Microbiome Dysbiosis with Enterococcus Presence in the Upper Gastrointestinal Tract is A Risk Factor for Mortality in Patients Undergoing Surgery for Pancreatic Cancer.

BACKGROUND: Recent retrospective studies suggest a role for distinct microbiota in the perioperative morbidity and mortality of pancreatic head resections. OBJECTIVE: We aimed to prospectively investigate the microbial colonization of critical operative sites of pancreatic head resections to identify microbial stratification factors for surgical and long-term oncologic outcomes. METHODS: Prospective biomarker study applying 16S rRNA sequencing and microbial culturing to samples collected from various sites of the GI tract and surgical sites of patients during pancreatic head resections at a German single high-volume pancreatic center. RESULTS: A total of 101 patients were included (38 non-cancer, 63 cancer patients [50 PDAC patients]) in the study. In a first data analysis series, 16S rRNA sequencing data were utilized from 96 patients to assess associations of microbiome profiles with clinical parameters and outcomes. In general, microbiome composition varied according to sampling site, cancer, age or preoperative ERCP intervention, notably for the bile microbiome. In the PDAC subcohort, compositional variance of the bile or periampullary microbiome was significantly associated with postoperative complications such as ICU admission; on a taxonomic level we observed Enterococcus spp. to be significantly more abundant in patients developing deep or organ-space surgical site infections (SSI). Elevated Enterococcus relative abundances in the upper GI tract, in turn, were associated with 6-months mortality rates. In a second step, we focused on microbiological cultures collected from bile aspirates during surgery and investigated associations with perioperative complications and long-term survival. Notably, Enterococcus spp. were among the most prevalent pathobiont isolates observed in cancer patient bile specimens that were associated with severe SSIs, and thereby elevated mortality rates up to 24 months. Clinically relevant postoperative pancreatic fistulas or severe SSI were found as other major variables determining short-term mortality in this cancer patient cohort. In the context of adverse microbiological factors, a preoperative ERCP was also observed to segregate long-term survival, and it appeared to interact with the presence of Enterococcus spp. as highest mortality rates were observed in PDAC patients with both preoperative ERCP and presence of E. faecalis in bile aspirates. CONCLUSIONS: The presence of Enterococcus spp. in bile ducts of PDAC patients undergoing pancreatic surgery represents a significant risk factor for perioperative infections and, thereby, elevated postoperative and long-term mortality. This finding supports previous data on the use of the antibiotic drug piperacillin-tazobactam as appropriate perioperative antibiotic prophylaxis for preventing adverse outcomes after pancreatoduodenectomy.

Preoperative ultrasound elastography for postoperative pancreatic fistula prediction after pancreatoduodenectomy: A prospective study.

BACKGROUND: Postoperative pancreatic fistulas are the most frequent major complications after pancreatoduodenectomy. The soft pancreatic texture is a critical, independent risk factor for postoperative pancreatic fistulas after pancreatoduodenectomy. The current gold standard for postoperative pancreatic fistula risk evaluation consists of the surgeon's intraoperative palpation of the pancreatic texture and, thus, lacks objectivity. In this prospective study, we used ultrasound-based shear-wave elastography, image data analysis, and a fistula risk score calculator to correlate the stiffness of pancreatic tissue with the occurrence of clinically relevant postoperative pancreatic fistulas. METHODS: We included 100 patients with pancreatic pathologies (71% pancreatic ductal adenocarcinoma) and 100 healthy individuals who were preoperatively assessed via real-time tissue ultrasound-based shear-wave elastography on a Philips EPIQ 7 ultrasound device and had pancreatic parenchyma histologically evaluated with manually stained images. RESULTS: We found a significant difference in the mean elasticity between the soft (1.22 m/s) and the hard pancreas group (2.10 m/s; P < .0001). The mean elasticity significantly correlated with the pancreatic fibrosis rate and the appearance of a postoperative pancreatic fistula after pancreatoduodenectomy. Low elasticity (≤1.2 m/s, mean) correlated with soft and high elasticity (>2.0 m/s, mean) with hard pancreatic parenchyma, as assessed by pathologic evaluation. Multivariate analysis revealed a mean elasticity of <1.3 m/s as a significant cut-off predictor for clinically relevant postoperative pancreatic fistulas (P = .003; Youden-Index = 0.6945). CONCLUSION: Preoperative ultrasound-based shear-wave elastography is a feasible and objective clinical diagnostic modality in evaluating pancreatic tissue stiffness. A mean pancreatic elasticity of <1.3 m/s was a significant independent risk predictor of clinically relevant postoperative pancreatic fistulas after pancreatoduodenectomy.

Neuromuscular end-point predictive capability of published rocuronium pharmacokinetic/pharmacodynamic models: An observational trial.

BACKGROUND: Objective neuromuscular monitoring remains the single most reliable method to ensure optimal perioperative neuromuscular management. Nevertheless, the prediction of clinical neuromuscular endpoints by means of Pharmacokinetic (PK) and Pharmacodynamic (PD) modelling has the potential to complement monitoring and improve perioperative neuromuscular management.s STUDY OBJECTIVE: The present study aims to assess the performance of published Rocuronium PK/PD models in predicting intraoperative Train-of-four (TOF) ratios when benchmarked against electromyographic TOF measurements. DESIGN: Observational trial. SETTING: Tertiary Belgian hospital, from August 2020 up to September 2021. PATIENTS AND INTERVENTIONS: Seventy-four patients undergoing general anaesthesia for elective surgery requiring the administration of rocuronium and subject to continuous EMG neuromuscular monitoring were included. PK/PD-simulated TOF ratios were plotted and synchronised with their measured electromyographic counterparts and their differences analysed by means of Predictive Error derivatives (Varvel criteria). MAIN RESULTS: Published rocuronium PK/PD models overestimated clinically registered TOF ratios. The models of Wierda, Szenohradszky, Cooper, Alvarez-Gomez and McCoy showed significant predictive consistency between themselves, displaying Median Absolute Performance Errors between 38% and 41%, and intra-individual differences (Wobble) between 14 and 15%. The Kleijn model outperformed the former with a lower Median Absolute Performance Error (16%, 95%CI [0.01; 57]) and Wobble (11%, 95%CI [0.01; 34]). All models displayed considerably wide 95% confidence intervals for all performance metrics, suggesting a significantly variable performance. CONCLUSIONS: Simulated TOF ratios based on published PK/PD models do not accurately predict real intraoperative TOF ratio dynamics. TRIAL REGISTRATION: NCT04518761 (clinicaltrials.gov), registered on 19 August 2020.

A Retrospective Analysis of Biliary Tract Cancer Patients Presented to the Molecular Tumor Board at the Comprehensive Cancer Center Munich.

BACKGROUND AND OBJECTIVE: With the rising importance of precision oncology in biliary tract cancer (BTC), the aim of this retrospective single-center analysis was to describe the clinical and molecular characteristics of patients with BTC who underwent comprehensive genomic profiling (CGP) and were discussed in the CCCMunichLMU molecular tumor board (MTB). PATIENTS AND METHODS: In this single-center observational study, we included BTC patients with intrahepatic cholangiocarcinoma (iCCA), extrahepatic CCA (eCCA), and gallbladder cancer (GB), who had been discussed in the institutional MTB from May 29, 2017, to July 25, 2022. Patients were followed up until 31 January 2023. Data were retrospectively collected by review of medical charts, and MTB recommendation. RESULTS: In total, 153 cases were registered to the MTB with a median follow-up of 15 months. Testing was successful in 81.7% of the patients. CGP detected targetable alterations in 35.3% of our BTC patients (most commonly ARID1A/ERBB2/IDH1/PIK3CA/BRAF-mutations and FGFR2-fusions). Recommendations for molecularly guided therapy were given in 46.4%. Of those, treatment implementation of targeted therapy followed in 19.4%. In patients receiving the recommended treatment, response rate was 57% and median overall survival was 19 months (vs 8 months in the untreated cohort). The progression-free survival ratio of 1.45 suggest a clinical benefit of molecularly guided treatment. CONCLUSIONS: In line with previous work, our series demonstrates feasibility and clinical utility of comprehensive genomic profiling in BTC patients. With the growing number of targeted agents with clinical activity in BTC, CGP should become standard of care in the management of this group of patients.

Long-Term Effect of Guided Implant Surgery on Clinical Outcomes and Peri-Implantitis of Maxillary Implants-An Observational Cohort Study.

(1) Although the accuracy of static computer-aided implant surgery (sCAIP) is well reported, information on its long-term effect on peri-implant health and complications is scarce. (2) Twenty-six patients initially treated were recalled. Implant survival, radiographic bone level, peri-implant health, and complications were registered. A multilevel regression model was applied to study the relationship between the research variables. (3) Sixteen patients participated in this study (average age 58.5 years; range 27.8-73.8). The mean follow-up time was 9.1 years (range 7.3-11.3). Two implants failed, resulting in a survival rate of 97.1%. The mean bone level change corresponded to a loss of 0.63 mm (SD 1.90) for the whole group, 0.17 mm (SD 1.46), and 0.91 mm (SD 2.09) for tooth- and mucosa-supported guides, respectively. The mean PPD for the total group was 4.24 mm (SD 1.25), and 3.79 mm (SD 0.97) and 4.51 mm (SD 1.33) for the tooth- and mucosa-supported guides, respectively. Four implants (6.3%) were diagnosed with peri-implantitis. Coronal deviation was slightly associated with having a negative impact on bone level at follow-up, but this was not statistically significant. Seven patients (43.8%) experienced technical complications. Biological complications were seen in 3/16 patients (18.75%). (4) SCAIP may contribute to more predictable implant placement; the long-term clinical outcome is similar to conventional nonguided surgery.

Incidence of Peri-Implantitis, Technical and Biological Complications of Single Implants Placed with Flap or Flapless Surgery-A 10-12-Year Case-Series.

BACKGROUND: Long-term follow-up of single implants and crowns is scarce, especially when inserted using flapless surgery. AIM: Evaluate survival, peri-implantitis incidence, and technical/biologic complications of solitary implants/crowns after 10-12 years of function. MATERIAL AND METHODS: 49 patients with 53 single implants, initially operated with a one-stage flap (F) or flapless (FL) surgery and delayed loading, were recalled. Implant survival, radiographic bone-level changes compared to baseline, peri-implant health, and soft tissue aesthetics were registered. Differences in implant level between and within groups were statistically tested using the Mann-Whitney U-Test and Wilcoxon Signed Ranks Test, respectively. RESULTS: 36 patients with 40 implants were reassessed, yielding 100% implant and 97.5% crown survival. The bone loss in F (n = 19) was 0.56 mm (SD 0.89; range -0.9-2.02) and -0.85 mm (SD 0.98; range -2.84-0.53) in FL (n = 21), indicative of bone gain in FL (p = 0.003), the latter due to a difference at baseline but bone-level was comparable (p = 0.126). Groups were comparable for probing pocket depth (PPD); (3.32 vs. 3.19 mm), Bleeding Index (BI); (0.15 vs. 0.22), and gingival recession; (0.38 vs. 0.17 mm). According to international criteria, the peri-implantitis incidence was 0%, but 32.5% of the implants/crowns experienced biological or technical complications irrespective of surgical technique. CONCLUSIONS: Solitary implants and crowns show good long-term clinical outcomes and peri-implant health. Flapless surgery is a good alternative to conventional in straightforward cases with sufficient bone volume and proper treatment planning.

SPOCK2 gene expression is downregulated in pancreatic ductal adenocarcinoma cells and correlates with prognosis of patients with pancreatic cancer.

OBJECTIVES: Pancreatic ductal adenocarcinoma (PDAC) represents a widespread form of malignant pancreatic neoplasms and a leading oncologic cause of death in Europe and the USA. Despite advances in understanding its molecular biology, the 5-year survival rate remains low at 10%. The extracellular matrix in PDAC contains proteins, including SPOCK2, which are essential for tumorigenicity and drug resistance. The present study aims to explore the possible role of SPOCK2 in the pathogenesis of PDAC. MATERIALS AND METHODS: Expression of SPOCK2 was evaluated in 7 PDAC cell lines and 1 normal pancreatic cell line using quantitative RT-PCR. Demethylation of the gene was carried out using 5-aza-2'-deoxycytidine (5-aza-dC) treatment with subsequent validation Western Blot analysis. In vitro downregulation of SPOCK2 gene was performed using siRNA transfection. MTT and transwell assays were employed to evaluate the impact of the SPOK2 demethylation on the proliferation and migration of PDAC cells. KM Plotter was applied to analyze a correlation between SPOCK2 mRNA expression and the survival of PDAC patients. RESULTS: In contrast to the normal pancreatic cell line, SPOCK2 expression was significantly downregulated in PDAC cell lines. Treatment with 5-aza-dC, led to increase in SPOCK2 expression in the cell lines tested. Importantly, compared with control cells, transfected with SPOCK2 siRNA cells exhibited increased growth rates and more migration ability. Finally, we demonstrated that a high SPOCK2 expression level correlated with longer overall survival of patients with PDAC. CONCLUSION: The expression of SPOCK2 is downregulated in PDAC as a result of hypermethylation of its corresponding gene. SPOCK2 expression as well as the demethylation of its gene could be a potential marker for PDAC.

[Potential risk to patient safety by discontinuation of production of classical T-drains? : Nationwide survey in Germany and statement of the surgical working group for liver, gall bladder and pancreatic diseases (CALGP) of the German Society for General and Visceral Surgery (DGAV)]. / Potenzielle Patientengefährdung durch Produktionsstopp klassischer T-Drainagen? : Deutschlandweite Umfrage und Stellungnahme der Chirurgischen Arbeitsgemeinschaft für Leber­, Galle- und Pankreaserkrankungen (CALGP) der Deutschen Gesellschaft für Allgemein- und Viszeralchirurgie (DGAV).

The revision of the medical device regulation (MDR) legislation by the European Union and supplementations by the member states has been implemented for good reasons but causes dramatic side effects. It is no longer allowed to produce some rarely used medical devices by various manufacturers that have been successfully used for decades. Before production, a new application to the MDR would be necessary, which is not a realistic business case for companies producing rarely used devices. This problem currently relates to the Kehr T­drain made from soft rubber or latex that has been in use since the late nineteenth century. A surgically placed T­drain, although rarely necessary nowadays, is still in use worldwide for special indications in an attempt to avoid severe complications. These special indications include complex hepato-pancreato-biliary (HPB) procedures and perforations of the upper gastrointestinal (GI) tract where T­drains may be used to secure the hepatojejunostomy or to create a stable fistula. The HPB working group (CALGP) of the German Society of General and Visceral Surgery (DGAV) provides a statement from a surgical perspective on this matter after a survey of all its members. Politics should be very careful not to generalize when implementing useful new regulations at a European and national level. Established and comprehensible treatment concepts should not be restricted and exemption permits should be quickly granted in these cases because the discontinuation of these niche products may lead to potential patient safety issues and even fatalities.

Precision Oncology in Pancreatic Cancer: Experiences and Challenges of the CCCMunichLMU Molecular Tumor Board.

BACKGROUND: In pancreatic cancer, systemic treatment options in addition to chemotherapy remain scarce, and so far only a small proportion of patients benefit from targeted therapies. OBJECTIVE: The patients with pancreatic cancer discussed in the CCCMunichLMU Molecular Tumor Board were reviewed to gain a better real-world understanding of the challenges and chances of precision oncology in this hard-to-treat cancer. METHODS: Patients with pancreatic cancer who received comprehensive genomic profiling and were discussed in the interdisciplinary Molecular Tumor Board between May 2017 and July 2022 were included. These patients' medical charts, comprehensive genomic profiling results, and Molecular Tumor Board recommendations were analyzed in this retrospective cohort study. RESULTS: Molecular profiles of 165 patients with pancreatic cancer were discussed in the Molecular Tumor Board. In the 149 cases where comprehensive genomic profiling was successful, KRAS mutations were detected in 87.9%, TP53 in 53.0%, and CDKN2A in 14.1%. 33.3% of KRAS wild-type patients harbored targetable mutations, while these were only found in 19.1% of patients with the KRAS mutation; however, this difference was not statistically significant. 63.8% of patients with successful testing received a targeted treatment recommendation by the Molecular Tumor Board; however, only 3.2% of these were put into practice. Compared to a historic cohort of patients with pancreatic cancer with synchronous metastatic disease diagnosed between 2010 and 2017, the patients from the pancreatic cancer cohort with synchronous metastatic disease had a longer survival. CONCLUSIONS: This single-center experience emphasizes the challenges of targeted treatment in pancreatic cancer. Very few patients ultimately received the recommended therapies, highlighting the need for more and better targeted treatment options in pancreatic cancer, early comprehensive genomic profiling to allow sufficient time to put Molecular Tumor Board recommendations into practice, and close cooperation with clinical trial units to give patients access to otherwise not available targeted treatments.

Outcomes and risks in palliative pancreatic surgery: an analysis of the German StuDoQ|Pancreas registry.

BACKGROUND: Non-resectability is common in patients with pancreatic ductal adenocarcinoma (PDAC) due to local invasion or distant metastases. Then, biliary or gastroenteric bypasses or both are often established despite associated morbidity and mortality. The current study explores outcomes after palliative bypass surgery in patients with non-resectable PDAC. METHODS: From the prospectively maintained German StuDoQ|Pancreas registry, all patients with histopathologically confirmed PDAC who underwent non-resective pancreatic surgery between 2013 and 2018 were retrospectively identified, and the influence of the surgical procedure on morbidity and mortality was analyzed. RESULTS: Of 389 included patients, 127 (32.6%) underwent explorative surgery only, and a biliary, gastroenteric or double bypass was established in 92 (23.7%), 65 (16.7%) and 105 (27.0%). After exploration only, patients had a significantly shorter stay in the intensive care unit (mean 0.5 days [SD 1.7] vs. 1.9 [3.6], 2.0 [2.8] or 2.1 [2.8]; P < 0.0001) and in the hospital (median 7 days [IQR 4-11] vs. 12 [10-18], 12 [8-19] or 12 [9-17]; P < 0.0001), and complications occurred less frequently (22/127 [17.3%] vs. 37/92 [40.2%], 29/65 [44.6%] or 48/105 [45.7%]; P < 0.0001). In multivariable logistic regression, biliary stents were associated with less major (Clavien-Dindo grade ≥ IIIa) complications (OR 0.49 [95% CI 0.25-0.96], P = 0.037), whereas-compared to exploration only-biliary, gastroenteric, and double bypass were associated with more major complications (OR 3.58 [1.48-8.64], P = 0.005; 3.50 [1.39-8.81], P = 0.008; 4.96 [2.15-11.43], P < 0.001). CONCLUSIONS: In patients with non-resectable PDAC, biliary, gastroenteric or double bypass surgery is associated with relevant morbidity and mortality. Although surgical palliation is indicated if interventional alternatives are inapplicable, or life expectancy is high, less invasive options should be considered.

Textbook outcome in hepato-pancreato-biliary surgery: systematic review.

BACKGROUND: Textbook outcome (TO) is a multidimensional measure reflecting the ideal outcome after surgery. As a benchmarking tool, it provides an objective overview of quality of care. Uniform definitions of TO in hepato-pancreato-biliary (HPB) surgery are missing. This study aimed to provide a definition of TO in HPB surgery and identify obstacles and predictors for achieving it. METHODS: A systematic literature search was conducted using PubMed, Embase, and Cochrane Database according to PRISMA guidelines. Studies published between 1993 and 2021 were retrieved. After selection, two independent reviewers extracted descriptive statistics and derived summary estimates of the occurrence of TO criteria and obstacles for achieving TO using co-occurrence maps. RESULTS: Overall, 30 studies were included. TO rates ranged between 16-69 per cent. Commonly chosen co-occurring criteria to define TO included 'no prolonged length of stay (LOS)', 'no complications', 'no readmission', and 'no deaths'. Major obstacles for achieving TO in HPB surgery were prolonged LOS, complications, and readmission. On multivariable analysis, TO predicted better overall and disease-free survival in patients with cancer. Achievement of TO was more likely in dedicated centres and associated with procedural and structural indicators, including high case-mix index and surgical volume. CONCLUSION: TO is a useful quality measure to benchmark surgical outcome. Future definitions of TO in HPB surgery should include 'no prolonged LOS', 'no complications', 'no readmission', and 'no deaths'.

Intraoral Scanning as an Alternative to Evaluate the Accuracy of Dental Implant Placements in Partially Edentate Situations: A Prospective Clinical Case Series.

(1) Background: For years, Cone-Beam Computed Tomography's (CBCT) have been the golden standard to evaluate implant placement accuracy. By validating Intraoral Scans (IOS) as an alternative to determine implant placement accuracy, a second CBCT could be avoided. (2) Methods: Using dynamic guided implant surgery, 23 implants were placed in 16 partially edentate patients. Preoperatively, both CBCT and IOS (Trios® 3) were obtained and subsequently imported into DTX Studio™ planning software to determine the ideal implant location. A CBCT scan and an IOS including scan abutments were acquired immediately after placement. Both postoperative CBCT and postoperative IOS were used to compare the achieved implant position with the planned implant position and were projected and analyzed using the Implant Position Orthogonal Projection (IPOP) method. (3) Results: Mean differences between the CBCT and IOS methods on the mesio−distal plane were 0.09 mm (p = 0.419) at the tip, 0.01 mm (p = 0.910) at the shoulder, −0.55° (p = 0.273) in angulation, and 0.2 mm (p = 0.280) in implant depth. Mean differences between both methods on the bucco-lingual/bucco-palatal plane were 0.25 mm (p = 0.000) at the tip, 0.12 mm (p = 0.011) at the shoulder, −0.81° (p = 0.002) in angulation, and 0.17 mm (p = 0.372) in implant depth. A statistical analysis was performed using a paired t-test. All mesiodistal deviations between the two methods showed no significant differences (p > 0.05). Buccolingual/buccopalatal deviations showed no significant difference in implant depth deviation. However, significant differences were found at the tip, shoulder, and angulation (p < 0.05). These values are of minimal clinical significance. (4) Conclusions: This study supports the hypothesis that a postoperative IOS is a valid alternative for determining implant placement accuracy.

Patient disposition using the Emergency Severity Index: a retrospective observational study at an interdisciplinary emergency department.

OBJECTIVES: Early patient disposition is crucial to prevent crowding in emergency departments (EDs). Our study aimed to characterise the need of in-house resources for patients treated in the ED according to the Emergency Severity Index (ESI) and the presenting complaint at the timepoint of triage. DESIGN: A retrospective single-centre study was conducted. SETTING: Data of all patients who presented to the interdisciplinary ED of a tertiary care hospital in Munich, Germany, from 2014 to 2017 were analysed. PARTICIPANTS: n=113 694 patients were included. MEASURES: ESI Score, medical speciality according to the chief complaint, mode of arrival, admission rates and discharge destination from the ED were evaluated. RESULTS: Patient disposition varied according to ESI scores in combination with the chief complaint. Patients with low ESI scores were more likely to be admitted after treatment in the ED than patients with high ESI scores. Highly prioritised patients (ESI 1) mainly required admission to an intensive care unit (ICU, 27%), intermediate care unit (IMC, 37%) or immediate intervention (11%). In this critical patient group, 30% of patients with neurological or medical symptoms required immediate intensive care, whereas only 17% of patients with surgical problems were admitted to an ICU. A significant number of patients (particularly with neurological or medical problems) required hospital (and in some cases even ICU or IMC) admission despite high ESI scores. CONCLUSIONS: Overall, ESI seems to be a useful tool to anticipate the need for specialised in-hospital resources on arrival. Patients with symptoms pointing at neurological or medical problems need particular attention as ESI may fail to sufficiently predict the care facility level for this patient group.

Implant-Retained Mandibular Overdentures: Patient-Related Outcome Measurements after Seven Years of Function.

Denture wearers often complain about jeopardized function and reduced quality of life due to lack of prosthesis' retention. Implant-retained mandibular overdentures, on two non-connected implants (2IOD) are well-proven solutions to overcome these issues. We prospectively assessed 69 patients and scrutinized clinical records until at least seven years of function. Thirty-six were retained on Locator® Abutments (LA) and thirty-tree on Ball Abutments (BA). Both systems were compared regarding the type, amount, and total cost of required maintenance. One implant was lost, yielding 98.7% survival after seven years. In total, 438 technical issues occurred: 121 (27.35%) in BA and 317 (72.4%) in LA. Out of these, 343 events (78%) were solved chairside: 191 (43.6%) were replacements of retention caps, 113 (25.8%) were minor acrylic repairs, 26 (5.9%) pressure ulcers had to be relieved, and 13 (3%) were related to abutments. LA required 179 insert replacements compared to 12 in the BA group. The overall initial treatment cost was EUR 3850 (base year of the analysis: 2003). The average total maintenance cost in relation to the initial cost for the LA and BA groups was 19.11 (range 0-82.24%) and 18.91% (range 0-113.26%) respectively (p = 0.540). Conclusions: The seven-year maintenance costs for a 2IOD is acceptable when the patient is regularly checked and professionally maintained. Most events are easily solvable chairside, but a few patients required more expensive interventions, regardless of the type of attachment used.

Case Series on the Long-Term Effect of Three Different Types of Maxillary Implant-Supported Overdentures on Clinical Outcomes and Complications.

(1) Long-term data on maxillary implant overdentures (IODs) are scarce. This case series evaluated three types of IODs supported by six, four or three implants (Anyridge®, Mega'Gen Implant Co., Ltd., Daegu, South-Korea), after 3-5 years in function. (2) A total of 31 patients, with 132 implants, were non-randomly allocated based on available bone or financial limitations. IOD-6 received a telescopic overdenture; IOD-4 a bar; and IOD-3, non-connected implants with locator abutments. Implant survival, bone level changes, probing pocket depth (PPD), plaque index, bleeding on probing (BOP), and technical, biological and aesthetic complications were registered. Impact of suprastructures on bone loss and PPD was analyzed using mixed-effect linear regression models. Differences between groups were analyzed using the ANOVA test for BOP, and Kruskal Wallis test for complications. (3) In total, 23 patients participated in the follow-up (9 female, 14 male), with average age of 62.2 years; 7, 11 and 5 patients in IOD-6, IOD-4 and IOD-3, respectively. Implant survival after 4.4 years on average, was 98% in total; 100%, 97.8% and 93.3% for IOD-6, IOD-4 and IOD-3, respectively. Mean bone loss corresponded to 0.68 mm (SD 1.06, range -4.57-1.51), 0.39 mm (SD 1.06, range -3.6-2.43), and 1.42 mm (SD 1.68, range -5.11-0.74) for IOD-6, IOD-4 and IOD-3, respectively. A statistically significant difference was seen in bone level when comparing IOD-6 to IOD-3 (p = 0.044), and IOD-4 to IOD-3 (p = 0.018). Mean PPD was 3.8 mm (SD: 0.69; range 2.5-5.3), 3.5 mm (SD 0.59; range 2.33-5), and 3.2 mm (SD 0.56; range 2-4) for IOD-6, IOD-4 and IOD-3, respectively, and differed significantly between IOD-6 and IOD-3 (p = 0.029). Incidence of peri-implantitis was 1%. No differences were seen for complications between groups. (4) Maxillary IOD supported by four to six implants is the most reliable treatment regarding implant survival and peri-implant health. More research is needed in the clinical outcomes, in particular the peri-implant health, and complications of maxillary IODs, especially with a reduced number of implants.

Specific intraoperative antibiotic therapy abrogates the negative effect of biliary contamination on the Comprehensive Complication Index after pancreatic head resection.

BACKGROUND: The effect of bacterobilia on morbidity after pancreatoduodenectomy remains unclear. The aim of this study was to examine the influence of positive intraoperative bile cultures and perioperative antibiotic prophylaxis on morbidity measured using the Comprehensive Complication Index, a weighted composite of postoperative complications. METHODS: Intraoperative bile cultures of 182 patients who underwent pancreatoduodenectomy were obtained. We examined the effect of intraoperative bile cultures and perioperative antibiotic prophylaxis on the Comprehensive Complication Index and the occurrence of postoperative complications. To this aim, we performed general linear models controlling for relevant demographic and perioperative factors. RESULTS: Positive (versus negative) intraoperative bile cultures were associated with a higher mean Comprehensive Complication Index (25.34 vs 16.81, P = .025). The mean Comprehensive Complication Index differed significantly between individuals with positive intraoperative bile cultures and bacterial strains not covered by perioperative antibiotic prophylaxis (26.2) versus positive intraoperative bile cultures and bacterial strains sensitive to perioperative antibiotic prophylaxis (22.7) (P = .045). Positive (versus negative) intraoperative bile cultures were associated with 4.75 times (95% confidence interval: 1.74-13.00, P = .002) greater odds of wound infections. The odds of wound infection were 1.93 times (95% confidence interval: .47-8.04) greater in those with positive intraoperative bile cultures and adequate perioperative antibiotic prophylaxis and 6.14 times (95% confidence interval: 2.17-17.35) greater in those with positive intraoperative bile cultures and inadequate perioperative antibiotic prophylaxis (versus negative intraoperative bile cultures) (P = .001). CONCLUSION: Bacterobilia is associated with a significant increase in Comprehensive Complication Index and wound infections after pancreatoduodenectomy, which may be reduced by administration of a specific perioperative antibiotic prophylaxis. Acquisition of bile cultures sampled through the external conduit of patients with preoperative biliary drainage could help in selecting a specific perioperative antibiotic prophylaxis and patients with bile duct stents might benefit from broad spectrum perioperative antibiotic prophylaxis.

Stent-graft placement for hepatic arterial bleeding: assessment of technical efficacy and clinical outcome in a tertiary care center.

BACKGROUND: To evaluate technical and clinical results of stent-graft (SG) placement for bleeding from the hepatic artery (HA). METHODS: All patients intended and treated with SG deployment for bleeding from the HA at single center from January 2012 to May 2020 were retrospectively identified, and procedural details, risk factors for rebleeding, SG occlusion and mortality were analyzed. RESULTS: Twenty-seven patients (mean age 68.8 ± 10.1) were identified, and 25 patients underwent 26 SG procedures. Twenty-four patients had recent surgery. The technical success rate was 92.8%. Three patients (3/25) had rebleeding (88% clinical success). Intensive-care need before the procedure (p = 0.013) and smaller stent-graft size (≤4 mm, p = 0.032) were related to clinical failure. Twenty-two patients had follow-up imaging. The SG maintained patency in 10 (45.4%) patients at the most recent imaging. Only placement of SG distal to the HA bifurcation (p = 0.012) was related to occlusion. The 30-day and in-hospital mortality rate after SG was 8% and 24%. In-hospital mortality was associated with the intraabdominal septic source (p = 0.010) and revision surgery (p = 0.001). CONCLUSION: Stent-grafts are effective in the emergent treatment of HA bleeding. Mortality is mainly related to the general condition of the patient, and stent-grafts offer time to treat underlying medical problems sufficiently.

Pylorus resection versus pylorus preservation in pancreatoduodenectomy (PyloResPres): study protocol and statistical analysis plan for a German multicentre, single-blind, surgical, registry-based randomised controlled trial.

INTRODUCTION: Partial pancreatoduodenectomy (PD) is the treatment of choice for various benign and malignant tumours of the pancreatic head or the periampullary region. For reconstruction of the gastrointestinal passage, two stomach-preserving PD variants exist: pylorus preservation PD (ppPD) or pylorus resection PD (prPD) with preservation of the stomach. In pancreatic surgery, delayed gastric emptying (DGE) remains a serious complication after PD with an incidence varying between 4.5% and 45%, potentially delaying hospital discharge or further treatment, for example, adjuvant chemotherapy. Evidence is lacking to assess, which variant of PD entails fewer postoperative DGE. METHODS AND ANALYSIS: The protocol of a large-scale, multicentre, pragmatic, two-arm parallel-group, registry-based randomised controlled trial (rRCT) using a two-stage group-sequential design is presented. This patient-blind rRCT aims to demonstrate the superiority of prPD over ppPD with respect to the overall incidence of DGE within 30 days after index surgery in a German real-world setting. A total of 984 adults undergoing elective PD for any indication will be randomised in a 1:1 ratio. Patients will be recruited at about 30 hospitals being members of the StuDoQ|Pancreas registry established by the German Society of General and Visceral Surgery. The postoperative follow-up for each patient will be 30 days. The primary analysis will follow an intention-to-treat approach and applies a binary logistic random intercepts model. Secondary perioperative outcomes include overall severe morbidity (Clavien-Dindo classification), blood loss, 30-day all-cause mortality, postoperative hospital stay and operation time. Complication rates and adverse events will be closely monitored. ETHICS AND DISSEMINATION: This protocol was approved by the leading ethics committee of the Medical Faculty of the Ludwig-Maximilians-Universität, Munich (reference number 19-221). The results will be published in a peer-reviewed journal and presented at international conferences. Study findings will also be disseminated via the website (http://www.dgav.de/studoq/pylorespres/). TRIAL REGISTRATION NUMBER: DRKS-ID: DRKS00018842.

[Conservative or surgical treatment of chronic pancreatitis?] / Konservative oder chirurgische Therapie der chronischen Pankreatitis?

The cardinal symptom of chronic pancreatitis is severe belt-like upper abdominal pain, which requires immediate and adequate treatment. Furthermore, advanced stage chronic pancreatitis is often associated with complications, such as pancreatic pseudocysts, pancreatic duct stones and stenosis as well as biliary stenosis. The various endoscopic and surgical treatment options for chronic pancreatitis patients have been controversially discussed for decades. The new German S3 guidelines on pancreatitis now clearly define the best treatment options depending on the indications for treatment. For the treatment of pain in chronic pancreatitis it has been known for a long time that a surgical intervention is superior to endoscopic intervention concerning long-term pain relief. The recently published ESCAPE study has further underlined this by showing that early surgical intervention was superior to a step-up approach with initial endoscopic treatment. For the treatment of pancreatic pain, an initial endoscopic treatment attempt is therefore justified for short-term pain relief but in the midterm and long term, surgical intervention is the treatment of choice. In contrast, pancreatic pseudocysts, solitary proximally situated pancreatic duct stones and benign biliary strictures (except in calcifying pancreatitis) can nowadays generally be managed endoscopically. For distal pancreatic duct stones and symptomatic pancreatic duct stenosis surgical treatment is again the method of choice. This review article discusses these indication-related procedures in detail and explains them in relation to the recently published S3 guidelines on pancreatitis of the German Society for Gastroenterology, Digestive and Metabolic Diseases (DGVS).