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.

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.

Treatment of esophageal leakages with the Microtech®-VAC-Stent: a monocentric early experience of three cases.

Background: Endoscopic approaches in the treatment of transmural esophageal defects, either after esophageal resection or due to perforation, have demonstrated convincing feasibility. Surgical options are limited and associated with high morbidity and mortality rates. Currently, internal endoscopic drainage with pigtail stents, self-expanding metal stent (SEMS), or endoscopic vacuum therapy (EVT) are options for first-line treatment. Here, we report the outcome of the recently developed combination of SEMS and EVT using the endoscopic Microtech®-VAC-Stent (EVS). Methods: Between June and July 2022, three consecutive patients (one female and two males) with esophageal transmural defects were treated with the Microtech®-VAC-Stent. Two patients suffered from an anastomotic leak after oncologic gastroesophageal surgery, and one patient presented with esophageal perforation due to Boerhaave syndrome. Results: Three consecutive patients were successfully treated with EVS. In one patient, one EVS treatment was sufficient, whereas the other two patients needed two and six EVS exchanges. Exchanges were scheduled every 7 days and no procedural adverse events were observed. Conclusion: In line with the former case series, EVS therapy is a promising new approach for the treatment of esophageal leaks. Exchange of the EVS seems feasible every 7 days reducing interventions for the individual patient. Prospective studies comparing EVS with other endoscopic therapies are needed to define the best therapeutic approach.

A Systematic Review and Meta-Analysis of Surgery for Retroperitoneal Sarcoma With Vascular Resection.

This meta-analysis examines the outcomes of patients undergoing surgery with vascular resection for retroperitoneal sarcoma. A systematic literature search based on Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines was conducted, identifying five comparative retrospective cohort studies published from 2015 to 2021, with a total of 1,417 patients (180 in the vascular resection (VR) group and 1,237 in the control (no VR) group). The meta-analysis found that 30-day morbidity rates, as classified by Clavien-Dindo classification > 3, were higher in the VR group compared to the no VR group (46% versus 25%, odds ratio (OR): 1.84, 95% confidence interval (CI): 0.39-8.69, p=0.44). Local recurrence rates during the follow-up period were similar between the two groups (30% versus 30%, OR: 1.46, 95% CI: 0.50-4.25, p=0.49). However, distant recurrence was more frequent in the VR group (32% versus 8.5%, OR: 2.54, 95% CI: 1.05-6.13, p=0.04). In conclusion, although oncovascular procedures are feasible for patients with retroperitoneal sarcomas, the long-term outcomes appear to be worse when compared to procedures that do not involve vessel resections.

Surgical Treatment of Gastrointestinal Cancers.

Even though there have been remarkable advances in systemic treatment of gastrointestinal malignancies over the last few decades, in the vast majority of instances, surgery remains the sole therapeutic approach offering a chance for a definite cure [...].

Single-Center Retrospective Subgroup Analysis of "Primary Aortic" (Aneurysm, Aortic Dissection, PAU) and "Secondary Aortic" (Iatrogenic, Trauma, Aortoesophageal Fistula) Indications for Emergency TEVAR.

BACKGROUND: The aim of this study was to analyze the outcome of emergency thoracic endovascular aortic repair (TEVAR) in the treatment of "primary aortic" (aneurysm, aortic dissection, penetrating aortic ulcer (PAU)) and "secondary aortic" (iatrogenic, trauma, and aortoesophageal fistula) pathologies. METHODS: Retrospective review of a cohort of patients treated at a single tertiary referral center from 2015 to 2021. The primary end point was postoperative in-hospital mortality. Secondary end points were the duration of the procedure, duration of postoperative intensive care treatment, length of hospital stay, and the nature and severity of postoperative complications according to the Dindo-Clavien classification. RESULTS: A total of 34 patients underwent TEVAR for emergency indications. Twenty-two patients were treated for primary and twelve patients for secondary aortic pathologies. Concerning in-hospital mortality, no statistically significant difference could be observed between the primary and secondary aortic groups (27.3% vs. 33.3%, p = 0.711). Patients with an aortoesophageal fistula had a mortality rate of 66.7%. Postoperative morbidity (Dindo-Clavien > 3) was also not statistically significantly different between the primary and secondary aortic groups (36.4% vs. 33.3%, p = 0.86). Preoperative hemoglobin level (p < 0.001 for mortality, p = 0.002 for morbidity), hemoglobin level difference (p = 0.022, p = 0.032), postoperative creatinine level (p = 0.009, p = 0.035), and pre- and postoperative lactate levels (p < 0.001 for both mortality and morbidity) were found to be independent factors associated with postoperative mortality and morbidity (Dindo-Clavien > 3), respectively. The preoperative creatinine level was found to be associated with mortality (p = 0.024) but not morbidity. CONCLUSIONS: Morbidity and in-hospital mortality are still considerable after emergency TEVAR for both primary and secondary aortic indications. Pre- and postoperative levels of hemoglobin, creatinine, and lactate may be valuable to predict patient outcomes.

Endovascular and open repair of visceral aneurysms: A retrospective single­center analysis.

The aim of the present study was to analyze the outcome of open surgical and endovascular interventions for the treatment of visceral aneurysms. A retrospective review of a cohort of visceral aneurysm patients treated at a single tertiary referral center was conducted. STROBE guidelines were followed. The primary endpoint was postoperative in-hospital mortality. Secondary endpoints were major morbidity (Dindo-Clavien score, >3), the duration of the procedure, technical success and the length of hospital stay. As a result, 12 patients underwent open or endovascular surgery. No 30-day mortality or major morbidity were observed. The median aneurysm diameter was 2.0 cm (range, 1.5-5.0 cm). The median postoperative stay was four days for all procedures and significantly longer after open surgery compared with endovascular repair (ER) (7 vs. 3 days). Overall, the evidence from the present retrospective analysis shows no mortality and a shorter length of stay for patients undergoing ER for the treatment of a visceral aneurysm (VAA). Although the results are in line with the fact that ER is considered to be the first line treatment for VAA, this may be prone to selection bias.

Is it feasible and ethical to randomize patients between surgery and non-surgical treatments for gastrointestinal cancers?

Background: In several settings in the treatment of gastrointestinal cancers, it is unclear if the addition of surgery to a multimodal treatment strategy, or in some circumstances its omission, lead to a better outcome for patients. In such situations of clinical equipoise, high-quality evidence from randomised-controlled trials is needed to decide which treatment approach is preferable. Objective: In this article, we outline the importance of randomised trials comparing surgery with non-surgical therapies for specific scenarios in the treatment of gastrointestinal cancers. We explain the difficulties and solutions of designing these trials and recruiting patients in this context. Methods: We performed a selective review based on a not systematic literature search in core databases, supplemented by browsing health information journals and citation searching. Only articles in English were selected. Based on this search, we discuss the results and methodological characteristics of several trials which randomised patients with gastrointestinal cancers between surgery and non-surgical treatments, highlighting their differences, advantages, and limitations. Results and conclusions: Innovative and effective cancer treatment requires randomised trials, also comparing surgery and non-surgical treatments for defined scenarios in the treatment of gastrointestinal malignancies. Nevertheless, potential obstacles to designing and carrying out these trials must be recognised ahead of time to avoid problems before or during the trial.

Fibroblast Activation Protein Overexpression in Gastrointestinal Tumors: Protocol for a Systematic Review and Meta-analysis.

BACKGROUND: A hallmark of gastrointestinal cancer, especially pancreatic cancer, is the dense stromal tumor microenvironment in which cancer-associated fibroblasts (CAFs) represent the major stromal cell type. Preclinical studies have demonstrated that depletion of fibroblast activation protein (FAP)-positive CAFs results in increased survival. OBJECTIVE: We present the protocol for a systematic review and meta-analysis that aim to assess the currently available evidence on the effect of FAP expression on survival and clinical characteristics in gastrointestinal cancers. METHODS: The literature search and data analysis will be conducted in accordance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) 2020 statement. The databases PubMed/MEDLINE, Web of Science Core Collection, Cochrane Library, and ClinicalTrials.gov will be searched via their respective online search engines. A meta-analysis comparing patients with and without FAP overexpression with the following outcomes will be performed: postoperative survival (overall and median survival; 1-, 2-, 3-, and 5-year survival rates), histological differentiation (grading), local tumor invasion, lymph node metastases, and distant metastases. Odds ratios will be calculated for binary data, and weighted mean differences and relative SD differences will be determined for continuous data. The 95% CI, heterogeneity measures, and statistical significance will be reported for each outcome. The chi-square and Kruskal-Wallis tests will be used to evaluate statistical significance. A P value of <.05 will be considered statistically significant. RESULTS: Database searches will commence in April 2023. The meta-analysis will be completed by December 2023. CONCLUSIONS: In recent years, several publications on FAP overexpression in gastrointestinal tumors have been published. The only published meta-analysis on this topic dates to 2015. It included 15 studies on various solid tumors and only 8 studies focusing exclusively on gastrointestinal tumors. The expected results of the present analysis will provide new evidence on the prognostic value of FAP in gastrointestinal tumors and thereby support health care professionals and patients in their decision-making. TRIAL REGISTRATION: PROSPERO CRD42022372194; https://tinyurl.com/352ae8b8. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/45176.

Visceral Aneurysms: Systematic Review and Meta-analysis of Endovascular Versus Open Repair.

SYSTEMATIC REVIEW REGISTRATION: PROSPERO ID 348699.

Association of Tumor Volumetry with Postoperative Outcomes for Cervical Paraganglioma.

Objectives: To analyze the association of tumor volume with outcome after surgery for cervical paraganglioma. Materials and Methods: This retrospective study included consecutive patients undergoing surgery for cervical paraganglioma from 2009-2020. Outcomes were 30-day morbidity, mortality, cranial nerve injury, and stroke. Preoperative CT/MRI was used for tumor volumetry. An association between the volume and the outcomes was explored in univariate and multivariable analyses. A receiver operating characteristic (ROC) curve was plotted, and the area under the curve (AUC) was calculated. The study was conducted and reported according to the STROBE statement. Results: Volumetry was successful in 37/47 (78.8%) of included patients. A 30-day morbidity occurred in 13/47 (27.6%) patients with no mortality. Fifteen cranial nerve lesions occurred in eleven patients. The mean tumor volume was 6.92 cm3 in patients without and 15.89 cm3 in patients with complications (p = 0.035) and 7.64 cm3 in patients without and 16.28 cm3 in patients with cranial nerve injury (p = 0.05). Neither the volume nor Shamblin grade was significantly associated with complications on multivariable analysis. The AUC was 0.691, indicating a poor to fair performance of volumetry in predicting postoperative complications. Conclusions: Surgery for cervical paraganglioma bears a relevant morbidity with a particular risk of cranial nerve lesions. Tumor volume is associated with morbidity, and MRI/CT volumetry can be used for risk stratification.

Postoperative Sigmoidoscopy and Biopsy After Elective Endovascular and Open Aortic Surgery for Preventing Mortality by Colonic Ischemia (PSB-Aorta-CI): Protocol for a Prospective Study.

BACKGROUND: Endovascular aortic repair is considered the standard procedure in treating patients diagnosed with pathologies of the abdominal aorta with suitable anatomy. Open surgery remains an option mostly for patients not suitable for endovascular surgery. Colonic ischemia is an important and life-threatening postoperative complication of these procedures. OBJECTIVE: The aim of this study is to evaluate the clinical value and safety of performing a planned sigmoidoscopy and biopsy for detection of colonic ischemia in patients undergoing elective aortic surgery. We also aim to develop prediction scores which could identify patients at risk for colonic ischemia and facilitate their timely treatment. METHODS: The trial is designed as a prospective study. The decision for aortic surgery and eligibility for these procedures will be ascertained according to current guidelines. Afterward, screening of the patient for the remaining inclusion and exclusion criteria will occur. If eligibility for study inclusion is confirmed, the patient will be informed about the aims of the study and all study-specific procedures (sigmoidoscopy and biopsy) and asked to provide informed consent. RESULTS: The primary end point is the proportion of patients diagnosed endoscopically with subclinical and clinically relevant colonic ischemia among all patients undergoing aortic surgery. Patient recruitment started on June 2021. The final patient is expected to be treated by the end of June 2023. Institutional Review Board review has been completed at the University of Halle (Saale; reference #052-2021). CONCLUSIONS: this shows that sigmoidoscopy can be performed safely and is effective for the timely diagnosis of colonic ischemia in these patients, this could result in its routine implementation in both elective and emergency settings. TRIAL REGISTRATION: German Clinical Trials Register DRKS00025587; https://www.drks.de/drks_web/navigate.do?navigationId =trial.HTML&TRIAL_ID=DRKS00025587. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/39071.

Open Surgical Thrombendarterectomy Versus Endovascular Treatment in Occlusive Processes of the Femoral Artery Bifurcation.

BACKGROUND: The standard treatment of occlusive processes of the femoral artery bifurcation is thrombendarterectomy (TEA). Endovascular techniques (ENDO) have recently been put forward as a potential alternative. It is unclear so far which modality yields better outcomes with respect to long-term revascularization and periprocedural complications. Method: Multiple databases were systematically searched for pertinent publications (publication date November 1965 to February 2022). From the included studies, individual patient data (IPD) were requested. Aggregate data (AD) were used when no IPD were available. Primary and secondary patency (PP and SP), perioperative morbidity/mortality, and further endpoints were determined separately for TEA and ENDO and compared with each other. AD for each modality were summarized in meta-analyses. Time-to-event analyses and comparative meta-analyses with PP as primary endpoint were carried out using IPD. Results: 42 studies (3 IPD, 39 AD; 27 TEA, 12 ENDO, 3 comparisons of TEA versus ENDO) were included. In the combined meta-analysis of IPD and AD, PP for TEA was 97% at 6 months and 92% at 12 months, while PP for ENDO was 84% at 6 months and 85% at 12 months. The differences were not statistically significant. The comparative meta-analysis regarding PP did not reveal any significant differences either (TEA versus ENDO: HR 0.30 [0.06; 1.48]). SP at 12 months was 97% (TEA) and 93% (ENDO). The periprocedural morbidity was 16% for TEA and 9% for ENDO. Conclusion: In light of a higher PP, even without formal statistical proof of superiority, TEA can still be considered the standard treatment for occlusive processes of the femoral artery bifurcation. METHODS: Multiple databases were systematically searched for pertinent publications (publication date November 1965 to February 2022). From the included studies, individual patient data (IPD) were requested. Aggregate data (AD) were used when no IPD were available. Primary and secondary patency (PP and SP), perioperative morbidity/mortality, and further endpoints were determined separately for TEA and ENDO and compared with each other. AD for each modality were summarized in meta-analyses. Time-to-event analyses and comparative meta-analyses with PP as primary endpoint were carried out using IPD. RESULTS: 42 studies (3 IPD, 39 AD; 27 TEA, 12 ENDO, 3 comparisons of TEA versus ENDO) were included. In the combined meta-analysis of IPD and AD, PP for TEA was 97% at 6 months and 92% at 12 months, while PP for ENDO was 84% at 6 months and 85% at 12 months. The differences were not statistically significant. The comparative meta-analysis regarding PP did not reveal any significant differences either (TEA versus ENDO: HR 0.30 [0.06; 1.48]). SP at 12 months was 97% (TEA) and 93% (ENDO). The periprocedural morbidity was 16% for TEA and 9% for ENDO. CONCLUSION: In light of a higher PP, even without formal statistical proof of superiority, TEA can still be considered the standard treatment for occlusive processes of the femoral artery bifurcation.

Comparison of percutaneous and cutdown access­related minor complications after endovascular aortic repair.

The aim of the present study was to compare the open surgical and percutaneous access for thoracic/endovascular aortic repair (T/EVAR) regarding in-hospital and post-hospital minor-complications. Percutaneous (pEVAR) and cutdown (cEVAR) techniques for femoral vessel access for T/EVAR were compared regarding their minor complications. The basic population of this retrospective cohort study consisted of 44 percutaneous and 215 cutdown accesses for endovascular aortic repair (T/EVAR-procedure) conducted between August 2008 and October 2019. The primary outcome consisted of conservatively treatable minor complications until hospital discharge and during follow up. Secondary outcomes comprised postoperative pain and complications requiring invasive treatment. Minor complications were observed in 11.4% (pEVAR) vs. 9% (cEVAR) of cases throughout index hospital stay and 10 vs. 13.7% during follow-up. No significant differences were noticed regarding overall complication rate between pEVAR and cEVAR. Only bleedings treatable through compression occurred significantly more often in the pEVAR-group (6.8 vs. 0.5%; P=0.02). In conclusions, the percutaneous technique represents a safe and quickly executable alternative to cutdown access. A significant difference in overall minor complications could not be observed. In both techniques, complications may occur even months after surgery. In order to demonstrate the superiority of the percutaneous technique compared with cutdown access, possible predictors for the use of the percutaneous technique should be defined in the future.

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.