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ObjectiveThe optimal management of acute cholecystitis in patients at very high risk for cholecystectomy is uncertain. The aim of the current study was to compare endoscopic ultrasound (EUS)-guided gallbladder drainage (EUS-GBD) to percutaneous cholecystostomy (PT-GBD) as a definitive treatment in these patients under a randomised controlled trial.DesignConsecutive patients suffering from acute calculous cholecystitis but were at very high-risk for cholecystectomy were recruited. The primary outcome was the 1-year adverse events rate. Secondary outcomes include technical and clinical success, 30-day adverse events, pain scores, unplanned readmissions, re-interventions and mortalities.ResultsBetween August 2014 to February 2018, 80 patients were recruited. EUS-GBD significantly reduced 1 year adverse events (10 (25.6%) vs 31 (77.5%), p<0.001), 30-day adverse events (5 (12.8%) vs 19 (47.5%), p=0.010), re-interventions after 30 days (1/39 (2.6%) vs 12/40 (30%), p=0.001), number of unplanned readmissions (6/39 (15.4%) vs 20/40 (50%), p=0.002) and recurrent cholecystitis (1/39 (2.6%) vs 8/40 (20%), p=0.029). Postprocedural pain scores and analgesic requirements were also less (p=0.034). The technical success (97.4% vs 100%, p=0.494), clinical success (92.3% vs 92.5%, p=1) and 30-day mortality (7.7% vs 10%, p=1) were statistically similar. The predictor to recurrent acute cholecystitis was the performance of PT-GBD (OR (95% CI)=5.63 (1.20–53.90), p=0.027).ConclusionEUS-GBD improved outcomes as compared to PT-GBD in those patients that not candidates for cholecystectomy. EUS-GBD should be the procedure of choice provided that the expertise is available after a multi-disciplinary meeting. Further studies are required to determine the long-term efficacy.Trial registration number NCT02212717

Background Laparoscopic cholecystectomy in acute calculous cholecystitis in high risk patients can lead to significant morbidity and mortality. Percutaneous cholecystostomy may be an alternative treatment option but the current literature does not provide the surgical community with evidence based advice. Methods/Design The CHOCOLATE trial is a randomised controlled, parallel-group, superiority multicenter trial. High risk patients, defined as APACHE-II score 7-14, with acute calculous cholecystitis will be randomised to laparoscopic cholecystectomy or percutaneous cholecystostomy. During a two year period 284 patients will be enrolled from 30 high volume teaching hospitals. The primary endpoint is a composite endpoint of major complications within three months following randomization and need for re-intervention and mortality during the follow-up period of one year. Secondary endpoints include all other complications, duration of hospital admission, difficulty of procedures and total costs. Discussion The CHOCOLATE trial is designed to provide the surgical community with an evidence based guideline in the treatment of acute calculous cholecystitis in high risk patients. Trial Registration Netherlands Trial Register (NTR): NTR2666

Background and aimSurgical cholecystectomy is the gold standard strategy for the management of acute cholecystitis (AC). However, some patients are considered unfit for surgery due to certain comorbid conditions. As such, we aimed to compare less invasive treatment strategies such as endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) and percutaneous gallbladder drainage (PT-GBD) for the management of patients with AC who are suboptimal candidates for surgical cholecystectomy.MethodsA comprehensive search of multiple electronic databases was performed to identify all the studies comparing EUS-GBD versus PT-GBD for patients with AC who were unfit for surgery. A subgroup analysis was also performed for comparison of the group undergoing drainage via cautery-enhanced lumen-apposing metal stents (LAMS) versus PT-GBD. The outcomes included technical and clinical success, adverse events (AEs), recurrent cholecystitis, reintervention, and hospital readmission.ResultsEleven studies including 1155 patients were included in the statistical analysis. There was no difference between PT-GBD and EUS-GBD in all the evaluated outcomes. On the subgroup analysis, the endoscopic approach with cautery-enhanced LAMS was associated with lower rates of adverse events (RD =  − 0.33 (95% CI − 0.52 to − 0.14; p = 0.0006), recurrent cholecystitis (− 0.05 RD (95% CI − 0.09 to − 0.02; p = 0.02), and hospital readmission (− 0.36 RD (95% CI–0.70 to – 0.03; p = 0.03) when compared to PT-GBD. All other outcomes were similar in the subgroup analyses.ConclusionsEUS-GBD using cautery-enhanced LAMS is superior to PT-GBD in terms of safety profile, recurrent cholecystitis, and hospital readmission rates in the management of patients with acute cholecystitis who are suboptimal candidates for cholecystectomy. However, when cautery-enhanced LAMS are not used, the outcomes of EUS-GBD and PT-GBD are similar. Thus, EUS-GBD with cautery-enhanced LAMS should be considered the preferable approach for gallbladder drainage for this challenging population.

Background Endoscopic ultrasound-guided transmural stenting for gallbladder drainage is an emerging alternative for the treatment of acute cholecystitis in high-risk surgical patients. A variety of stents have been described, including plastic stents, self-expandable metal stents (SEMSs), and lumen-apposing metal stents (LAMSs). LAMSs represent the only specifically designed stent for transmural gallbladder drainage. A systematic review was performed to evaluate the feasibility and efficacy of EUS-guided drainage (EUS-GBD) in acute cholecystitis using different types of stents. Methods A computer-assisted literature search up to September 2015 was performed using two electronic databases, MEDLINE and EMBASE. Search terms included MeSH and non-MeSH terms relating to acute cholecystitis, gallbladder drainage, endoscopic gallbladder drainage, endoscopic ultrasound gallbladder drainage, alone or in combination. Additional articles were retrieved by hand-searching from references of relevant studies. Pooled technical success, clinical success, and adverse event rates were calculated. Results Twenty-one studies met the inclusion criteria, and the eligible cases were 166. The overall technical success rate, clinical success rate, and frequency of adverse events were 95.8, 93.4, and 12.0 %, respectively. The technical success rate was 100 % using plastic stents, 98.6 % using SEMSs, and 91.5 % using LAMSs. The clinical success rate was 100, 94.4, and 90.1 % after the deployment of plastic stents, SEMSs, and LAMSs, respectively. The frequency of adverse events was 18.2 % using plastic stents, 12.3 % using SEMSs, and 9.9 % using LAMSs. Conclusions Among the different drainage approaches in the non-surgical management of acute cholecystitis, EUS-guided transmural stenting for gallbladder drainage appears to be feasible, safe, and effective. LAMSs seem to have high potentials in terms of efficacy and safety, although further prospective studies are needed.

Background White blood cell levels (WBC) is the only biologic determinant criterion of the severity assessment of acute cholecystitis (AC) in the revised Tokyo Guidelines 2018 (TG18). The aims of this study were to evaluate the discriminative powers of common inflammatory markers (neutrophil-to-lymphocyte ratio (NLR), and C-reactive protein (CRP)) compared with WBC for the severity of AC, and the risk for conversion to open surgery and to determine their diagnostic cutoff levels. Methods This was a prospective cohort study. Over 3 years, 556 patients underwent laparoscopic cholecystectomy for AC. Patients were classified into two groups: 139 cases of advanced acute cholecystitis (AAC) (gangrenous cholecystitis, pericholecystic abscess, hepatic abscess, biliary peritonitis, emphysematous cholecystitis), and 417 cases of non-advanced acute cholecystitis (NAAC). Multiple logistic regression and receiver-operating characteristic curve analysis were employed to explore which variables (WBC, CRP, and neutrophil-to-lymphocyte ratio (NLR)) were statistically significant in predicting AAC and conversion to open surgery. Results On multivariable logistic regression analysis, male gender (OR = 0.4; p = 0.05), diabetes mellitus (OR = 7.8; p = 0.005), 3–4 ASA score (OR = 5.34; p = 0.037), body temperature (OR = 2.65; p = 0.014), and CRP (OR = 1.01; p = 0.0001) were associated independently with AAC. The value of the area under the curve (AUC) of the CRP (0.75) was higher than that of WBC (0.67) and NLR (0.62) for diagnosing AAC. CRP was the only predictive factor of conversion in multivariate analysis (OR = 1.008 [1.003–1.013]. Comparing areas under the receiver operating characteristic curves, it was the CRP that had the highest discriminative power in terms of conversion. Conclusion CRP is the best inflammatory marker predictive of AAC and of conversion to open surgery. We think that our results would support a multicenter—international study to confirm the findings, and if supported, CRP should be considered as a severity criterion of acute cholecystitis in the next revised version of the Guidelines of Tokyo.

BackgroundAlthough long-term stent placement using endoscopic gallbladder stenting (EGBS) reportedly reduces cholecystitis recurrence in patients unfit to undergo cholecystectomy, its efficacy and safety remain uncertain.AimsThis study aimed to examine the long-term effect of EGBS in poor surgical candidates of cholecystectomy.MethodsA total of 528 high-risk surgical patients with acute calculous cholecystitis met this study’s eligibility criteria. The technical success and adverse events (AE) were compared between patients who underwent EGBS and those who underwent percutaneous transhepatic gallbladder drainage (PTGBD). Elective stent exchange and removal were not performed after EGBS. The external tube was removed after improvement of cholecystitis following PTGBD.ResultsThe technical success rate was significantly lower with EGBS compared to PTGBD (75.4% versus 98.7%, P < 0.001), while the early-AE rate did not differ significantly between the two methods (7.7% versus 4.3%, P = 0.146). The 1-, 3-, and 5-year cumulative incidence rates of cholecystitis were 3.8%, 7.2%, and 7.2% with EGBS, and 11.7%, 17.6%, and 30.2% with PTGBD, respectively (P = 0.001). Conversely, those of symptomatic late-AE (except cholecystitis) were 8.2%, 22.7%, and 31.4% with EGBS, and 7.5%, 10.9%, and 13.1% with PTGBD, respectively (P = 0.035). Thus, the 1-, 3-, and 5-year cumulative incidence of overall late-AE was 12.0%, 30.4%, and 40.4% with EGBS, and 19.2%, 28.3%, and 42.5% with PTGBD, respectively (P = 0.649).ConclusionsLong-term stent placement via EGBS is useful for preventing the recurrence of cholecystitis, but the success rate is low and the frequency of other late-AE increases with the prolongation of the indwelling period.

Background In medical practice, the tendency to remove an inflamed gallbladder is deeply rooted. Cholecystectomy, however, is associated with relatively high complication rates, and therefore the decision whether or not to perform surgery should be well considered. For some patients, the surgical risk–benefit profile may favour conservative treatment. The objective of this study was to examine the short- and long-term outcome of conservative treatment of patients with acute calculous cholecystitis. Methods A systematic search of MEDLINE, Embase and Cochrane Library databases was performed. Prospective studies reporting on the success rate of conservative treatment (i.e. non-invasive treatment) of acute cholecystitis during index admission were included, as well as prospective and retrospective studies reporting on the recurrence rate of gallstone-related disease during long-term follow - up (i.e. ≥12 months) after initial non-surgical management. Study selection was undertaken independently by two reviewers using predefined criteria. The risk of bias was assessed. The pooled success and mortality rate during index admission and the pooled recurrence rate of gallstone-related disease during long-term follow-up were calculated using a random-effects model. Results A total of 1841 patients were included in 10 randomized controlled trials and 14 non-randomized studies. Conservative treatment during index admission was successful in 87 % of patients with acute calculous cholecystitis and in 96 % of patients with mild disease. In the long term, 22 % of the patients developed recurrent gallstone-related disease. Pooled analysis showed a success rate of 86 % (95 % CI 0.8–0.9), a mortality rate of 0.5 % (95 % CI 0.001–0.009) and a recurrence rate of 20 % (95 % CI 0.1–0.3). Discussion Conservative treatment of acute calculous cholecystitis during index admission seems feasible and safe, especially in patients with mild disease. During long-term follow-up, less than a quarter of the patients appear to develop recurrent gallstone-related disease, although this outcome is based on limited data.

Background Acute cholecystitis is a common complication to gallstone disease. The relation between the severity of acute cholecystitis and risk of bile duct injury during cholecystectomy has not yet been addressed and is the main focus of this study. Methods All cases with iatrogenic bile duct injury during cholecystectomy, within the Lake Mälaren region, Sweden, were identified through ICD procedure codes for biliary reconstruction within the Swedish Inpatient Register and matched to non-injured cholecystectomized controls. Information regarding perioperative variables was collected through medical record review. Results After review, 158 cases and 623 controls remained for analyses. Adjusted risk of bile duct injury was doubled among patients with acute cholecystitis (OR 1.97 95 % CI 1.05–3.72), whereas a mild acute cholecystitis (Tokyo grade I) did not affect the risk of bile duct injury (OR 0.96 95 % CI 0.41–2.25), a moderate (Tokyo grade II) more than doubled the risk (OR 2.41 95 % CI 1.21–4.80). Severe cholecystitis (Tokyo grade III) had a close to significant eightfold increase in risk (OR 8.43 95 % CI 0.97–72.9). The intention to use intraoperative cholangiography reduced injury risk by 52 % (OR 0.48, 95 % CI 0.29–0.81). Conclusions Patients with on-going acute cholecystitis had twice the risk of sustaining a biliary lesion compared to patients without acute cholecystitis. There was a relation between the Tokyo guidelines severity grading of acute cholecystitis and injury risk and the intention to use intraoperative cholangiography halved the risk of reconstructed bile duct injury during cholecystectomy.

The risk factor for cholelithiasis include low physical activity. With an aging society, the number of bedridden patients who undergo percutaneous endoscopic gastrostomy (PEG) has increased, and cholelithiasis has often been found in these patients. This study aimed to evaluate the risk factors correlated with cholelithiasis in adults who underwent PEG. This retrospective single-center design study reviewed patients who underwent PEG and were confirmed to have cholelithiasis through imaging from March 1996 to December 2021. The investigated variables were age, sex, body mass index (BMI, kg/m 2 ), cause of PEG insertion, initial physical activity status, laboratory findings on PEG insertion day, and incidence of acute cholecystitis. The differences between categorical and continuous variables were analyzed using Student’s t test and chi- square test. We enrolled 576 eligible patients who underwent PEG insertion. A total of 161 patients were detected with cholelithiasis (28.0%). The overall independent risk factors for cholelithiasis in patients who underwent PEG insertion were increased C-reactive protein (CRP) levels and decreased physical activity status (bedridden state). The incidence of cholelithiasis was increased by up to 30.7%, especially in patients with bedridden status. However, the incidence of acute cholecystitis among cholelithiasis group was only 5.6%. BMI and total cholesterol were positively correlated with the size of gallbladder (GB) stones. One of the major risk factors for cholelithiasis is decreased physical activity, especially in patients who underwent PEG insertion. Abdominal imaging is recommended to confirm the presence of cholelithiasis and to consider prophylaxis for cholelithiasis, especially in bedridden patients with elevated initial CRP levels at the time of PEG insertion.

BackgroundIn elderly patients with calculous acute cholecystitis, the risk of emergency surgery is high, and percutaneous cholecystostomy tube drainage (PC) combined with delayed laparoscopic cholecystectomy (DLC) may be a good choice. We retrospectively compared laparoscopic cholecystectomy (LC) to DLC after PC to determine which is the better treatment strategy.MethodWe performed a retrospective cohort analysis of 752 patients with acute calculous cholecystitis. Patients with the following conditions were included: (1) age > 65 years old; (2) patients with a grade 2 or 3 severity of cholecystitis according to the 2013 Tokyo Guidelines (TG13); (3) the surgeons who performed the LC were professors or associate professors and (4) the DLC was performed in our hospital after PC. Patients who missed their 30-day follow-up; were diagnosed with bile duct stones, cholangitis or gallstone pancreatitis or were pregnant were excluded from the study. A total of 51 of 314 patients who underwent LC and 73 of 438 patients who underwent PC + DLC were assessed. PC + DLC and LC patients were matched by cholecystitis severity grade according to the TG13, and the National Surgical Quality Improvement Program (NSQIP) calculator was used to predict mortality (n = 21/group). Preoperative characteristics and postoperative outcomes were analysed.ResultsCompared to the matched LC group, the DLC group had less intraoperative bleeding (42.2 vs 75.3 mL, p = 0.014), shorter hospital stays (4.9 vs 7.4 days, p = 0.010) and lower rates of type A bile duct injury (4.8% vs 14.3%, p = 0.035) and type D (0 vs 9.5%, p = 0.002) according to Strasberg classification, residual stones (4.8 vs 14.3%, p = 0.035) and gastrointestinal organ injury (0 vs 3.6%, p < 0.001). Patients in the DLC group had lower incidences of ICU admission and death and a significantly lower incidence of repeat surgery.ConclusionIn elderly patients treated for acute calculous cholecystitis, the 30-day mortality and complication rates were lower for PC + DLC than for LC. However, the total hospitalisation time was significantly prolonged and the costs were significantly higher for PC + DLC.