Menopausal hormone therapy increases the risk of gallstones: Health Insurance Database in South Korea (HISK)-based cohort study.

OBJECTIVE: To determine whether menopausal hormone therapy (MHT) increases the risk of gallstones and gallbladder cancer. DESIGN: A retrospective cohort study. PATIENTS OR OTHER PARTICIPANTS: Data from the Korea National Health Insurance Corporation was obtained between January 1, 2002, and December 31, 2019. INTERVENTIONS: Participants were divided into MHT and non-MHT groups; the MHT group was analyzed in detail by dividing participants into tibolone, combined estrogen plus progestin by the manufacturer (CEPM) or physician (CEPP), oral estrogen alone, and topical estrogen subgroups. MAIN OUTCOME MEASURES: The incidence of gallstones and gallbladder cancer was compared between the two groups. RESULTS: This study enrolled 1,004,034 and 381,711 patients in the non-MHT and the MHT groups, respectively. The incidence of gallstones was 2.6% in the non-MHT group and 3.4%, 2.6%, 3.4%, 3.2%, and 4.4% in the tibolone, CEPM, oral estrogen alone, CEPP, and topical estrogen groups, respectively. Cox proportional hazard analysis revealed that all hormones increased the risk of gallstones ([tibolone] hazard ratio [HR]: 1.347, 95% confidence interval [CI]: 1.309-1.387, [CEPM] HR: 1.146, 95% CI: 1.1-1.19, [oral estrogen alone] HR: 1.241, 95% CI: 1.18-1.305, [CEPP] HR: 1.164, 95% CI: 1.01-1.341, [topical estrogen] HR: 1.602, 95% CI: 1.295-1.983). However, the risk of gallbladder cancer did not change with any hormone therapy. CONCLUSIONS: All types of MHT including tibolone, increased the risk of gallstones. This risk was the highest with topical estrogen, which may be a result of selection bias due to concerns regarding the adverse effects of CEE and MPA.

Diagnostic accuracy of updated risk assessment criteria and development of novel computational prediction models for patients with suspected choledocholithiasis.

BACKGROUND: There are risks of choledocholithiasis in symptomatic gallstones, and some surgeons have proposed the identification of choledocholithiasis before cholecystectomy. Our goal was to evaluate the diagnostic accuracy of the latest guidelines and create computational prediction models for the accurate prediction of choledocholithiasis. METHODS: We retrospectively reviewed symptomatic gallstone patients hospitalized with suspected choledocholithiasis. The diagnostic performance of 2019 and 2010 guidelines of the American Society for Gastrointestinal Endoscopy (ASGE) and 2019 guideline of the European Society of Gastrointestinal Endoscopy (ESGE) in different risks. Lastly, we developed novel prediction models based on the preoperative predictors. RESULTS: A total of 1199 patients were identified and 681 (56.8%) had concurrent choledocholithiasis and were included in the analysis. The specificity of the 2019 ASGE, 2010 ASGE, and 2019 ESGE high-risk criteria was 85.91%, 72.2%, and 88.42%, respectively, and their positive predictive values were 85.5%, 77.4%, and 87.3%, respectively. For Mid-risk patients who followed 2019 ASGE about 61.8% of them did not have CBD stones in our study. On the choice of surgical procedure, laparoscopic cholecystectomy + laparoscopic transcystic common bile duct exploration can be considered the optimal treatment choice for cholecysto-choledocholithiasis instead of Endoscopic Retrograde Cholangio-Pancreatography (ERCP). We build seven machine learning models and an AI diagnosis prediction model (ModelArts). The area under the receiver operating curve of the machine learning models was from 0.77 to 0.81. ModelArts AI model showed predictive accuracy of 0.97, recall of 0.97, precision of 0.971, and F1 score of 0.97, surpassing any other available methods. CONCLUSION: The 2019 ASGE guideline and 2019 ESGE guideline have demonstrated higher specificity and positive predictive value for high-risk criteria compared to the 2010 ASGE guideline. The excellent diagnostic performance of the new artificial intelligence prediction model may make it a better choice than traditional guidelines for managing patients with suspected choledocholithiasis in future.

Incidence of symptomatic gallstones after bariatric surgery: the impact of expectant management.

BACKGROUND: Bariatric surgery is the most effective treatment for sustained weight reduction and obesity-related comorbidities. The development of gallstones as a result of rapid weight loss is a well-known consequence of bariatric procedures. It remains unclear, if there is an increased risk of these gallstones becoming symptomatic. METHODS: A retrospective analysis of 505 consecutive patients submitted to either Roux-en-Y Gastric Bypass or Sleeve Gastrectomy between January and December 2019 was performed. The aim of our study was to determine the incidence of symptomatic cholelithiasis in asymptomatic patients with their gallbladder in situ after bariatric surgery and to identify potential risk factors for its development. RESULTS: Of the 505 patients included, 79 (15.6%) underwent either previous cholecystectomy. (n = 67, 84.8%) or concomitant cholecystectomy during bariatric surgery (n = 12, 15.2%). Among the remaining 426 (84.4%) patients, only 8 (1.9%) became symptomatic during the 12-month follow-up period. When compared with patients who remained asymptomatic, they had a higher median preoperative BMI (47.0 vs. 42.8, p = 0.046) and prevalence of cholelithiasis on preoperative ultrasound (62.5% vs. 10.7%, p = 0.001). Multivariate analysis revealed preoperative BMI and cholelithiasis on preoperative ultrasound as independent risk factors for symptomatic biliary disease (OR 1.187, 95%CI 1.025-1.376, p = 0.022 and OR 10.720, 95%CI 1.613-71.246, p = 0.014, respectively). CONCLUSION: Considering a low incidence of symptomatic gallstones after bariatric surgery, concomitant cholecystectomy should only be performed in symptomatic patients undergoing bariatric surgery. Preoperative factors, such as a higher BMI and positive ultrasound for cholelithiasis, may be related to the development of symptomatic gallstones.

Decreased Emergency Cholecystectomy and Case Fatality Rate, Not Explained by Expansion of Medicaid.

INTRODUCTION: Population data on longitudinal trends for cholecystectomies and their outcomes are scarce. We evaluated the incidence and case fatality rate of emergency and ambulatory cholecystectomies in New Jersey (NJ) and whether the Medicaid expansion changed trends. MATERIALS AND METHODS: A retrospective population cohort design was used to study the incidence of cholecystectomies and their case fatality rate from 2009 to 2018. Using linear and logistic regression we explored the trends of incidence and the odds of case fatality after versus before the January 1, 2014 Medicaid expansion. RESULTS: Overall, 93,423 emergency cholecystectomies were performed, with 644 fatalities; 87,239 ambulatory cholecystectomies were performed, with fewer than 10 fatalities. The 2009 to 2018 annual incidence of emergency cholecystectomies dropped markedly from 114.8 to 77.5 per 100,000 NJ population (P < 0.0001); ambulatory cholecystectomies increased from 93.5 to 95.6 per 100,000 (P = 0.053). The incidence of emergency cholecystectomies dropped more after than before Medicaid expansion (P < 0.0001). The odds ratio for case fatality among those undergoing emergency cholecystectomies after versus before expansion was 0.85 (95% CI, 0.72-0.99). This decrease in case fatality, apparent only in those over age 65, was not explained by the addition of Medicaid. CONCLUSIONS: A marked decrease in the incidence of emergency cholecystectomies occurred after Medicaid expansion, which was not accounted for by a minimal increase in the incidence of ambulatory cholecystectomies. Case fatality from emergency cholecystectomy decreased over time due to factors other than Medicaid. Further work is needed to reconcile these findings with the previously reported lack of decrease in overall gallstone disease mortality in NJ.

Cost-effectiveness of cholecystectomy compared to conservative management in people presenting with uncomplicated symptomatic gallstones or cholecystitis in India.

OBJECTIVES: Gallstone diseases impose a significant economic burden on the health care system; thus, determining cost-effective management for gallstones is essential. We aim to estimate the cost-effectiveness of cholecystectomy compared with conservative management in individuals with uncomplicated symptomatic gallstones or cholecystitis in India. METHODS: A decision-analytic Markov model was used to compare the costs and QALY of early laparoscopic cholecystectomy (ELC), delayed laparoscopic cholecystectomy (DLC), and conservative management (CM) in patients with symptomatic uncomplicated gallstone/cholecystitis from an Indian health system perspective. Incremental cost-effectiveness ratio (ICER) was calculated. One-way and probabilistic sensitivity analyses were performed to test parameter uncertainties. RESULTS: ELC and DLC, compared to CM, incurred an incremental cost of -₹10,948 ($146) and ₹1,054 ($14) for the 0.032 QALYs gained. The ICER was -₹3,42,758 ($4577) for ELC vs. CM, and ₹33,183 ($443) for DLC vs. CM, suggesting ELC and DLC are cost-effective. ELC saved ₹12,001 ($160) for 0.0002 QALYs gained compared to DLC, resulting in an ICER of -₹6,43,89,441 ($8,59,733). The results were robust to changes in the input parameters in sensitivity analyses. CONCLUSION: ELC is dominant compared to both DLC and CM, and DLC is more cost-effective than CM. Thus, ELC may be preferable to other gallstone disease managements.

EAES rapid guideline: updated systematic review, network meta-analysis, CINeMA and GRADE assessment, and evidence-informed European recommendations on the management of common bile duct stones.

BACKGROUND: Choledocholithiasis presents in a considerable proportion of patients with gallbladder disease. There are several management options, including preoperative or intraoperative endoscopic cholangiopancreatography (ERCP), and laparoscopic common bile duct exploration (LCBDE). OBJECTIVE: To develop evidence-informed, interdisciplinary, European recommendations on the management of common bile duct stones in the context of intact gallbladder with a clinical decision to intervene to both the gallbladder and the common bile duct stones. METHODS: We updated a systematic review and network meta-analysis of LCBDE, preoperative, intraoperative, and postoperative ERCP. We formed evidence summaries using the GRADE and the CINeMA methodology, and a panel of general surgeons, gastroenterologists, and a patient representative contributed to the development of a GRADE evidence-to-decision framework to select among multiple interventions. RESULTS: The panel reached unanimous consensus on the first Delphi round. We suggest LCBDE over preoperative, intraoperative, or postoperative ERCP, when surgical experience and expertise are available; intraoperative ERCP over LCBDE, preoperative or postoperative ERCP, when this is logistically feasible in a given healthcare setting; and preoperative ERCP over LCBDE or postoperative ERCP, when intraoperative ERCP is not feasible and there is insufficient experience or expertise with LCBDE (weak recommendation). The evidence summaries and decision aids are available on the platform MAGICapp ( https://app.magicapp.org/#/guideline/nJ5zyL ). CONCLUSION: We developed a rapid guideline on the management of common bile duct stones in line with latest methodological standards. It can be used by healthcare professionals and other stakeholders to inform clinical and policy decisions. GUIDELINE REGISTRATION NUMBER: IPGRP-2022CN170.

Cost-effectiveness of ursodeoxycholic acid in preventing new-onset symptomatic gallstone disease after Roux-en-Y gastric bypass surgery.

BACKGROUND: The aim was to evaluate the cost-effectiveness and cost-utility of ursodeoxycholic acid (UDCA) prophylaxis for the prevention of symptomatic gallstone disease after Roux-en-Y gastric bypass (RYGB) in patients without gallstones before surgery. METHODS: Data from a multicentre, double-blind, randomized placebo-controlled superiority trial were used. Patients scheduled for laparoscopic RYGB or sleeve gastrectomy were randomized to receive 900 mg UDCA or placebo for 6 months. Indicated by the clinical report, prophylactic prescription of UDCA was evaluated economically against placebo from a healthcare and societal perspective for the subgroup of patients without gallstones before surgery who underwent RYGB. Volumes and costs of in-hospital care, out-of-hospital care, out-of-pocket expenses, and productivity loss were assessed. Main outcomes were the costs per patient free from symptomatic gallstone disease and the costs per quality-adjusted life-year (QALY). RESULTS: Patients receiving UDCA prophylaxis were more likely to remain free from symptomatic gallstone disease (relative risk 1.06, 95 per cent c.i. 1.02 to 1.11; P = 0.002) compared with patients in the placebo group. The gain in QALYs, corrected for a baseline difference in health utility, was 0.047 (95 per cent bias-corrected and accelerated (Bca) c.i. 0.007 to 0.088) higher (P = 0.022). Differences in costs were -€356 (95 per cent Bca c.i. €-1573 to 761) from a healthcare perspective and -€1392 (-3807 to 917) from a societal perspective including out-of-pocket expenses and productivity loss, both statistically non-significant, in favour of UDCA prophylaxis. The probability of UDCA prophylaxis being cost-effective was at least 0.872. CONCLUSION: UDCA prophylaxis after RYGB in patients without gallstones before surgery was cost-effective.

Incremental net benefit of cholecystectomy compared with alternative treatments in people with gallstones or cholecystitis: a systematic review and meta-analysis of cost-utility studies.

INTRODUCTION: Cholecystectomy is a standard treatment in the management of symptomatic gallstone disease. Current literature has contradicting views on the cost-effectiveness of different cholecystectomy treatments. We have conducted a systematic reappraisal of literature concerning the cost-effectiveness of cholecystectomy in management of gallstone disease. METHODS: We systematically searched for economic evaluation studies from PubMed, Embase and Scopus for eligible studies from inception up to July 2020. We pooled the incremental net benefit (INB) with a 95% CI using a random-effects model. We assessed the heterogeneity using the Cochrane-Q test, I2 statistic. We have used the modified economic evaluation bias (ECOBIAS) checklist for quality assessment of the selected studies. We assessed the possibility of publication bias using a funnel plot and Egger's test. RESULTS: We have selected 28 studies for systematic review from a search that retrieved 8710 studies. Among them, seven studies were eligible for meta-analysis, all from high-income countries (HIC). Studies mainly reported comparisons between surgical treatments, but non-surgical gallstone disease management studies were limited. The early laparoscopic cholecystectomy (ELC) was significantly more cost-effective compared with the delayed laparoscopic cholecystectomy (DLC) with an INB of US$1221 (US$187 to US$2255) but with high heterogeneity (I2=73.32%). The subgroup and sensitivity analysis also supported that ELC is the most cost-effective option for managing gallstone disease or cholecystitis. CONCLUSION: ELC is more cost-effective than DLC in the treatment of gallstone disease or cholecystitis in HICs. There was insufficient literature on comparison with other treatment options, such as conservative management and limited evidence from other economies. PROSPERO REGISTRATION NUMBER: CRD42020194052.

Assessment of postoperative common bile duct stones after endoscopic extraction and subsequent cholecystectomy.

BACKGROUND: Common bile duct stones (CBDSs) occasionally cause serious diseases, and endoscopic extraction is the standard procedure for CBDS. To prevent biliary complications, cholecystectomy is recommended for patients who present with gallbladder (GB) stones after endoscopic CBDS extraction. However, CBDS can occasionally recur. To date, the occurrence of CBDS after endoscopic CBDS extraction and subsequent cholecystectomy is not fully understood. Hence, the current study aimed to evaluate the incidence of postoperative CBDSs. METHODS: This retrospective observational study included consecutive patients who underwent postoperative endoscopic retrograde cholangiography after endoscopic CBDS extraction and subsequent cholecystectomy between April 2012 and June 2021 at our institution. After endoscopic CBDS extraction, a biliary plastic stent was inserted to prevent obstructive cholangitis. Endoscopic retrograde cholangiography was performed to evaluate postoperative CBDSs after cholecystectomy until hospital discharge. The outcomes were the incidence of postoperative CBDSs and CBDSs/sludge. Moreover, the predictive factors for postoperative CBDSs were evaluated via univariate and multivariate analyses. RESULTS: Of eligible 204 patients, 52 patients (25.5%) presented with postoperative CBDSs. The incidence rate of CBDS/sludge was 36.8% (n = 75). Based on the univariate analysis, the significant predictive factors for postoperative CBDSs were ≥ 6 CBDSs, presence of cystic duct stones, and ≥ 10 GB stones (P < 0.05). Moreover, male sex and < 60-mm minor axis in GB might be predictive factors (P < 0.10). Based on the multivariate analysis, ≥ 6 CBDSs (odds ratio = 6.65, P < 0.01), presence of cystic duct stones (odds ratio = 4.39, P < 0.01), and ≥ 10 GB stones (odds ratio = 2.55, P = 0.01) were independent predictive factors for postoperative CBDSs. CONCLUSIONS: The incidence of postoperative CBDS was relatively high. Hence, patients with predictive factors for postoperative CBDS must undergo imaging tests or additional endoscopic procedure after cholecystectomy.

Evaluation of socioeconomic and healthcare disparities on same admission cholecystectomy after endoscopic retrograde cholangiopancreatography among patients with acute gallstone pancreatitis.

BACKGROUND: Despite literature and guidelines recommending same admission cholecystectomy (CCY) after endoscopic retrograde cholangiopancreatography (ERCP) for patients with acute gallstone pancreatitis, clinical practice remains variable. The aim of this study was to investigate the role of clinical and socio-demographic factors in the management of acute gallstone pancreatitis. METHODS: Patients with acute gallstone pancreatitis who underwent ERCP during hospitalization were reviewed from the U.S. Nationwide Inpatient Sample database between 2008 and 2014. Patients were classified by treatment strategy: ERCP + same admission CCY (ERCP + CCY) versus ERCP alone. Measured variables including age, race/ethnicity, Charlson Comorbidity Index (CCI), hospital type/region, insurance payer, household income, length of hospital stay (LOS), hospitalization cost, and in-hospital mortality were compared between cohorts using χ2 and ANOVA. Multivariable logistic regression was performed to identify specific predictors of same admission CCY. RESULTS: A total of 205,012 patients (ERCP + CCY: n = 118,318 versus ERCP alone: n = 86,694) were analyzed. A majority (53.4%) of patients that did not receive same admission CCY were at urban-teaching hospitals. LOS was longer with higher associated costs for patients with same admission CCY [(6.8 ± 5.6 versus 6.4 ± 6.5 days; P < 0.001) and ($69,135 ± 65,913 versus $52,739 ± 66,681; P < 0.001)]. Mortality was decreased significantly for patients who underwent ERCP + CCY versus ERCP alone (0.4% vs 1.1%; P < 0.001). Multivariable regression demonstrated female gender, Black race, higher CCI, Medicare payer status, urban-teaching hospital location, and household income decreased the odds of undergoing same admission CCY + ERCP (all P < 0.001). CONCLUSION: Based upon this analysis, multiple socioeconomic and healthcare-related disparities influenced the surgical management of acute gallstone pancreatitis. Further studies to investigate these disparities are indicated.

Cost-effectiveness of Restrictive Strategy Versus Usual Care for Cholecystectomy in Patients With Gallstones and Abdominal Pain (SECURE-trial).

OBJECTIVE: To perform a cost-effectiveness analysis of restrictive strategy versus usual care in patients with gallstones and abdominal pain. SUMMARY OF BACKGROUND DATA: A restrictive selection strategy for surgery in patients with gallstones reduces cholecystectomies, but the impact on overall costs and cost-effectiveness is unknown. METHODS: Data of a multicentre, randomized-controlled trial (SECURE-trial) were used. Adult patients with gallstones and abdominal pain were included. Restrictive strategy was economically evaluated against usual care from a societal perspective. Hospital-use of resources was gathered with case-report forms and out-of-hospital consultations, out-of-pocket expenses, and productivity loss were collected with questionnaires. National unit costing was applied. The primary outcome was the cost per pain-free patient after 12 months. RESULTS: All 1067 randomized patients (49.0 years, 73.7% females) were included. After 12 months, 56.2% of patients were pain-free in restrictive strategy versus 59.8% after usual care. The restrictive strategy significantly reduced the cholecystectomy rate with 7.7% and reduced surgical costs with €160 per patient, €162 was saved from a societal perspective. The cost-effectiveness plane showed that restrictive strategy was cost saving in 89.1%, but resulted in less pain-free patients in 88.5%. Overall, the restrictive strategy saved €4563 from a societal perspective per pain-free patient lost. CONCLUSIONS: A restrictive selection strategy for cholecystectomy saves €162 compared to usual care, but results in fewer pain-free patients. The incremental cost per pain-free patient are savings of €4563 per pain-free patient lost. The higher societal willingness to pay for 1 extra pain-free patient, the lower the probability that the restrictive strategy will be cost-effective. TRIAL REGISTRATION: The Netherlands National Trial Register NTR4022. Registered on 5 June 2013.

Patterns of prevalence and contemporary clinical management strategies in complicated acute biliary calculous disease: an ESTES 'snapshot audit' of practice.

BACKGROUND: Acute complications of biliary calculi are common, morbid, and complex to manage. Variability exists in the techniques utilized to treat these conditions at an individual surgeon and unit level. AIM: To identify, through an international prospective nonrandomized cohort study, the epidemiology and areas of practice variability in management of acute complicated calculous biliary disease (ACCBD) and to correlate them against reported outcomes. METHODS: A preplanned analysis of the European Society of Trauma and Emergency Surgery (ESTES) 2018 Complicated Biliary Calculous Disease audit was performed. Patients undergoing emergency hospital admission with ACCBD between 1 October 2018 and 31 October 2018 were included. All eligible patients with acute complicated biliary calculous disease were recorded contemporaneously using a standardized predetermined protocol and a secure online database and followed-up through to 60 days from their admission. ENDPOINTS: A two-stage data collection strategy collecting patient demographics, details of operative, endoscopic and radiologic intervention, and outcome metrics. Outcome measures included mortality, surgical morbidity, ICU stay, timing of operative intervention, and length of hospital stay. RESULTS: Three hundred thirty-eight patients were included, with a mean age of 65 years and 54% were female. Diagnosis at admission were: cholecystitis (45.6%), biliary pancreatitis (21%), choledocholithiasis with and without cholangitis (13.9% and 18%). Index admission cholecystectomy was performed in just 50% of cases, and 28% had an ERCP performed. Morbidity and mortality were low. CONCLUSION: This first ESTES snapshot audit, a purely descriptive collaborative study, gives rich 'real world' insights into local variability in surgical practice as compared to international guidelines, and how this may impact upon outcomes. These granular data will serve to improve overall patient care as well as being hypothesis generating and inform areas needing future prospective study.

Demographic, Chemical, and Helicobacter pylori Positivity Assessment in Different Types of Gallstones and the Bile in a Random Sample of Cholecystectomied Iranian Patients with Cholelithiasis.

Background: The occurrence of stones in the gallbladder or common bile duct and the symptoms and complications they cause is called gallstone disease. The symptoms of gallstone disease range from mild, nonspecific symptoms to a severe right quadrant abdominal pain. Characteristics of gallstone types in an Iranian population have not been well studied before and there are very limited studies on the demographic pattern of stone types in our country, so this study is one of the first studies on its kind on the epidemiology of gallstone types in Iran. As information on chemical components of the stone will help in the management and prevention of gallstones, in this study, we aimed to do chemical component analysis of gallstones including cholesterol, bilirubin, and calcium. Given the conflicting reports about the relationship between H. pylori infections and gallstone formation, this study aimed to investigate the relationship between H. pylori positivity in the bile specimen of Iranian patients with cholelithiasis and formation and type of stone. Methods: This prospective study reviewed a total of 196 patients who underwent cholecystectomy for symptomatic cholelithiasis at Shahid Beheshti Training and Research Hospital affiliated to the Yasuj University of Medical Sciences between September 2015 and May 2018. Chemical analysis of gallstone components performed using the colorimetry method. Microbiological analysis for H. pylori was done using the OnSite H. pylori Ag Rapid Test on the bile sample. For the validation test of bile, the H. pylori Rapid Stool Ag Test on stool was used, and Cohen's Kappa statistical analysis was done next. Results: There were significant associations between the stone types and age, chemical composition of the stones such as calcium, cholesterol, and bilirubin levels, and also H. pylori positivity and cholesterol and bilirubin levels; however, no significant association was found between the stone types and sex, H. pylori positivity and age, sex, stone types, and calcium level. The main bile and validity tests were matched to the substantial agreement according to Cohen's Kappa analysis. The most common drugs used were proton pump inhibitors, nonsteroidal anti-inflammatory drugs, antihypertensive drugs, and oral contraceptives. Conclusions: This study suggested that the chemical composition of the stones could predict the presence of bacteria, there is no correlation between H. pylori and gallstone formation, and some of the drugs could be predisposing factors for gallstones. This work provides an objective basis for further research into gallbladder stone formation; meanwhile, it has great significance in the treatment and prevention of gallbladder stones. Trial registration. The project was found to be in accordance to the ethical principles and the national norms and standards for conducting research in Iran with the approval ID IR.YUMS.REC.1399.147 and date 2020.09.23, and this project is the result of a residency dissertation to obtain the specialty in general surgery, which has been registered with the research project number 960159 in the Vice Chancellor for Research and Technology Development of the Yasuj University of Medical Sciences, Yasuj, Iran, URL: https://ethics.research.ac.ir/EthicsProposalViewEn.php?id=160634.

When Should We Perform Intraoperative Cholangiography? A Prospective Assessment of 1000 Consecutive Laparoscopic Cholecystectomies.

BACKGROUND: Intraoperative cholangiography (IOC) has been historically used to detect common bile duct (CBD) stones, delineate biliary anatomy, and avoid or promptly diagnose bile duct injuries (BDIs) during laparoscopic cholecystectomy (LC). We aimed to determine the usefulness of routine IOC during LC in an urban teaching hospital. METHODS: A consecutive series of patients undergoing LC with routine IOC from 2016 to 2018 was prospectively analyzed. Primary outcomes of interest were: CBD stones, BDI, and anatomical variations of the biliary tract. Secondary outcomes of interest were: IOC success rate, IOC time, and readmission for residual lithiasis. A comparative analysis was performed between patients with and without preoperative suspicion of CBD stones. RESULTS: A total of 1003 LC were analyzed; IOC was successful in 918 (91.5%) patients. Mean IOC time was 10 (4 to 30) minutes. Mean radiation received by the surgeon per procedure was 0.06 millisieverts (mSv). Normal IOC was found in 856 (93.2%) patients. CBD stones and aberrant biliary anatomy were present in 58 (6.3%) and 4 (0.4%) cases, respectively. Two patients (0.2%) underwent unnecessary CBD exploration because of false-positive IOC. Four patients (0.4%) with normal IOC were readmitted for residual CBD stones. Five (0.5%) minor BDI undetected by the IOC were diagnosed. Patients with preoperative suspicion of CBD stones had significantly higher rates of CBD stones detected on IOC as compared with those without suspicion (23.2% vs. 2.1%, P<0.0001). CONCLUSION: Routine use of IOC resulted in low rates of BDI diagnosis, aberrant biliary anatomy identification and/or CBD stones detection. Selection of patients for IOC, rather than routine use of IOC appears a more reasonable approach.

Budget Impact of Restrictive Strategy Versus Usual Care for Cholecystectomy (SECURE-Trial).

OBJECTIVES: A cost-effectiveness analysis of a multicenter randomized-controlled trial comparing restrictive strategy versus usual care in patients with gallstones showed that savings by restrictive strategy could not compensate for the lower proportion of pain-free patients. However, four subgroups based on combined stratification factors resulted in less cholecystectomies and more pain-free patients in restrictive strategy (female-low volume-BMI > 30, female-low volume-BMI25-30, female-high volume-BMI25-30, and male-low volume-BMI < 25). The aim of this study was to explore the budget impact from a hospital healthcare perspective of implementation of restrictive strategy in these subgroups. METHODS: Data of the SECURE-trial were used to calculate the hospital budget impact with a time horizon of four years. Based on a study into practice variation, about 19% of hospitals treat patients according restrictive strategy. This represents the proportion of patients treated according restrictive strategy at the start of budget period. Three subanalyses were performed: a scenario analysis in which 30% of patients fall under a restrictive strategy in clinical practice, a sensitivity analysis in which we calculated the budget impact with the low and high 95% confidence limits of the expected future number of patients, a subgroup analysis in which restrictive strategy was also implemented in two additional subgroups (male-high volume-BMI < 25 and female-high volume-BMI >30). RESULTS: Budget impact analysis showed savings of €6.7-€15.6 million (2.2%-5.6%) for the period 2021-2024/2025 by implementing the restrictive strategy in the four subgroups and provision of usual care in other patients. Sensitivity analysis with 30% of patients already in the restrictive strategy at the start of the budget period, resulted in savings between €5.4 million and €14.0 million (1.7%-5.0%). CONCLUSION: Performing a restrictive strategy for selection of cholecystectomy in subgroups of patients and provision of usual care in other patients will result in a lower overall hospital budget needed to treat patients with abdominal pain and gallstones. TRIAL REGISTRATION: The Netherlands National Trial Register NTR4022. Registered on June 5, 2013.

Impact of Early Cholecystectomy on the Cost of Treating Mild Gallstone Pancreatitis: Gallstone PANC Trial.

BACKGROUND: The Gallstone Pancreatitis: Admission vs Normal Cholecystectomy (Gallstone PANC) Trial demonstrated that cholecystectomy within 24 hours of admission (early) compared with after clinical resolution (control) for mild gallstone pancreatitis, significantly reduced 30-day length-of-stay (LOS) without increasing major postoperative complications. We assessed whether early cholecystectomy decreased 90-day healthcare use and costs. STUDY DESIGN: A secondary economic evaluation of the Gallstone PANC Trial was performed from the healthcare system perspective. Costs for index admissions and all gallstone pancreatitis-related care 90 days post-discharge were obtained from the hospital accounting system and inflated to 2020 USD. Negative binomial regression models and generalized linear models with log-link and gamma distribution, adjusting for randomization strata, were used. Bayesian analysis with neutral prior was used to estimate the probability of cost reduction with early cholecystectomy. RESULTS: Of 98 randomized patients, 97 were included in the analyses. Baseline characteristics were similar in early (n = 49) and control (n = 48) groups. Early cholecystectomy resulted in a mean absolute difference in LOS of -0.96 days (95% CI, -1.91 to 0.00, p = 0.05). Ninety-day mean total costs were $14,974 (early) vs $16,190 (control) (cost ratio [CR], 0.92; 95% CI, 0.73-1.15, p = 0.47), with a mean absolute difference of $1,216 less (95% CI, -$4,782 to $2,349, p = 0.50) per patient in the early group. On Bayesian analysis, there was an 81% posterior probability that early cholecystectomy reduced 90-day total costs. CONCLUSION: In this single-center trial, early cholecystectomy for mild gallstone pancreatitis reduced 90-day LOS and had an 81% probability of reducing 90-day healthcare system costs.

Randomised controlled trial to establish the clinical and cost-effectiveness of expectant management versus preoperative imaging with magnetic resonance cholangiopancreatography in patients with symptomatic gallbladder disease undergoing laparoscopic cholecystectomy at low or moderate risk of common bile duct stones (The Sunflower Study): a study protocol.

INTRODUCTION: Surgery to remove the gallbladder (laparoscopic cholecystectomy (LC)) is the standard treatment for symptomatic gallbladder disease. One potential complication of gallbladder disease is that gallstones can pass into the common bile duct (CBD) where they may remain dormant, pass spontaneously into the bowel or cause problems such as obstructive jaundice or pancreatitis. Patients requiring LC are assessed preoperatively for their risk of CBD stones using liver function tests and imaging. If the risk is high, guidelines recommend further investigation and treatment. Further investigation of patients at low or moderate risk of CBD stones is not standardised, and the practice of imaging the CBD using magnetic resonance cholangiopancreatography (MRCP) in these patients varies across the UK. The consequences of these decisions may lead to overtreatment or undertreatment of patients. METHODS AND ANALYSIS: We are conducting a UK multicentre, pragmatic, open, randomised controlled trial with internal pilot phase to compare the effectiveness and cost-effectiveness of preoperative imaging with MRCP versus expectant management (ie, no preoperative imaging) in adult patients with symptomatic gallbladder disease undergoing urgent or elective LC who are at low or moderate risk of CBD stones. We aim to recruit 13 680 patients over 48 months. The primary outcome is any hospital admission within 18 months of randomisation for a complication of gallstones. This includes complications of endoscopic retrograde cholangiopancreatography for the treatment of gallstones and complications of LC. This will be determined using routine data sources, for example, National Health Service Digital Hospital Episode Statistics for participants in England. Secondary outcomes include cost-effectiveness and patient-reported quality of life, with participants followed up for a median of 18 months. ETHICS AND DISSEMINATION: This study received approval from Yorkshire & The Humber - South Yorkshire Research Ethics Committee. Results will be submitted for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: ISRCTN10378861.

Protocol for a randomised controlled trial comparing laparoscopic cholecystectomy with observation/conservative management for preventing recurrent symptoms and complications in adults with uncomplicated symptomatic gallstones (C-Gall trial).

BACKGROUND: Gallstone disease (cholelithiasis) is common. In most people it is asymptomatic and does not require treatment, but in about 20% it can become symptomatic, causing pain and other complications requiring medical attention and/or surgery. A proportion of symptomatic people with uncomplicated gallstone disease do not experience further episodes of pain and, therefore, could be treated conservatively. Moreover, surgery carries risks of perioperative and postoperative complications. METHODS AND ANALYSIS: C-Gall is a pragmatic, multicentre, randomised controlled trial and economic evaluation to assess whether cholecystectomy is cost-effective compared with observation/ conservative management (here after referred to as medical management) at 18 months post-randomisation (with internal pilot). PRIMARY OUTCOME MEASURE: Patient-reported quality of life (QoL) (36-Item Short Form Survey (SF-36) bodily pain domain) up to 18 months after randomisation.The primary economic outcome is incremental cost per quality-adjusted life year gained at 18 months. SECONDARY OUTCOME MEASURES: Secondary outcome measures include condition-specific QoL, SF-36 domains, complications, further treatment, persistent symptoms, healthcare resource use, and costs assessed at 18 and 24 months after randomisation. The bodily pain domain of the SF-36 will also be assessed at 24 months after randomisation.A sample size of 430 participants was calculated. Computer-generated 1:1 randomisation was used.The C-Gall Study is currently in follow-up in 20 UK research centres. The first patient was randomised on 1 August 2016, with follow-up to be completed by 30 November 2021. STATISTICAL ANALYSIS: Statistical analysis of the primary outcome will be intention-to-treat and a per-protocol analysis. The primary outcome, area under the curve (AUC) for the SF-36 bodily pain up to 18 months, will be generated using the Trapezium rule and analysed using linear regression with adjustment for the minimisation variables (recruitment site, sex and age). For the secondary outcome, SF-36 bodily pain, AUC up to 24 months will be analysed in a similar way. Other secondary outcomes will be analysed using generalised linear models with adjustment for minimisation and baseline variables, as appropriate. Statistical significance will be at the two-sided 5% level with corresponding CIs. ETHICS AND DISSEMINATION: The North of Scotland Research Ethics Committee approved this study (16/NS/0053). The dissemination plans include Health Technology Assessment monograph, international scientific meetings and publications in high-impact, open-access journals. TRIAL REGISTRATION NUMBER: ISRCTN55215960; pre-results.

The Efficiency of Laparoscopic Common Bile Duct Exploration in Endoscopic Retrograde-Cholangiopancreatography-Limited Setting in a Peripheral University Hospital.

Background: The aim of this study is to evaluate complications and costs in patients treated with laparoscopic and open method for common bile duct (CBD) stones. Secondary aim is to compare the effectiveness, safety, and outcomes of these methods. In addition, it is aimed to review the feasibility of laparoscopic method in rural areas. Methods: Seventy-one patients were analyzed retrospectively. Patients were divided into two groups as open and laparoscopic surgical method. These groups were analyzed comparatively in terms of complications and costs. Subgroups were formed from patients who underwent T-tube drainage, primary closure, and biliary anastomosis as choledochotomy management. As a secondary outcome, these three subgroups were investigated in terms of complications and cost. Results: The cost was lower in open method compared to laparoscopic method (484$, 707$, P = .002). There was no significant difference in postoperative complications between groups (P = .257). While the mean hospital stay was longer in the open group, the operation time was shorter (P = .002, P = .03). The mean length of hospital stay in the T-tube group was significantly higher than the primary closure (P = .001). The cost in the T-tube group was significantly higher than the primary closure and biliary anastomosis groups. Conclusion: Laparoscopic CBD exploration by experienced surgeons in endoscopic retrograde-cholangiopancreatography-limited settings is an effective and safe method in the treatment of choledocholithiasis. This procedure should not be limited to reference centers and should be performed safely in rural areas by well-trained surgeons.

National trends and outcomes of inpatient robotic-assisted versus laparoscopic cholecystectomy.

BACKGROUND: Laparoscopic cholecystectomy has reached nearly universal adoption in the management of gallstone-related disease. With advances in operative technology, robotic-assisted cholecystectomy has been used increasingly in many practices, but few studies have examined the adoption of robotic assistance for inpatient cholecystectomy and the temporal outcomes on a national scale. The present study aimed to identify trends in utilization, as well as outcomes and factors associated with the use of robotic-assisted cholecystectomy. METHODS: The 2008 to 2017 database of the National Inpatient Sample was used to identify patients undergoing inpatient cholecystectomy. Independent predictors of the use of robotic assistance for cholecystectomy were identified using multivariable logistic regression adjusting for patient and hospital characteristics. RESULTS: Of an estimated 3,193,697 patients undergoing cholecystectomy, 98.7% underwent laparoscopic cholecystectomy and 1.3% robotic-assisted cholecystectomy. Rates of robotic-assisted cholecystectomy increased from 0.02% in 2008 to 3.2% in 2017 (nptrend < .001). Compared with laparoscopic cholecystectomy, patients undergoing robotic-assisted cholecystectomy had a greater burden of comorbidities as measured by the Elixhauser index (2.2 vs 1.9, P < .001). Although mortality rates were similar, robotic-assisted cholecystectomy was associated with greater complication rates (15.5% vs 11.7%, P < .001), most notably gastrointestinal-related complications (3.7% vs 1.5%, P < .001). On multivariable regression, robotic-assisted cholecystectomy was associated with increased costs of hospitalization (ß: $2,398, P < .001). CONCLUSION: Using the largest national database available, we found a dramatic increase in the use of robotic-assisted cholecystectomy with no difference in mortality or duration of hospital stay, but there was a statistically significant increase in complications and costs. These findings warrant further investigation.