Emergency treatment of popliteal aneurysms: Single center experience and systematic review and meta-analysis of endovascular versus open repair.

BACKGROUND: Popliteal artery aneurysms (PAA) were traditionally treated by open repair (OR). Endovascular repair (ER) has become a new treatment strategy. The aim of this systemic review and meta-analysis was to evaluate and compare the current outcomes of OR and ER in the emergency treatment of PAA. METHODS: A systematic literature search of the PubMed/Medline database was carried out. Outcomes were 30-day mortality, morbidity, major amputation rate (30 days), major amputation rate (1 year), 1-year primary patency rate, 1-year secondary patency rate and 1-year survival. Additionally, we included clinical data of patients with popliteal aneurysms treated between 2009 and 2021 at the Martin-Luther University Halle-Wittenberg. RESULTS: We identified two cohort studies from 2014 and 2015 with a total of 199 patients that underwent emergent surgery (39 ER and 160 OR). We also included 26 patients from our institution. For emergency treatment, 30-day major amputation rates (18% vs 3%, Odds Ratio 5.82, 95% CI [1.75; 19.30], p = .004), 30-day mortality rates (10% vs 1%, Odds Ratio 5.57, 95% CI [1.01; 30.58], p = .05), 1-year major amputation rates (15% vs 6% Odds Ratio 3.61, 95% CI [1.18; 11.09], p = .02), 1-year loss of primary patency (54% vs 23%, Odds Ratio 3.19, 95% CI [0.91; 11.20], p = .07), and 1-year loss of secondary patency (44% vs 12%, Odds Ratio 6.91, 95% CI [3.01; 15.83], p < .05) were higher in the ER group when compared to the OR group. CONCLUSION: Endovascular repair represents an alternative approach for the emergency treatment of PAA. Limited evidence from the available non-randomized studies shows unfavorable outcomes for patients undergoing ER. However, the results are prone to selection bias, and only randomized trials comparing ER to OR might reveal whether a subgroup of patients would benefit from ER as primary treatment of PAA in an emergency setting.

Acute and chronic mesenteric ischemia: single center analysis of open, endovascular, and hybrid surgery.

BACKGROUND: The aim of the study was to analyse the outcome of open surgical, endovascular, and hybrid interventions in the treatment of acute (AMI) and chronic (CMI) mesenteric ischemia. METHODS: Retrospective review of a cohort of mesenteric ischemia patients at a single tertiary referral center from 2015 to 2021. Primary end point was postoperative in-hospital mortality. Secondary end points were the number of bowel resections, duration of the procedure, length of postoperative intensive care treatment, length of hospital stay, revision surgery (number and type), and the nature and severity of postoperative complications according to Dindo-Clavien. RESULTS: A total of 64 patients, 20 with CMI and 44 with AMI, underwent open, hybrid or endovascular surgery. Bowel resection was performed in 45.5% of the patients with AMI (29.5% small intestine, 2.3% colon and 13.6% both). There was no in-hospital mortality in the CMI cohort as compared to 29.5% in the AMI cohort (p = 0.03), with no differences regarding endovascular and open surgery (29.6 vs 29.4%). Severe postoperative morbidity (Dindo-Clavien ≥ 3) was also significantly more frequent in the AMI group when compared to the CMI group (20 vs 77.3%, p < 0.001). ASA classification and intensive care stay were identified as factors associated with mortality in AMI patients. CONCLUSIONS: Morbidity and in-hospital mortality are low in CMI patients, but substantial in AMI patients. Early diagnosis and open or endovascular treatment may be decisive for the outcome of these patients.

Needle tract seeding and abdominal recurrence following pre-treatment biopsy of gastrointestinal stromal tumors (GIST): results of a systematic review.

BACKGROUND: Gastrointestinal stromal tumors (GIST) are rare abdominal tumors. Pretreatment biopsies may be used to diagnose a GIST and enable tailored treatment. Some experts are skeptical about biopsies because they fear tumor cell seeding. The objective of this study was to determine if pretreatment biopsy is associated with increased tumor recurrence. METHODS: We performed a systematic literature search and included studies assessing the oncological outcome of GIST patients who underwent a pre-treatment core needle biopsy or fine needle aspiration. We assessed methodological quality with the Newcastle-Ottawa-Scale for non-randomized studies. This review was registered in the PROSPERO database (CRD42021170290). RESULTS: Three non-randomized studies and eight case reports comprising 350 patients were eligible for inclusion. No prospective study designed to answer the review question was found. One case of needle tract seeding after percutaneous core needle biopsy of GIST was reported. None of the studies reported an increased rate of abdominal recurrence in patients with pretreatment biopsy. CONCLUSIONS: The existing evidence does not indicate a relevant risk of needle tract seeding or abdominal recurrence after pre-treatment biopsy of GIST. Biopsy can safely be done to differentiate GIST from other tumors and to select the most appropriate treatment.

Systematic review and meta-analysis of surgery for hilar cholangiocarcinoma with arterial resection.

BACKGROUND: With the advances in multimodality treatment, an analysis of the outcome of arterial resections (AR) in surgery of cholangiocarcinoma is lacking. The aim of this meta-analysis was to summarize the currently available evidence onof AR for the treatment of cholangiocarcinoma. METHODS: A systematic literature search was carried out according to PRISMA guidelines. RESULTS: 10 retrospective cohort studies published from 2007 to 2020 with 2530 patients (408 AR group and 2122 control group) were identified. Higher in-hospital mortality rates (6.8% vs 3.3%, OR 2.65, 95% CI [1.27; 5.32], p = 0.009), higher morbidity rates (Clavien-Dindo classification ≥3 ) (52% vs 47%, OR 1.44, 95% CI [1.02; 1.75], p = 0.04) and lower 1-year, 3-year and 5-year survival rates (54% vs 69%, OR 0.55, 95% CI [0.34; 0.91 p = 0.02), (34% vs 38%, OR 0.74, 95% CI [0.55; 0.98, p = 0.03), (18% vs 29%, OR 0.54, 95% CI [0.39; 0.75, p = 0.0002) were observed in the AR group when compared to the control group. CONCLUSION: Evidence from non-randomized studies shows a higher morbidity and mortality and shorter long-term survival in patients undergoing AR. However, the results are prone to selection bias, and only randomized trials comparing AR and palliative treatments AR might reveal a possible benefit of AR. SYSTEMATIC REVIEW REGISTRATION: PROSPERO ID 223396.

[Improvement in the Quality of the OP Surgery Checklist by Optimisation of Content and Structural, as well as Measures to Promote Compliance]. / Verbesserung der Ausfüllqualität der OP-Sicherheits-Checkliste durch inhaltliche und strukturelle Optimierung sowie compliancefördernde Maßnahmen.

BACKGROUND: Complications occur in 3 to 16% of surgical procedures. According to experts, about 50% of these adverse events are avoidable. It is empirically proven that mortality and complication rates can be reduced by introducing checklists. MATERIAL AND METHOD: In this study, the quality of completion of the new checklist, which has already been used for several years, was compared with a checklist optimised by the Quality and Clinical Risk Management Department. The new surgical checklist was introduced at the beginning of January 2017 in a hospital providing primary and regular care. In addition, compliance-promoting measures (training, etc.) were carried out to encourage the use of the new checklist. RESULTS: A total of 293 surgical safety checklists each (pre and post) were evaluated. With the introduction of the new checklist for a total of 8 items, the quality of the surgical safety checklists consisting of 11 items improved. In the course of the implementation of the new surgical safety checklist, there was no item for which the quality of completion was reduced compared to the old list. CONCLUSION: It was proven that the introduction of these optimised surgical safety checklists in connection with compliance promoting measures resulted in a significantly improved quality of completion. However, in view of the literature on this topic, it can also be stated that the compliance-promoting measures made an important contribution to this result.

Surgery for Gastric Remnant Cancer Results in Similar Overall Survival Rates Compared with Primary Gastric Cancer: A Propensity Score-Matched Analysis.

BACKGROUND: The purpose of this study was to investigate clinical features, prognostic factors, and overall survival (OS) in surgical patients with gastric remnant cancer (GRC). METHODS: A retrospective analysis of patients with gastrectomy for pT1-4 gastric cancer between October 1972 and February 2014 at our institution was performed. Clinical characteristics were compared between patients with GRC and those with primary gastric cancer (PGC). Multivariable Cox regression analysis was performed to determine the prognostic factors for OS in patients with GRC. A propensity score-matched cohort was used to investigate OS between the GRC and PGC groups. RESULTS: Of a baseline cohort of 1440 patients, 95 patients with GRC were identified. Patients with GRC underwent more multivisceral resections (p < 0.001) than patients with PGC despite lower tumor stages (p = 0.018); however, R0 resection rates were not significantly different (p = 0.211). The postoperative overall (p = 0.032) and major surgical (p = 0.021) complication rates and the 30-day (p = 0.003) and in-hospital (p = 0.008) mortality rates were higher in patients with GRC. In multivariable analysis, the only prognostic factors for worse OS in GRC were higher tumor stage (p < 0.001) and the occurrence of postoperative complications (p < 0.001). OS between propensity score-matched GRC and PGC groups was not significantly different (p = 0.772). CONCLUSIONS: GRC required more invasive surgery than PGC; however, the feasibility of R0 resection was similar. The prognostic factors of GRC were similar to those of PGC, and OS was not significantly different between both groups. Patients with GRC benefit from extensive surgery when performed with low morbidity and mortality.

RACE-trial: neoadjuvant radiochemotherapy versus chemotherapy for patients with locally advanced, potentially resectable adenocarcinoma of the gastroesophageal junction - a randomized phase III joint study of the AIO, ARO and DGAV.

BACKGROUND: Despite obvious advances over the last decades, locally advanced adenocarcinomas of the gastroesophageal junction (GEJ) still carry a dismal prognosis with overall 5-year survival rates of less than 50% even when using modern optimized treatment protocols such as perioperative chemotherapy based on the FLOT regimen or radiochemotherapy. Therefore the question remains whether neoadjuvant chemotherapy or neoadjuvant radiochemotherapy is eliciting the best results in patients with GEJ cancer. Hence, an adequately powered multicentre trial comparing both therapeutic strategies is clearly warranted. METHODS: The RACE trial is a an investigator initiated multicenter, prospective, randomized, stratified phase III clinical trial and seeks to investigate the role of preoperative induction chemotherapy (2 cycles of FLOT: 5-FU, leucovorin, oxaliplatin, docetaxel) with subsequent preoperative radiochemotherapy (oxaliplatin weekly, 5-FU plus concurrent fractioned radiotherapy to a dose of 45 Gy) compared to preoperative chemotherapy alone (4 cycles of FLOT), both followed by resection and postoperative completion of chemotherapy (4 cycles of FLOT), in the treatment of locally advanced, potentially resectable adenocarcinoma of the gastroesophageal junction. Patients with cT3-4, any N, M0 or cT2 N+, M0 adenocarcinoma of the GEJ are eligible for inclusion. The RACE trial aims to enrol 340 patients to be allocated to both treatment arms in a 1:1 ratio stratified by tumour site. The primary endpoint of the trial is progression-free survival assessed with follow-up of maximum 60 months. Secondary endpoints include overall survival, R0 resection rate, number of harvested lymph nodes, site of tumour relapse, perioperative morbidity and mortality, safety and toxicity and quality of life. DISCUSSION: The RACE trial compares induction chemotherapy with FLOT followed by preoperative oxaliplatin and 5-Fluorouracil-based chemoradiation versus preoperative chemotherapy with FLOT alone, both followed by surgery and postoperative completion of FLOT chemotherapy in the treatment of locally advanced, non-metastatic adenocarcinoma of the GEJ. The trial aims to show superiority of the combined chemotherapy/radiochemotherapy treatment, assessed by progression-free survival, over perioperative chemotherapy alone. TRIAL REGISTRATION: ClinicalTrials.gov ; NCT04375605 ; Registered 4th May 2020.

Systematic review and meta-analysis of contemporary pancreas surgery with arterial resection.

OBJECTIVE: Advances in multimodality treatment paralleled increasing numbers of complex pancreatic procedures with major vascular resections. The aim of this meta-analysis was to evaluate the current outcomes of arterial resection (AR) in pancreatic surgery. METHODS: A systematic literature search was carried out from January 2011 until January 2020. MOOSE guidelines were followed. Predefined outcomes were morbidity, pancreatic fistula, postoperative bleeding and delayed gastric emptying, reoperation rate, mortality, hospital stay, R0 resection rate, and lymph node positivity. Duration of surgery, blood loss, and survival were also analyzed. RESULTS: Eight hundred and forty-one AR patients were identified in a cohort of 7111 patients. Morbidity and mortality rates in these patients were 66.8% and 5.3%, respectively. Seven studies (579 AR patients) were included in the meta-analysis. Overall morbidity (48% vs 39%, p = 0.1) and mortality (3.2% vs 1.5%, p = 0.27) were not significantly different in the groups with or without AR. R0 was less frequent in the AR group, both in patients without (69% vs 89%, p < 0.001) and with neoadjuvant treatment (50% vs 86%, p < 0.001). Weighted median survival was shorter in the AR group (18.6 vs 32 months, range 14.8-43.1 months, p = 0.037). CONCLUSIONS: Arterial resections increase the complexity of pancreatic surgery, as demonstrated by relevant morbidity and mortality rates. Careful patient selection and multidisciplinary planning remain important.

Preoperative Pazopanib in High-Risk Soft Tissue Sarcoma: Phase II Window-of Opportunity Study of the German Interdisciplinary Sarcoma Group (NOPASS/GISG-04).

BACKGROUND: Preoperative devascularization might improve local control and thus the outcome of patients with soft tissue sarcoma (STS). The multikinase inhibitor pazopanib has antiangiogenic effects and is approved for treating metastatic STS. We conducted a trial of preoperative pazopanib therapy in high-risk STS. METHODS: This single-arm, phase II trial included patients with resectable, non-metastatic, treatment-naïve, high-risk STS. Patients received pazopanib 800 mg daily while waiting for surgery (21-day 'window of opportunity'). The primary endpoint was metabolic response rate (MRR; proportion of patients with ≥ 50% reduction of mean standardized uptake value [SUVmean] in post- vs. pretreatment fluorodeoxyglucose-positron emission tomography/computed tomography [FDG-PET-CT]). Planned sample size was 35 patients (type I error, 5%; type II error, 20%). A translational substudy explored associations between response and concentration of circulating angiogenic factors. RESULTS: Futility analysis was performed after 21 patients (11 female, mean age 67 years; liposarcoma n = 15); 17/21 patients were evaluable for the primary endpoint. The MRR was 1/17 (5.9%, 95% confidence interval < 0.01-0.29). Mean change in SUVmean of post- versus pretreatment PET was a 6% decrease (range 65% decrease to 34% increase); 7/21 (33.3%) patients had 12 grade 3/4 toxicities, and 19/21 (95.2%) patients were resected (all R0). One (4.8%) patient suffered a grade 4 postoperative complication (anastomotic leakage). Circulating endothelial progenitor cells, soluble vascular endothelial growth factor, and angiopoietin-2 concentrations showed no relevant changes during treatment. CONCLUSIONS: Although this study showed that preoperative pazopanib is not effective for unselected high-risk STS patients, relevant treatment effects were observed in a single patient. Future research needs to better define subgroups potentially benefiting from preoperative pazopanib treatment. CLINICALTRIALS. GOV IDENTIFIER: NCT01543802.

Impact of routine completion angiography on outcome after carotid endarterectomy.

OBJECTIVE: The objective of this study was to analyze the impact of completion digital subtraction angiography (cDSA) after carotid endarterectomy (CEA) on technical and early clinical results. METHODS: This retrospective study included consecutive patients undergoing CEA from January 2011 to January 2015. Routine cDSA was performed in all patients. Study end points were the incidence of pathologic findings on completion angiography necessitating intraoperative revision, type of revision, periprocedural stroke rate, mortality, morbidity, and recurrent stenosis rate during follow-up (median, 5 months; range, 0-39 months). RESULTS: There were 827 procedures performed in 770 patients (male, 72.5%; median age, 70.6 years) with extracranial internal carotid artery (ICA) stenosis (asymptomatic, 57.3%); 426 patients underwent conventional endarterectomy (cCEA) with patch angioplasty (51.6%), 393 patients (47.5%) received an eversion technique (eCEA), and 8 patients (1%) underwent other revascularization. Immediate surgical revision based on angiographic findings after CEA was performed in 6.9% (57/827) of cases. Reasons for revision of the ICA were mural thrombus in 7.0% (4/57), dissections in 7.0% (4/57), residual stenosis in 8.7% (5/57), and intimal flaps of ICA in 1.8% (1/57). In six cases, combined pathologic changes of the ICA and external carotid artery led to revision. Thirty-five revisions (4.2%) were performed for isolated pathologic angiographic findings of the external carotid artery; in two cases, revision was performed for residual stenosis of the common carotid artery. There was no significant difference regarding the frequency of revision between surgical techniques (cCEA, 56.4%; eCEA, 63.6%; P = .76). However, mural thrombus as a reason for revision was more common in the cCEA group; plaque residues were more common in the eCEA group. Periprocedural (30-day) stroke rate was 0.5% (4/827); six additional patients suffered transient ischemic attack (0.7%). The mortality rate within 30 days was 0.1% (1/827); 30-day morbidity was 4.2% (35/827). The rate of recurrent stenosis (>50%) during follow-up was 0.8%. There was no significant correlation between pathologic findings on cDSA with consecutive revision and perioperative stroke rate, recurrent stenosis rate, mortality, or morbidity. CONCLUSIONS: In this study, cDSA after CEA detected findings leading to immediate intraoperative surgical revision in a relevant proportion of cases. Therefore, cDSA represents a reasonable quality control without being associated with significantly prolonged operating times. Whether cDSA reduces perioperative stroke rate, procedure-related mortality, morbidity, or incidence of early recurrent stenosis cannot be proven with the current study design.

Feasibility, acceptance, safety, and effectiveness of antibiotic therapy as alternative treatment approach to appendectomy in uncomplicated acute appendicitis.

PURPOSE: Based on results from randomized controlled trials, there is an increasing discussion if antibiotic treatment is an equivalent therapeutic approach to appendectomy in uncomplicated acute appendicitis. This observational prospective study evaluates its feasibility, safety, and effectiveness in clinical practice. METHODS: The study included all consecutive adults treated for acute appendicitis over an 18-month period in one hospital. Patients receiving antibiotics were compared to those treated surgically. Follow-up comprised 1 year. The primary endpoint was treatment success, defined as no secondary appendectomy during follow-up (antibiotic group) or successful appendectomy (primary surgical group). Secondary endpoints were complications, duration of hospital stay, pain intensity, and length of absence from work. RESULTS: 54/124 (43.6%) patients were primarily treated with antibiotics and 70/124 (56.4%) surgically. Treatment success at 1 year was 77.1% (95%-CI 62.8-88%) for antibiotic and 100% for surgical treatment. Complications were non-significantly less frequent both among all patients treated with antibiotics and among patients undergoing secondary appendectomy compared to patients undergoing primary appendectomy (20.8% vs. 27.1% and 9.1% vs. 27.1%). The initial hospital stay was significantly shorter in the antibiotic group (mean 3.6 vs. 4.8 days, median 3 days, p = 0.03). After 1 year, the cumulative hospital stay was not different between groups. CONCLUSIONS: Appendectomy remains the most effective treatment for the definitive cure of acute appendicitis. However, antibiotic therapy can be a safe alternative approach for selected patients with uncomplicated acute appendicitis. TRIAL REGISTRATION: DRKS00010401.

Antibiotic therapy for acute uncomplicated appendicitis: a systematic review and meta-analysis.

PURPOSE: Appendectomy has been the gold standard for every form of appendicitis. In recent years, though, it has repeatedly been claimed that for acute uncomplicated appendicitis, antibiotic therapy can be an equivalent treatment. The aim of this meta-analysis was to determine if antibiotic therapy is a safe and effective alternative to appendectomy for acute uncomplicated appendicitis. METHODS: In a systematic literature review, relevant databases were searched for randomized studies comparing appendectomy with antibiotic treatment for uncomplicated acute appendicitis. Two independent reviewers performed study selection and data extraction. The primary endpoint was the successful treatment of appendicitis. Secondary endpoints were pain intensity, duration of hospitalization, absence from work, and the incidence of complications. RESULTS: Five randomized controlled studies (n = 1430 patients) fulfilled the inclusion criteria. Of the 727 patients treated initially with antibiotics, 272 (37.4%) underwent secondary appendectomy within 1 year (treatment effectiveness: 62.6% compared to 96.3% in the surgical group, RR 0.65, 95% CI 0.55-0.76, p < 0.00001). Neither duration of hospital stay (MD 0.11 days, 95% CI: - 0.22-0.43, p = 0.53) nor the probability of complication-free treatment (RR 1.08, 95% CI: 0.97-1.22, p = 0.16) were significantly different between the two treatments. Absence from work was significantly shorter in the antibiotic group (MD - 2.49 days, 95% CI: - 4.59-- 0.40, p = 0.02). CONCLUSIONS: This meta-analysis shows that appendectomy is more effective than antibiotic therapy for definitive cure of acute uncomplicated appendicitis. However, since the incidence of complications does not differ between the two treatments, antibiotic therapy might be a reasonable alternative for selected patients.

Histopathological regression after neoadjuvant docetaxel, oxaliplatin, fluorouracil, and leucovorin versus epirubicin, cisplatin, and fluorouracil or capecitabine in patients with resectable gastric or gastro-oesophageal junction adenocarcinoma (FLOT4-AIO): results from the phase 2 part of a multicentre, open-label, randomised phase 2/3 trial.

BACKGROUND: Docetaxel-based chemotherapy is effective in metastatic gastric and gastro-oesophageal junction adenocarcinoma, but has not yet been evaluated in the context of resectable patients. Here we report findings from the phase 2 part of the phase 2/3 FLOT4 trial, which compared histopathological regression in patients treated with a docetaxel-based triplet chemotherapy versus an anthracycline-based triplet chemotherapy before surgical resection. METHODS: In this randomised, open-label, phase 2/3 study, eligible participants were recruited from 28 German oncology centres. Patients with resectable gastric or gastro-oesophageal junction cancer who had clinical stage cT2 or higher, nodal positive (cN+) disease, or both were randomly assigned (1:1) to either three preoperative and three postoperative 3-week cycles of intravenous epirubicin 50 mg/m2 on day 1, intravenous cisplatin 60 mg/m2 on day 1, and either fluorouracil 200 mg/m2 as continuous intravenous infusion or capecitabine 1250 mg/m2 orally (two doses of 625 mg/m2 per day) on days 1 to 21 (ECF/ECX group) or four preoperative and four postoperative 2-week cycles of docetaxel 50 mg/m2, intravenous oxaliplatin 85 mg/m2, intravenous leucovorin 200 mg/m2, and fluorouracil 2600 mg/m2 as a 24 h infusion, all on day 1 (FLOT group). Randomisation was done centrally with an interactive web-response system based on a sequence generated with blocks (block size 2) stratified by Eastern Cooperative Oncology Group performance status, location of primary tumour, age, and nodal status. No masking was done. Central assessment of pathological regression was done according to the Becker criteria. The primary endpoint was pathological complete regression (tumour regression grade TRG1a) and was analysed in the modified intention-to-treat population, defined as all patients who were randomly assigned to treatment excluding patients who had surgery but did not provide resection specimens for central evaluation. The study (including the phase 3 part) has completed enrolment, but follow-up is ongoing and this is an interim analysis. The trial is registered with ClinicalTrials.gov, number NCT01216644. FINDINGS: Between Aug 18, 2010, and Aug 10, 2012, 300 patients (152 patients in the ECF/ECX group; 148 patients in the FLOT group) were enrolled into the phase 2 part of the study, 265 of whom (137 in the ECF/ECX group; 128 in the FLOT group) were assessable on a modified intention-to-treat basis. 119 (93%) of 128 patients in the FLOT group and 126 (92%) of 137 patients in the ECF/ECX group were given all planned preoperative cycles of treatment. FLOT was associated with significantly higher proportions of patients achieving pathological complete regression than was ECF/ECX (20 [16%; 95% CI 10-23] of 128 patients vs eight [6%; 3-11] of 137 patients; p=0·02). 44 (40%) of 111 patients in the ECF/ECX group and 30 (25%) of 119 patients in the FLOT group had at least one serious adverse event involving a perioperative medical or surgical complication. The most common non-surgical grade 3-4 adverse events were neutropenia (52 [38%] of 137 patients in the ECF/ECX group vs 67 [52%] of 128 patients in the FLOT group), leucopenia (28 [20%] vs 36 [28%]), nausea (23 [17%] vs 12 [9%]), infection (16 [12%] vs 15 [12%]), fatigue (19 [14%] vs 11 [9%]), and vomiting (13 [10%] vs four [3%]). INTERPRETATION: Perioperative FLOT was active and feasible to administer, and might represent an option for patients with locally advanced, resectable gastric or gastro-eosophageal junction adenocarcinoma. FUNDING: None.

What is a clinical pathway? Refinement of an operational definition to identify clinical pathway studies for a Cochrane systematic review.

Clinical pathways (CPWs) are a common component in the quest to improve the quality of health. CPWs are used to reduce variation, improve quality of care, and maximize the outcomes for specific groups of patients. An ongoing challenge is the operationalization of a definition of CPW in healthcare. This may be attributable to both the differences in definition and a lack of conceptualization in the field of clinical pathways. This correspondence article describes a process of refinement of an operational definition for CPW research and proposes an operational definition for the future syntheses of CPWs literature. Following the approach proposed by Kinsman et al. (BMC Medicine 8(1):31, 2010) and Wieland et al. (Alternative Therapies in Health and Medicine 17(2):50, 2011), we used a four-stage process to generate a five criteria checklist for the definition of CPWs. We refined the operational definition, through consensus, merging two of the checklist's criteria, leading to a more inclusive criterion for accommodating CPW studies conducted in various healthcare settings. The following four criteria for CPW operational definition, derived from the refinement process described above, are (1) the intervention was a structured multidisciplinary plan of care; (2) the intervention was used to translate guidelines or evidence into local structures; (3) the intervention detailed the steps in a course of treatment or care in a plan, pathway, algorithm, guideline, protocol or other 'inventory of actions' (i.e. the intervention had time-frames or criteria-based progression); and (4) the intervention aimed to standardize care for a specific population. An intervention meeting all four criteria was considered to be a CPW. The development of operational definitions for complex interventions is a useful approach to appraise and synthesize evidence for policy development and quality improvement.

Combined radiation therapy and sunitinib for preoperative treatment of soft tissue sarcoma.

BACKGROUND: Antiangiogenic substances and radiation therapy (RT) may have synergistic effects and improve irradiation efficacy. We present a cohort study evaluating the toxicity of combined sunitinib and RT as neoadjuvant treatment of extremity and retroperitoneal soft tissue sarcoma (STS). METHODS: Sixteen patients with locally advanced extremity (6/16) or retroperitoneal (10/16) STS were treated with continuous-dosing sunitinib (15/16: 37.5 mg daily; 1/16: 25 mg daily) and standard RT (45-50.4 Gy) preoperatively. Surgery was scheduled 5-9 weeks following neoadjuvant treatment. The primary goal of the study was to determine combined treatment toxicity according to the Common Terminology Criteria for Adverse Events. Secondary goals were the evaluation of postoperative morbidity and treatment response. RESULTS: Eight of 16 patients developed grade 3, and one patient developed grade 4, hematological toxicity. One patient experienced grade 3 hand-foot syndrome. The most frequent treatment toxicities of any grade were hematological (15/16) or dermatological (9/16). Three patients had partial response, 11 had stable disease, and 2 had progressive disease according to Response Evaluation Criteria in Solid Tumors (RECIST). Fourteen of 16 patients underwent surgery; tumors were not removed in two patients because of patient refusal or intercurrent metastatic disease. The proportion of tumor necrosis exceeded 90 % in 5 of 14 patients, and 4 patients had postoperative complications requiring reintervention. CONCLUSIONS: Preoperative treatment with concurrent sunitinib and RT was tolerable, and postoperative morbidity did not increase. Combined treatment with RT and sunitinib was also feasible in patients with retroperitoneal STS, and warrants further investigation.

Functional outcomes and quality of life after proximal gastrectomy with esophagogastrostomy using a narrow gastric conduit.

BACKGROUND: The best surgical approach for tumors of the proximal stomach remains controversial. For proximal gastrectomy (PG), the evidence regarding quality of life (QoL) and functional outcomes is controversial. Moreover, there are limited data from non-Asian settings. METHODS: All patients who underwent PG from September 2005 to July 2013 were identified from an institutional database. Demographic, perioperative and pathologic characteristics were retrieved. Symptom scores (0 = best/4 = worst) for reflux symptoms, dysphagia and validated QoL metrics (FACT scale, where a higher score is better) were assessed during early and late follow-up. Eligible patients for analysis were those with no evidence of recurrence. RESULTS: Of 465 upper gastrointestinal cancer resections, 50 were PG for adenocarcinoma (42; 84%), neuroendocrine carcinoma (5; 10%) or other pathologies (3; 6%). R0 resection was achieved in 44 (89.8%) of 49 patients with malignant tumors. Median lymph node collection was 32 (range 7-57). QoL scores did not differ from preoperative to early follow-up but increased compared to both at late follow-up [preoperative, 125 (interquartile range 105-140); early follow-up, 122.5 (97-142); late follow-up, 147 (132-159); p < 0.05]. At early and late follow-up, 9 (21.4%) of 42 and 10 (33.3%) of 30 patients reported reflux symptoms, but most were mild. Endoscopic signs of esophagitis were found in 7 (29%) of 24 patients, but only two of these reported reflux symptoms. Conversely only three of eight patients with reflux symptoms had esophagitis on endoscopy. CONCLUSIONS: Global QoL is not reduced early after PG, and increases compared to baseline at late follow-up. Although reflux symptoms are reported by a quarter of patients, most are mild, and there is little correlation with esophagitis. PG should remain a viable option in the management of proximal gastric tumors.

Multivisceral Oncological Resections Involving the Pancreas: Protocol for a Systematic Review and Meta-Analysis.

BACKGROUND: With the continuous advancement of cancer treatments, a comprehensive analysis of the impact of multivisceral oncological pancreatic resections on morbidity, mortality, and long-term survival is currently lacking. OBJECTIVE: This manuscript presents the protocol for a systematic review and meta-analysis designed to summarize the existing evidence concerning the outcomes of multivisceral oncological pancreatic resections across diverse tumor entities. METHODS: We will conduct a systematic search of the PubMed or MEDLINE, Embase, Cochrane Library, CINAHL, and ClinicalTrials.gov databases in strict accordance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. The predefined outcomes encompass postoperative mortality, postoperative morbidity, overall and disease-free survival (1- to 5-year survival rates), the proportion of macroscopically complete (R0) resections (according to the Royal College of Pathologists definition), duration of hospital stay (in days), reoperation rate (%), postoperative complications (covering all complications according to the Clavien-Dindo classification), as well as pancreatic fistula, postpancreatectomy hemorrhage, and delayed gastric emptying (all according to the definitions of the International Study Group of Pancreas Surgery). RESULTS: Systematic database searches will begin in July 2024. The completion of the meta-analysis is anticipated by December 2024. Before completion, the literature search will be checked for new publications that must be considered in the context of the work. CONCLUSIONS: The forthcoming findings will provide an up-to-date overview of the feasibility, safety, and oncological efficacy of multivisceral pancreatic resections across diverse tumor entities. This data will serve as a valuable resource for health care professionals and patients to make well-informed clinical decisions. TRIAL REGISTRATION: PROSPERO CRD42023437858; https://tinyurl.com/bde5xmfw. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/54089.

Approaches for the treatment of perforated peptic ulcers: a network meta-analysis of randomised controlled trials - study protocol.

INTRODUCTION: Perforated peptic ulcers are a life-threatening complication associated with high morbidity and mortality. Several treatment approaches are available. The aim of this network meta-analysis (NMA) is to compare surgical and alternative approaches for the treatment of perforated peptic ulcers regarding mortality and other patient-relevant outcomes. METHODS AND ANALYSIS: A systematic literature search of PubMed/MEDLINE, Cochrane Library, Embase, CINAHL, ClinicalTrials.gov trial registry and ICTRP will be conducted with predefined search terms.To address the question of the most effective treatment approach, an NMA will be performed for each of the outcomes mentioned above. A closed network of interventions is expected. The standardised mean difference with its 95% CI will be used as the effect measure for the continuous outcomes, and the ORs with 95% CI will be calculated for the binary outcomes. ETHICS AND DISSEMINATION: In accordance with the nature of the data used in this meta-analysis, which involves aggregate information from previously published studies ethical approval is deemed unnecessary. Results will be disseminated directly to decision-makers (eg, surgeons, gastroenterologists) through publication in peer-reviewed journals and presentation at conferences. PROSPERO REGISTRATION NUMBER: CRD42023482932.