Recurrent aneurysmatic bleeding of pancreaticoduodenal aneurysm due to median arcuate ligament syndrome: a case report.

Median arcuate ligament syndrome (MALS) involves coeliac artery compression, causing a range of symptoms from chronic pain to life-threatening complications. This case features a 52-year-old patient with recurrent retroperitoneal bleeding from MALS-related inferior pancreaticoduodenal artery aneurysms (PDAAs). Emergency interventions, including surgical bleeding control, angioplasty, percutaneous drainage, and median arcuate ligament release, were conducted. The case highlights challenges in diagnosing and managing MALS-related PDAA, emphasizing the importance of early identification and tailored interventions based on clinical symptoms and imaging. Surgical intervention to release the ligament is the primary treatment, with considerations for prophylactic intervention in PDAA cases. Lack of established PDAA management protocols underscores the need for prompt intervention to prevent complications. In conclusion, this report stresses the association between MALS and PDAA, advocating for early identification and tailored management to mitigate complications.

A machine learning predictive model for recurrence of resected distal cholangiocarcinoma: Development and validation of predictive model using artificial intelligence.

INTRODUCTION: Distal Cholangiocarcinoma (dCCA) represents a challenge in hepatobiliary oncology, that requires nuanced post-resection prognostic modeling. Conventional staging criteria may oversimplify dCCA complexities, prompting the exploration of novel prognostic factors and methodologies, including machine learning algorithms. This study aims to develop a machine learning predictive model for recurrence after resected dCCA. MATERIAL AND METHODS: This retrospective multicentric observational study included patients with dCCA from 13 international centers who underwent curative pancreaticoduodenectomy (PD). A LASSO-regularized Cox regression model was used to feature selection, examine the path of the coefficient and create a model to predict recurrence. Internal and external validation and model performance were assessed using the C-index score. Additionally, a web application was developed to enhance the clinical use of the algorithm. RESULTS: Among 654 patients, LNR (Lymph Node Ratio) 15, neural invasion, N stage, surgical radicality, and differentiation grade emerged as significant predictors of disease-free survival (DFS). The model showed the best discrimination capacity with a C-index value of 0.8 (CI 95 %, 0.77%-0.86 %) and highlighted LNR15 as the most influential factor. Internal and external validations showed the model's robustness and discriminative ability with an Area Under the Curve of 92.4 % (95 % CI, 88.2%-94.4 %) and 91.5 % (95 % CI, 88.4%-93.5 %), respectively. The predictive model is available at https://imim.shinyapps.io/LassoCholangioca/. CONCLUSIONS: This study pioneers the integration of machine learning into prognostic modeling for dCCA, yielding a robust predictive model for DFS following PD. The tool can provide information to both patients and healthcare providers, enhancing tailored treatments and follow-up.

Cecal volvolus herniation through the Winslow Foramen: a case report and literature review of surgical management.

Both cecal volvolus and Winslow hernia are rare clinical presentations accounting for 1-1.5 and 0.08% of bowel obstructions. The combination of the two phenomena has been described so far in 13 case reports. Our patient underwent laparotomy with lesser Sac opening, manual hernia reduction, right hemicolectomy and partial Foramen closure with two simple stitches of PDS 4.0. Due to the scarcity of literature guidelines are not available, the intraoperative state of the tissues and the likelihood of a hernia recurrence play a decisive role in surgical management.

A Predictive Noninvasive Single-Nucleotide Variation-Based Biomarker Signature for Resectable Pancreatic Cancer: Protocol for a Prospective Validation Study.

BACKGROUND: Single-nucleotide variations (SNVs; formerly SNPs) are inherited genetic variants that can be easily determined in routine clinical practice using a simple blood or saliva test. SNVs have potential to serve as noninvasive biomarkers for predicting cancer-specific patient outcomes after resection of pancreatic ductal adenocarcinoma (PDAC). Two recent analyses led to the identification and validation of three SNVs in the CD44 and CHI3L2 genes (rs187115, rs353630, and rs684559), which can be used as predictive biomarkers to help select patients most likely to benefit from pancreatic resection. These variants were associated with an over 2-fold increased risk for tumor-related death in three independent PDAC study cohorts from Europe and the United States, including The Cancer Genome Atlas cohorts (reaching a P value of 1×10-8). However, these analyses were limited by the inherent biases of a retrospective study design, such as selection and publication biases, thereby limiting the clinical use of these promising biomarkers in guiding PDAC therapy. OBJECTIVE: To overcome the limitations of previous retrospectively designed studies and translate the findings into clinical practice, we aim to validate the association of the identified SNVs with survival in a controlled setting using a prospective cohort of patients with PDAC following pancreatic resection. METHODS: All patients with PDAC who will undergo pancreatic resection at three participating hospitals in Switzerland and fulfill the inclusion criteria will be included in the study consecutively. The SNV genotypes will be determined using standard genotyping techniques from patient blood samples. For each genotyped locus, log-rank and Cox multivariate regression tests will be performed, accounting for the relevant covariates American Joint Committee on Cancer stage and resection status. Clinical follow-up data will be collected for at least 3 years. Sample size calculation resulted in a required sample of 150 patients to sufficiently power the analysis. RESULTS: The follow-up data collection started in August 2019 and the estimated end of data collection will be in May 2027. The study is still recruiting participants and 142 patients have been recruited as of November 2023. The DNA extraction and genotyping of the SNVs will be performed after inclusion of the last patient. Since no SNV genotypes have been determined, no data analysis has been performed to date. The results are expected to be published in 2027. CONCLUSIONS: This is the first prospective study of the CD44 and CHI3L2 SNV-based biomarker signature in PDAC. A prospective validation of this signature would enable its clinical use as a noninvasive predictive biomarker of survival after pancreatic resection that is readily available at the time of diagnosis and can assist in guiding PDAC therapy. The results of this study may help to individualize treatment decisions and potentially improve patient outcomes. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/54042.

Liver regeneration after portal and hepatic vein embolization improves overall survival compared with portal vein embolization alone: mid-term survival analysis of the multicentre DRAGON 0 cohort.

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.

Applying augmented reality in teaching of surgical residents-telementoring, a "stress-free" way to surgical autonomy?

BACKGROUND: Achieving surgical autonomy can be considered the ultimate goal of surgical training. Innovative head-mounted augmented reality (AR) devices enable visualization of the operating field and teaching from remote. Therefore, utilization of AR glasses may be a novel approach to achieve autonomy. The aim of this pilot study is to analyze the feasibility of AR application in surgical training and to assess its impact on intraoperative stress. METHODS: A head-mounted RealWear Navigator® 500 glasses and the TeamViewer software were used. Initial "dry lab" testing of AR glasses was performed in combination with the Symbionix LAP Mentor™. Subsequently, residents performed various stage-adapted surgical procedures semi-autonomously (SA) (on-demand consultation of senior surgeon, who is in theatre but not scrubbed) versus permanent remote supervision (senior surgeon not present) via augmented reality (AR) glasses, worn by the resident in theatre. Stress was measured by intraoperative heart rate (Polar® pulse belt) and State-Trait Anxiety Inventory (STAI) questionnaire. RESULTS: After "dry lab" testing, N = 5 senior residents performed equally N = 25 procedures SA and with AR glasses. For both, open and laparoscopic procedure AR remote assistance showed satisfactory applicability. Utilization of AR significantly reduced intraoperative peak pulse rate from 131 to 119 bpm (p = 0.004), as compared with the semi-autonomous group. Likewise, subjectively perceived stress according to STAI was significantly lower in the AR group (p = 0.011). CONCLUSION: AR can be applied in surgical training and may help to reduce stress in theatre. In the future, AR has a huge potential to become a stepping stone to surgical autonomy.

How Is the Spectrum of Sarcoma Surgery Assessed?

PURPOSE: To meet the challenges of the precision medicine era, quality assessment of shared sarcoma care becomes pivotal. The MDT approach is the most important parameter for a successful outcome. Of all MDT disciplines, surgery is the key step to rendering sarcoma patients disease free; therefore, defining its spectrum is critical. To the best of the authors' knowledge, a comprehensive interoperable digital platform to assess the scope of sarcoma surgery in its full complexity is lacking. METHODS: An interoperable digital platform on sarcoma surgery has been created to assess the clinical exposure, tumor characteristics, and surgical settings and techniques applied for both resections and reconstructions of sarcomas. RESULTS: The surgical exposure of an individual surgeon over time served as a pilot. Over the study period of 10 years, there were 723 sarcoma board/MDT meetings discussing 3130 patients. A total of 1094 patients underwent 1250 surgical interventions on mesenchymal tumors by one single sarcoma surgeon. These included 615 deep soft tissue tumors (197 benign, 102 intermediate, 281 malignant, 27 simulator, 7 metastasis, 1 blood); 116 superficial soft tissue tumors (45 benign, 12 intermediate, 40 malignant, 18 simulator, 1 blood); and 519 bone tumors (129 benign, 112 intermediate, 182 malignant, 18 simulator, 46 metastasis, 14 blood, and 18 sequelae of first treatment). Detailed types of resections and reconstructions were analyzed. CONCLUSIONS: An interoperable digital data platform on sarcoma surgery with transparent real-time descriptive analytics is feasible and enables large-scale definition of the spectrum of sarcoma surgery to meet the challenges of sarcoma precision care in the future.

Definition of the Surgical Case Complexity in the Treatment of Soft Tissue Tumors of the Extremities and Trunk.

BACKGROUND: We intend to establish a complexity score for soft tissue tumor surgeries to compare the complexities of different soft tissue tumor surgeries and to ultimately assign affected patients to appropriate treatments. METHODS: We developed a soft tissue tumor complexity score (STS-SCS) based on three pillars: in addition to patient-related factors, tumor biology and surgery-associated parameters were taken into account. The STS-SCS was applied to our sampling group of 711 patients. RESULTS: The minimum STS-SCS was 4, the maximum score was 34 and the average score 11.4 ± 5.9. The scores of patients with malignant diagnoses were notably higher and more widely scattered than those of patients with benign or intermediate malignant tumors. To better categorize the complexities of individual surgeries, we established four categories using the collected data as a reference dataset. Each of the categories contained approximately one-quarter of the registered patients. DISCUSSION: The STS-SCS allows soft tissue tumor surgeries to be retrospectively evaluated for their complexity and forms the basis for the creation of a prospective concept to provide patients with the right intervention in the right geographic location, which can lead to better results and provision of the most cost-effective overall treatment.

Prehabilitation in patients undergoing colorectal surgery fails to confer reduction in overall morbidity: results of a single-center, blinded, randomized controlled trial.

BACKGROUND: Currently, there are solely weak recommendations in the enhanced recovery after surgery (ERAS) protocol regarding the role of preoperative physical activity and prehabilitation in patients undergoing colorectal surgery. Studies in heterogenous groups showed contradictory results regarding the impact of prehabilitation on the reduction of postoperative complications. The aim of this study was to assess the impact of prehabilitation on postoperative complications in patients undergoing colorectal surgery within an ERAS protocol. METHODS: Between July 2016 and June 2019, a single-center, blinded, randomized controlled trial designed to test whether physiotherapeutic prehabilitation vs. normal physical activities prior to colorectal surgery may decrease morbidity within a stringent ERAS protocol was carried out. The primary endpoint was postoperative complications assessed by Comprehensive Complications Index (CCI®). Primary and secondary endpoints for both groups were analyzed and compared. RESULTS: A total of 107 patients (54 in the prehabilitation enhanced recovery after colorectal surgery [pERACS] group and 53 in the control group) were included in the study and randomized. Dropout rate was 4.5% (n = 5). Baseline characteristics were comparable between the pERACS and control groups. The percentage of colorectal adenocarcinoma was low in both groups (pERACS 32% vs. control 23%, p = 0.384). Almost all patients underwent minimally invasive surgery in both groups (96% vs. 98%, p = 1.000). There was no between-group difference in the primary outcome, as the mean CCI at 30-day postoperative in the pERACS group was 18 (SD 0-43) compared to 15 (SD 0-49) in the control group (p = 0.059). Secondary outcome as complications assessed according to Clavien-Dindo, length of hospital stay, reoperation rate, and mortality showed no difference between both groups. CONCLUSIONS: Routine physiotherapeutic prehabilitation has no additional benefit for patients undergoing colorectal surgery within an ERAS protocol. TRIAL REGISTRATION: ClinicalTrial.gov: ID: NCT02746731; Institution Ethical Board Approval: KEK-ZH Nr. 2016-00,229.

Development of a value-based healthcare delivery model for sarcoma patients.

The urgent need to restructure healthcare delivery to address rising costs has been recognised. Value-based health care aims to deliver high and rising value for the patient by addressing unmet needs and controlling costs. Sarcoma is a rare disease and its care is therefore usually not organised as an institutional discipline. It comprises a set of various diagnostic entities and is highly transdisciplinary. A bottom-up approach to establishing sarcoma integrated practice units (IPUs) faces many challenges, but ultimately allows the scaling up of quality and outcomes of patient care, specific knowledge, experience and education. The key for value-based health care - besides defining the shared value of quality - is an integrated information technology platform that allows transparency by sharing values, brings all stakeholders together in real-time, and offers the opportunity to assess quality of care and outcomes, thereby ultimately saving costs. Sarcoma as a rare disease may serve as a model of how to establish IPUs through a supraregional network by increased connectivity, to advance patient care, to improve science and education, and to control costs in the future, thereby restructuring healthcare delivery. This article describes how the value-based health care delivery principles are being adopted and fine-tuned to the care of sarcoma patients, and already partially integrated in seven major referral hospitals in Switzerland.

Is laparoscopic major hepatectomy feasible and safe in Swiss cantonal hospitals?

BACKGROUND: The number of laparoscopic liver resections is increasing worldwide, including in Switzerland. However, laparoscopy is mostly used for minor resections. Little is known about indications for and outcomes of major liver resections performed laparoscopically. The aim of this study was to compare the clinical outcome of open and laparoscopic major liver resection cohorts in two Swiss centres. METHODS: Patients undergoing open or laparoscopic major hepatectomy (>3 segments) in two cantonal hospitals from January 2015 to December 2019 were analysed. All disease types except perihilar cholangiocarcinomas, rare malignancies and resections with biliary reconstruction were included. The primary outcome was the number of complications incurred. Operation time, blood loss, hospital stay and 90-day mortality were secondary outcomes investigated. A separate analysis was performed for colorectal liver metastases, the most common indication. Potential risk factors for major complications were evaluated in a multivariate analysis. RESULTS: A total of 88 patients were identified. Among those, 34 patients underwent laparoscopic major hepatectomy (LAPH) and 54 patients open major hepatectomy (OH). The two groups did not differ in demographics. The most common indication was malignancy (LAPH 94% vs OH 98%), mainly colorectal liver metastases (LAPH 53% vs OH 59%). There was no significant difference in major complications (21% vs 15%, p = 0.565). Median operation time (LAPH 433 minutes, interquartile range [IQR 351-482 vs OH 397 minutes, IQR 296-446; p = 0.222), blood loss (325 ml, IQR 200-575 vs 475 ml, IQR 300-800; p = 0.150) and hospital stay (9 days, IQR 8-14 vs 11 days, IQR 9-14; p = 0.441) were comparable between the two cohorts. There was no significant difference in 90-day mortality (3% vs 7%, p = 0.881). The laparoscopic technique was not identified as a risk factor for major complications in a multivariate analysis. CONCLUSION: This first report from Switzerland evaluating outcomes of laparoscopic major hepatectomies showed no difference in complications and clinical non-inferiority compared with open major hepatectomy.

[Gallbladder carcinoma and extrahepatic cholangiocarcinoma]. / Gallenblasenkarzinome und Tumore der extrahepatischen Gallenwege.

Gallbladder carcinoma and extrahepatic cholangiocarcinoma Abstract. In this article, we focus on three entities of malignant biliary tumors: gallbladder carcinoma, distal and perihilar cholangiocarcinoma. Those are rare malignant tumors which require an extensive interdisciplinary expertise in the treatment of hepato-pancreato-biliary conditions in order to provide an appropriate diagnostic work-up, correctly assess resectability and come up with a clear-cut multimodal treatment plan. Perihilar cholangiocarcinoma (Klatskin-tumour) usually requires the most complex evaluation of resectability, which involves not only the assessment of vascular in- and outflow and an adequate biliary drainage, but also aims to ensure that enough functional liver tissue is left after resection. To this end, preoperative portal vein embolization may be used to increase the size the future liver remnant. In highly selected, unresectable cases of perihilar cholangiocarinoma, or if a primary sclerosing cholangitis is present, neoadjuvant chemoradiotherapy followed by liver transplantation can be evaluated as a curative option. Distal cholangiocarcinomas usually are treated by a partial pancreaticoduodenectomy (Whipple operation). The surgical treatment of gallbladder cancer ranges from simple cholecystectomy to major liver resection with complex biliary and vascular reconstruction, dependent on tumour stage. The surgical treatment is usually followed by an adjuvant regimen of Capecitabine which can significantly improve survival, while a combination Cisplatin and Gemcitabine is used in the palliative setting.

A Coxoperitoneal Shunt as Salvage for a Recurrent Giant Seroma of the Hip After Periprosthetic Joint Infection: A Case Report.

CASE: A giant seroma developed in the hip of a 44-year-old man after resection arthroplasty performed for recurrent periprosthetic joint infection (PJI). The seroma persisted despite joint reconstruction but was ultimately treated successfully by internal drainage through a coxoperitoneal shunt. CONCLUSION: Resection arthroplasty of the hip is considered a salvage procedure for failed implant retention in the situation of persistent PJI. Nevertheless, functional results are poor and further soft-tissue complications may occur. A giant seroma of the hip may be drained into the peritoneal cavity, permitting healing without risking contamination from external, percutaneous drainage.

Association of a prehabilitation program with anxiety and depression before colorectal surgery: a post hoc analysis of the pERACS randomized controlled trial.

PURPOSE: Hospital-associated anxiety and depression are major preoperative stressors and common in colorectal cancer surgery and major abdominal surgery. The prehabilitation Enhanced Recovery After Colorectal Surgery (pERACS) study is a single-center, single-blinded randomized controlled trial (RCT) evaluating the effect of a structured prehabilitation program. We evaluate within this RCT the association of a prehabilitation program with anxiety and depression before colorectal surgery. METHODS: Treatment allocation randomized and single-blinded. Regardless of group allocation, patients were treated according to our institutional Enhanced Recovery After Surgery (ERAS) protocol. Inclusion criteria consisted of adult patients suffering from colorectal disease requiring surgical treatment and who were treated according to the ERAS protocol. Anxiety and depression scores were assessed at baseline and at admission according to the Hospital Anxiety and Depression Scale (HADS), with its subcomponents for depression (HADS-D) and for anxiety (HADS-A). RESULTS: A total of 23 patients randomized to prehabilitation (mean age: 64.8±11.5 years) and 25 patients randomized to the control group (64.0±11.9 years) were included. There was no statistically significant difference in HADS-Anxiety improvement (Prehabilitation: -1.7±2.8 points vs. control: -0.4±3.4 points, p=0.132). Similarly, the difference in HADS-Depression improvement among the prehabilitation (1.0±2.4 points) and control (-0.3 ± 4.0 points) groups (p = 0.543) was non-significant. Clinically meaningful improvement in anxiety (60.9%/40.0%, p=0.149) and depression (34.8%/20.0%, p=0.250) was similar among the groups. CONCLUSION: In a post hoc analysis of a randomized trial, prehabilitation had no effect on preoperative reduction of anxiety and depression measures. TRIAL REGISTRATION NUMBER: Clinicaltrials.gov NCT02746731. Date of registration: April 21, 2016.

Combination of HAI-FUDR and Systemic Gemcitabine and Cisplatin in Unresectable Cholangiocarcinoma: A Dose Finding Single Center Study.

BACKGROUND: Unresectable cholangiocarcinoma has a poor prognosis and treatment options are limited. Combined systemic and intrahepatic chemotherapy may improve local control and enable downsizing. The aim of this study was to determine the maximum tolerated dose (MTD) of intravenous gemcitabine combined with intravenous cisplatin and hepatic arterial infusion (HAI) with floxuridine (FUDR) in patients with unresectable intrahepatic or hilar cholangiocarcinoma. METHODS: Twelve patients were treated within a 3 + 3 dose escalation algorithm with 600, 800, or 1,000 mg/m2 gemcitabine and predefined doses of cisplatin 25 mg/m2 on days 1 and 8, q21, for 4 cycles, and FUDR 0.2 mg/kg on days 1-14 as continuous HAI, q28, for 3 cycles. Safety and toxicity as well as resectability rates after 3 months and preliminary survival data are reported. RESULTS: The determined MTD for gemcitabine was 800 mg/m2. Dose limiting toxicities were neutropenic fever and biliary tract infections. In total, 27% of the patients showed partial remission and 73% stable disease. Although none of the patients achieved resectability after 3 months, the 3-year overall survival rate was 33%, median overall survival 23.9 months (range 1-49), and median progression-free survival 10.1 months (range 2-40). CONCLUSIONS: Intravenous gemcitabine/cisplatin plus HAI-FUDR is feasible and appears effective for disease control. Larger prospective studies evaluating this triplet combination are warranted.

Potential benefit in information providing and influence on patient anxiety and satisfaction by means of preoperative explanatory videos in total extraperitoneal inguinal hernioplasty: study protocol of a multicentre, double-blinded, randomised parallel-group controlled trial.

INTRODUCTION: The use of electronic media in informed consent giving has become increasingly important in recent years. Due to the easy access to information via electronical media, patients are primed in a heterogeneous manner concerning expectations and wishes regarding surgical interventions. Inherent to its nature elective interventions are critically questioned as there is time for information gathering and reflection. In this study, we set out to investigate the effect of an educational video as a supporting element in the process of informed consent giving for one the most frequently performed interventions in general surgery, namely inguinal hernia repair. METHODS AND ANALYSIS: In a multicentre setup, eligible patients for primary inguinal hernia repair will be randomly assigned to one of three groups. All three groups will have a preoperative informed consent discussion with a physician in which they will eventually sign the informed consent sheet if participation is desired. Eventually, all three groups will get an online link. For two groups, the link will lead to a video with audiovisual information (an inguinal hernia video for the intervention group and a mock video for the control group). The intervention video provides basic principles of endoscopic extraperitoneal hernia repair. The second video is similar in length and design and displays general aspects of day surgery in the two study centres. All the three study groups will be provided with a copy of the informed consent form as it is standard by now. The third group's link will lead to the digital version of the informed consent brochure. Primary outcomes will consist of (1) score in a multiple choice test assessing gain of knowledge regarding hernia repair, (2) difference in the State-Trait Anxiety Inventory and (3) patient satisfaction questionnaire Individual Clinician Feedback (ICF, Picker Institute, Germany) as assessed 1-2 days after the first consultation. The study design guarantees double blinding, there will be no unblinding at any point. All patients will receive the same, quality and number of medical consultations as well as in the same surgical treatment. (Minor differences in the total extraperitoneal technique of the surgical treatment due to anatomical or pathophysiological differences are independent of the group allocation). Except for the additional videos, there will be no difference in in the information provided and the treatment prior, during or after the hernia repair. ETHICS AND DISSEMINATION: We plan to publish the study in a peer-reviewed journal. The proposed research project has been reviewed by the Cantonal Ethics Committee (BASEC-No 2020-01548). In accordance with national legal regulations in Switzerland stated by the Human Research Act, the proposed project was declared exempt from approval requirement. TRIAL REGISTRATION NUMBER: NCT04494087; Pre-results.

Extended lymph node resection versus standard resection for pancreatic and periampullary adenocarcinoma.

BACKGROUND: Pancreatic and periampullary adenocarcinomas account for some of the most aggressive malignancies, and the leading causes of cancer-related mortalities. Partial pancreaticoduodenectomy (PD) with negative resection margins is the only potentially curative therapy. The high prevalence of lymph node metastases has led to the hypothesis that wider excision with the removal of more lymphatic tissue could result in an improvement of survival, and higher rates of negative resection margins. OBJECTIVES: To compare overall survival following standard (SLA) versus extended lymph lymphadenectomy (ELA) for pancreatic head and periampullary adenocarcinoma. We also compared secondary outcomes, such as morbidity, mortality, and tumour involvement of the resection margins between the two procedures. SEARCH METHODS: We searched CENTRAL, MEDLINE, PubMed, and Embase from 1973 to September 2020; we applied no language restrictions. SELECTION CRITERIA: Randomised controlled trials (RCT) comparing PD with SLA versus PD with ELA, including participants with pancreatic head and periampullary adenocarcinoma. DATA COLLECTION AND ANALYSIS: Two review authors independently screened references and extracted data from study reports. We calculated pooled risk ratios (RR) for most binary outcomes except for postoperative mortality, for which we estimated a Peto odds ratio (Peto OR), and mean differences (MD) for continuous outcomes. We used a fixed-effect model in the absence of substantial heterogeneity (I² < 25%), and a random-effects model in cases of substantial heterogeneity (I² > 25%). Two review authors independently assessed risk of bias, and we used GRADE to assess the quality of the evidence for important outcomes. MAIN RESULTS: We included seven studies with 843 participants (421 ELA and 422 SLA). All seven studies included Kaplan-Meier curves for overall survival. There was little or no difference in survival between groups (log hazard ratio (log HR) 0.12, 95% confidence interval (CI) -3.06 to 3.31; P = 0.94; seven studies, 843 participants; very low-quality evidence). There was little or no difference in postoperative mortality between the groups (Peto odds ratio (OR) 1.20, 95% CI 0.51 to 2.80; seven studies, 843 participants; low-quality evidence). Operating time was probably longer for ELA (mean difference (MD) 50.13 minutes, 95% CI 19.19 to 81.06 minutes; five studies, 670 participants; moderate-quality evidence). There was substantial heterogeneity between the studies (I² = 88%; P < 0.00001). There may have been more blood loss during ELA (MD 137.43 mL, 95% CI 11.55 to 263.30 mL; two studies, 463 participants; very low-quality evidence). There was substantial heterogeneity between the studies (I² = 81%, P = 0.02). There may have been more lymph nodes retrieved during ELA (MD 11.09 nodes, 95% CI 7.16 to 15.02; five studies, 670 participants; moderate-quality evidence). There was substantial heterogeneity between the studies (I² = 81%, P < 0.00001). There was little or no difference in the incidence of positive resection margins between groups (RR 0.81, 95% CI 0.58 to 1.13; six studies, 783 participants; very low-quality evidence). AUTHORS' CONCLUSIONS: There is no evidence of an impact on survival with extended versus standard lymph node resection. However, the operating time may have been longer and blood loss greater in the extended resection group. In conclusion, current evidence neither supports nor refutes the effect of extended lymph lymphadenectomy in people with adenocarcinoma of the head of the pancreas.