessed until post-operative day (POD) 5. Liver functionFLR/DPL was defined as the inverse value of time from injection of gadoxetic acid to the blood pool-corrected maximum signal intensityFLR/DPL multiplied by the volumeFLR/DPL. RESULTS: In ALPPS (n = 6), LR (n = 6) and PVL (n = 6), volumeFLR and functionFLR increased proportionally, except on POD 1. Thereafter, functionFLR exceeded volumeFLR increase in LR and ALPPS, but not in PVL. Total liver function was significantly reduced after LR until POD 3, but never undercuts 60% of its pre-operative value following ALPPS and PVL. DISCUSSION: This study shows for the first time that functional increase is proportional to volume increase in ALPPS using gadoxetic acid avidity in MRI.
Gadolinium DTPA , Liver Neoplasms , Liver Regeneration , Rats , Animals , Rats, Wistar , Liver/diagnostic imaging , Liver/surgery , Liver/blood supply , Hepatectomy/methods , Portal Vein/diagnostic imaging , Portal Vein/surgery , Portal Vein/pathology , Liver Neoplasms/surgery , Magnetic Resonance Imaging , Ligation/methods
PURPOSE: This trial evaluates the addition of the PD-L1 antibody atezolizumab (ATZ) to standard-of-care fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) as a perioperative treatment for patients with resectable esophagogastric adenocarcinoma (EGA). METHODS: DANTE started as multicenter, randomized phase II trial, which was subsequently converted to a phase III trial. Here, we present the results of the phase II proportion, focusing on surgical pathology and safety outcomes on an exploratory basis. Patients with resectable EGA (≥cT2 or cN+) were assigned to either four preoperative and postoperative cycles of FLOT combined with ATZ, followed by eight cycles of ATZ maintenance (arm A) or FLOT alone (arm B). RESULTS: Two hundred ninety-five patients were randomly assigned (A, 146; B, 149) with balanced baseline characteristics between arms. Twenty-three patients (8%) had tumors with microsatellite instability (MSI), and 58% patients had tumors with a PD-L1 combined positive score (CPS) of ≥1. Surgical morbidity (A, 45%; B, 42%) and 60-day mortality (A, 3%; B, 2%) were comparable between arms. Downstaging favored arm A versus arm B (ypT0, 23% v 15% [one-sided P = .044]; ypT0-T2, 61% v 48% [one-sided P = .015]; ypN0, 68% v 54% [one-sided P = .012]). Histopathologic complete regression rates (pathologic complete response or TRG1a) were higher after FLOT plus ATZ (A, 24%; B, 15%; one-sided P = .032), and the difference was more pronounced in the PD-L1 CPS ≥10 (A, 33%; B, 12%) and MSI (A, 63%; B, 27%) subpopulations. Complete margin-free (R0) resection rates were relatively high in both arms (A, 96%; B, 95%). The incidence and severity of adverse events were similar in both groups. CONCLUSION: Within the limitations of the exploratory nature of the data, the addition of ATZ to perioperative FLOT is safe and improved postoperative stage and histopathologic regression.
Adenocarcinoma , Antibodies, Monoclonal, Humanized , Esophageal Neoplasms , Stomach Neoplasms , Humans , Adenocarcinoma/drug therapy , Adenocarcinoma/surgery , Adenocarcinoma/pathology , Antineoplastic Combined Chemotherapy Protocols/adverse effects , B7-H1 Antigen/therapeutic use , Docetaxel/therapeutic use , Esophageal Neoplasms/drug therapy , Esophageal Neoplasms/surgery , Esophagogastric Junction/pathology , Fluorouracil/adverse effects , Leucovorin/adverse effects , Neoadjuvant Therapy/methods , Oxaliplatin/therapeutic use , Stomach Neoplasms/drug therapy , Stomach Neoplasms/surgery , Stomach Neoplasms/pathology
BACKGROUND: Appendectomy in children is performed either lapa - roscopically (LA) or by open surgery (OA). We studied whether, and how, the outcome is affected by the technique used and by the intraoperative conversion of LA to OA. METHODS: We analyzed routine data from children and adolescents in three age groups (1-5 years, 6-12 years, and 13-17 years) who were insured by the AOK statutory health insurance carrier in Germany and who underwent appendectomy in the period 2017-2019. General surgical complications and reoperations within 90 days were assessed with relevant indicators. Associations between the surgical technique and these indicators were studied with logistic regression. RESULTS: Of the 21 541 patients included in the study, general surgical complications were observed in 2.1% and reoperations in 1.8% overall. Broken down by age group, the corresponding figures were 5.4% and 4.4% (age 1 to 5), 2.5% and 1.8% (age 6 to 12), and 1.5% and 1.6% (age 13 to 17). The main risk factors for complications and reoperations were acute complicated appendicitis and conversion from LA to OA. Regression analysis revealed similar outcomes with OA compared to LA in the 1-to-5 age group, (odds ratios and 95% confidence intervals: 1.1 [0.6; 2.1] for general surgical complications and 1.5 [0.8; 2.7] for reoperations), but worse outcomes with OA in the other two age groups (age 6 to 12: 1.9 [1.2; 2.9] and 2.1 [1.5; 2.9]; age 13 to 17: 1.7 [1.0; 2.9] and 2.2 [1.4; 3.6]). When conversions were assigned to the LA group, the odds ratio (OA compared to LA) for reoperation across all age groups was 3.5 [2.8; 4.4] in patients with acute uncomplicated appendicitis and 4.2 [3.4; 5.3] in patients with complicated appendicitis. Complicated appendicitis also increased the rate of general surgical complications and the length of stay in hospital. CONCLUSION: Among children in the two older age groups, LA was followed by fewer general surgical complications and reoperations than OA. These differences were less pronounced when conversions were counted as belonging to the LA group. Children aged 1-5 appear to benefit the least from the lapa - roscopic technique.
Appendicitis , Laparoscopy , Adolescent , Child , Humans , Aged , Infant , Child, Preschool , Appendectomy/adverse effects , Appendicitis/epidemiology , Appendicitis/surgery , Reoperation , Germany/epidemiology
BACKGROUND: To date, liver transplantation (LT) is the only curative treatment for cirrhosis and early-diagnosed progressive acute liver failure (ALF). However, LT results in morbidities and mortality even post-LT. Different comorbidities may follow and further increase mortality and morbidity. In this study, we investigated the outcomes and their trends over a period of 14 years among hospitalized patients evaluated for LT, transplant and post-LT in Germany. METHODS: This German nationwide study investigated the number of admissions of patients hospitalized for evaluation of LT and post-LT on related comorbidities and complications between 2005 and 2018 based on the DRG system with ICD-10/OPS codes. 14â 745 patients were put on the LT waiting list and 12â 836 underwent LT during the observational period. RESULTS: The LT number decreased by 2.3% over time, while the waiting list mortality rate increased by 5%. By contrast, the in-hospital mortality rate decreased by 3%, especially in ALF patients (decrease of 16%). Interestingly, admissions of post-LT patients for complications almost doubled, driven mainly by complications of immunosuppression (tripled). Importantly, post-LT patients with acute kidney injury (20.2%) and biliodigestive anastomosis (18.4%) showed the highest in-hospital mortality rate of all complications. CONCLUSION: In conclusion, the decrease in LT leads most probably to the increased in-hospital mortality of patients on the waiting list. Interestingly, in-hospital mortality decreased in LT patients. Post-LT comorbidities requiring hospitalization increased in the observational period and management of patients post-LT with AKI or biliodigestive anastomosis should be addressed.
Acute Kidney Injury , Liver Failure, Acute , Liver Transplantation , Humans , Liver Transplantation/adverse effects , Germany/epidemiology , Liver Cirrhosis , Anastomosis, Surgical
BACKGROUND AND AIMS: Chemotherapy (CTx) with targeted therapy (TT) have increased the overall response rate (ORR) and improved survival in unresectable or borderline resectable metastatic colorectal cancer (mCRC). However, the resection rate is an endpoint with often suboptimal expert involvement. The aim was to investigate whether the improvements in ORR have translated to improved resection rates (RR). STUDY DESIGN: A systematic literature search was performed using the PICO process. STATISTICAL ANALYSIS: Odds ratios, and 95% confidence intervals (OR, 95% CI) were analyzed for ORR and RR using dichotomous values with the Mantel-Haenszel method. Progression-free survival (PFS) and overall survival (OS) were analyzed using the inverse-variance method and displayed as hazard ratios and 95% confidence intervals (HR, 95% CI). RESULTS: The literature search returned 469 records. Sixteen articles with 5724 patients were selected for analysis. The qualitative analysis revealed low and moderate risk of bias endpoints. Higher ORR was observed with CTx + TT versus CTx only (OR: 0.62 [95% CI 0.45; 0.82], p = 0.002) and with triplet CTx + TT versus doublet CTx + TT (OR: 0.61 [95% CI 0.46; 0.81], p < 0.001). PFS and OS were improved by use of TT (HR: 0.68-0.84; p < 0.001 to 0.04). The overall RR was low (< 15%) and did not improve in the same way as the other endpoints. CONCLUSION: The ORR and survival rates in unresectable and borderline resectable mCRC were improved by modern CTx and TT that did not translate into higher RR, mostly due to the lack of expert involvement.
