BACKGROUND:Internal herniation is a serious complication after Roux-en-Y gastric bypass (RYGB). Diagnosis is challenging due to nonspecific clinical findings, heterogeneous computed tomography (CT)-based predictive models, and lack of consensus on the optimal diagnostic strategy. Although diagnostic laparoscopic surgery (DLS) is considered the reference standard, it frequently results in negative explorations. OBJECTIVES:To identify predictive clinical parameters and CT signs for internal herniation in post-RYGB patients presenting with abdominal pain, and to evaluate the clinical decision-making process leading to DLS. SETTING:Emergency department of a high-volume nonacademic teaching hospital with a dedicated bariatric center in the Netherlands. METHODS:This prospective diagnostic accuracy study included all adults presenting with acute abdominal pain more than 30 days post-RYGB between March 2023 and June 2024. Standardized clinical, laboratory, and CT assessments were performed. A bariatric surgeon assigned a clinical suspicion score (CSS) and a dedicated radiologist a radiological suspicion score (RSS). Patient management followed a predefined protocol. Predictors were analyzed using Least Absolute Shrinkage and Selection Operator regression. RESULTS:In total, 125 patients were included. DLS was performed in 84 patients (67%), confirming internal herniation in 30 (36%). CSS was not associated with internal herniation, whereas a higher RSS was strongly associated with its presence (P < .001). Venous congestion, swirl sign, and mushroom sign were identified as independent predictors. CONCLUSION:Clinical assessment alone has limited reliability in guiding decision-making regarding DLS in post-RYGB patients with abdominal pain. Structured CT assessment by a dedicated abdominal radiologist is the most accurate diagnostic tool and should be performed in all such patients.
Importance:The poor prognosis and limited treatment options in patients with locally advanced pancreatic cancer (LAPC) highlight the need for novel therapies to increase survival. Objective:To assess whether the addition of radiofrequency ablation (RFA) to chemotherapy improves survival when compared with chemotherapy only in patients with nonprogressive LAPC. Design, Setting, and Participants:This international randomized clinical trial was performed from April 7, 2015, through December 6, 2022, in patients with unresectable LAPC with at least stable disease after 2 months of induction chemotherapy. The predefined study protocol reported a follow-up period of 18 months. Data analysis was performed from February 1, 2024, through January 15, 2025. Intervention:Randomization to receive either RFA with chemotherapy or chemotherapy alone. Main Outcomes and Measures:Primary outcome was overall survival. Secondary outcomes included progression-free survival, adverse events, and quality of life using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire and pancreatic cancer module. Results:Overall, 188 patients (median [IQR] age, 65 [57-70] years; 100 [53%] men) were randomized, 95 to RFA with chemotherapy and 93 to chemotherapy only. Before randomization, induction chemotherapy had consisted of modified FOLFIRINOX (fluorouracil, oxaliplatin, irinotecan, and leucovorin) in 81 patients (85%) and a gemcitabine-based regimen in 14 patients (15%) in the RFA group vs 80 patients (86%) and 13 patients (14%) in the chemotherapy group, respectively. After a median follow-up of 55 months, median overall survival from randomization was 12.1 months (95% CI, 9.9-14.3 months) in the RFA group vs 11.6 months (95% CI, 9.4-13.9 months) in the chemotherapy group (hazard ratio, 1.07; 95% CI, 0.80-1.45; P = .64). Median progression-free survival was 5.8 months (95% CI, 4.4-7.2 months) in the RFA group and 6.9 months (95% CI, 5.3-8.5 months) in the chemotherapy group (P = .47). Grade 3 or higher serious adverse events were reported more often in the RFA group: 26 patients (27%) vs 10 patients (11%) (P = .004). Mean changes from baseline of -14.6, -12.0, and -18.4 were observed for the Global Health Status quality-of-life scores at 1, 3, and 18 months, respectively, numerically exceeding the threshold of 10 points for clinical relevance. In the chemotherapy-only group, mean changes from baseline on the Global Health Status remained below the threshold for clinical relevance. Conclusions and Relevance:This randomized clinical trial of patients with LAPC after 2 months of multiagent chemotherapy found that local ablative therapy with RFA did not improve survival compared with chemotherapy only and adversely affected patient's quality of life. Trial Registration:ClinicalTrials.gov Identifier: NCT03690323.
QuestionCan the addition of radiofrequency ablation (RFA) to chemotherapy improve survival compared with chemotherapy only in patients with nonprogressive locally advanced pancreatic cancer (LAPC) after 2 months of multiagent chemotherapy?FindingsThis international randomized clinical trial, including 188 patients with LAPC after 2 months of multiagent chemotherapy, found that local ablative therapy with RFA did not improve survival compared with chemotherapy only and worsened quality of life.MeaningThe findings in this trial provide evidence against the use of RFA after chemotherapy in patients with LAPC. This randomized clinical trial evaluates the efficacy of radiofrequency ablation (RFA) and chemotherapy compared with chemotherapy only in patients with locally advanced pancreatic cancer. ImportanceThe poor prognosis and limited treatment options in patients with locally advanced pancreatic cancer (LAPC) highlight the need for novel therapies to increase survival.ObjectiveTo assess whether the addition of radiofrequency ablation (RFA) to chemotherapy improves survival when compared with chemotherapy only in patients with nonprogressive LAPC.Design, Setting, and ParticipantsThis international randomized clinical trial was performed from April 7, 2015, through December 6, 2022, in patients with unresectable LAPC with at least stable disease after 2 months of induction chemotherapy. The predefined study protocol reported a follow-up period of 18 months. Data analysis was performed from February 1, 2024, through January 15, 2025.InterventionRandomization to receive either RFA with chemotherapy or chemotherapy alone.Main Outcomes and MeasuresPrimary outcome was overall survival. Secondary outcomes included progression-free survival, adverse events, and quality of life using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire and pancreatic cancer module.ResultsOverall, 188 patients (median [IQR] age, 65 [57-70] years; 100 [53%] men) were randomized, 95 to RFA with chemotherapy and 93 to chemotherapy only. Before randomization, induction chemotherapy had consisted of modified FOLFIRINOX (fluorouracil, oxaliplatin, irinotecan, and leucovorin) in 81 patients (85%) and a gemcitabine-based regimen in 14 patients (15%) in the RFA group vs 80 patients (86%) and 13 patients (14%) in the chemotherapy group, respectively. After a median follow-up of 55 months, median overall survival from randomization was 12.1 months (95% CI, 9.9-14.3 months) in the RFA group vs 11.6 months (95% CI, 9.4-13.9 months) in the chemotherapy group (hazard ratio, 1.07; 95% CI, 0.80-1.45; P = .64). Median progression-free survival was 5.8 months (95% CI, 4.4-7.2 months) in the RFA group and 6.9 months (95% CI, 5.3-8.5 months) in the chemotherapy group (P = .47). Grade 3 or higher serious adverse events were reported more often in the RFA group: 26 patients (27%) vs 10 patients (11%) (P = .004). Mean changes from baseline of -14.6, -12.0, and -18.4 were observed for the Global Health Status quality-of-life scores at 1, 3, and 18 months, respectively, numerically exceeding the threshold of 10 points for clinical relevance. In the chemotherapy-only group, mean changes from baseline on the Global Health Status remained below the threshold for clinical relevance.Conclusions and RelevanceThis randomized clinical trial of patients with LAPC after 2 months of multiagent chemotherapy found that local ablative therapy with RFA did not improve survival compared with chemotherapy only and adversely affected patient's quality of life.Trial RegistrationClinicalTrials.gov Identifier: NCT03690323
BACKGROUND:There is a paucity of data on the cost-utility of endoscopic ultrasonography-guided gastroenterostomy (EUS-GE) compared with surgical gastrojejunostomy (SGJ) as palliative treatment of malignant gastric outlet obstruction. METHODS:In the ENDURO trial, 98 patients with malignant gastric outlet obstruction from 12 Dutch hospitals were randomized between EUS-GE (N = 48) and SGJ (N = 50). Cost utility was evaluated from a healthcare perspective with a time horizon of 1 month. A bottom-up approach was used to calculate the costs of each intervention, including the per-minute price of the endoscopy and operating room (OR), considering personnel, construction, inventory and overhead costs. Other in-hospital costs were calculated using insurance claim data. Effectiveness was displayed as quality-adjusted life years (QALY). Bootstrapping was performed to estimate uncertainty. RESULTS:The calculated per-minute price for the endoscopy room was €8.64 (US $9.34). The per-minute price for an OR was €11.78 (US $12.74). The mean intervention costs were estimated at €4405.40 (US $4762.68) for EUS-GE and €3393.71 (US $3668.93) for SGJ. Mean total in-hospital costs were lower following EUS-GE (€5172 [US $5591]) than after SGJ (€10,458 [US $11,306]), mainly due to a shorter length of hospital stay following EUS-GE. Bootstrapping showed that 99.9% of iterations resulted in lower costs for EUS-GE. Mean difference in 1-month QALY contribution was 0.004 in favor of EUS-GE. Most iterations fall within the bottom right quadrant (95.6%) of the cost-effectiveness plane, indicating lower costs and improved QALY contribution for EUS-GE. DISCUSSION:In this study, EUS-GE was more cost effective than SGJ. The additional intervention costs were clearly outweighed by a decrease in in-hospital costs after the procedure.
Background Preoperative endoscopic biliary drainage may lead to complications (16%-24%), potentially hampering surgical exploration. Endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) may reduce drainage-related complications, however it is unknown whether EUS-CDS could in itself hamper surgical exploration as series with surgeon reported outcomes are lacking. Aim is to assess the impact of preoperative EUS-CDS on pancreatoduodenectomy. Method Consecutive patients who underwent pancreatoduodenectomy after preoperative biliary drainage were included in all eight centers that performed EUS-CDS in the mandatory Dutch Pancreatic Cancer Audit (Jan 2020-Dec 2022). Primary outcome was major postoperative complications. Secondary outcomes included bile leak grade B/C, postoperative pancreatic fistula (POPF) grade B/C, and overall postoperative complications. A propensity score matching (1:3) analysis was performed. Surgeons who performed a pancreatoduodenectomy after EUS-CDS were asked to complete a survey. Results Overall, 937 patients with pancreatoduodenectomy after preoperative biliary drainage were included (42 EUS-CDS, 895 ERCP). Major postoperative complications occurred in eight patients (19%) in the EUS-CDS group and 292 patients (33%) in the ERCP group (RR 0.50; 95%CI, 0.23-1.07). No significant differences were observed in overall complications (RR 0.95; 95%CI, 0.51-1.76), bile leak (RR 1.25; 95%CI, 0.31-4.98) or POPF (RR 0.62; 95%CI, 0.25-1.56). Results were similar after matching. The survey was completed for 29 pancreatoduodenectomies; surgery was not (n=13, 45%), ‘slightly’ (n=8, 28%), ‘clearly’ (n=5, 17%) or ‘severely’ (n=2, 7%) more complex because of the EUS-CDS. Conclusion This early experience suggests that preoperative biliary drainage with EUS-CDS does not increase the rate of complications after pancreatoduodenectomy and only infrequently hampers surgical exploration.
BACKGROUND:In patients with malignant gastric outlet obstruction, endoscopic ultrasonography-guided gastroenterostomy might be superior to surgical gastroenterostomy, but randomised trials are scarce. We aimed to assess time to resumption of oral intake and the rate of persistent or recurrent obstructive symptoms requiring re-intervention following endoscopic ultrasonography-guided gastroenterostomy compared with surgical gastroenterostomy. METHODS:ENDURO was a multicentre, randomised controlled trial conducted at 12 Dutch academic and teaching hospitals. Hospitals with experience in at least 20 LAMS placements of any indication, at least ten endoscopic gastroenterostomies, and approved competence were eligible to perform endoscopic gastroenterostomy independently within the trial. Adults aged 18 years and older with symptomatic, malignant gastric outlet obstruction in a palliative setting were randomly assigned (1:1) to endoscopic or surgical gastroenterostomy. Randomisation was performed with an electronic data capture system using randomly generated permuted blocks of 2 and 4 and stratified by WHO performance status (0-1 and 2-3). The first coprimary outcome was time to resumption of solid oral intake (Gastric Outlet Obstruction Scoring System score ≥2). The second coprimary outcome was non-inferiority for persistent or recurrent obstructive symptoms requiring re-intervention. The predefined non-inferiority margin of the risk difference was 20%. All outcomes were analysed in all randomly assigned participants. This trial was registered in the International Clinical Trials Registry Platform, NL9592, and is completed. FINDINGS:Between Feb 18, 2022, and Feb 26, 2024, 250 patients were screened, 98 of whom were randomly assigned to endoscopic gastroenterostomy (n=48) or surgical gastroenterostomy (n=50). 43 (44%) patients were female and 55 (56%) were male. Endoscopic gastroenterostomy had a shorter time to solid oral intake than surgical gastroenterostomy (median 1 day [IQR 1-3] vs 3 days [1-6], hazard ratio 2·21 [95% CI 1·43-3·42]; p=0·0003). Endoscopic gastroenterostomy was non-inferior to surgical gastroenterostomy for persistent or recurrent obstructive symptoms requiring re-intervention (five [10%] vs six [12%], risk difference 1·6% [upper limit of 90% CI 8·9]). Overall adverse events were reported in 28 (58%) patients in the endoscopic gastroenterostomy group and 32 (64%) in the surgical gastroenterostomy group (relative risk 0·91 [95% CI 0·66-1·25]). One fatal event occurred in the endoscopic gastroenterostomy group and three fatal events occurred in the surgical gastroenterostomy group. INTERPRETATION:In patients with malignant gastric outlet obstruction, palliative treatment with endoscopic gastroenterostomy was superior to surgical gastroenterostomy for time to resumption of solid oral intake and was non-inferior for the rate of persistent or recurrent obstructive symptoms requiring re-intervention. Based on these results, endoscopic gastroenterostomy should be the preferred palliative treatment for patients with malignant gastric outlet obstruction. FUNDING:KWF Dutch Cancer Society.
BACKGROUND:Robotic pancreatoduodenectomy (RPD) is increasingly being implemented to enhance patient recovery, but it is unclear what happens to patient outcomes after the initial learning curve. The aim of this study was to evaluate the first 1000 consecutive RPD performed in the Netherlands. METHODS:A nationwide analysis of patients who underwent RPD in 13 centres (March 2016-August 2023) from the Dutch Pancreatic Cancer Audit was performed. Patients were grouped based on published learning curve cut-offs (phases 1-4): 1-15, 16-62, 63-84, and >84 RPD per centre respectively. Outcomes were compared between the four learning curve phases. Ideal Outcome rates were used to compare outcomes between centres. RESULTS:Overall, 1000 patients after RPD were included. The conversion rate was 10.1%, the rate of Clavien-Dindo complications of grade ≥III was 41.3%, the rate of postoperative pancreatic fistula of grade B/C was 24.4%, and the rate of in-hospital/30-day mortality was 3.9%. Of the patients, 71.1% had a high updated alternative fistula risk score. Improvements between the phases were found for five outcomes: median operating time (420, 360, 349, and 369 min respectively; P < 0.001), conversion rate (21.7%, 10.0%, 2.8%, and 7.5% respectively; P < 0.001), rate of delayed gastric emptying (DGE) of grade B/C (32.3%, 22.6%, 15.4%, and 20.2% respectively; P = 0.003), reoperation rate (9.9%, 11.3%, 9.8%, and 4.9% respectively; P = 0.026), and median duration of hospital stay (12, 11, 10, and 10 days respectively; P = 0.035). The rate of Clavien-Dindo complications of grade ≥III and the rate of in-hospital/30-day mortality remained stable. The Ideal Outcome rate (mean 47%) did not differ between centres. CONCLUSION:Across four learning curve phases in a nationwide cohort, improvements were observed for operating time, conversion rate, rate of DGE of grade B/C, reoperation rate, and duration of hospital stay.
BACKGROUND:Major liver resection is frequently performed for primary and secondary liver tumors. However, 90-day mortality rates can exceed 10% in high-risk patients. This study aimed to develop a preoperative risk score for postoperative mortality after major liver resection. METHODS:All major liver resections between 2014 and 2019 in 2 Dutch tertiary referral centers were identified. A validation cohort consisted of all consecutive patients who underwent a major liver resection in the nationwide Dutch Hepato Biliary Audit from 2014 to 2020. Multivariate logistic regression was used to identify prognostic factors and develop a mortality risk score. RESULTS:Major liver resection was performed in 513 patients, of whom 238 (46.4%) had a primary liver cancer, and in 148 patients (28.8%), a hepaticojejunostomy was performed; 90-day mortality occurred in 56 patients (10.8%). Mortality was independently predicted by 5 risk factors: age ≥ 65 years, diabetes mellitus type 2, diagnosis of primary liver cancer, American Society of Anesthesiologists ≥ 3, and extended hemihepatectomy. A risk score with 1 point assigned to each risk factor showed good discrimination (area under the curve [AUC], 0.77; 95% CI, 0.71-0.83). The predicted 90-day mortality was 3.5% for low-risk (0 or 1 points; 53.8% of all patients), 11.1% for intermediate-risk (2 points; 25.3%), and 29.7% for high-risk patients (3-5 points; 20.9%). External validation in the nationwide cohort with 1617 patients showed similar concordance (AUC, 0.69; 95% CI, 0.64-0.75). CONCLUSION:The proposed and validated risk score can aid in shared decision making.
Background: Unfavorable intraoperative findings or incidents during minimally invasive liver surgery may necessitate conversion to open surgery. This study aimed to identify predictors for conversion in minimally invasive liver surgery and gain insight into outcomes following conversions. Methods: This nationwide, retrospective cohort study compared converted and non-converted minimally invasive liver surgery procedures using data from 20 centers in the Dutch Hepatobiliary Audit (2014-2022). Propensity score matching was applied. Subgroup analyses of converted robotic liver resection versus laparoscopic liver resection and emergency versus non-emergency conversions were performed. Predictors for conversions were identified using backward stepwise multivariable logistic regression. Results: Of 3,530 patients undergoing minimally invasive liver surgery (792 robotic liver resection, 2,738 laparoscopic liver resection), 408 (11.6%) were converted (4.9% robotic liver resection, 13.5% laparoscopic liver resection). Conversion was associated with increased blood loss (580 mL [interquartile range 250-1,200] vs 200 mL [interquartile range 50-500], P < .001), major blood loss (>= 500 mL, 58.8% vs 26.7%, P < .001), intensive care admission (19.0% vs 8.4%, P = .005), overall morbidity (38.9% vs 21.0%, P < .001), severe morbidity (17.9% vs 9.6%, P = .002), and a longer hospital stay (6 days [interquartile range 5-8] vs 4 days [interquartile range 2-5], P < .001) but not mortality (2.2% vs 1.2%, P = .387). Emergency conversions had increased intraoperative blood loss (1,500 mL [interquartile range 700-2,800] vs 525 mL [interquartile range 208-1,000], P < .001), major blood loss (87.5% vs 59.3%, P = .005), and intensive care admission (27.9% vs 10.6%, P = .029), compared with non-emergency conversions. Robotic liver resection was linked to lower conversion risk, whereas American Society of Anesthesiologists grade >= 3, larger lesion size, concurrent ablation, technically major, and anatomically major resections were risk factors. Conclusion: Both emergency and non-emergency conversions negatively impact perioperative outcomes in minimally invasive liver surgery. Robotic liver resection reduces conversion risk compared to laparoscopic liver resection. (c) 2024 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
Introduction Body contouring surgery (BCS) can be applied to reduce the physical and mental burden of excess skin after massive weight loss. Self-reported outcomes of patients are used to assess this burden and to evaluate the effectiveness of BCS. The aim of this study is to clarify what is reflected in self-reports of excess skin after bariatric surgery. We hypothesise that the self-reported burden of excess skin is associated with both objectively assessed excess skin and the disposition to experience negative emotions.Methods and analysis This cross-sectional study will include 68 outpatients presenting at a plastic surgery clinic with a request for BCS. Patients fill out two questionnaires (the BODY-Q and the Sahlgrenska Excess Skin Questionnaire (SESQ)) to measure the size and burden of excess skin as well as the Big Five Inventory (BFI) to measure the disposition towards negative emotionality. Anonymised photographs of excess skin will be rated independently by four plastic surgeons using the Pittsburgh Rating Scale (PRS) Rainbow Classification to establish the objective amount of excess skin. Multiple linear regression analyses will be performed to identify the association of BODY-Q and SESQ scores with objective appraisals of excess skin by plastic surgeons, negative emotionality and demographics. Interobserver agreement for PRS Rainbow Classification will be established by Fleiss’ kappa.Ethics and dissemination Ethical approval was obtained from the regional medical ethics committee (METC; W20.258) and the institutional review board (Lokale Toetsing, St. Antonius Hospital in Nieuwegein, no. Z23.035). Informed consent of participants will be obtained. The results of this study will be submitted for publication in a peer-reviewed journal.
Structured assessment of abdominal computed tomography (CT)-scans is increasingly used to identify signs of internal herniation after Roux-en-Y gastric bypass (RYGB), aiding in the decision-making process to perform a diagnostic laparoscopy (DLS). This study aimed to develop a prediction score based on structured assessment of CT-signs for internal herniation. Patients presenting with abdominal pain after RYGB, who underwent a CT-scan for suspicion of internal herniation and subsequently DLS, were included. CT-scans were reassessed for presence of ten CT-signs for internal herniation by two radiologists and two registrars. Diagnostic accuracy for detection of internal herniation for each sign and an overall suspicion score were calculated and compared with the original CT-reports. Interobserver agreement was measured using Fleiss’ kappa. A prediction score was developed based on variables identified by multivariable logistic regression. With DLS 44 internal herniations (114 CT-scans, 92 patients) were identified. Structured assessment improved diagnostic accuracy compared to the original CT-report (AUC of 0.69 to 0.79, p = 0.03), and the positive (67
BACKGROUND:Preoperative endoscopic biliary drainage may lead to complications (16 %-24 %), potentially hampering surgical exploration. Endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) may reduce drainage-related complications; however, in the absence of surgeon-reported outcomes, it is unknown whether EUS-CDS may hamper surgical exploration. This study assessed the impact of preoperative EUS-CDS on pancreatoduodenectomy. METHOD:Consecutive patients who underwent pancreatoduodenectomy after preoperative biliary drainage were included in all eight centers performing EUS-CDS in the mandatory Dutch Pancreatic Cancer Audit (Jan 2020-Dec 2022). The primary outcome was major postoperative complications. Secondary outcomes included bile leak grade B/C, postoperative pancreatic fistula (POPF) grade B/C, and overall postoperative complications. A propensity score-matching (1:3) analysis was performed. Surgeons performing pancreatoduodenectomy after EUS-CDS completed a survey on surgical difficulty. RESULTS:937 patients with pancreatoduodenectomy after preoperative biliary drainage were included (42 EUS-CDS, 895 endoscopic retrograde cholangiopancreatography [ERCP]). Major postoperative complications occurred in 8 patients (19.0 %) in the EUS-CDS group and 292 (32.6 %) in the ERCP group (relative risk [RR] 0.50; 95 %CI 0.23-1.07). No significant differences were observed in overall complications (RR 0.95; 95 %CI 0.51-1.76), bile leak (RR 1.25; 95 %CI 0.31-4.98), or POPF (RR 0.62; 95 %CI 0.25-1.56). Results were similar after matching. The survey was completed for 29 pancreatoduodenectomies; surgery was not (13, 45 %), "slightly" (9, 31 %), "clearly" (5,17 %), and "severely" (2, 7 %) more complex because of EUS-CDS. CONCLUSION:This early experience suggests that preoperative biliary drainage with EUS-CDS does not increase the rate of complications after pancreatoduodenectomy and only infrequently hampers surgical exploration.
Bariatric surgery may induce changes in the effects of oral medication, which may result in medication related problems. Therefore, tailored pharmacotherapy is necessary for individual patients following surgery. In case pharmacotherapy is not adjusted, adverse drug events and even unplanned hospital readmissions may occur. The prevalence of these medication-related readmissions is not known. The primary objective of this study was to determine the prevalence of medication-related readmissions within two years after bariatric surgery. Secondary objectives were to determine the percentage of potentially preventable medication-related readmissions. The reasons for readmission, the associated medication, and medication errors involved in the potentially preventable readmissions were also determined. A retrospective, observational study in a large Dutch teaching hospital was performed. Unplanned readmissions of patients who underwent primary bariatric surgery between January 1, 2018 and August 31, 2020 were included with a follow-up of two years. Records were screened to identify potential medication-related reasons for readmissions. Identified records were independently assessed using adjusted versions of the algorithms of Kramer, Schumock Thornton for causality and preventability by a doctor and pharmacist. All readmissions assessed as possibly (Kamer scores 0 through 3) or probably (Kramer score 4) related to medication were included. In addition, reasons for readmission, associated medication and medication errors were recorded. Descriptive statistics were used to analyze the data. In total, 606 unplanned readmissions of 356 individual patients were included. Eighty-three of 606 (13.7
IMPORTANCE Unintended tumor-positive resection margins occur frequently during minimally invasive surgery for colorectal liver metastases and potentially negatively influence oncologic outcomes. OBJECTIVE To assess whether indocyanine green (ICG)-fluorescence-guided surgery is associated with achieving a higher radical resection rate in minimally invasive colorectal liver metastasis surgery and to assess the accuracy of ICG fluorescence for predicting the resection margin status. DESIGN, SETTING, AND PARTICIPANTS The MIMIC (Minimally Invasive, Indocyanine-Guided Metastasectomy in Patients With Colorectal Liver Metastases) trial was designed as a prospective single-arm multicenter cohort study in 8 Dutch liver surgery centers. Patients were scheduled to undergo minimally invasive (laparoscopic or robot-assisted) resections of colorectal liver metastases between September 1, 2018, and June 30, 2021. EXPOSURES All patients received a single intravenous bolus of 10 mg of ICG 24 hours prior to surgery. During surgery, ICG-fluorescence imaging was used as an adjunct to ultrasonography and regular laparoscopy to guide and assess the resection margin in real time. The ICG-fluorescence imaging was performed during and after liver parenchymal transection to enable real-time assessment of the tumor margin. Absence of ICG fluorescence was favorable both during transection and in the tumor bed directly after resection. MAIN OUTCOMES AND MEASURES The primary outcome measure was the radical (R0) resection rate, defined by the percentage of colorectal liver metastases resected with at least a 1 mm distance between the tumor and resection plane. Secondary outcomes were the accuracy of ICG fluorescence in detecting margin-positive (R1; <1 mm margin) resections and the change in surgical management. RESULTS In total, 225 patients were enrolled, of whom 201 (116 [57.7%] male; median age, 65 [IQR, 57-72] years) with 316 histologically proven colorectal liver metastases were included in the final analysis. The overall R0 resection rate was 92.4%. Re-resection of ICG-fluorescent tissue in the resection cavity was associated with a 5.0% increase in the R0 percentage (from 87.4% to 92.4%; P < .001). The sensitivity and specificity for real-time resection margin assessment were 60% and 90%, respectively (area under the receiver operating characteristic curve, 0.751; 95% CI, 0.668-0.833), with a positive predictive value of 54% and a negative predictive value of 92%. After training and proctoring of the first procedures, participating centers that were new to the technique had a comparable false-positive rate for predicting R1 resections during the first 10 procedures (odds ratio, 1.36; 95% CI, 0.44-4.24). The ICG-fluorescence imaging was associated with changes in intraoperative surgical management in 56 (27.9%) of the patients. CONCLUSIONS AND RELEVANCE In this multicenter prospective cohort study, ICG-fluorescence imaging was associated with an increased rate of tumor margin-negative resection and changes in surgical management in more than one-quarter of the patients. The absence of ICG fluorescence during liver parenchymal transection predicted an R0 resection with 92% accuracy. These results suggest that use of ICG fluorescence may provide real-time feedback of the tumor margin and a higher rate of complete oncologic resection.
Abstract: Obesity is associated with an increased risk of cancers, such as breast cancer. Roux-en-Y gastric bypass (RYGB) is a common surgical intervention used to induce weight loss, reduce comorbidities, and improve overall survival. Due to alterations in the gastrointestinal tract, RYGB is associated with changes in oral drug disposition, which can affect treatment outcomes. Oral antihormonal agents were monitored in 9 patients who previously underwent RYGB. The results of therapeutic drug monitoring and estradiol concentrations were analyzed, and a review of the relevant literature was performed. As only 1 of the 6 patients prescribed tamoxifen achieved a therapeutic endoxifen concentration with the standard dose of 20 mg/d, a higher starting dose of 40 mg/d was recommended to increase the probability of attaining a therapeutic plasma concentration. All patients with decreased CYP2D6 metabolic activity could not achieve therapeutic plasma concentrations; therefore, CYP2D6 genotyping was recommended before the initiation of tamoxifen therapy to identify patients who should be switched to aromatase inhibitors. Anastrozole and letrozole exposure in patients who underwent RYGB patients appeared sufficient, with no dose adjustment required. However, until more data become available, monitoring aromatase inhibitor efficacy is recommended. Monitoring the drug concentrations is a viable option; however, only indicative data on therapeutic drug monitoring are available. Therefore, estradiol concentrations should be measured.
Objective: To compare nationwide outcomes of robotic liver resection (RLR) with laparoscopic liver resection (LLR). Background: Minimally invasive liver resection is increasingly performed using the robotic approach as this could help overcome inherent technical limitations of laparoscopy. It is unknown if this translates to improved patient outcomes. Methods: Data from the mandatory Dutch Hepatobiliary Audit were used to compare perioperative outcomes of RLR and LLR in 20 centers in the Netherlands (2014–2022). Propensity score matching (PSM) was used to mitigate selection bias. Sensitivity analyses assessed the impact of the learning curve (≥50 procedures for LLR and ≥25 procedures for RLR), concurrent noncholecystectomy operations, high-volume centers, and conversion on outcomes. Results: Overall, 792 RLR and 2738 LLR were included. After PSM (781 RLR vs 781 LLR), RLR was associated with less blood loss (median: 100 mL [interquartile range (IQR): 50–300] vs 200 mL [IQR: 50–500], P = 0.002), less major blood loss (≥500 mL,18.6% vs 25.2%, P = 0.011), less conversions (4.9% vs 12.8%, P < 0.001), and shorter hospital stay (median: 3 days [IQR: 2–5] vs 4 days [IQR: 2–6], P < 0.001), compared with LLR. There were no significant differences in overall and severe morbidity, readmissions, mortality, and R0 resection rate. Sensitivity analyses yielded similar results. When excluding conversions, RLR was only associated with a reduction in reoperations (1.1% vs 2.7%, P = 0.038). Conclusion: In this nationwide analysis, RLR was associated with a reduction in conversion, blood loss and length of hospital stay without compromising patient safety, also when excluding a learning curve effect. The benefits of RLR seem to be mostly related to a reduction in conversions.
BACKGROUND:In 2013, the nationwide Dutch Hepato Biliary Audit (DHBA) was initiated. The aim of this study was to evaluate changes in indications for and outcomes of liver surgery in the last decade. METHODS:This nationwide study included all patients who underwent liver surgery for four indications, including colorectal liver metastases (CRLM), hepatocellular carcinoma (HCC), and intrahepatic- and perihilar cholangiocarcinoma (iCCA - pCCA) between 2014 and 2022. Trends in postoperative outcomes were evaluated separately for each indication using multilevel multivariable logistic regression analyses. RESULTS:This study included 8057 procedures for CRLM, 838 for HCC, 290 for iCCA, and 300 for pCCA. Over time, these patients had higher risk profiles (more ASA-III patients and more comorbidities). Adjusted mortality decreased over time for CRLM, HCC and iCCA, respectively aOR 0.83, 95%CI 0.75-0.92, P < 0.001; aOR 0.86, 95%CI 0.75-0.99, P = 0.045; aOR 0.40, 95%CI 0.20-0.73, P < 0.001. Failure to rescue (FTR) also decreased for these groups, respectively aOR 0.84, 95%CI 0.76-0.93, P = 0.001; aOR 0.81, 95%CI 0.68-0.97, P = 0.024; aOR 0.29, 95%CI 0.08-0.84, P = 0.021). For iCCA severe complications (aOR 0.65 95%CI 0.43-0.99, P = 0.043) also decreased. No significant outcome differences were observed in pCCA. The number of centres performing liver resections decreased from 26 to 22 between 2014 and 2022, while median annual volumes did not change (40-49, P = 0.66). CONCLUSION:Over time, postoperative mortality and FTR decreased after liver surgery, despite treating higher-risk patients. The DHBA continues its focus on providing feedback and benchmark results to further enhance outcomes.
Background: In colorectal liver metastases (CRLM) patients, combination of liver resection and ablation permit a more parenchymal-sparing approach. This study assessed trends in use of combined resection and ablation, outcomes, and overall survival (OS). Methods: This population-based study included all CRLM patients who underwent liver resection be-tween 2014 and 2022. To assess OS, data was linked to two databases containing date of death for patients treated between 2014 and 2018. Hospital variation in the use of combined minor liver resection and ablation versus major liver resection alone in patients with 2-3 CRLM and <= 3 cm was assessed. Propensity score matching (PSM) was applied to evaluate outcomes. Results: This study included 3593 patients, of whom 1336 (37.2%) underwent combined resection and ablation. Combined resection increased from 31.7% in 2014 to 47.9% in 2022. Significant hospital variation (range 5.9-53.8%) was observed in the use of combined minor liver resection and ablation. PSM resulted in 1005 patients in each group. Major morbidity was not different (11.6% vs. 5%, P = 1.00). Liver failure occurred less often after combined resection and ablation (1.9% vs. 0.6%, P = 0.017). Five-year OS rates were not different (39.3% vs. 33.9%, P = 0.145). Conclusion: Combined resection and ablation should be available and considered as an alternative to resection alone in any patient with multiple metastases.
Background: Postoperative cholangitis is a common complication after pancreatoduodenectomy that can occur with or without anatomical biliary obstruction. This study aimed to investigate the incidence, diagnosis, treatment, and risk factors of cholangitis after pancreatoduodenectomy. Methods: We performed a retrospective cohort study of consecutive patients who underwent pancreatoduodenectomy in 2 Dutch tertiary pancreatic centers (2010-2019). Primary outcome was postoperative cholangitis, defined as systemic inflammation with abnormal liver tests without another focus of infection, at least 1 month after resection. Diagnostic and therapeutic strategies were evaluated. Two types of postoperative cholangitis were distinguished; obstructive cholangitis (benign stenosis of the hepaticojejunostomy) and nonobstructive cholangitis. Potential risk factors were identified using logistic regression analysis. Results: Postoperative cholangitis occurred in 93 of 900 patients (10.3%). Median time to first episode of cholangitis was 8 months (interquartile range 4-16) after pancreatoduodenectomy. Multiple episodes of cholangitis occurred in 44 patients (47.3%) and readmission was necessary in 83 patients (89.2%). No cholangitis-related mortality was observed. Obstructive cholangitis was seen in 37 patients (39.8%) and nonobstructive cholangitis in 56 patients (60.2%). Surgery was performed for cholangitis in 7 patients (7.5%) and consisted of revision of the hepaticojejunostomy or elongation of the biliary limb. Postoperative biliary leakage (odds ratio 2.56; 95% confidence interval 1.42-4.62; P 1 / 4 .0018) was independently associated with postoperative cholangitis. Conclusion: Postoperative cholangitis unrelated to cancer recurrence was seen in 10% of patients after pancreatoduodenectomy. Nonobstructive cholangitis was more common than obstructive cholangitis. Postoperative biliary leakage was an independent risk factor. (c) 2024 Elsevier Inc. All rights are reserved, including those for text and data mining, AI training, and similar technologies.