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1.
Ann Surg ; 279(1): 45-57, 2024 01 01.
Article in English | MEDLINE | ID: mdl-37450702

ABSTRACT

OBJECTIVE: To develop and update evidence-based and consensus-based guidelines on laparoscopic and robotic pancreatic surgery. SUMMARY BACKGROUND DATA: Minimally invasive pancreatic surgery (MIPS), including laparoscopic and robotic surgery, is complex and technically demanding. Minimizing the risk for patients requires stringent, evidence-based guidelines. Since the International Miami Guidelines on MIPS in 2019, new developments and key publications have been reported, necessitating an update. METHODS: Evidence-based guidelines on 22 topics in 8 domains were proposed: terminology, indications, patients, procedures, surgical techniques and instrumentation, assessment tools, implementation and training, and artificial intelligence. The Brescia Internationally Validated European Guidelines on Minimally Invasive Pancreatic Surgery (EGUMIPS, September 2022) used the Scottish Intercollegiate Guidelines Network (SIGN) methodology to assess the evidence and develop guideline recommendations, the Delphi method to establish consensus on the recommendations among the Expert Committee, and the AGREE II-GRS tool for guideline quality assessment and external validation by a Validation Committee. RESULTS: Overall, 27 European experts, 6 international experts, 22 international Validation Committee members, 11 Jury Committee members, 18 Research Committee members, and 121 registered attendees of the 2-day meeting were involved in the development and validation of the guidelines. In total, 98 recommendations were developed, including 33 on laparoscopic, 34 on robotic, and 31 on general MIPS, covering 22 topics in 8 domains. Out of 98 recommendations, 97 reached at least 80% consensus among the experts and congress attendees, and all recommendations were externally validated by the Validation Committee. CONCLUSIONS: The EGUMIPS evidence-based guidelines on laparoscopic and robotic MIPS can be applied in current clinical practice to provide guidance to patients, surgeons, policy-makers, and medical societies.


Subject(s)
Laparoscopy , Surgeons , Humans , Artificial Intelligence , Pancreas/surgery , Minimally Invasive Surgical Procedures/methods , Laparoscopy/methods
2.
Int J Mol Sci ; 25(9)2024 May 03.
Article in English | MEDLINE | ID: mdl-38732204

ABSTRACT

The extraocular muscles (EOMs) possess unique characteristics that set them apart from other skeletal muscles. These muscles, responsible for eye movements, exhibit remarkable resistance to various muscular dystrophies and aging, presenting a significant contrast to the vulnerability of skeletal muscles to these conditions. In this review, we delve into the cellular and molecular underpinnings of the distinct properties of EOMs. We explore their structural complexity, highlighting differences in fiber types, innervation patterns, and developmental origins. Notably, EOM fibers express a diverse array of myosin heavy-chain isoforms, retaining embryonic forms into adulthood. Moreover, their motor innervation is characterized by a high ratio of nerve fibers to muscle fibers and the presence of unique neuromuscular junctions. These features contribute to the specialized functions of EOMs, including rapid and precise eye movements. Understanding the mechanisms behind the resilience of EOMs to disease and aging may offer insights into potential therapeutic strategies for treating muscular dystrophies and myopathies affecting other skeletal muscles.


Subject(s)
Aging , Oculomotor Muscles , Humans , Oculomotor Muscles/physiology , Aging/physiology , Animals , Muscular Dystrophies , Neuromuscular Junction/physiology , Neuromuscular Junction/metabolism , Muscle, Skeletal/physiology , Muscle, Skeletal/metabolism
3.
HPB (Oxford) ; 26(1): 63-72, 2024 Jan.
Article in English | MEDLINE | ID: mdl-37739876

ABSTRACT

BACKGROUND: Evidence on the value of minimally invasive pancreatic surgery (MIPS) has been increasing but it is unclear how this has influenced the view of pancreatic surgeons on MIPS. METHODS: An anonymous survey was sent to members of eight international Hepato-Pancreato-Biliary Associations. Outcomes were compared with the 2016 international survey. RESULTS: Overall, 315 surgeons from 47 countries participated. The median volume of pancreatic resections per center was 70 (IQR 40-120). Most surgeons considered minimally invasive distal pancreatectomy (MIDP) superior to open (ODP) (94.6%) and open pancreatoduodenectomy (OPD) superior to minimally invasive (MIPD) (67.9%). Since 2016, there has been an increase in the number of surgeons performing both MIDP (79%-85.7%, p = 0.024) and MIPD (29%-45.7%, p < 0.001), and an increase in the use of the robot-assisted approach for both MIDP (16%-45.6%, p < 0.001) and MIPD (23%-47.9%, p < 0.001). The use of laparoscopy remained stable for MIDP (91% vs. 88.1%, p = 0.245) and decreased for MIPD (51%-36.8%, p = 0.024). CONCLUSION: This survey showed considerable changes of MIPS since 2016 with most surgeons considering MIDP superior to ODP and an increased use of robot-assisted MIPS. Surgeons prefer OPD and therefore the value of MIPD remains to be determined in randomized trials.


Subject(s)
Laparoscopy , Pancreatic Neoplasms , Robotic Surgical Procedures , Robotics , Humans , Pancreatic Neoplasms/surgery , Follow-Up Studies , Robotic Surgical Procedures/adverse effects , Treatment Outcome , Pancreatectomy/adverse effects , Pancreaticoduodenectomy/adverse effects , Laparoscopy/adverse effects , Minimally Invasive Surgical Procedures , Postoperative Complications/surgery , Retrospective Studies
4.
Curr Issues Mol Biol ; 45(8): 6383-6394, 2023 Jul 31.
Article in English | MEDLINE | ID: mdl-37623222

ABSTRACT

Gastric cancer is a major challenge in modern oncology due to its high detection rate and prevalence. While sporadic cases make up the majority of gastric cancer, hereditary gastric cancer is caused by germline mutations in several genes linked to different syndromes. Thus, identifying hereditary forms of gastric cancer is considered crucial globally. A survey study using NGS-based analysis was conducted to determine the frequency of different types of hereditary gastric cancer in the yet-unstudied Kyrgyz population. The study cohort included 113 patients with diagnosed gastric cancer from Kyrgyzstan. The age of patients was 57.6 ± 8.9. Next-generation sequencing analysis of genomic DNA was performed using a custom Roche NimbleGen enrichment panel. The results showed that 6.2% (7/113) of the patients had pathogenic or likely pathogenic genetic variants. Additionally, 3.5% (4/113) of the patients carried heterozygous pathogenic/likely pathogenic variants in high penetrance genes, such as TP53, POLD1, RET, and BRCA2. Moreover, 2.7% (3/113) of the patients carried heterozygous mutations in genes linked to autosomal recessive conditions, specifically PALB2, FANCA, and FANCD2. We have not identified any genetic variants in hereditary GC-associated genes: CDH1, STK11, SMAD4, BMPRIA, APC, MLH1, and others. Our study included patients with sporadic features of GC. The use of recognized criteria (NCCN, Gastric Cancer, Version 2.2022) would increase the number of identified genetic variants in hereditary GC-associated genes. Further research is required to determine the clinical relevance of the genetic variants identified in the current study.

5.
Ann Surg ; 277(2): 313-320, 2023 02 01.
Article in English | MEDLINE | ID: mdl-34261885

ABSTRACT

OBJECTIVE: To assess postoperative 90-day outcomes after minimally invasive (laparoscopic/robot-assisted) total pancreatectomy (MITP) in selected patients versus open total pancreatectomy (OTP) among European centers. BACKGROUND: Minimally invasive pancreatic surgery is becoming increasingly popular but data on MITP are scarce and multicenter studies comparing outcomes versus OTP are lacking. It therefore remains unclear if MITP is a valid alternative. METHODS: Multicenter retrospective propensity-score matched study including consecutive adult patients undergoing MITP or OTP for all indications at 16 European centers in 7 countries (2008-2017). Patients after MITP were matched (1:1, caliper 0.02) to OTP controls. Missing data were imputed. The primary outcome was 90-day major morbidity (Clavien-Dindo ≥3a). Secondary outcomes included 90-day mortality, length of hospital stay, and survival. RESULTS: Of 361 patients (99MITP/262 OTP), 70 MITP procedures (50 laparoscopic, 15 robotic, 5 hybrid) could be matched to 70 OTP controls. After matching, MITP was associated with a lower rate of major morbidity (17% MITP vs. 31% OTP, P = 0.022). The 90-day mortality (1.4% MITP vs. 7.1% OTP, P = 0.209) and median hospital stay (17 [IQR 11-24] MITP vs. 12 [10-23] days OTP, P = 0.876) did not differ significantly. Among 81 patients with PDAC, overall survival was 3.7 (IQR 1.7-N/A) versus 0.9 (IQR 0.5-N/ A) years, for MITP versus OTP, which was nonsignificant after stratification by T-stage. CONCLUSION: This international propensity score matched study showed that MITP may be a valuable alternative to OTP in selected patients, given the associated lower rate of major morbidity.


Subject(s)
Pancreatic Neoplasms , Robotic Surgical Procedures , Adult , Humans , Pancreatectomy/methods , Retrospective Studies , Pancreatic Neoplasms/surgery , Propensity Score , Robotic Surgical Procedures/methods
6.
Int J Mol Sci ; 24(11)2023 May 29.
Article in English | MEDLINE | ID: mdl-37298385

ABSTRACT

Helicobacter pylori is one of the most common cause of human infections. Infected patients develop chronic active gastritis in all cases, which can lead to peptic ulcer, atrophic gastritis, gastric cancer and gastric MALT-lymphoma. The prevalence of H. pylori infection in the population has regional characteristics and can reach 80%. Constantly increasing antibiotic resistance of H. pylori is a major cause of treatment failure and a major problem. According to the VI Maastricht Consensus, two main strategies for choosing eradication therapy are recommended: individualized based on evaluating sensitivity to antibacterial drugs (phenotypic or molecular genetic method) prior to their appointment, and empirical, which takes into account data on local H. pylori resistance to clarithromycin and monitoring effectiveness schemes in the region. Therefore, the determination of H. pylori resistance to antibiotics, especially clarithromycin, prior to choosing therapeutic strategy is extremely important for the implementation of these treatment regimens.


Subject(s)
Helicobacter Infections , Helicobacter pylori , Humans , Clarithromycin/pharmacology , Clarithromycin/therapeutic use , Helicobacter pylori/genetics , Helicobacter Infections/diagnosis , Helicobacter Infections/drug therapy , Helicobacter Infections/microbiology , Anti-Bacterial Agents/pharmacology , Anti-Bacterial Agents/therapeutic use , Drug Resistance, Microbial , Amoxicillin
7.
Int J Mol Sci ; 24(9)2023 Apr 27.
Article in English | MEDLINE | ID: mdl-37175647

ABSTRACT

More than 275 million people in the world are carriers of a heterozygous mutation of the CFTR gene, associated with cystic fibrosis, the most common autosomal recessive disease among Caucasians. Some recent studies assessed the association between carriers of CFTR variants and some pathologies, including cancer risk. The aim of this study is to analyze the landscape of germline pathogenic heterozygous CFTR variants in patients with diagnosed malignant neoplasms. For the first time in Russia, we evaluated the frequency of CFTR pathogenic variants by whole-genome sequencing in 1800 patients with cancer and compared this with frequencies of CFTR variants in the control group (1825 people) adjusted for age and 10,000 healthy individuals. In the issue, 47 out of 1800 patients (2.6%) were carriers of CFTR pathogenic genetic variants: 0.028 (42/1525) (2.8%) among breast cancer patients, 0.017 (3/181) (1.7%) among colorectal cancer patients and 0.021 (2/94) (2.1%) among ovarian cancer patients. Pathogenic CFTR variants were found in 52/1825 cases (2.85%) in the control group and 221 (2.21%) in 10,000 healthy individuals. Based on the results of the comparison, there was no significant difference in the frequency and distribution of pathogenic variants of the CFTR gene, which is probably due to the study limitations. Obviously, additional studies are needed to assess the clinical significance of the heterozygous carriage of CFTR pathogenic variants in the development of various pathologies in the future, particularly cancer.


Subject(s)
Breast Neoplasms , Cystic Fibrosis Transmembrane Conductance Regulator , Humans , Female , Cystic Fibrosis Transmembrane Conductance Regulator/genetics , Genetic Predisposition to Disease , Mutation , Germ Cells
8.
HPB (Oxford) ; 25(8): 924-932, 2023 08.
Article in English | MEDLINE | ID: mdl-37198070

ABSTRACT

BACKGROUND: Surgery for hepatopancreaticobiliary (HPB) conditions is performed worldwide. This investigation aimed to develop a set of globally accepted procedural quality performance indicators (QPI) for HPB surgical procedures. METHODS: A systematic literature review generated a dataset of published QPI for hepatectomy, pancreatectomy, complex biliary surgery and cholecystectomy. Using a modified Delphi process, three rounds were conducted with working groups composed of self-nominating members of the International Hepatopancreaticobiliary Association (IHPBA). The final set of QPI was circulated to the full membership of the IHPBA for review. RESULTS: Seven "core" indicators were agreed for hepatectomy, pancreatectomy, and complex biliary surgery (availability of specific services on site, a specialised surgical team with at least two certified HPB surgeons, a satisfactory institutional case volume, synoptic pathology reporting, undertaking of unplanned reintervention procedures within 90 days, the incidence of post-procedure bile leak and Clavien-Dindo grade ≥III complications and 90-day post-procedural mortality). Three further procedure specific QPI were proposed for pancreatectomy, six for hepatectomy and complex biliary surgery. Nine procedure-specific QPIs were proposed for cholecystectomy. The final set of proposed indicators were reviewed and approved by 102 IHPBA members from 34 countries. CONCLUSIONS: This work presents a core set of internationally agreed QPI for HPB surgery.


Subject(s)
Biliary Tract Surgical Procedures , Pancreatectomy , Humans , Pancreatectomy/adverse effects , Hepatectomy/adverse effects , Consensus , Cholecystectomy
9.
HPB (Oxford) ; 25(4): 400-408, 2023 04.
Article in English | MEDLINE | ID: mdl-37028826

ABSTRACT

BACKGROUND: The European registry for minimally invasive pancreatic surgery (E-MIPS) collects data on laparoscopic and robotic MIPS in low- and high-volume centers across Europe. METHODS: Analysis of the first year (2019) of the E-MIPS registry, including minimally invasive distal pancreatectomy (MIDP) and minimally invasive pancreatoduodenectomy (MIPD). Primary outcome was 90-day mortality. RESULTS: Overall, 959 patients from 54 centers in 15 countries were included, 558 patients underwent MIDP and 401 patients MIPD. Median volume of MIDP was 10 (7-20) and 9 (2-20) for MIPD. Median use of MIDP was 56.0% (IQR 39.0-77.3%) and median use of MIPD 27.7% (IQR 9.7-45.3%). MIDP was mostly performed laparoscopic (401/558, 71.9%) and MIPD mostly robotic (234/401, 58.3%). MIPD was performed in 50/54 (89.3%) centers, of which 15/50 (30.0%) performed ≥20 MIPD annually. This was 30/54 (55.6%) centers and 13/30 (43%) centers for MIPD respectively. Conversion rate was 10.9% for MIDP and 8.4% for MIPD. Overall 90 day mortality was 1.1% (n = 6) for MIDP and 3.7% (n = 15) for MIPD. CONCLUSION: Within the E-MIPS registry, MIDP is performed in about half of all patients, mostly using laparoscopy. MIPD is performed in about a quarter of patients, slightly more often using the robotic approach. A minority of centers met the Miami guideline volume criteria for MIPD.


Subject(s)
Laparoscopy , Pancreatic Neoplasms , Robotic Surgical Procedures , Humans , Pancreatic Neoplasms/surgery , Robotic Surgical Procedures/adverse effects , Pancreas/surgery , Pancreatectomy/adverse effects , Pancreaticoduodenectomy/adverse effects , Minimally Invasive Surgical Procedures , Laparoscopy/adverse effects , Registries , Postoperative Complications/etiology , Treatment Outcome
10.
Surg Endosc ; 36(2): 1515-1526, 2022 02.
Article in English | MEDLINE | ID: mdl-33825015

ABSTRACT

INTRODUCTION: There are limited numbers of high-volume centers performing minimally invasive pancreatoduodenectomy (MIPD) routinely. Several approaches to MIPD have been described. Aim of this analysis was to show the learning curve of three different approaches to MIPD. Focus was on determining the number of cases necessary to obtain proficient level in MIPD. PATIENTS AND METHODS: Retrospective study wherein outcomes of 300 consecutive patients at three centers-at each center the initial 100 consecutive patients undergoing MIPD for malignant and benign tumors of the head of the pancreas and perimpullary area, performed by three experienced surgeons were collected and analyzed. RESULTS: Overall, 300 patients after MIPD were included: the three different cohorts (laparoscopic n = 100, hybrid n = 100, robotic n = 100). CUSUM analysis of operating time in each center demonstrated that the plateau for laparoscopic PD was n = 61, for hybrid PDes was n = 32 and for robotic PD was n = 68. Median operative time for laparoscopic, hybrid, and robotic approaches was 395 min, 404 min, 510 min, respectively. Intraoperative blood loss for laparoscopic PD, hybrid PD, and robotic PD was 250 ml, 250 ml, and 413 ml, respectively. Delayed gastric emptying occurred 12% in laparoscopic cohort, 10% in hybrid, and 53% in robotic cohort. Major complications (Clavien-Dindo III/IV) rate for laparoscopic PD, hybrid PD, and robotic PD was 32%, 37%, and 22% with 5% death in each cohorts, respectively. CONCLUSION: This analysis of the learning curve of three European centers found a shorter learning curve with hybrid PD as compared to laparoscopic and robotic PD. In implementation of a MIPD program, a stepwise approach might be beneficial.


Subject(s)
Laparoscopy , Robotic Surgical Procedures , Humans , Laparoscopy/adverse effects , Learning Curve , Operative Time , Pancreaticoduodenectomy/adverse effects , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Retrospective Studies , Robotic Surgical Procedures/adverse effects
11.
Ann Surg ; 273(2): 334-340, 2021 02 01.
Article in English | MEDLINE | ID: mdl-30829699

ABSTRACT

OBJECTIVE: The aim of the study was to validate and optimize the alternative Fistula Risk Score (a-FRS) for patients undergoing minimally invasive pancreatoduodenectomy (MIPD) in a large pan-European cohort. BACKGROUND: MIPD may be associated with an increased risk of postoperative pancreatic fistula (POPF). The a-FRS could allow for risk-adjusted comparisons in research and improve preventive strategies for high-risk patients. The a-FRS, however, has not yet been validated specifically for laparoscopic, robot-assisted, and hybrid MIPD. METHODS: A validation study was performed in a pan-European cohort of 952 consecutive patients undergoing MIPD (543 laparoscopic, 258 robot-assisted, 151 hybrid) in 26 centers from 7 countries between 2007 and 2017. The primary outcome was POPF (International Study Group on Pancreatic Surgery grade B/C). Model performance was assessed using the area under the receiver operating curve (AUC; discrimination) and calibration plots. Validation included univariable screening for clinical variables that could improve performance. RESULTS: Overall, 202 of 952 patients (21%) developed POPF after MIPD. Before adjustment, the original a-FRS performed moderately (AUC 0.68) and calibration was inadequate with systematic underestimation of the POPF risk. Single-row pancreatojejunostomy (odds ratio 4.6, 95 confidence interval [CI] 2.8-7.6) and male sex (odds ratio 1.9, 95 CI 1.4-2.7) were identified as important risk factors for POPF in MIPD. The updated a-FRS, consisting of body mass index, pancreatic texture, duct size, and male sex, showed good discrimination (AUC 0.75, 95 CI 0.71-0.79) and adequate calibration. Performance was adequate for laparoscopic, robot-assisted, and hybrid MIPD and open pancreatoduodenectomy. CONCLUSIONS: The updated a-FRS (www.pancreascalculator.com) now includes male sex as a risk factor and is validated for both MIPD and open pancreatoduodenectomy. The increased risk of POPF in laparoscopic MIPD was associated with single-row pancreatojejunostomy, which should therefore be discouraged.


Subject(s)
Laparoscopy/adverse effects , Pancreatic Diseases/surgery , Pancreatic Fistula/epidemiology , Pancreaticoduodenectomy/adverse effects , Postoperative Complications/epidemiology , Robotic Surgical Procedures/adverse effects , Aged , Cohort Studies , Europe , Female , Humans , Male , Middle Aged , Pancreatic Diseases/complications , Pancreatic Diseases/pathology , Risk Factors , Sensitivity and Specificity
12.
HPB (Oxford) ; 23(9): 1332-1338, 2021 09.
Article in English | MEDLINE | ID: mdl-33618991

ABSTRACT

BACKGROUND: No prospective randomized trials comparing transection techniques for the liver parenchyma transection during laparoscopic liver resection have been performed. The aim of the study was to compare the immediate outcomes of hydro-jet dissection with ultrasonic surgical aspirator in laparoscopic liver parenchyma transection in a prospective randomized single-center study. METHODS: Consecutive patients with liver benign and malignant tumors presenting to a single center from May 2017 to May 2020 were enrolled in the study. The primary endpoint was the intraoperative estimated blood loss. The secondary endpoints included duration of parenchymal transection, morbidity, and overall hospital stay. RESULTS: A total of 68 patients were enrolled in the study, with 34 patients in each group. There were no differences between groups in the difficulty of resection (according to IWATE criteria and IMM score) and other basic surgical parameters. No differences were found in all primary and secondary endpoints except the expenditure. The cost of equipment was significantly higher in the group of ultrasonic aspirator. CONCLUSION: Despite the wider use of the ultrasonic aspirator in laparoscopic liver surgery, hydro-jet and ultrasonic surgical aspirators have shown similar efficacy and safety for transection of the liver parenchyma during laparoscopic resection.


Subject(s)
Laparoscopy , Liver Neoplasms , Blood Loss, Surgical/prevention & control , Dissection , Hepatectomy/adverse effects , Humans , Laparoscopy/adverse effects , Liver/diagnostic imaging , Liver/surgery , Liver Neoplasms/diagnostic imaging , Liver Neoplasms/surgery , Prospective Studies , Ultrasonics
13.
HPB (Oxford) ; 23(4): 566-574, 2021 04.
Article in English | MEDLINE | ID: mdl-32933843

ABSTRACT

BACKGROUND: The recent Miami international evidence-based guidelines on minimally invasive pancreatic surgery (MIPS) advise all centers that perform MIPS to participate in multicenter registries to safeguard optimal outcomes and patient safety. During the design phase of a pan-European registry on MIPS, the European consortium of Minimally Invasive Pancreatic Surgery (E-MIPS) sought input from European HPB surgeons. METHODS: An anonymous online questionnaire with 23 questions on MIPS practice was sent to all member centers of the European-African Hepato-Pancreato-Biliary Association (E-AHPBA) and E-MIPS. RESULTS: Completed questionnaires were obtained from 98 centers in 23 countries, of which 75 (76.5%) were academic centers. Centers had a median annual pancreatoduodenectomy volume of 45. The most-performed MIPS procedure was laparoscopic distal pancreatectomy (93.9% of centers). Minimally invasive pancreatoduodenectomy was performed in 49% of all centers. Some 25 centers already participated in an ongoing national registry, and were willing to share their data with the European registry on MIPS. The most mentioned (45.4%) maximum time for processing one patient's data into the registry was 10-15 min. CONCLUSION: This European survey showed considerable support for the European registry on MIPS.


Subject(s)
Laparoscopy , Pancreatectomy , Humans , Laparoscopy/adverse effects , Minimally Invasive Surgical Procedures , Pancreas/surgery , Pancreatectomy/adverse effects , Pancreaticoduodenectomy/adverse effects , Registries , Surveys and Questionnaires
14.
J Hepatol ; 72(3): 498-505, 2020 03.
Article in English | MEDLINE | ID: mdl-31626819

ABSTRACT

BACKGROUND & AIMS: In a variety of animal models, omega-3 polyunsaturated fatty acids (Ω3-FAs) conferred strong protective effects, alleviating hepatic ischemia/reperfusion injury and steatosis, as well as enhancing regeneration after major tissue loss. Given these benefits along with its safety profile, we hypothesized that perioperative administration of Ω3-FAs in patients undergoing liver surgery may ameliorate the postoperative course. The aim of this study was to investigate the perioperative use of Ω3-FAs to reduce postoperative complications after liver surgery. METHODS: Between July 2013 and July 2018, we carried out a multicentric, double-blind, randomized, placebo-controlled trial designed to test whether 2 single intravenous infusions of Omegaven® (Ω3-FAs) vs. placebo may decrease morbidity. The primary endpoints were postoperative complications by severity (Clavien-Dindo classification) integrated within the comprehensive complication index (CCI). RESULTS: A total of 261 patients (132 in the Omegaven and 129 in the placebo groups) from 3 centers were included in the trial. Most cases (87%, n = 227) underwent open liver surgery and 56% (n = 105) were major resections (≥3 segments). In an intention-to-treat analysis including the dropout cases, the mortality rate was 4% and 2% in the Omegaven and placebo groups (odds ratio0.40;95% CI 0.04-2.51; p = 0.447), respectively. Any complications and major complications (Clavien-Dindo ≥ 3b) occurred in 46% vs. 43% (p = 0.709) and 12% vs. 10% (p = 0.69) in the Omegaven and placebo groups, respectively. The mean CCI was 17 (±23) vs.14 (±20) (p = 0.417). An analysis excluding the dropouts provided similar results. CONCLUSIONS: The routine perioperative use of 2 single doses of intravenous Ω3-FAs (100 ml Omegaven) cannot be recommended in patients undergoing liver surgery (Grade A recommendation). LAY SUMMARY: Despite strong evidence of omega-3 fatty acids having liver-directed, anti-inflammatory and pro-regenerative action in various rodent models, 2 single omega-3 fatty acid infusions given to patients before and during liver surgery failed to reduce complications. Because single omega-3 fatty acid infusions failed to confer liver protection in this trial, they cannot currently be recommended. TRIAL REGISTRATION: ClinicalTrial.gov: ID: NCT01884948; Institution Ethical Board Approval: KEK-ZH-Nr. 2010-0038; Swissmedic Notification: 2012DR3215.


Subject(s)
Fatty Acids, Omega-3/administration & dosage , Fish Oils/administration & dosage , Liver Neoplasms/surgery , Perioperative Care/mortality , Perioperative Care/methods , Postoperative Complications/mortality , Postoperative Complications/prevention & control , Protective Agents/administration & dosage , Triglycerides/administration & dosage , Adult , Aged , Double-Blind Method , Female , Humans , Infusions, Intravenous , Male , Middle Aged , Prospective Studies , Treatment Failure
15.
Ann Surg ; 271(2): 356-363, 2020 02.
Article in English | MEDLINE | ID: mdl-29864089

ABSTRACT

OBJECTIVE: To assess short-term outcomes after minimally invasive (laparoscopic, robot-assisted, and hybrid) pancreatoduodenectomy (MIPD) versus open pancreatoduodenectomy (OPD) among European centers. BACKGROUND: Current evidence on MIPD is based on national registries or single expert centers. International, matched studies comparing outcomes for MIPD and OPD are lacking. METHODS: Retrospective propensity score matched study comparing MIPD in 14 centers (7 countries) performing ≥10 MIPDs annually (2012-2017) versus OPD in 53 German/Dutch surgical registry centers performing ≥10 OPDs annually (2014-2017). Primary outcome was 30-day major morbidity (Clavien-Dindo ≥3). RESULTS: Of 4220 patients, 729/730 MIPDs (412 laparoscopic, 184 robot-assisted, and 130 hybrid) were matched to 729 OPDs. Median annual case-volume was 19 MIPDs (interquartile range, IQR 13-22), including the first MIPDs performed in 10/14 centers, and 31 OPDs (IQR 21-38). Major morbidity (28% vs 30%, P = 0.526), mortality (4.0% vs 3.3%, P = 0.576), percutaneous drainage (12% vs 12%, P = 0.809), reoperation (11% vs 13%, P = 0.329), and hospital stay (mean 17 vs 17 days, P > 0.99) were comparable between MIPD and OPD. Grade-B/C postoperative pancreatic fistula (POPF) (23% vs 13%, P < 0.001) occurred more frequently after MIPD. Single-row pancreatojejunostomy was associated with POPF in MIPD (odds ratio, OR 2.95, P < 0.001), but not in OPD. Laparoscopic, robot-assisted, and hybrid MIPD had comparable major morbidity (27% vs 27% vs 35%), POPF (24% vs 19% vs 25%), and mortality (2.9% vs 5.2% vs 5.4%), with a fewer conversions in robot-assisted- versus laparoscopic MIPD (5% vs 26%, P < 0.001). CONCLUSIONS: In the early experience of 14 European centers performing ≥10 MIPDs annually, no differences were found in major morbidity, mortality, and hospital stay between MIPD and OPD. The high rates of POPF and conversion, and the lack of superior outcomes (ie, hospital stay, morbidity) could indicate that more experience and higher annual MIPD volumes are needed.


Subject(s)
Minimally Invasive Surgical Procedures , Pancreatic Diseases/surgery , Pancreaticoduodenectomy/methods , Aged , Europe , Female , Humans , Length of Stay/statistics & numerical data , Male , Middle Aged , Minimally Invasive Surgical Procedures/mortality , Outcome and Process Assessment, Health Care , Pancreatic Diseases/mortality , Pancreaticoduodenectomy/mortality , Propensity Score , Retrospective Studies
16.
Ann Surg ; 271(1): 1-14, 2020 01.
Article in English | MEDLINE | ID: mdl-31567509

ABSTRACT

OBJECTIVE: The aim of this study was to develop and externally validate the first evidence-based guidelines on minimally invasive pancreas resection (MIPR) before and during the International Evidence-based Guidelines on Minimally Invasive Pancreas Resection (IG-MIPR) meeting in Miami (March 2019). SUMMARY BACKGROUND DATA: MIPR has seen rapid development in the past decade. Promising outcomes have been reported by early adopters from high-volume centers. Subsequently, multicenter series as well as randomized controlled trials were reported; however, guidelines for clinical practice were lacking. METHODS: The Scottisch Intercollegiate Guidelines Network (SIGN) methodology was used, incorporating these 4 items: systematic reviews using PubMed, Embase, and Cochrane databases to answer clinical questions, whenever possible in PICO style, the GRADE approach for assessment of the quality of evidence, the Delphi method for establishing consensus on the developed recommendations, and the AGREE-II instrument for the assessment of guideline quality and external validation. The current guidelines are cosponsored by the International Hepato-Pancreato-Biliary Association, the Americas Hepato-Pancreato-Biliary Association, the Asian-Pacific Hepato-Pancreato-Biliary Association, the European-African Hepato-Pancreato-Biliary Association, the European Association for Endoscopic Surgery, Pancreas Club, the Society of American Gastrointestinal and Endoscopic Surgery, the Society for Surgery of the Alimentary Tract, and the Society of Surgical Oncology. RESULTS: After screening 16,069 titles, 694 studies were reviewed, and 291 were included. The final 28 recommendations covered 6 topics; laparoscopic and robotic distal pancreatectomy, central pancreatectomy, pancreatoduodenectomy, as well as patient selection, training, learning curve, and minimal annual center volume required to obtain optimal outcomes and patient safety. CONCLUSION: The IG-MIPR using SIGN methodology give guidance to surgeons, hospital administrators, patients, and medical societies on the use and outcome of MIPR as well as the approach to be taken regarding this challenging type of surgery.


Subject(s)
Evidence-Based Medicine/standards , Minimally Invasive Surgical Procedures/standards , Pancreatectomy/standards , Pancreatic Diseases/surgery , Practice Guidelines as Topic , Societies, Medical , Congresses as Topic , Florida , Humans , Pancreatectomy/methods
17.
Medicina (Kaunas) ; 56(3)2020 Mar 13.
Article in English | MEDLINE | ID: mdl-32183010

ABSTRACT

Isolated hydatid cysts of the pancreas are rare lesions, even in endemic regions. In this report, we present the case of a 76-year-old patient who was admitted to our clinic with a diagnosis of a cystic lesion in the tail of the pancreas. On preoperative computed tomography (CT) and magnetic resonance (MR) examination, the cyst was characterized as a mucinous cystadenoma. A laparoscopic distal pancreatectomy followed. A histopathological examination revealed a large hydatid cyst in the tail of the pancreas.


Subject(s)
Echinococcosis/diagnosis , Pancreas/abnormalities , Aged , Animals , Cattle/parasitology , Cystadenoma, Mucinous/diagnosis , Cystadenoma, Mucinous/diagnostic imaging , Cystadenoma, Mucinous/physiopathology , Diagnostic Errors , Echinococcosis/complications , Echinococcosis/physiopathology , Echinococcus granulosus/parasitology , Female , Humans , Pancreas/pathology , Pancreas/surgery , Tomography, X-Ray Computed/methods
18.
Ann Surg ; 269(1): 10-17, 2019 01.
Article in English | MEDLINE | ID: mdl-29099399

ABSTRACT

OBJECTIVE: The aim of this study was to compare oncological outcomes after minimally invasive distal pancreatectomy (MIDP) with open distal pancreatectomy (ODP) in patients with pancreatic ductal adenocarcinoma (PDAC). BACKGROUND: Cohort studies have suggested superior short-term outcomes of MIDP vs. ODP. Recent international surveys, however, revealed that surgeons have concerns about the oncological outcomes of MIDP for PDAC. METHODS: This is a pan-European propensity score matched study including patients who underwent MIDP (laparoscopic or robot-assisted) or ODP for PDAC between January 1, 2007 and July 1, 2015. MIDP patients were matched to ODP patients in a 1:1 ratio. Main outcomes were radical (R0) resection, lymph node retrieval, and survival. RESULTS: In total, 1212 patients were included from 34 centers in 11 countries. Of 356 (29%) MIDP patients, 340 could be matched. After matching, the MIDP conversion rate was 19% (n = 62). Median blood loss [200 mL (60-400) vs 300 mL (150-500), P = 0.001] and hospital stay [8 (6-12) vs 9 (7-14) days, P < 0.001] were lower after MIDP. Clavien-Dindo grade ≥3 complications (18% vs 21%, P = 0.431) and 90-day mortality (2% vs 3%, P > 0.99) were comparable for MIDP and ODP, respectively. R0 resection rate was higher (67% vs 58%, P = 0.019), whereas Gerota's fascia resection (31% vs 60%, P < 0.001) and lymph node retrieval [14 (8-22) vs 22 (14-31), P < 0.001] were lower after MIDP. Median overall survival was 28 [95% confidence interval (CI), 22-34] versus 31 (95% CI, 26-36) months (P = 0.929). CONCLUSIONS: Comparable survival was seen after MIDP and ODP for PDAC, but the opposing differences in R0 resection rate, resection of Gerota's fascia, and lymph node retrieval strengthen the need for a randomized trial to confirm the oncological safety of MIDP.


Subject(s)
Carcinoma, Pancreatic Ductal/surgery , Minimally Invasive Surgical Procedures/methods , Pancreatectomy/methods , Pancreatic Neoplasms/surgery , Propensity Score , Aged , Carcinoma, Pancreatic Ductal/diagnosis , Carcinoma, Pancreatic Ductal/mortality , Europe/epidemiology , Female , Humans , Incidence , Laparoscopy/methods , Length of Stay/trends , Male , Neoplasm Staging , Pancreatic Neoplasms/diagnosis , Pancreatic Neoplasms/mortality , Postoperative Complications/epidemiology , Retrospective Studies , Robotic Surgical Procedures/methods , Survival Rate/trends , Treatment Outcome
20.
HPB (Oxford) ; 21(11): 1513-1519, 2019 11.
Article in English | MEDLINE | ID: mdl-30956162

ABSTRACT

BACKGROUND: Distal cholangiocarcinoma (DCC) is a rare malignancy and validated prognostic markers remain scarce. We aimed to evaluate the role of serum CA19-9 as a potential biomarker in DCC. METHODS: Patients operated for DCC at 6 high-volume surgical centers from 1994 to 2015 were identified from prospectively maintained databases. Patient baseline characteristics, surgical and histopathological parameters, as well as overall survival after resection were assessed for correlation with preoperative bilirubin-adjusted serum carbohydrate antigen 19-9 (CA19-9). Preoperative CA19-9 to bilirubin ratio (CA19-9/BR) was classified as elevated (≥ 25 U/ml/mg/dl) according to the upper serum normal values of CA19-9 (37 U/ml) and bilirubin (1.5 mg/dl) giving a cut-off at ≥ 25 U/ml/mg/dl. RESULTS: In total 179 patients underwent resection for DCC during the study period. High preoperative CA19-9/BR was associated with advanced age and regional lymph node metastases. Median overall survival after resection was 27 months. Elevated preoperative serum CA19-9/bilirubin ratio (HR 1.6, p = 0.025), T3/4 stage (HR 1.8, p = 0.022), distant metastasis (HR 2.5, p = 0.007), tumor grade (HR 1.9, p = 0.001) and R status (HR 1.7, p = 0.023) were identified as independent negative prognostic factors following multivariable analysis. CONCLUSION: Elevated preoperative bilirubin-adjusted serum CA19-9 correlates with regional lymph node metastases and constitutes a negative independent prognostic factor after resection of DCC.


Subject(s)
Bilirubin/blood , CA-19-9 Antigen/blood , Cholangiocarcinoma/blood , Cholangiocarcinoma/mortality , Adult , Aged , Aged, 80 and over , Biomarkers/blood , Female , Humans , Male , Middle Aged , Prognosis , Survival Rate
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