Importance Total pancreatectomy (TP) is indicated for advanced pancreatic cancer or multifocal tumors. Furthermore, TP may be performed to avoid the risk of pancreatic fistula in selected patients to improve the perioperative risk profile. Objective To define reference values for TP based on a low-risk cohort treated at expert centers. Design, Setting, and Participants This multicenter study analyzed outcomes from patients undergoing primary TP for malignant or benign lesions from 25 international expert centers from January 2017 to November 2023. Low-risk patients undergoing TP (LR-TP) were without vascular resections or significant comorbidities. Exposures TP. Main Outcomes and Measures Twenty reference values were derived from the 75th or the 25th percentile of the median values of all centers. Outcomes of LR-TP were compared with a cohort of TP with vascular resection, TP due to high-risk pancreatic anastomosis, and the benchmark values for low-risk pancreatoduodenectomy. Results Of 994 patients, 333 (33.5%; median [IQR] age, 66 [58-72] years; 171 male [51.4%]) qualified as the LR-TP cohort. Reference values included blood loss (≤1000 mL), major complications (≤37%), 3-month postoperative mortality (<6%), and retrieved lymph nodes (≥29). Compared with TP with vascular resections, reference cutoffs were not met for major complications (51% vs LR-TP ≤37%) and 90-day mortality (11% vs LR-TP ≤6%). For TP due to high-risk anastomosis, failure to rescue rate (38% vs ≤6%) and 90-day mortality (11% vs LR-TP ≤6%) were not met. Compared with pancreatoduodenectomy, reference values for postoperative mortality were 3 times higher for LR-TP (≤2% vs ≤6%) and less for resected lymph nodes (≥16 vs ≥29). Conclusions and Relevance This case-control study provided global reference values for TP, indicating significantly higher postoperative morbidity and mortality compared with pancreatoduodenectomy. Perioperative morbidity of TP was especially increased in patients with vascular resections. These reference values can serve for quality control of pancreatic surgery.
BACKGROUND:Following neoadjuvant treatment (NAT) and resection with radical intent, not all patients with pancreatic ductal adenocarcinoma (PDAC) seem to achieve a meaningful survival benefit, as some experience very-early recurrence and succumb shortly thereafter. This study aimed to identify preoperative risk factors of mortality within 1-year after NAT and surgery. PATIENTS AND METHODS:Retrospective analysis of all patients who underwent radical resection for PDAC after at least 3-months of NAT between January 2015 and March 2023. Early-death (ED) was defined as disease-related mortality within 12-months of surgery, excluding surgery-related mortality. Receiver operating characteristic (ROC) curve analysis was used to determine statistically derived thresholds for continuous variables. Multivariable logistic regression was conducted to identify factors associated with ED, which were subsequently evaluated in an external cohort. RESULTS:Overall, 418 patients were included. After a median follow-up of 37 months (95%CI 34-39), 44 patients (10.5%) experienced ED, with a median survival from diagnosis of 17 months (95%CI 15-18) and a disease-free survival of 4 months (95%CI 3-4). Radiological tumor size ≥ 25 mm (OR 3.81, 95%CI 1.84-7.91, p < 0.001) and CA19-9 ≥ 100 U/mL (OR 2.93, 95%CI 1.41-6.05, p = 0.004) were independently associated with ED. These associations were confirmed in the external cohort of 473 patients (OR 3.93, 95%CI 2.39-6.45, p < 0.001 and OR 1.81, 95%CI 1.08-3.03, p = 0.023, respectively). CONCLUSIONS:In this study, post-treatment CA19-9 ≥ 100 U/mL and tumor size ≥ 25 mm were associated with an increased risk of early-death after resection following NAT, representing warning signs in surgical decision-making and preoperative counselling.
The oncologically appropriate surgery for neck pancreatic ductal adenocarcinoma (PDAC) remains challenging due to the absence of standardized criteria. This study aims to preoperatively identify patients with neck PDAC at high risk of metastatic body-tail peripancreatic lymph nodes (BT-PLNs). This retrospective cohort study included adult patients undergoing resection for neck PDAC at San Raffaele Hospital (Milan, Italy). Patients with metastatic BT-PLNs were identified from histopathological records. Age, preoperative tumor size, preoperative Ca19.9, radiological response to neoadjuvant chemotherapy (NAT), resectability at diagnosis, and tumor site (distance in millimeters from the superior mesenteric vein and the point where the Wirsung duct starts dilating [W-SMV] on preoperative CT scan) were evaluated as potential predictors of metastatic BT-PLNs. Predictors were selected using multiple logistic regression with stepwise backward selection and then included in a predictive model to identify patients at high risk of metastatic BT-PLNs (online calculator: www.pancreaticneck.altervista.org ). A total of 143 patients were included (67 years [IQR 59–73], 60
Background Endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) is usually contraindicated in perforated cholecystitis, although initial reports suggest feasibility in contained perforation. Methods This prospective single-center cohort study aimed to explore EUS-GBD outcomes in patients with acute cholecystitis with contained perforation (cp-AC; Niemeier classification type 2). A secondary exploratory comparison was performed with a contemporaneous cohort of patients with intact gallbladder walls. Results Between January 2021 and March 2025, 23 patients with cp-AC (39.7% of the overall EUS-GBD cohort) were enrolled. This subgroup showed high prevalence of underlying malignancy (87.0%) and previous endoscopic retrograde cholangiopancreatography with placement of metal stents (65.2%). Median operative space and interluminal distance were 30.5 mm (interquartile range [IQR] 26.0-37.0) and 5 mm (IQR 2-8), respectively. Technical and clinical success of EUS-GBD were 100% (95%CI 85.7-100) and 87.0% (95%CI 67.9-95.5), respectively. The adverse event rate was 21.7% (95%CI 9.7-41.9) and did not differ significantly from that in the cohort with intact gallbladder walls; however, two fatal events occurred in the cp-AC group. Conclusions EUS-GBD appeared to be technically feasible in patients with contained perforation, despite the additional complexity. However, this represents a particularly high-risk population, and the procedure may be considered only for carefully selected patients in expert centers.
Background The first randomisation results from the PACT-21/CASSANDRA trial demonstrated that cisplatin, nab-paclitaxel, capecitabine, and gemcitabine (PAXG) is a standard neoadjuvant treatment option for resectable/borderline resectable (R/BR) pancreatic adenocarcinoma (PDAC). Here, we report the results of the second randomisation comparing long versus short pre-operative chemotherapy. Methods PACT-21/CASSANDRA was a 2 × 2 factorial phase 3 trial involving 17 academic hospitals across 10 regions in Italy. Eligible patients were aged 18–75 years with pathologically confirmed R/BR PDAC and were first randomly assigned to either PAXG or fluorouracil, leucovorin, irinotecan, oxaliplatin (mFOLFIRINOX). Patients without progression or limiting toxicity after 4 months were randomised to receive 2 further months of the same chemotherapy either before (long) or after (short) surgery. The trial was designed under a two-sided superiority hypothesis (H0: HR long versus short = 1.0; H1: HR ≠ 1.0). Randomisation lists were stratified according to previous chemotherapy. The primary endpoint was event-free survival (EFS) in the intention-to-treat (ITT) population. Secondary endpoints were radiological, CA19.9 and complete pathological response, R0 and N0 resections, chemotherapy dose-density, and overall survival (OS). Analyses were performed using SAS version 9.4. This trial is registered with ClinicalTrials.gov (NCT04793932) and EudraCT (2020-003080-26 and 2024-519031-42-00). Findings Between Feb 23, 2021, and Sept 03, 2024, 86 patients were assigned to long and 79 to short preoperative chemotherapy. No difference in EFS was observed between the two groups in the intention-to-treat population (unadjusted HR 0.98; 95% CI; 0.68–1.41; P = 0.90). CA19-9 response (58 [97%] of 60 versus 41 [84%] of 49 patients; P = 0.02), pathological complete response (4 [5%] of 86 versus 0 of 79 patients; P = 0.05), N0 resection rate (39 [45%] of 86 versus 21 [27%] of 79 patients; P = 0.01), and chemotherapy dose-density were improved by longer chemotherapy. OS data are not yet mature. Interpretation Long and short preoperative chemotherapy obtains similar EFS in R/BR PDAC. Future research should focus on more effective treatment regimens and explore the optimal post-operative therapy. Funding MyEverest and Codice Viola (patients’ associations).
Pancreatic cancer surgery is challenging and associated with up to a 70
BACKGROUND:Preliminary evidence suggests that multimodal prehabilitation may reduce postoperative complications in patients undergoing cancer surgery. However, its true effectiveness has yet to be fully demonstrated, and there are still significant gaps in knowledge that need to be addressed. METHODS:This is a two-arm, multicenter, randomized controlled trial including 400 adult oncological patients undergoing major gastrointestinal surgery. Patients are randomized with a 1:1 allocation ratio either to receive a multimodal prehabilitation program in addition to standard care or standard care alone. The prehabilitation program consists of four weeks of intervention including exercise training, nutritional support, and psychological counseling. The standard of care is delivered in accordance with the Enhanced Recovery After Surgery (ERAS) pathways. RESULTS:The trial is ongoing and currently recruiting. The primary outcome is the rate of patients experiencing major postoperative complications within 30 days after surgery. We hypothesize that prehabilitation will reduce this rate from 40% to 25%. Secondary outcomes include the time of functional recovery, length of hospital stay, and complication severity. CONCLUSION:The PROGRESS trial will provide data to assess whether a prehabilitation program can reduce major postoperative complications and facilitate recovery in patients undergoing major oncological gastrointestinal surgery. TRIAL REGISTRATION:This trial was registered on ClinicalTrials.gov with the trial identification NCT06404489.
Intraductal papillary mucinous neoplasms (IPMNs) involving both branch ducts and the main pancreatic duct (MPD), known as Mixed-IPMNs, generally behave like main duct (MD-) IPMNs. However, a subgroup of Mixed-IPMNs with minimal involvement of MPD (Min–Mix IPMN) has been described. Aim of this study was to analyse the biological behaviour of patients with Min–Mix IPMNs. Retrospectively collected data from all patients resected for pathologically confirmed IPMN at San Raffaele Hospital between 2009 and 2019 was prospectively analysed. Demographic, perioperative and survival data was analysed, comparing Min–Mix-IPMNs with other IPMNs. Among 464 patients included, 35 Min–Mix IPMNs were identified. When compared with MD and “typical” mixed-IPMNs, patients were younger, less frequently presented altered Ca19.9 or jaundice at diagnosis (p = 0.006). Most Min–Mix IPMNs presented only worrisome features, like BD-IPMNs (71
BACKGROUND & AIMS:Nutritional status alterations are common in pancreatic ductal adenocarcinoma (PDAC), but their prognostic role in patients undergoing chemotherapy remains unclear. We assessed the impact of clinical-nutritional variables on treatment outcomes in advanced PDAC patients. METHODS:Clinical, anthropometric, and radiological data of locally advanced/metastatic PDAC patients treated with polychemotherapy (2019-2021), prospectively collected within the observational PAC-MAIN study (NCT04112836) were analyzed. Key predictors of progression-free (PFS) and overall survival (OS) were identified through a multistep feature selection process, developing the Pancreatic Adenocarcinoma Nutritional-Clinical Index (PANCIN). Associations with CA19.9, radiological response, chemotherapy dose intensity and toxicity were explored. RESULTS:Among 74 patients, Vitamin B12 levels, Mid-Upper Arm Circumference, and Visceral Fat-to-Muscle area Ratio were included in the PANCIN, emerging as strongest PFS/OS predictors. According to PANCIN stratification, median PFS was 6.2 (95% CI 3.5-9.7) vs 14.1 (8.8-20.3) months, and median OS was 10.4 (7.5-15.1) vs 19.8 (11.3-31.1) months, for high- vs low-risk patients, respectively (p < 0.001). PANCIN significantly correlated with CA19.9 and radiological response, infections and grade ≥3 hematologic toxicities. CONCLUSIONS:PANCIN is a novel prognostic tool combining clinical-nutritional and radiological features, potentially aiding risk stratification and early nutritional support in advanced PDAC patients.
BACKGROUND:Prehabilitation, a process of building physiological reserve before surgery to improve postoperative outcomes, is a complex, multimodal intervention that requires rigorous evaluation in clinical trials. Incomplete reporting by such trials obscures essential intervention components and delivery contexts, hindering comparability and interpretability. This, in turn, limits clinical implementation and the replication or refinement of interventions by researchers. The aim of this study was to develop a reporting checklist for RCTs of prehabilitation. METHODS:A modified two-round Delphi process using the EQUATOR framework with 53 international experts across exercise, nutrition, psychological, and perioperative care disciplines was conducted. An initial checklist of candidate items was adapted from existing reporting standards, contextualized for prehabilitation, and iteratively refined through expert voting. Items rated eight to nine on a nine-point scale by ≥70% of participants in round two were classified as 'essential' and those rated seven were considered 'important'. RESULTS:The final checklist comprised 40 items. Sixteen items were classified as 'essential' and 24 items were classified as 'important' for guiding comprehensive reporting of prehabilitation interventions. These items span key domains including intervention components, delivery methods, adherence, participant characteristics, and outcome measures. High agreement among experts underscores the checklist's relevance and usability. CONCLUSION:Adoption of Standards for reporting research methods, interventions, and Outcomes in Surgical Prehabilitation studies (SOS-Prehab), alongside methodological and outcome-reporting items of CONSORT could improve transparency, completeness, and interpretability of prehabilitation trials. This could enable better reproducibility, robust evidence synthesis, and accelerate translation into clinical practice and policy.
Importance:The role of preoperative radiotherapy after neoadjuvant chemotherapy for pancreatic cancer remains controversial. Objective:To evaluate whether the addition of radiotherapy to chemotherapy is associated with improved oncologic outcomes in patients undergoing resection for pancreatic cancer. Design, Setting, and Participants:This was a retrospective propensity score-matched cohort study of patients undergoing pancreatic cancer resection between 2015 and 2023, with a median follow-up of 44 months. Patients were recruited from 2 high-volume referral centers. Of patients undergoing pancreatectomy after neoadjuvant treatment for pancreatic ductal adenocarcinoma, those treated with fluorouracil, leucovorin, irinotecan, and oxaliplatin or gemcitabine/nab-paclitaxel with or without preoperative radiation met eligibility criteria. Patients with metastatic disease, surgery-related mortality, or follow-up less than 12 months were excluded. Treatment groups were matched 1:1 on age, sex, comorbidity, tumor characteristics, baseline carbohydrate antigen 19-9 level, resectability status, and chemotherapy exposure. Exposure:Neoadjuvant chemotherapy with or without radiotherapy. Main Outcomes and Measures:Event-free survival, pattern of recurrence, and overall survival. Results:Of 1201 consecutive patients undergoing pancreatectomy after neoadjuvant treatment for pancreatic ductal adenocarcinoma, 869 met eligibility criteria. Among 800 included patients (median [IQR] age, 65 [58-71] years; 402 men [50.2%]), 438 received neoadjuvant chemotherapy and radiotherapy and 362 chemotherapy alone. After matching, 226 patients per group were analyzed; most had resectable (117 of 226 [51.1%]) or borderline-resectable (104 of 226 [46.5%]) disease. Radiotherapy was associated with higher rates of pathologic complete response (15 of 226 [6.6%] vs 10 of 226 [4.4%]), node-negative disease (139 of 226 [61.5%] vs 76 of 226 [33.6%]), and R0 resection (192 of 226 [85.0%] vs 118 of 226 [52.2%]). Recurrence patterns were similar, with distant recurrence as the predominant first site of failure in both groups (116 of 226 [51.3%] vs 109 of 226 [48.3%]). In competing risk analysis, the cumulative incidence of locoregional recurrence did not differ (subdistribution hazard ratio [HR], 0.90; 95% CI, 0.53-1.54; P = .71). Radiotherapy was not associated with improved event-free survival (HR, 1.10; 95% CI, 0.88-1.37; P = .38) or overall survival (HR, 1.02; 95% CI, 0.79-1.32; P = .84). Conclusions and Relevance:Results of this cohort study suggest that although the addition of radiotherapy to neoadjuvant chemotherapy was associated with an improved pathologic response, it was not associated with survival benefit or reduced recurrence in resectable and borderline-resectable pancreatic cancer. These findings highlight the limited impact of locoregional control in a disease driven by systemic progression.
BACKGROUND:The PROMIS-29 questionnaire assesses general aspects of physical and mental health that may be relevant to surgical recovery. Although this tool has been endorsed by expert consensus for use in perioperative care, evidence regarding its psychometric performance in this context is limited. This study aimed to assess the content validity, internal consistency, construct validity, and responsiveness of PROMIS-29 as a measure of recovery after colorectal surgery. METHODS:This study was conducted according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines. A cohort of adult patients undergoing elective colorectal resection at two academic hospitals in Canada completed the PROMIS-29 questionnaire preoperatively and weekly until postoperative week (POW) 4. Physical Health Summary (PHS) and Mental Health Summary (MHS) scores were derived from PROMIS-29 t-scores (higher = better health status). Content validity was assessed by comparing PROMIS-29 items against a previously reported conceptual framework of recovery after abdominal surgery. Internal consistency was assessed using Cronbach α. Construct validity was assessed by testing a priori hypotheses that PROMIS-29 scores would be better in patients: (1) with shorter length of stay (≤4 days); (2) without 30-day complications; (3) undergoing minimally invasive surgery; and (4) without a new stoma. Responsiveness was examined by hypothesizing that PROMIS-29 scores would follow the expected recovery trajectory-showing an initial postoperative decline followed by gradual improvement toward preoperative levels. Consistent with PROMIS guidelines, a minimal important difference of 3 points was used as the criterion for confirming hypotheses. RESULTS:A total of 282 patients were included (mean±SD age 59±16 years; 48% female; 78% minimally invasive; 19% with stoma; median [IQR] hospital stay 3 [1-6] days). PROMIS-29 items covered 36% of health domains considered important by patients in the conceptual framework, indicating limited content validity. Internal consistency across PROMIS domains was acceptable, with Cronbach α ranging from 0.81 to 0.98. Construct validity of PHS and MHS was limited, with 0 of 4 predefined hypotheses supported on POW1 and only 1 to 2 hypotheses supported in subsequent weeks (mean difference between groups ≥3). Responsiveness was supported until POW2 (mean difference between timepoints ≥3), but not after. CONCLUSION:Despite demonstrating adequate internal consistency, PROMIS-29 has limited content validity, construct validity, and responsiveness within the first 4 weeks after colorectal surgery. These findings suggest that PROMIS-29 may not fully capture patients' recovery experiences, underscoring the need for psychometrically sound PROMs tailored to the context of perioperative care.
The DIPLOMA trial showed comparable radical resection rates after minimally invasive left pancreatectomy (MILP) and open left pancreatectomy (OLP) in patients with upfront resectable pancreatic cancer. Data on long-term overall survival (OS) and disease-free survival (DFS) are currently lacking, but are required before the oncological efficacy of MILP can be confirmed. To determine the long-term oncological outcome, including OS and DFS, of MILP vs OLP in patients with upfront resectable left-sided pancreatic cancer in the DIPLOMA trial. The randomized, patient-blinded and pathologist-blinded DIPLOMA trial was conducted between 2018 and 2021, with a follow-up duration of at least 36 months. It was a multicenter international trial that took place in 35 centers in 12 countries worldwide. Patients with upfront resectable pancreatic ductal adenocarcinoma of the body or tail of the pancreas were included. Participants were randomly assigned to undergo MILP (laparoscopic and robotic) or OLP. Patients were blinded for the surgical approach. Main outcomes included OS and DFS. Other outcomes include receipt of adjuvant therapy and time to start of adjuvant therapy. Between May 2018 and May 2021, 258 patients were randomized to the MILP (131 patients) and OLP (127 patients) groups. After a median follow-up of 38 (IQR 36-46) months, 134 patients (52%) had died and 127 patients (55%) experienced disease recurrence. OS did not differ significantly between the MILP and OLP groups (median, 32 vs 34 months; stratified hazard ratio, 1.02; 95% CI, 0.72-1.44; P = .92). Also, DFS did not significantly differ between the MILP and OLP groups (median, 21 vs 17 months; stratified hazard ratio, 0.96; 95% CI, 0.68-1.35; P = .81). Adjuvant therapy was administered in 79 patients after MILP (79 of 113 [70%]) and 79 patients after OLP (79 of 110 [72%]) ( P = .63). Time to adjuvant therapy was comparable between groups (median 59 vs 56 days; P = .92). In this long-term follow-up of the randomized DIPLOMA trial in patients with upfront resectable pancreatic cancer, oncological outcomes after MILP and OLP did not differ significantly, confirming the oncological safety of MILP. International Standard Registered Clinical/Social Study Number Registry Identifier: ISRCTN44897265
The six-minute walking test (6MWT) is a measure of functional capacity, but there is limited evidence supporting its use as a postoperative recovery outcome. This study aims to contribute evidence for the validity of 6MWT as a measure of recovery after pancreatic surgery. Following the COSMIN checklist, we analyzed data from patients enrolled in a prospective cohort study at San Raffaele Hospital (2020–2022). Construct validity was tested by hypothesizing that the distance walked in 6 min (6MWD) at 30 days after surgery would be greater in patients known to recover better: (1) younger vs. older, (2) with higher physical status vs. lower, (3) undergoing distal vs. proximal pancreatectomy, (4) laparoscopic vs. open resection, (5) with a shorter vs. longer length of stay, and (6) without severe complications vs. with. Additionally, 6MWD with patient-reported outcomes, including Duke Activity Status Index (DASI) and PROMIS-29 Physical Health Summary Score (PHS), were assessed. Patients (n=151) who completed the 6MWT preoperatively and at 30 days after surgery were analyzed. Data supported construct validity of the 6MWT, showing significantly higher 6MWD in 5 of 6 (83
OBJECTIVE:To estimate the minimal important difference (MID) of the Comprehensive Complication Index (CCI ® ) in patients undergoing abdominal surgery. BACKGROUND:The CCI ® is a validated metric that quantifies cumulative surgical morbidity. While the CCI ® is a sensitive endpoint to detect treatment effects, a statistically significant effect does not necessarily translate into clinical relevance. Relevant differences from the patients' perspective are best captured by the MID. METHODS:Individual patient data were extracted from surgical studies reporting CCI ® at 30 days and using patient-reported outcome measures with established MIDs at baseline and 30 days. To determine the MID for the CCI ® , we used an anchor-based approach as recommended by methods guidelines. A patient-reported outcome measure was selected as an anchor only if the Spearman correlation coefficient between its change in score (baseline to 30 days postoperative) and the CCI ® was ≥|0.30|. We used linear regression to estimate the MID of the CCI ® across different anchors, and triangulation to determine a single MID. RESULTS:Data were extracted from 3 published randomized controlled trials and 1 prospective observational study (n = 1583 patients) in major abdominal surgery. In colorectal surgery cohorts, 2 subscores of the Short Form-36, 2 subscores of the Multidimensional Fatigue Inventory-20, the EuroQol-5-Dimension Index Score, and the EuroQol Visual Analog Scale showed a correlation with the CCI ® of ≥|0.30|. This resulted in MID estimates for the CCI ® ranging from 6.1 to 22.2. In hepato-pancreato-biliary surgery, 1 subscore of the Short Form-36, and 2 subscores of the Patient Reported Outcome Measure Information System-29 questionnaire qualified as anchors providing MID estimates ranging from 6.2 to 13.8. CONCLUSIONS:We propose a mean difference of 12 points in the CCI ® between treatment groups as a relevant difference in patients undergoing abdominal surgery. This MID provides an important foundation for sample size calculations and interpretation of randomized controlled trials and large real-world observational studies.
BACKGROUND:Nonfunctioning pancreatic neuroendocrine tumors are typically indolent neoplasms with a rising incidence. Distal pancreatectomy remains the standard treatment for localized tumors in the pancreatic body/tail. Given the favorable long-term prognosis, accurate assessment of postoperative morbidity, particularly postoperative new-onset diabetes mellitus, is critical. Aims of the study were to identify preoperative predictors of postoperative new-onset diabetes mellitus in patients who underwent distal pancreatectomy for nonfunctioning pancreatic neuroendocrine tumors and to develop a predictive model for individualized risk assessment. METHODS:Consecutive patients who underwent curative distal pancreatectomy for localized nonfunctioning pancreatic neuroendocrine tumors at San Raffaele Hospital between 2015 and 2022 were included. Exclusion criteria included pre-existing diabetes and follow-up <24 months. Clinical and radiological data were evaluated. RESULTS:After a median follow-up of 58 months, 27 of 65 patients (41%) developed postoperative new-onset diabetes mellitus. Postoperative new-onset diabetes mellitus was significantly associated with elevated body mass index (P = .016), pancreatic atrophy (P = .044), increased total (P = .014) and visceral fat area (P = .021), and a higher proportion of pancreatic parenchyma distal to the tumor (P = .046). On Cox regression, higher body mass index (hazard ratio: 1.187; P = .001), elevated hemoglobin A1c (hazard ratio: 1.169; P = .001), and distal higher proportion of pancreatic parenchyma (hazard ratio: 1.030; P = .018) were identified as significant risk factors of postoperative new-onset diabetes mellitus. A nomogram and online risk calculator (https://net-distal-pancreatectomy.shinyapps.io/postoperative-diabetes-risk-calculator/) were developed to predict individual risk at 1, 3, and 5 years, with good discriminatory performance (area under the curve: 0.766; P < .001). CONCLUSION:Postoperative new-onset diabetes mellitus occurred in 41% of patients who underwent distal pancreatectomy for nonfunctioning pancreatic neuroendocrine tumors. Elevated preoperative body mass index, hemoglobin A1c levels, and proportion of distal higher pancreatic parenchyma emerged as significant risk factors of postoperative new-onset diabetes mellitus. The developed nomogram and web-based calculator may support preoperative counseling and guide tailored prehabilitation or parenchyma-sparing strategies in high-risk patients.
Pancreatic neuroendocrine tumor liver metastases (PanNET LMs) are traditionally classified into three types based on their distribution. Surgery is generally considered for patients with type I/II LMs, while those with type III LMs are typically regarded as unresectable; however, type III LMs encompass a wide range of clinical scenarios, some of which may allow surgical resection. The aim of this study was to identify preoperative predictors of early progression following surgery (≤6 months) in patients with PanNETs and LMs. Consecutive patients with PanNETs and LMs who underwent surgery at San Raffaele Hospital (2010–2023) were included. After a median follow-up of 56 months, 18/54 patients (34
BACKGROUND AND AIMS:Factors predicting the need for step-up procedures after endoscopic ultrasound (EUS)-guided fluid collection drainage (EUS-FCD) of peripancreatic fluid collections (PFCs) were explored in retrospective studies restricted to walled-off necrosis (WON) and lumen-apposing metal stents (LAMSs). METHODS:All consecutive candidates for EUS-FCD from 2020 to 2024 were included in a Prospective Registry of Therapeutic EUS (PROTECT, NCT04813055), with prospective monthly follow-up evaluating clinical success, adverse events, and recurrences. Prospectively assessed baseline clinical and morphologic factors, including the Quadrant-Necrosis-Infection (QNI) classification, were included in a stepwise logistic regression model to predict the need for step-up. The agreement between EUS and radiology in assessing the extent of necrosis was compared with the use of Cohen's kappa. RESULTS:Seventy patients (29 postsurgical collections, 21 pseudocysts, and 20 WONs) were treated with double-pigtail plastic stents (DPPSs) in 59% of cases and LAMSs in 41%. Clinical success was 92.9%, with a need for step-up (mostly endoscopic necrosectomy) in 35.7% of cases. Necrosis ≥60% (odds ratio [OR], 7.7; 95% confidence interval [CI], 1.4-43) and being in the high-risk QNI group (OR, 4.6; 95% CI, 1.4-15) were the only independent predictors of any step-up. The same factors predicted the endoscopist's decision to allocate PFCs to LAMSs vs DPPSs. The high-risk QNI group was associated with a significantly longer hospital stay (12 days vs 4 days; P = .004). EUS tended to upscale the necrotic content compared with preprocedural radiology (κ = 0.31). CONCLUSIONS:The extent of necrosis and the QNI classification strongly correlated with the need for step-up and allocation to LAMS versus DPPS drainage, suggesting a central role in treatment personalization.