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Routine versus selective intraoperative cholangiography during cholecystectomy: systematic review, meta-analysis and health economic model analysis of iatrogenic bile duct injury.

ABSTRACT: Bile duct injury (BDI) is a severe complication following cholecystectomy. Early recognition and treatment of BDI has been shown to reduce costs and improve patients' quality of life. The aim of this study was to assess the effect and cost-effectiveness of routine versus selective intraoperative cholangiography (IOC) in cholecystectomy. A systematic review and meta-analysis, combined with a health economic model analysis in the Swedish setting, was performed. Costs per quality-adjusted life-year (QALY) for routine versus selective IOC during cholecystectomy for different scenarios were calculated. In this meta-analysis, eight studies with more than 2 million patients subjected to cholecystectomy and 9000 BDIs were included. The rate of BDI was estimated to 0.36 per cent when IOC was performed routinely, compared with to 0.53 per cent when used selectively, indicating an increased risk for BDI of 43 per cent when IOC was used selectively (odds ratio 1.43, 95 per cent c.i. 1.22 to 1.67). The model analysis estimated that seven injuries were avoided annually by routine IOC in Sweden, a population of 10 million. Over a 10-year period, 33 QALYs would be gained at an approximate net cost of €808 000 , at a cost per QALY of about €24 900. Routine IOC during cholecystectomy reduces the risk of BDI compared with the selective strategy and is a potentially cost-effective intervention.

SUBMITTER: Rystedt JML

PROVIDER: S-EPMC7944855 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Significant controversy exists regarding routine intraoperative cholangiography in preventing common duct injury during cholecystectomy.To investigate the association between intraoperative cholangiography use during cholecystectomy and common duct injury.Retrospective cohort study of all Texas Medicare claims data from 2000 through 2009. We identified Medicare beneficiaries 66 years or older who underwent inpatient or outpatient cholecystectomy for biliary colic or biliary dyskinesia, acute cholecystitis, or chronic cholecystitis. We compared results from multilevel logistic regression models to the instrumental variable analyses.Intraoperative cholangiography use during cholecystectomy was determined at the level of the patients (yes/no), hospitals (percentage intraoperative cholangiography use for all cholecystectomies at the hospital), and surgeons (percentage use for all cholecystectomies performed by the surgeon). Percentage of use at the hospital and percentage of use by surgeon were the instrumental variables.Patients with claims for common duct repair operations within 1 year of cholecystectomy were considered as having major common duct injury.Of 92,932 patients undergoing cholecystectomy, 37,533 (40.4%) underwent concurrent intraoperative cholangiography and 280 (0.30%) had a common duct injury. The common duct injury rate was 0.21% among patients with intraoperative cholangiography and 0.36% among patients without it. In a logistic regression model controlling for patient, surgeon, and hospital characteristics, the odds of common duct injury for cholecystectomies performed without intraoperative cholangiography were increased compared with those performed with it (OR,?1.79 [95% CI, 1.35-2.36]; P?<?.001). When confounding was controlled with instrumental variable analysis, the association between cholecystectomy performed without intraoperative cholangiography and duct injury was no longer significant (OR,?1.26 [95% CI, 0.81-1.96]; P?=?.31).When confounders were controlled with instrumental variable analysis, there was no statistically significant association between intraoperative cholangiography and common duct injury. Intraoperative cholangiography is not effective as a preventive strategy against common duct injury during cholecystectomy.

Project description:BackgroundDespite some evidence of improved survival with intraoperative cholangiography during cholecystectomy, debate has raged about its benefit, in part because of its questionable benefit, time, and resources required to complete.MethodsAn International Prospective Register of Systematic Reviews-registered (ID CRD42018102154) meta-analysis following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines using PubMed, Scopus, Web of Science, and Cochrane library from 2003 to 2018 was undertaken including search strategy "intraoperative AND cholangiogra* AND cholecystectomy." Articles scoring ≥ 16 for comparative and ≥ 10 for noncomparative using the Methodological Index for Non-Randomized Studies criteria were included. A dichotomous random effects meta-analysis using the Mantel-Haenszel method performed on Review Manager Version 5.3 was carried out.ResultsOf 2,059 articles reviewed, 62 met criteria for final analysis. The mean rate of intraoperative cholangiography was 38.8% (range 1.6%-96.4%).There was greater detection of bile duct stones during cholecystectomy with routine intraoperative cholangiography compared with selective intraoperative cholangiography (odds ratio = 3.28, confidence interval = 2.80-3.86, P value < .001). While bile duct injury during cholecystectomy was less with intraoperative cholangiography (0.39%) than without intraoperative cholangiography (0.43%), it was not statistically significant (odds ratio = 0.88, confidence interval = 0.65-1.19, P value = .41). Readmission following cholecystectomy with intraoperative cholangiography was 3.0% compared to 3.5% without intraoperative cholangiography (odds ratio = 0.91, confidence interval = 0.78-1.06, P value = .23).ConclusionThe use of intraoperative cholangiography still has its place in cholecystectomy based on the detection of choledocholithiasis and the potential reduction of unfavorable outcomes associated with common bile duct stones. This meta-analysis, the first to review intraoperative cholangiography use, identified a marked variation in cholangiography use. Retrospective studies limit the ability to critically define association between intraoperative cholangiography use and bile duct injury.

Project description:BackgroundEndoscopic retrograde cholangiography (ERC) with stone extraction and papillotomy with subsequent laparoscopic cholecystectomy-the two-step approach-is the standard treatment of common bile duct stones in many countries. However, ERC is associated with a high risk of complications and more than half of patients require multiple ERCs. Meta-analyses of randomised clinical trials find no major differences of the two-step approach in comparison with laparoscopic cholecystectomy with intraoperative laparoscopic stone clearance-the one-step approach. Currently, there are insufficient data to ascertain superiority.MethodsThe preGallstep trial is an investigator-initiated, multicentre randomised feasibility and pilot clinical trial with blinded outcome assessment. Eligible patients are patients with common bile duct stones (identified by magnetic resonance cholagiopancreatography), age 18 years or above with the possibility to perform both interventions within a reasonable time. We intent to randomise 150 participants allocated 1:1. The experimental intervention is the one-step approach. This consists of laparoscopic common bile duct exploration plus laparoscopic cholecystectomy. The control intervention is the two-step approach which consists of ERC plus sphincterotomy (first step) and subsequent laparoscopic cholecystectomy (second step). Feasibility outcomes include the proportion of eligible patients not wanting to participate, reasons for rejection to participate, difficulties during the informed consent procedure, difficulties with randomisation, difficulties with data management, difficulties with blinding patient charts and forms and difficulties with maintaining blinding for the outcome assessors. The primary pilot outcome is the proportion of participants with at least one postoperative complication according to the Clavien-Dindo score grade II and above until 90 days after randomisation. This outcome will be used for a future sample size calculation of a larger pragmatic trial. Further, a range of clinical explorative outcomes will be assessed.DiscussionAs no sample size is estimated in this trial, there is a risk of wrongly assessing the effect on the patient-related outcome. The surgical procedures cannot be blinded. However, blinding will be employed in all other aspects of the trial, including the establishment of a blinded outcome adjudication committee with three independent assessors. Heterogeneity in screening, randomisation, diagnostics, treatment procedures, interventions and follow-up across trial sites may cause challenges in conducting a larger pragmatic trial. To monitor inter-site differences, we have implemented a central data monitoring scheme.Trial registrationClinicalTrials.gov identification: NCT04801238 , Registered on 16 March 2021.

Project description:To assess the role of laparoscopic ultrasound (LUS) as a substitute for intraoperative cholangiography (IOC) during cholecystectomy.We present a MEDLINE and PubMed literature search, having used the key-words "laparoscopic intraoperative ultrasound" and "laparoscopic cholecystectomy". All relevant English language publications from 2000 to 2016 were identified, with data extracted for the role of LUS in the anatomical delineation of the biliary tract, detection of common bile duct stones (CBDS), prevention or early detection of biliary duct injury (BDI), and incidental findings during laparoscopic cholecystectomy. Data for the role of LUS vs IOC in complex situations (i.e., inflammatory disease/fibrosis) were specifically analyzed.We report data from eighteen reports, 13 prospective non-randomized trials, 5 retrospective trials, and two meta-analyses assessing diagnostic accuracy, with one analysis also assessing costs, duration of the examination, and anatomical mapping. Overall, LUS was shown to provide highly sensitive mapping of the extra-pancreatic biliary anatomy in 92%-100% of patients, with more difficulty encountered in delineation of the intra-pancreatic segment of the biliary tract (73.8%-98%). Identification of vascular and biliary variations has been documented in two studies. Although inflammatory disease hampered accuracy, LUS was still advantageous vs IOC in patients with obscured anatomy. LUS can be performed before any dissection and repeated at will to guide the surgeon especially when hilar mapping is difficult due to fibrosis and inflammation. In two studies LUS prevented conversion in 91% of patients with difficult scenarios. Considering CBDS detection, LUS sensitivity and specificity were 76%-100% and 96.2%-100%, respectively. LUS allowed the diagnosis/treatment of incidental findings of adjacent organs. No valuable data for BDI prevention or detection could be retrieved, even if no BDI was documented in the reports analyzed. Literature analysis proved LUS as a safe, quick, non-irradiating, cost-effective technique, which is comparatively well known although largely under-utilized, probably due to the perception of a difficult learning curve.We highlight the advantages and limitations of laparoscopic ultrasound during cholecystectomy, and underline its value in difficult scenarios when the anatomy is obscured.

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Routine versus selective intraoperative cholangiography during cholecystectomy: systematic review, meta-analysis and health economic model analysis of iatrogenic bile duct injury.

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