TG13 management bundles for acute cholangitis and cholecystitis

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1 J Hepatobiliary Pancreat Sci (2013) 20:55 59 DOI /s GUIDELINE TG13: Updated Tokyo Guidelines for acute colangitis and acute colecystitis TG13 management bundles for acute colangitis and colecystitis Koji Okamoto Tadairo Takada Steven M. Strasberg Josep S. Solomkin Henry A. Pitt O. James Garden Markus W. Bücler Masairo Yosida Fumiiko Miura Yasutosi Kimura Ryota Higuci Yuici Yamasita Tosiiko Mayumi Harumi Gomi Sinya Kusaci Seiki Kiriyama Masamici Yokoe Wan-Yee Lau Myung-Hwan Kim Publised online: 11 January 2013 Ó Japanese Society of Hepato-Biliary-Pancreatic Surgery and Springer 2012 Abstract Bundles tat define mandatory items or procedures to be performed in clinical practice ave been increasingly used in guidelines in recent years. Observance of bundles enables improvement of te prognosis of target diseases as well as guideline preparation. Tere were no bundles adopted in te Tokyo Guidelines 2007, but te updated Tokyo Guidelines 2013 (TG13) ave adopted tis useful tool. Items or procedures strongly recommended in clinical practice ave been prepared in te practical guidelines and presented as management bundles. TG13 defined te mandatory items for te management of acute colangitis and acute colecystitis. Critical parts of te bundles in TG13 include diagnostic process, severity assessment, transfer of patients if necessary, terapeutic approac, and time course. Teir observance sould improve te prognosis of acute colangitis and colecystitis. Wen utilizing TG13 management bundles, furter clinical researc needs to be conducted to evaluate te effectiveness and outcomes of te bundles. It is also expected tat te present report will lead to evidence construction and contribute to furter updating of te Tokyo Guidelines. Free full-text articles and a mobile application of TG13 are available via ttp:// Keywords Colangitis bundle Colecystitis bundle K. Okamoto (&) Department of Surgery, Kitakyusu Municipal Yaata Hospital, Nision-maci, Yaataigasi-ku, Kitakyusu, Fukuoka , Japan koji.okamot@gmail.com T. Takada F. Miura Department of Surgery, Teikyo University Scool of Medicine, Tokyo, Japan S. M. Strasberg Section of Hepatobiliary and Pancreatic Surgery, Wasington University in Saint Louis Scool of Medicine, Saint Louis, MO, USA J. S. Solomkin Department of Surgery, University of Cincinnati College of Medicine, Cincinnati, OH, USA H. A. Pitt Department of Surgery, Indiana University Scool of Medicine, Indianapolis, IN, USA O. J. Garden Clinical Surgery, Te University of Edinburg, Edinburg, UK M. W. Bücler Department of Surgery, University of Heidelberg, Heidelberg, Germany M. Yosida Clinical Researc Center Kaken Hospital, International University of Healt and Welfare, Icikawa, Japan Y. Kimura Department of Surgical Oncology and Gastroenterological Surgery, Sapporo Medical University Scool of Medicine, Sapporo, Japan R. Higuci Department of Surgery, Institute of Gastroenterology, Tokyo Women s Medical University, Tokyo, Japan Y. Yamasita Department of Gastroenterological Surgery, Fukuoka University Scool of Medicine, Fukuoka, Japan T. Mayumi Department of Emergency and Critical Care Medicine, Icinomiya Municipal Hospital, Icinomiya, Japan

2 56 J Hepatobiliary Pancreat Sci (2013) 20:55 59 Introduction A bundle is a group of terapies for a disease tat, wen implemented togeter, may result in better outcomes tan if implemented individually. In recent years, bundles tat define mandatory items or procedures to be performed in clinical practice ave been increasingly used in guidelines [1]. Compliance wit bundles results in te preparation of guidelines as well as an improved prognosis of targeted diseases arising from te use of te guidelines [2, 3]. Levy et al. [4] reported tat data from 15,022 subjects at 165 sites were analyzed to determine compliance wit bundle targets and association wit ospital mortality, and compliance wit te entire resuscitation bundle increased linearly from 10.9 % in te first site quarter to 31.3 % by te end of 2 years. Furtermore te odds ratio for mortality improved te longer a site was in te Surviving Sepsis Campaign, resulting in an adjusted absolute drop of 0.8 % per quarter and 5.4 % over 2 years. Murata et al. [5, 6] examined a total of 60,842 patients wit acute colangitis using te Japanese national administrative database. Tis report demonstrated te improved prognosis of in-ospital mortality wit odds ratio of among patients wo were managed wit ig compliance wit te items of recommendation Grades A and B in Tokyo Guidelines 2007 (TG07) as compared wit te patients wo were low-compliance. Tis sows te importance of preparing bundles by setting te recommended items to be observed in te guidelines. Altoug TG07 did not prepare bundles at tat time, te updated Tokyo Guidelines 2013 (TG13) ave adopted te management bundles for acute colangitis and colecystitis. Te care bundles are designed H. Gomi Center for Clinical Infectious Diseases, Jici Medical University, Tocigi, Japan S. Kusaci Department of Surgery, Too University Medical Center Oasi Hospital, Tokyo, Japan S. Kiriyama Department of Gastroenterology, Ogaki Municipal Hospital, Ogaki, Japan M. Yokoe General Internal Medicine Nagoya Daini Red Cross Hospital, Nagoya, Japan W.-Y. Lau Faculty of Medicine, Te Cinese University of Hong Kong, Satin, Hong Kong M.-H. Kim Department of Internal Medicine, Asan Medical Center, University of Ulsan, Seoul, Korea to be easily acievable and sustainable bot to implement and to audit. Furtermore, we made a cecklist. We ope to use te acute colangitis and colecystitis bundle cecklist to elp track your organization s compliance wit implementing eac element of tese bundles. Efficacy of te bundle In te process of developing TG13, mandatory items or Revision Committee members. Te bundles ave been developed and finalized by obtaining consensus. Based on te recommendations in TG13, items wic are expected to yield favorable treatment results are included in te bundles. To underscore te time course or timing of te performance of eac item, management bundles for acute colangitis and colecystitis ave been developed. A cecklist as also been prepared to confirm compliance wit te bundles. Te bundles suc as sepsis bundle [7 9], ventilator bundle [10, 11] or central line bundle [12], wen implemented togeter, may result in better outcomes tan if implemented individually. Good prognosis is also reported in cases in wic a bundle as been acieved, but tis may sow tat tose cases wic ave acieved a bundle are in suc good condition as to enable acievement of a bundle. However, te improvement in prognosis in patients acieved troug education concerning bundles demonstrates tat implementation of bundles and education concerning tem ave been useful [9, 13]. Controversial points and armful effects of bundles Tere are many problems to be solved for te spread and implementation of bundles. In te guidelines, even if useful items ave been implemented, te prognosis in patients is not improved witout common knowledge of management bundles among medical care workers [13]. Furtermore, it is not possible to put bundles into practice witout sufficient manpower and equipment [14], wic sould be improved, if possible. If improvement is impossible, an alternative treatment sould be provided or patients sould be transferred to a medical facility were te contents of bundles can be put into practice [15]. Tere is also a concern tat bundles are used not for te purpose of improving te prognosis in patients and increasing efficiency, but for limiting te contents of medical care to keep ealt care costs down. Furtermore,

3 J Hepatobiliary Pancreat Sci (2013) 20: failure to carry out te contents of bundles sould not lead to lawsuits [15]. Acute colangitis management bundle (Table 1) Items in te colangitis management bundle are described in Table 1. Te content of every bundle is developed from te recommendation of TG13. Te mandatory items or Revision Committee members. Te diagnostic criteria and te severity assessment of acute colangitis in TG13 was made based on te article of Kiriyama et al. [16]. Acute colecystitis management bundle (Table 2) Items in te colecystitis management bundle are described in Table 2. Te content of every bundle is classified into Table 1 Management bundle of acute colangitis 1. Wen acute colangitis is suspected, diagnostic assessment is made using TG13 diagnostic criteria every Abdominal X-ray (KUB) and abdominal US are carried out, followed by CT scan, MRI, MRCP and HIDA scan 3. Severity is repeatedly assessed using severity assessment criteria; at diagnosis, witin 24 after diagnosis, and during te time zone of As soon as a diagnosis as been made, te initial treatment is provided. Te treatment is as follows: sufficient fluids replacement, electrolyte compensation, and intravenous administration of analgesics and full dose of antimicrobial agents are provided 5. For patients wit Grade I (mild), wen no response to te initial treatment is observed witin 24, biliary tract drainage is carried out immediately 6. For patients wit Grade II (moderate), biliary tract drainage is immediately performed along wit te initial treatment. If early drainage cannot be performed due to te lack of facilities or skilled personnel, transfer of te patient is considered 7. For patients wit Grade III (severe), urgent biliary tract drainage is performed along wit te initial treatment and general supportive care. If urgent drainage cannot be performed due to te lack of facilities or skilled personnel, transfer of te patient is considered 8. For patient wit Grade III (severe), organ supports (noninvasive/invasive positive pressure ventilation, use of vasopressors and antimicrobial agents, etc.) are immediately performed 9. Blood culture and/or bile culture is performed for Grade II (moderate) and III (severe) patients 10. Treatment for etiology of acute colangitis wit endoscopic, percutaneous, or operative intervention is considered once acute illness as resolved. Colecystectomy sould be performed for colecystolitiasis after acute colangitis as resolved KUB kidney ureter bladder, US ultrasonograpy, CT computed tomograpy, MRI magnetic resonance imaging, MRCP magnetic resonance colangiopancreatograpy, HIDA epatobiliary iminodiacetic acid Table 2 Management bundle of acute colecystitis 1. Wen acute colecystitis is suspected, diagnostic assessment is made using TG13 diagnostic criteria every Abdominal US is carried out, followed by HIDA scan and CT scan if needed to make te diagnosis 3. Severity is repeatedly assessed using severity assessment criteria; at diagnosis, witin 24 after diagnosis, and during te time zone of Take tat colecystectomy is performed into consideration, as soon as a diagnosis as been made, te initial treatment takes place involving te replacement of sufficient fluid after fasting, electrolyte compensation, intravenous injection of analgesics and full dose antimicrobial agents 5. For patients wit Grade I (mild), colecystectomy at an early stage witin 72 of onset of symptoms is recommended 6. If conservative treatment patients wit Grade I (mild) is selected and no response to te initial treatment is observed witin 24, reconsider early colecystectomy if still witin 72 of onset of symptoms or biliary tract drainage 7. For patients wit Grade II (moderate), perform immediate biliary drainage or drainage if no early improvement (or colecystectomy in experienced centers) along wit te initial treatment 8. For patients wit Grade II (moderate) and III (severe) at ig surgical risk, biliary drainage is immediately carried out 9. Blood culture and/or bile culture is performed for Grade II (moderate) and III (severe) patients 10. Among patients wit Grade II (moderate), for tose wit serious local complications including biliary peritonitis, pericolecystic abscess, liver abscess or for tose wit gallbladder torsion, empysematous colecystitis, gangrenous colecystitis, and purulent colecystitis, emergency surgery is conducted (open or laparoscopic depending on experience) along wit te general supportive care of te patient. If surgery cannot be performed due to te lack of facilities or skilled personnel, transfer of te patient is considered 11. For patients wit Grade III (severe) wit jaundice and tose in poor general conditions, emergency gallbladder drainage is considered wit initial terapy wit antibiotics and general support measures. For patients wo are found to ave gallbladder stones during biliary drainage, colecystectomy is performed at after 3 mont interval after te patient s general conditions are improved US ultrasonograpy, CT computed tomograpy, HIDA epatobiliary iminodiacetic acid

4 58 J Hepatobiliary Pancreat Sci (2013) 20:55 59 Table 3 Acute colangitis bundle cecklist Repeat diagnosis every 6 12 Diagnostic imaging X-ray (KUB), US, CT scan, MRI, MRCP, HIDA scan Severity assessment at diagnosis and witin 24 after a diagnosis Repeat severity assessment every 24 Immediately start antibiotics administration and general supportive care Grade I (mild): carry out biliary drainage wen no symptom improvement is observed witin 24 Grade II (moderate): carry out biliary drainage immediately Grade III (severe): conduct emergency biliary drainage and perform organ support Consider transfer wen procedures are unavailable as above Grade II (moderate) and III (severe): blood culture and bile culture Consider surgical procedures to remove causes after biliary drainage and improvement of organ failure Table 4 Acute colecystitis bundle cecklist Repeat a diagnosis every 6 12 Diagnostic imaging US, HIDA scan and CT scan Severity assessment at diagnosis and witin 24 after diagnosis Repeat severity assessment every 24 Immediately initiate antibiotics administration and general supportive care Grade I (mild): Colecystectomy at an early stage witin 72 of onset of symptoms Conservative treatment for Grade I (mild): Worsening condition or no improvement is in condition observed witin 24. Reconsider early colecystectomy if still witin 72 or biliary drainage (colecystostomy) Grade II (moderate): Immediate biliary drainage or drainage if no early improvement (or colecystectomy in experienced centers) along wit te initial treatment* After drainage treatment for Grade II (moderate): Elective colecystectomy after symptom improvement at after 3 mont interval Poor local control** for Grade II (moderate): Emergency abdominal drainage and/or colecystectomy in experienced centers Grade II (moderate) and III (severe) at ig surgical risk: Immediately biliary drainage Grade II (moderate) and III (severe): Blood culture and/or bile culture Grade III (severe): Initiate terapy wit antibiotics and general support measures. Conduct emergency biliary drainage as soon as stable After drainage treatment for Grade III (severe): Elective colecystectomy after symptom improvement at after 3 mont interval Consider transfer wen procedures are unavailable as above * see bundle No.4 **see bundle No.10 te recommendation of TG13. Te mandatory items or Revision Committee members. Te diagnostic criteria and te severity assessment of acute colecystitis in TG13 was made based on te article of Yokoe et al. [17]. Ceck list for te use of management bundles for acute colangitis and colecystitis (Tables 3, 4) A ceck list is sown for te effective use of bundles. Te use of tis list for medical care ensures standards, and is tougt to improve effectiveness of te bundles. Tese ceck lists, including procedures, laboratories, monitoring and interventions required, sould be placed by te bedside. Conclusions Bundles consist of important items for te effective use of TG13. Compliance wit te bundles is expected to improve te prognosis of acute colangitis and acute colecystitis. Reports from various facilities ave demonstrated tat improved prognosis is expected troug te use of te Tokyo Guidelines for acute colangitis and colecystitis. Furtermore, good use of tose reports will contribute to evidence construction and future revision of TG13. Acknowledgments We would like to express our deep gratitude to te following organizations for teir great support and guidance in te preparation of TG13: Japanese Society for Abdominal Emergency Medicine, Japan Biliary Association, Japan Society for Surgical Infection, and te Japanese Society of Hepato-Biliary-Pancreatic Surgery. Conflict of interest References None. 1. Dellinger RP, Levy MM, Carlet JM, Bion J, Parker MM, Jaescke R, et al. Surviving sepsis campaign: international guidelines for management of severe sepsis and septic sock. Crit Care Med. 2008;36: Daniels R, Nutbeam T, McNamara G, Galvin C. Te sepsis six and te severe sepsis resuscitation bundle: a prospective observational coort study. Emerg Med J. 2011;28: Benneyan JC, Taseli A. Exact and approximate probability distributions of evidence-based bundle composite compliance measures. Healt Care Manag Sci. 2010;13: Levy MM, Dellinger RP, Townsend SR, Linde-Zwirble WT, Marsall JC, Bion J, et al. Te Surviving Sepsis Campaign: results of an international guideline-based performance improvement program targeting severe sepsis. Intensive Care Med. 2010;36: Murata A, Matsuda S, Kuwabara K, Fujino Y, Kubo T, Fujimori K, et al. Evaluation of compliance wit te Tokyo Guidelines for

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