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      Cholecystectomy vs. percutaneous cholecystostomy for the management of critically ill patients with acute cholecystitis: a protocol for a systematic review

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          Abstract

          Background

          Acute cholecystitis is a common diagnosis. However, the heterogeneity of presentation makes it difficult to standardize management. Although surgery is the mainstay of treatment, critically ill patients have been managed via percutaneous cholecystostomy. However, the role of percutaneous cholecystostomy in the management of such patients has not been clearly established. This systematic review will compare the outcomes of critically ill patients with acute cholecystitis managed with percutaneous cholecystostomy to those of similar patients managed with cholecystectomy.

          Methods/design

          Systematic searches will be conducted across relevant health databases including the Cochrane Library, Cumulative Index of Nursing and Allied Health Literature (CINAHL), MEDLINE, Embase, and Scopus using the following keywords: (acute cholecystitis OR severe cholecystitis OR cholecystitis) AND (cholecystectomy OR laparoscopic cholecystectomy OR open cholecystectomy) AND (Cholecystostomy OR percutaneous cholecystectomy OR gallbladder drain OR gallbladder tube OR transhepatic gallbladder drain OR transhepatic gallbladder tube OR cholecystostomy tube). The reference lists of eligible articles will be hand searched. Articles from 2000–2014 will be identified using the key terms “acute cholecystitis, cholecystectomy, and percutaneous cholecystostomy”. Studies including both interventions will be included. Relevant data will be extracted from eligible studies using a specially designed data extraction sheet. The Newcastle-Ottawa scale will be used to assess the quality of non-randomized studies. Central tendencies will be reported in terms of means and standard deviations where necessary, and risk ratios will be calculated where possible. All calculations will be performed with a 95 % confidence interval. Furthermore, the Fisher’s exact test will be used for the calculation of significance, which will be set at p < 0.05. Pooled estimates will be presented after consideration of both clinical and methodological heterogeneity of included studies. Both interventions would be compared with regard to in-hospital mortality, 30-day mortality, procedure-dependent complications, re-intervention, length of intensive care unit (ICU) stay, length of hospital stay, re-admission, and cost of treatment.

          The review will be reported using the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement.

          Discussion

          This systematic review aims at identifying and evaluating the clinical value of percutaneous cholecystostomy in the management of critically ill patients with acute cholecystitis.

          Systematic review registration

          PROSPERO CRD42015016205

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          Most cited references17

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          Acute cholecystitis: early versus delayed cholecystectomy, a multicenter randomized trial (ACDC study, NCT00447304).

          Acute cholecystitis is a common disease, and laparoscopic surgery is the standard of care. Optimal timing of surgery for acute cholecystitis remains controversial: either early surgery shortly after hospital admission or delayed elective surgery after a conservative treatment with antibiotics. The ACDC ("Acute Cholecystitis-early laparoscopic surgery versus antibiotic therapy and Delayed elective Cholecystectomy") study is a randomized, prospective, open-label, parallel group trial. Patients were randomly assigned to receive immediate surgery within 24 hours of hospital admission (group ILC) or initial antibiotic treatment, followed by delayed laparoscopic cholecystectomy at days 7 to 45 (group DLC). For infection, all patients were treated with moxifloxacin for at least 48 hours. Primary endpoint was occurrence of predefined relevant morbidity within 75 days. Secondary endpoints were as follows: (1) 75-day morbidity using a scoring system; (2) conversion rate; (3) change of antibiotic therapy; (4) mortality; (5) costs; and (6) length of hospital stay. Morbidity rate was significantly lower in group ILC (304 patients) than in group DLC (314 patients): 11.8% versus 34.4%. Conversion rate to open surgery and mortality did not differ significantly between groups. Mean length of hospital stay (5.4 days vs 10.0 days; P < 0.001) and total hospital costs (€2919 vs €4262; P < 0.001) were significantly lower in group ILC. In this large, randomized trial, laparoscopic cholecystectomy within 24 hours of hospital admission was shown to be superior to the conservative approach concerning morbidity and costs. Therefore, we believe that immediate laparoscopic cholecystectomy should become therapy of choice for acute cholecystitis in operable patients. (NCT00447304).
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            Systematic review of cholecystostomy as a treatment option in acute cholecystitis.

            Percutaneous cholecystostomy (PC) is an established low-mortality treatment option for elderly and critically ill patients with acute cholecystitis. The primary aim of this review is to find out if there is any evidence in the literature to recommend PC rather than cholecystectomy for acute cholecystitis in the elderly population. In April 2007, a systematic electronic database search was performed on the subject of PC and cholecystectomy in the elderly population. After exclusions, 53 studies remained, comprising 1918 patients. Three papers described randomized controlled trials (RCTs), but none compared the outcomes of PC and cholecystectomy. A total of 19 papers on mortality after cholecystectomy in patients aged >65 years were identified. Successful intervention was seen in 85.6% of patients with acute cholecystitis. A total of 40% of patients treated with PC were later cholecystectomized, with a mortality rate of 1.96%. Procedure mortality was 0.36%, but 30-day mortality rates were 15.4 % in patients treated with PC and 4.5% in those treated with acute cholecystectomy (P < 0.001). There are no controlled studies evaluating the outcome of PC vs. cholecystectomy and the papers reviewed are of evidence grade C. It is not possible to make definitive recommendations regarding treatment by PC or cholecystectomy in elderly or critically ill patients with acute cholecystitis. Low mortality rates after cholecystectomy in elderly patients with acute cholecystitis have been reported in recent years and therefore we believe it is time to launch an RCT to address this issue.
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              • Article: not found

              TG13 guidelines for diagnosis and severity grading of acute cholangitis (with videos).

              Since the publication of the Tokyo Guidelines for the management of acute cholangitis and cholecystitis (TG07), diagnostic criteria and severity assessment criteria for acute cholangitis have been presented and extensively used as the primary standard all over the world. However, it has been found that there are crucial limitations in these criteria. The diagnostic criteria of TG07 do not have enough sensitivity and specificity, and its severity assessment criteria are unsuitable for clinical use. A working team for the revision of TG07 was organized in June, 2010, and these criteria have been updated through clinical implementation and its assessment by means of multi-center analysis. The diagnostic criteria of acute cholangitis have been revised as criteria to establish the diagnosis where cholestasis and inflammation demonstrated by clinical signs or blood test in addition to biliary manifestations demonstrated by imaging are present. The diagnostic criteria of the updated Tokyo Guidelines (TG13) have high sensitivity (87.6 %) and high specificity (77.7 %). TG13 has better diagnostic capacity than TG07. Severity assessment is classified as follows: Grade III: associated with organ failure; Grade II: early biliary drainage should be conducted; Grade1: others. As for the severity assessment criteria of TG07, separating Grade II and Grade I at the time of diagnosis was impossible, so they were unsuitable for clinical practice. Therefore, the severity assessment criteria of TG13 have been revised so as not to lose the timing of biliary drainage or treatment for etiology. Based on evidence, five predictive factors for poor prognosis in acute cholangitis--hyperbilirubinemia, high fever, leukocytosis, elderly patient and hypoalbuminemia--have been extracted. Grade II can be diagnosed if two of these five factors are present. Free full-text articles and a mobile application of TG13 are available via http://www.jshbps.jp/en/guideline/tg13.html.
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                Author and article information

                Contributors
                00492028961544 , Peter.Ambe@helios-kliniken.de
                s.kaptanis@homerton.nhs.uk
                Marios.Papadakis@helios-kliniken.de
                Sebastian.Weber@hohenlind.de
                Hubert.Zirngibl@helios-kliniken.de
                Journal
                Syst Rev
                Syst Rev
                Systematic Reviews
                BioMed Central (London )
                2046-4053
                30 May 2015
                30 May 2015
                2015
                : 4
                : 77
                Affiliations
                [ ]Department of Surgery II, Helios Klinikum Wuppertal, Witten-Herdecke University, Heusner Str. 40, 42283 Wuppertal, Germany
                [ ]Homerton University Hospital NHS Foundation Trust, Homerton Row, London, E9 6ST UK
                [ ]Department of Internal Medicine, St. Elisabeth Hospital Hohenlind, Werthmannstr. 1, 50937 Cologne, Germany
                Article
                65
                10.1186/s13643-015-0065-8
                4458028
                26025467
                2bcdaa43-aa42-436f-854a-534ee3b4b311
                © Ambe et al. 2015

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 6 February 2015
                : 21 May 2015
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                Protocol
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                © The Author(s) 2015

                Public health
                Public health

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