Robot-assisted versus laparoscopic pancreatoduodenectomy: a pan-European multicenter propensity-matched study.

BACKGROUND: The use of robot-assisted and laparoscopic pancreatoduodenectomy is increasing, yet large adjusted analyses that can be generalized internationally are lacking. This study aimed to compare outcomes after robot-assisted pancreatoduodenectomy and laparoscopic pancreatoduodenectomy in a pan-European cohort. METHODS: An international multicenter retrospective study including patients after robot-assisted pancreatoduodenectomy and laparoscopic pancreatoduodenectomy from 50 centers in 12 European countries (2009-2020). Propensity score matching was performed in a 1:1 ratio. The primary outcome was major morbidity (Clavien-Dindo ≥III). RESULTS: Among 2,082 patients undergoing minimally invasive pancreatoduodenectomy, 1,006 underwent robot-assisted pancreatoduodenectomy and 1,076 laparoscopic pancreatoduodenectomy. After matching 812 versus 812 patients, the rates of major morbidity (31.9% vs 29.6%; P = .347) and 30-day/in-hospital mortality (4.3% vs 4.6%; P = .904) did not differ significantly between robot-assisted pancreatoduodenectomy and laparoscopic pancreatoduodenectomy, respectively. Robot-assisted pancreatoduodenectomy was associated with a lower conversion rate (6.7% vs 18.0%; P < .001) and higher lymph node retrieval (16 vs 14; P = .003). Laparoscopic pancreatoduodenectomy was associated with shorter operation time (446 minutes versus 400 minutes; P < .001), and lower rates of postoperative pancreatic fistula grade B/C (19.0% vs 11.7%; P < .001), delayed gastric emptying grade B/C (21.4% vs 7.4%; P < .001), and a higher R0-resection rate (73.2% vs 84.4%; P < .001). CONCLUSION: This European multicenter study found no differences in overall major morbidity and 30-day/in-hospital mortality after robot-assisted pancreatoduodenectomy compared with laparoscopic pancreatoduodenectomy. Further, laparoscopic pancreatoduodenectomy was associated with a lower rate of postoperative pancreatic fistula, delayed gastric emptying, wound infection, shorter length of stay, and a higher R0 resection rate than robot-assisted pancreatoduodenectomy. In contrast, robot-assisted pancreatoduodenectomy was associated with a lower conversion rate and a higher number of retrieved lymph nodes as compared with laparoscopic pancreatoduodenectomy.

Minimally invasive robot-assisted and laparoscopic distal pancreatectomy in a pan-European registry a retrospective cohort study.

BACKGROUND: International guidelines recommend monitoring of the use and outcome of minimally invasive pancreatic surgery (MIPS). However, data from prospective international audits on minimally invasive distal pancreatectomy (MIDP) are lacking. This study examined the use and outcome of robot-assisted (RDP) and laparoscopic (LDP) distal pancreatectomy in the E-MIPS registry. MATERIALS AND METHODS: Post-hoc analysis in a prospective audit on MIPS, including consecutive patients undergoing MIDP in 83 centers from 19 European countries (01-01-2019/31-12-2021). Primary outcomes included intraoperative events (grade 1: excessive blood loss, grade 2: conversion/change in operation, grade 3: intraoperative death), major morbidity, and in-hospital/30-day mortality. Multivariable logistic regression analyses identified high-risk groups for intraoperative events. RDP and LDP were compared in the total cohort and in high-risk groups. RESULTS: Overall, 1672 patients undergoing MIDP were included; 606 (36.2%) RDP and 1066 (63.8%) LDP. The annual use of RDP increased from 30.5% to 42.6% (P<0.001). RDP was associated with fewer grade 2 intraoperative events compared to LDP (9.6% vs. 16.8%, P<0.001), with longer operating time (238 vs. 201 minutes,P<0.001). No significant differences were observed between RDP and LDP regarding major morbidity (23.4% vs. 25.9%, P=0.264) and in-hospital/30-day mortality (0.3% vs. 0.8%, P=0.344). Three high-risk groups were identified; BMI>25 kg/m2, previous abdominal surgery, and vascular involvement. In each group, RDP was associated with fewer conversions and longer operative times. CONCLUSION: This European registry-based study demonstrated favorable outcomes for MIDP, with mortality rates below 1%. LDP remains the predominant approach, whereas the use of RDP is increasing. RDP was associated with less conversions and longer operative time, including in high-risk subgroups. Future randomized trials should confirm these findings and assess cost differences.

Iatrogenic or recurrent bladder neck contracture treated by the Palminteri-Ferrari technique: a new way to approach a frustrating condition.

PURPOSE: Bladder neck stricture (BNS) is a bothersome disease which may affect patients after trauma or prostatic surgery. It is frustrating due to the low durable success rate of currently available surgical techniques. The aim of the study is to explore the efficacy of a novel technique. MATERIALS & METHODS: The surgical protocol was developed by two high case-volume surgeons. The technique consists of Holmium laser incisions at 3-6-9-12 o'clock. Subsequently, triamcinolone acetonide 40 mg is injected. Two months later, the BNS is endoscopically checked in operatory room and re-procedure take place, if necessary (max 3 times). Failure was defined as the need of definitive urinary diversion. Subjective satisfaction was measured through PGI-I Questionnaire. RESULTS: A total of 45 patients were enrolled. Median age was 63 (IQR 59-69) years and BNS developed by different causes. Naïve BNS procedure patients were 12 (26.7%), others 33 (73.3%) underwent median 2 (IQR 1-4) previous urethrotomies, including 16 other surgeries. Suprapubic bladder catheter was present in 34 patients (75.6%). No complications were registered. Re-procedure at control was necessary in 24 patients (53.3%) for a median of 1 (IQR 1-3) procedures. At median follow-up of 18 months, failures were 4 (8.9%) and urinary incontinence was reported in 2 patients (4.5%) who required incontinence surgery. Median PGI-I was 2. CONCLUSIONS: Our technique of BNS treatment allows good outcomes and high rate of subjective improvement amongst patients. Moreover, naïve patients seem to have better results. However, longer follow-up and higher sample size are mandatory to further assess these data.

Office-based management of Non-Muscle Invasive Bladder Cancer (NMIBC): A position paper on current state of the art and future perspectives.

To the Editor, Bladder cancer is one of the most common cancers in humans, representing the 7th and 17th type of neoplasm in both genders. Its incidence and mortality are quite heterogeneous in different countries and are due to different risk factors, quality and prevalence of healthcare and the possibility of early diagnosis and treatment of the tumor and its potential recurrences [...].

Small intestinal submucosa graft bulbar urethroplasty is a viable technique: results compared to buccal mucosa graft urethroplasty after propensity score matching.

PURPOSE: Small intestinal submucosa (SIS) graft urethroplasty has been employed to decrease buccal mucosa morbidity and facilitate the procedure. The first published series had a short follow-up, inhomogeneous patient selection, and a lack of a control group. Our purpose is to report treatment outcomes at 13 years in a propensity score-matched cohort comparing bulbar urethroplasty with SIS (SISU) or buccal mucosa (BMU). METHODS: From our institutional database of 1132 bulbar urethroplasties, we used propensity score matching with the nearest-neighbor method without replacement to generate a study sample of 25 BMU and 25 SISU. Failure was defined as any treatment after urethroplasty. Survival analyses were used to analyze treatment failure occurrence with data censored at 156mo. RESULTS: Matching resulted in a complete correction of bias between the two samples except for the follow-up duration, which was slightly longer in the SIS group. The cumulative treatment success probability of BMU and SISU at 156mo was 83.4% and 68%, respectively. At multivariable Cox regression, SIS graft, previous urethrotomy, stricture length, and lower postoperative Qmax (within 2mo after catheter removal) were predictors of failure. Stricture length had a more remarkable effect in SISU, with estimated survival probabilities from the Cox model lower than 80% in strictures > = 3 cm. CONCLUSION: SIS has poorer outcomes compared to BM but may still be useful when BM grafting is not possible. The best candidates for SISU, with similar success to BMU, are patients with strictures shorter than 3 cm, preferably without a history of DVIU.

Preoperative lateral lymph node features and impact on local recurrence after neoadjuvant chemoradiotherapy and total mesorectal excision for locally advanced rectal cancer: results from a multicentre international cohort study.

AIM: Locally advanced rectal cancer (LARC) is commonly treated with neoadjuvant chemoradiotherapy (nCRT) and total mesorectal excision (TME) to reduce local recurrence (LR) and improve survival. However, LR, particularly associated with lateral lymph node (LLN) involvement, remains a concern. The aim of this study was to investigate preoperative factors associated with LLN involvement and their impact on LR rates in LARC patients undergoing nCRT and curative surgery. METHOD: This multicentre retrospective study, including four academic high-volume institutions, involved 301 consecutive adult LARC patients treated with nCRT and curative surgery between January 2014 and December 2019 who did not undergo lateral lymph node dissection (LLND). Baseline and restaging pelvic MRIs were evaluated for suspicious LLNs based on institutional criteria. Patients were divided into two groups: cLLN+ (positive nodes) and cLLN- (no suspicious nodes). Primary outcome measures were LR and lateral local recurrence (LLR) rates at 3 years. RESULTS: Among the cohort, 15.9% had suspicious LLNs on baseline MRI, and 9.3% had abnormal LLNs on restaging MRI. At 3 years, LR and LLR rates were 4.0% and 1.0%, respectively. Ten out of 12 (83.3%) patients with LR showed no suspicious LLNs at the baseline MRI. Abnormal LLNs on MRI were not independent risk factors for LR, distant recurrence or disease-free survival. CONCLUSION: Abnormal LLNs on baseline and restaging MRI assessment did not impact LR and LLR rates in this cohort of patients with LARC submitted to nCRT and curative TME surgery.

Implementation and outcome of minimally invasive pancreatoduodenectomy in Europe: a registry-based retrospective study A critical appraisal of the first 3 years of the E-MIPS registry.

BACKGROUND: International multicenter audit-based studies focusing on the outcome of minimally invasive pancreatoduodenectomy (MIPD) are lacking. The European registry for Minimally Invasive Pancreatic Surgery (E-MIPS) is the E-AHPBA endorsed registry aimed to monitor and safeguard the introduction of MIPD in Europe. MATERIALS AND METHODS: A planned analysis of outcomes among consecutive patients after MIPD from 45 centers in 14 European countries in the E-MIPS registry (2019-2021). Main outcomes of interest were major morbidity (Clavien-Dindo grade ≥3) and 30-day/in-hospital mortality. RESULTS: Overall, 1,336 patients after MIPD were included (835 robot-assisted (R-MIPD) and 501 laparoscopic MIPD (L-MIPD)). Overall, 20 centers performed R-MIPD, 15 centers L-MIPD, and 10 centers both. Between 2019 and 2021, the rate of centers performing L-MIPD decreased from 46.9% to 25%, whereas for R-MIPD this increased from 46.9% to 65.6%. Overall, the rate of major morbidity was 41.2%, 30-day/in-hospital mortality 4.5%, conversion rate 9.7%, POPF grade B/C 22.7%, and PPH grade B/C 10.8%. Median length of hospital stay was 12 days [IQR 8-21]. A lower rate of major morbidity, POPF grade B/C, PPH grade BH/C, DGE grade B/C, percutaneous drainage and readmission was found after L-MIPD. The number of centers meeting the Miami Guidelines volume cut-off of ≥20 MIPDs annually increased from 9 (28.1%) in 2019 to 12 (37.5%) in 2021 (P=0.424). Rates of conversion (7.4% vs. 14.8% P<0.001) and reoperation (8.9% vs. 15.1%) P<0.001) were lower in centers which fulfilled the Miami volume cut-off. CONCLUSION: During the first 3 years of the pan-European E-MIPS registry, morbidity and mortality rates after MIPD were acceptable. A shift is ongoing from L-MIPD to R-MIPD. Variations in outcomes between the two minimally invasive approaches and the impact of the volume-cut-off should be further evaluated over a longer time period.

Is water vapor thermal therapy safe and feasible in elderly and frail men? The Italian experience.

PURPOSE: In recent years, water vapor thermal therapy (WVTT) has spread as minimally invasive technique in lower urinary tract symptoms due to benign prostatic hyperplasia treatment. Even if its safety and feasibility have been largely proved in young men, nobody has proved the same feasibility and safety in the elderly (men older than 75 years old). Our aim is to compare WVTT safety outcomes in men older than 75 with younger men. METHODS: We prospectively collected data on men who underwent water vapor thermal therapy from 2019. We compared data on operative time, number of injections, intra-operative and post-operative complications, reinterventions rate. RESULTS: We enrolled 426 patients; among these, 60 were older than 75 years old, 366 were younger. Our cohorts of patients had similar results in terms of intra-operative and post-operative complications. Operative time accounts about 11 min for both groups (p = 0.535), total number of injections was seven for young men and eight for elderly (p = 0.314). We found no intra-operative complications in elderly men group and only one in the younger group (p = 0.678), while five younger men underwent clot retention, and two elderly men experienced this complication (p = 0.239). Only one transfusion occurred in the elderly group. No differences between groups occurred in terms of length of stay, post-operative urinary retention and reintervention rate, while catheterization time was longer in the elderly men. CONCLUSION: WVTT is a safe procedure in elderly patients with comparable intra-operative and post-operative complication rate in comparison with younger patients.

Pancreatojejunostomy: standing on the shoulders of giants. A single centre retrospective analysis.

Gaining experience in pancreatic surgery could be demanding especially when minimally invasive approach is used. Pancreatojejunostomy (PJ) is one of the most critical steps during pancreatoduodenectomy (PD). Our aim was to investigate the impact of a surgeon's experience in performing PJ, especially in a subgroup of patients undergoing laparoscopic PD (LPD). Data of consecutive patients undergoing PD from 2017 to 2022 were prospectively collected and retrospectively analyzed. Patients were divided into two groups: M group included patients in which PJ was performed by an experienced surgeon, D group included those receiving PJ by a less experienced one. The groups were compared in terms of postoperative outcomes. 187 patients were selected (157 in group M and 30 in group D). The cohorts differed in terms of median age (68 vs 74 years, p = 0.016), and previous abdominal surgery (41.4% vs 66.7%, p = 0.011), while no difference was found regarding risk of postoperative pancreatic fistula (POPF). The groups did not differ in terms of surgical outcomes. POPF rate was 15.9% and 10% in the M and D group (p = 0.578), respectively. Among patients undergoing laparoscopic PJ POPF rate was 16.0% and 17.7% in the M and D group (p = 0.867), respectively, without difference. No difference was found in terms of POPF in patients undergoing PD independently from the surgeon who performed the PJ, even during LPD. Moderate/high FRS, BMI > 30 kg/m2 and male sex, but not the surgeon who performed the PJ anastomosis, were independent predictors of POPF.

The Brescia Internationally Validated European Guidelines on Minimally Invasive Pancreatic Surgery (EGUMIPS).

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.

Valved Conduits for Right Ventricular Outflow Tract Reconstruction: A Review of Current Technologies and Future Directions.

The need for right ventricular outflow tract reconstruction is common and growing in congenital heart surgery given expanding indications for the repair of congenital as well as acquired heart disease. Various valved conduit options currently exist including homografts, xenograft pulmonary valved conduits (Contegra™), and porcine valved conduits. The major limitation for all conduits is implant durability, which requires reoperation. Currently, cryopreserved homografts are often used given their superiority shown in long-term data. Significant limitations remain in the cost and availability of the graft, particularly for smaller sizes. Contegra conduits are available in a variety of sizes. Nonetheless, the data regarding long-term durability are less robust and studies comparing durability with homografts have been conflicting. Additionally, there is concern for increased rates of late endocarditis in this conduit. Porcine valved conduits offer a reliable option but are limited by structural valve degeneration associated with all types of bioprosthetic heart valve replacements. New developments in the field of tissue engineering have produced promising bio-restorative valved conduits that may overcome many of the limitations of previous conduit technologies. These remain in the early stages of clinical testing. This review summarizes the clinical data surrounding the conduits used most commonly in clinical practice today and explores emerging technologies that may bring us closer to developing the ideal conduit.

New minimally invasive solutions for Benign Prostatic Obstruction (BPO) management: A position paper from the UrOP (Urologi Ospedalità Gestione Privata).

To the Editor, In recent years, alternative solutions have been proposed to obtain effective results comparable to TURP, which is currently considered the gold standard, and laser vapo-enucleation techniques (1, 2), but with the possibility of maintaining sexual functions. In recent years there has been a growing trend towards ejaculation preservation. Although the results of TURP (3), and most laser enucleation techniques are undoubted in the Benign Prostatic Hyperplasia (BPH) and Lower Urinary Tract Symptoms (LUTS) management, they often lack in the preservation of ejaculation. All the alternative recently proposed interventions (Rezum, AquaBeam, Urolift, TPLA, i-TIND, LEST) are procedures considered by some authors to be promising in both managing BPO and preserving sexual functions. However, all these methods are limited by a lack of long-term follow-up that would evaluate the efficacy over time, possible complications related to the method and the correct patient selection for a specific method. The aim of this letter is to summarize the available evidence and provide clinicians with practical recommendations on the use of the brand new minimally invasive techniques for the management of BPO. [...].

Minimally invasive versus open pancreatoduodenectomy for pancreatic and peri-ampullary neoplasm (DIPLOMA-2): study protocol for an international multicenter patient-blinded randomized controlled trial.

BACKGROUND: Minimally invasive pancreatoduodenectomy (MIPD) aims to reduce the negative impact of surgery as compared to open pancreatoduodenectomy (OPD) and is increasingly becoming part of clinical practice for selected patients worldwide. However, the safety of MIPD remains a topic of debate and the potential shorter time to functional recovery needs to be confirmed. To guide safe implementation of MIPD, large-scale international randomized trials comparing MIPD and OPD in experienced high-volume centers are needed. We hypothesize that MIPD is non-inferior in terms of overall complications, but superior regarding time to functional recovery, as compared to OPD. METHODS/DESIGN: The DIPLOMA-2 trial is an international randomized controlled, patient-blinded, non-inferiority trial performed in 14 high-volume pancreatic centers in Europe with a minimum annual volume of 30 MIPD and 30 OPD. A total of 288 patients with an indication for elective pancreatoduodenectomy for pre-malignant and malignant disease, eligible for both open and minimally invasive approach, are randomly allocated for MIPD or OPD in a 2:1 ratio. Centers perform either laparoscopic or robot-assisted MIPD based on their surgical expertise. The primary outcome is the Comprehensive Complication Index (CCI®), measuring all complications graded according to the Clavien-Dindo classification up to 90 days after surgery. The sample size is calculated with the following assumptions: 2.5% one-sided significance level (α), 80% power (1-ß), expected difference of the mean CCI® score of 0 points between MIPD and OPD, and a non-inferiority margin of 7.5 points. The main secondary outcome is time to functional recovery, which will be analyzed for superiority. Other secondary outcomes include post-operative 90-day Fitbit™ measured activity, operative outcomes (e.g., blood loss, operative time, conversion to open surgery, surgeon-reported outcomes), oncological findings in case of malignancy (e.g., R0-resection rate, time to adjuvant treatment, survival), postoperative outcomes (e.g., clinically relevant complications), healthcare resource utilization (length of stay, readmissions, intensive care stay), quality of life, and costs. Postoperative follow-up is up to 36 months. DISCUSSION: The DIPLOMA-2 trial aims to establish the safety of MIPD as the new standard of care for this selected patient population undergoing pancreatoduodenectomy in high-volume centers, ultimately aiming for superior patient recovery. TRIAL REGISTRATION: ISRCTN27483786. Registered on August 2, 2023.

Learning curve of laparoscopic cholecystectomy: a risk-adjusted cumulative summation (RA-CUSUM) analysis of six general surgery residents.

BACKGROUND: Laparoscopic cholecystectomy (LapC) is one of the most frequently performed surgical procedures worldwide. Reaching technical competency in performing LapC is considered one essential task for young surgeons. Investigating the learning curve for LapC (LC-LapC) may provide important information regarding the learning process and guide the training pathway of residents, improving educational outcomes. The present study aimed to investigate LC-LapC among general surgery residents (GSRs). METHODS: Operative surgical reports of consecutive patients undergoing LapC performed by GSRs attending the General Surgery Residency Program at the University of Milan were analysed. Data on patient- and surgery-related variables were obtained from the ICD-9-CM diagnosis codes and gathered. A multidimensional assessment of the LC was performed through Cumulative Sum (CUSUM) and Risk-Adjusted (RA)-CUSUM analysis. RESULTS: 340 patients operated by 6 GSRs were collected. The CUSUM and RA-CUSUM graphs based on surgical failures allowed to distinguish two defined phases for all GSRs: an initial phase ending at the peak, so-called learning phase, followed by a phase in which there was a significant decrease in failure incidence, so-called proficiency phase. The learning phase was completed for all GSRs at most within 25 procedures, but the trend of the curves and the number of procedures needed to achieve technical competency varied among operators ranging between 7 and 25. CONCLUSIONS: The present study suggested that at most 25 procedures might be sufficient to acquire technical competency in LapC. The variability in the number of procedures needed to complete the LC, ranging between 7 and 25, could be due to the heterogeneous scenarios in which LapC was performed, and deserves to be investigated through a prospective study involving a larger number of GSRs and institutions.

Functional differences in human aortic valve interstitial cells from patients with varying calcific aortic valve disease.

Calcific aortic valve disease (CAVD) is characterized by progressive stiffening of aortic valve (AV) tissues, inducing stenosis and insufficiency. Bicuspid aortic valve (BAV) is a common congenital defect in which the AV has two leaflets rather than three, with BAV patients developing CAVD decades years earlier than in the general population. Current treatment for CAVD remains surgical replacement with its continued durability problems, as there are no pharmaceutical therapies or other alternative treatments available. Before such therapeutic approaches can be developed, a deeper understanding of CAVD disease mechanisms is clearly required. It is known that AV interstitial cells (AVICs) maintain the AV extracellular matrix and are typically quiescent in the normal state, transitioning into an activated, myofibroblast-like state during periods of growth or disease. One proposed mechanism of CAVD is the subsequent transition of AVICs into an osteoblast-like phenotype. A sensitive indicator of AVIC phenotypic state is enhanced basal contractility (tonus), so that AVICs from diseased AV will exhibit a higher basal tonus level. The goals of the present study were thus to assess the hypothesis that different human CAVD states lead to different biophysical AVIC states. To accomplish this, we characterized AVIC basal tonus behaviors from diseased human AV tissues embedded in 3D hydrogels. Established methods were utilized to track AVIC-induced gel displacements and shape changes after the application of Cytochalasin D (an actin polymerization inhibitor) to depolymerize the AVIC stress fibers. Results indicated that human diseased AVICs from the non-calcified region of TAVs were significantly more activated than AVICs from the corresponding calcified region. In addition, AVICs from the raphe region of BAVs were more activated than from the non-raphe region. Interestingly, we observed significantly greater basal tonus levels in females compared to males. Furthermore, the overall AVIC shape changes after Cytochalasin suggested that AVICs from TAVs and BAVs develop different stress fiber architectures. These findings are the first evidence of sex-specific differences in basal tonus state in human AVICs in varying disease states. Future studies are underway to quantify stress fiber mechanical behaviors to further elucidate CAVD disease mechanisms.

Study protocol for a multicenter randomized controlled trial to compare radiofrequency ablation with surgical resection for treatment of pancreatic insulinoma.

BACKGROUND: Insulinoma is the most common functional pancreatic neuroendocrine tumor and treatment is required to address symptoms associated with insulin hypersecretion. Surgical resection is effective but burdened by high rate of adverse events (AEs). Endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) demonstrated encouraging results in terms of safety and efficacy for the management of these tumors. However, studies comparing surgery and EUS-RFA are lacking. AIMS: The primary aim is to compare EUS-RFA with surgery in term of safety (overall rate of AEs). Secondary endpoints include: (a) severe AEs rate; (b) clinical effectiveness; (c) patient's quality of life; (d) length of hospital stay; (e) rate of local/distance recurrence; (f) need of reintervention; (g) rate of endocrine and exocrine pancreatic insufficiency; (h) factors associated with EUS-RFA related AEs and clinical effectiveness. METHODS: ERASIN-RCT is an international randomized superiority ongoing trial in four countries. Sixty patients will be randomized in two arms (EUS-RFA vs surgery) and outcomes compared. Two EUS-RFA sessions will be allowed to achieve symptoms resolution. Randomization and data collection will be performed online. DISCUSSION: This study will ascertain if EUS-RFA can become the first-line therapy for management of small, sporadic, pancreatic insulinoma and be included in a step-up approach in case of clinical failure.

Prospective minimally invasive pancreatic resections from the IGOMIPS registry: a snapshot of daily practice in Italy on 1191 between 2019 and 2022.

This retrospective analysis of the prospective IGOMIPS registry reports on 1191 minimally invasive pancreatic resections (MIPR) performed in Italy between 2019 and 2022, including 668 distal pancreatectomies (DP) (55.7%), 435 pancreatoduodenectomies (PD) (36.3%), 44 total pancreatectomies (3.7%), 36 tumor enucleations (3.0%), and 8 central pancreatectomies (0.7%). Spleen-preserving DP was performed in 109 patients (16.3%). Overall incidence of severe complications (Clavien-Dindo ≥ 3) was 17.6% with a 90-day mortality of 1.9%. This registry analysis provided some important information. First, robotic assistance was preferred for all MIPR but DP with splenectomy. Second, robotic assistance reduced conversion to open surgery and blood loss in comparison to laparoscopy. Robotic PD was also associated with lower incidence of severe postoperative complications and a trend toward lower mortality. Fourth, the annual cut-off of ≥ 20 MIPR and ≥ 20 MIPD improved selected outcome measures. Fifth, most MIPR were performed by a single surgeon. Sixth, only two-thirds of the centers performed spleen-preserving DP. Seventh, DP with splenectomy was associated with higher conversion rate when compared to spleen-preserving DP. Eighth, the use of pancreatojejunostomy was the prevalent reconstruction in PD. Ninth, final histology was similar for MIPR performed at high- and low-volume centers, but neoadjuvant chemotherapy was used more frequently at high-volume centers. Finally, this registry analysis raises important concerns about the reliability of R1 assessment underscoring the importance of standardized pathology of pancreatic specimens. In conclusion, MIPR can be safely implemented on a national scale. Further analyses are required to understand nuances of implementation of MIPR in Italy.

Learning Curves of Minimally Invasive Distal Pancreatectomy in Experienced Pancreatic Centers.

Importance: Understanding the learning curve of a new complex surgical technique helps to reduce potential patient harm. Current series on the learning curve of minimally invasive distal pancreatectomy (MIDP) are mostly small, single-center series, thus providing limited data. Objective: To evaluate the length of pooled learning curves of MIDP in experienced centers. Design, Setting, and Participants: This international, multicenter, retrospective cohort study included MIDP procedures performed from January 1, 2006, through June 30, 2019, in 26 European centers from 8 countries that each performed more than 15 distal pancreatectomies annually, with an overall experience exceeding 50 MIDP procedures. Consecutive patients who underwent elective laparoscopic or robotic distal pancreatectomy for all indications were included. Data were analyzed between September 1, 2021, and May 1, 2022. Exposures: The learning curve for MIDP was estimated by pooling data from all centers. Main Outcomes and Measures: The learning curve was assessed for the primary textbook outcome (TBO), which is a composite measure that reflects optimal outcome, and for surgical mastery. Generalized additive models and a 2-piece linear model with a break point were used to estimate the learning curve length of MIDP. Case mix-expected probabilities were plotted and compared with observed outcomes to assess the association of changing case mix with outcomes. The learning curve also was assessed for the secondary outcomes of operation time, intraoperative blood loss, conversion to open rate, and postoperative pancreatic fistula grade B/C. Results: From a total of 2610 MIDP procedures, the learning curve analysis was conducted on 2041 procedures (mean [SD] patient age, 58 [15.3] years; among 2040 with reported sex, 1249 were female [61.2%] and 791 male [38.8%]). The 2-piece model showed an increase and eventually a break point for TBO at 85 procedures (95% CI, 13-157 procedures), with a plateau TBO rate at 70%. The learning-associated loss of TBO rate was estimated at 3.3%. For conversion, a break point was estimated at 40 procedures (95% CI, 11-68 procedures); for operation time, at 56 procedures (95% CI, 35-77 procedures); and for intraoperative blood loss, at 71 procedures (95% CI, 28-114 procedures). For postoperative pancreatic fistula, no break point could be estimated. Conclusion and Relevance: In experienced international centers, the learning curve length of MIDP for TBO was considerable with 85 procedures. These findings suggest that although learning curves for conversion, operation time, and intraoperative blood loss are completed earlier, extensive experience may be needed to master the learning curve of MIDP.

Variation of inflammatory indexes in patients with chronic abacterial prostatitis treated with an herbal compound/extract.

INTRODUCTION: Inflammation is a highly prevalent finding in the prostate. Men with inflammation have higher IPSS score and increased prostate size. For men with prostatic inflammation, there is a significantly increased risk of developing acute urinary retention and the need of a surgical approach to the disease. Some laboratory tests (i.e. fibrinogen, C-reactive protein), can play a role in identifying patients at greatest risk of complications and adverse outcomes after surgery. There have been several experiences exploring the role of nutraceutical approach to the prostate inflammation. Aim of our study were to describe the variation in symptoms and inflammatory indexes in men affected by chronic abacterial prostatitis, treated with an herbal extract containing Curcuma Longa 500 mg, Boswellia 300 mg, Urtica dioica 240 mg, Pinus pinaster 200 mg and glycine max 70 mg. MATERIALS AND METHODS: A prospective multicenter study was conducted from February 2021 and March 2022. One hundred patients, with a diagnosis of Chronic Prostatitis were enrolled in a multicentric phase III observational study. They were treated with the herbal extract, one capsule per day, for 60 days. No placebo arm was included. In each patient, inflammatory indexes, PSA, prostate volume, IIEF-5, PUF, uroflowmetry (Qmax), IPSS-QoL, NIH-CPPS were registered and statistically compared at baseline and at the follow up visit. RESULTS: The variation obtained on the inflammation indexes showed a global improvement after treatment, including the PSA reduction. We also recorded a significant improvement on IPSS-QoL, NIH-CPPS, PUF and Qmax scores. CONCLUSIONS: The herbal extract considered in our study may represent a promising and safe therapeutic agent leading to a reduction of inflammation markers, and could be used in the treatment of prostatitis and benign prostatic hyperplasia.