Introduction

No guidelines focusing on the management of biliary infection (cholangitis and cholecystitis) have previously been published, and no worldwide criteria exist for diagnostic and severity assessment. “Charcot’s triad”1 is still used for the diagnosis of acute cholangitis. However, these criteria were first proposed in 1877 (level 4), more than 100 years ago. Here, and throughout the series, levels of evidence are stated for referenced articles in accordance with the Oxford Centre for Evidence-Based Medicine Levels of Evidence of May 2001 (see Table 1). However only 50%–70% of cholangitis patients present clinically with Charcot’s triad.2–8 In addition, Murphy’s sign9 (level 5) is useful (sensitivity of 50%–70% and specificity of 79%–96%) in diagnosing cholecystitis, and this sign is widely used in every country. Moreover, as many of the symptoms and concepts of these diseases referred to in textbooks and reference books vary from those originally stated, the issue of worldwide criteria is problematic. In view of these unfavorable situations, we considered it necessary to clarify the definitions, concepts of disease, and treatment methods for acute cholangitis and acute cholecystitis and establish universal criteria that can be widely recognized and used.

Table 1 STARD checklist for the reporting of studies of diagnostic accuracy
Full size table

A working group to establish practical Guidelines for the Management of Cholangitis and Cholecystitis was organized in 2003 (chief researcher, Tadahiro Takada). This project was funded by a grant from the Japanese Ministry of Health, Labour, and Welfare, and was supported by the Japanese Society for Abdominal Emergency Medicine, the Japan Biliary Association, and the Japanese Society of Hepato-Biliary-Pancreatic Surgery. The working group consisted of physicians engaged in gastroenterology, internal medicine, surgery, emergency medicine, intensive care, and clinical epidemiology as the main members, and they started the work to prepare the Guidelines.

As the research progressed, the group was faced with the serious problem that high-level evidence regarding the treatment of acute biliary infection is poor. Therefore, an exective committee meeting was convened, and the committee came to the following decision: the Guidelines would be evidence-based in general, but areas without evidence or with poor evidence (such as diagnosis and severity assessment) should be completed by obtaining high-level consensus among experts worldwide.

We established a publication committee and held 12 meetings to prepare draft Guidelines in English (version 3). Then we had several discussions on these draft Guidelines with leading experts in the field throughout the world, via e-mail, leading to version 4. Finally, an International Consensus Meeting took place in Tokyo, on 1–2 April, 2006, to obtain international agreement on diagnostic criteria, severity assessment, and management.

We now publish the “Tokyo Guidelines for the Management of Cholangitis and cholecystitis”. These Guidelines consist of 13 articles, including “Discussion” sections containing comments of attendees at the consensus conference and analyses of audience voting at the meeting.

We hope that these Guidelines will help their users to give optimal treatment according to their own specialty and capability, and thus provide their patients with the best medical treatment.

Background of Tokyo Guidelines

Biliary infections (acute cholangitis and cholecystitis) require appropriate management in the acute phase. Serious acute cholangitis may be lethal unless it is appropriately managed in the acute phase. On the other hand, although various diagnostic and treatment methodologies have been developed in recent years, they have not been assessed objectively and none of them has been established as a standard method for the management of these diseases. We carried out an extensive review of the English-language literature and found that there was little high-level evidence in this field, and no systematically described practical manual for the field. Most importantly, there are no standardized diagnostic criteria and severity assessments for acute cholangitis and cholecystitis, therefore, we would like to establish standards for these items. The Tokyo Guidelines include evidence-based medicine and reflect the international consensus obtained through earnest discussions among professionals in the field on 1–2 April, 2006, at the Keio Plaza Hotel, Tokyo, Japan. Concerning the definitions in the practice guidelines, we have applied to the Japanese Institute of Medicine: Committee to Advise the Public Health Service on Clinical Practice Guidelines, to approve the systematically developed Guidelines to assist practioner and patient decisions about appropriate healthcare for specific clinical circumstances.

Notes on the use of the Guidelines

The Guidelines are evidence-based, with the grade of recommendation also based on the evidence. The Guidelines also present the diagnostic criteria for and severity assessment of acute biliary infection. As the Guidelines address so many different subjects, indices are included at the end for the convenience of readers.

The practice Guidelines promulgated in this work do not represent a standard of practice. They are suggested plans of care, based on best available evidence and the consensus of experts, but they do not exclude other approaches as being within the standard of practice. For example, they should not be used to compel adherence to a given method of medical management, which method should be finally determined after taking account of the conditions at the relevant medical institution (staff levels, experience, equipment, etc.) and the characteristics of the individual patient. However, responsibility for the results of treatment rests with those who are directly engaged therein, and not with the consensus group. The doses of medicines described in the text of the Guidelines are for adult patients.

Methods of formulating the guidelines

With evidence-based medicine (EBM) as a core concept, the Guidelines were prepared by the Research Group on the Preparation and Diffusion of Guidelines for the Management of Acute Cholangitis and Acute Cholecystitis (chief researcher, Tadahiro Takada), under the auspices of the Japanese Ministry of Health, Labour, and Welfare, and the Working Group for Guideline Preparation, whose members were selected from experts in abdominal emergency medicine and epidemiology by the Japanese Society for Abdominal Emergency Medicine, the Japan Biliary Association, and the Japanese Society of Hepato-Biliary-Pancreatic Surgery.

In principle, the preparation of the Guidelines progressed with the systematic search, collection, and assessment of references for the objective extraction of evidence. Next, the External Assessment Committee examined the Guidelines. Then we posted the draft guidelines on our website and had four open symposia, bginning in September 2004, to gain feedback for further review. Subsequently, a Publication Committee was set up, and this committee had 12 meetings to prepare draft Guidelines.

Re-examination of the draft Guidelines was then performed, via e-mail, with experts on cholangitis and cholecystitis throughout the world. After final agreement was reached at the International Consensus Meeting, held in Tokyo in April 2006, “the Tokyo Guidelines for the Management of Acute Cholangitis and Cholecystitis” were completed.

The process of extending the literature search

The literature was selected as follows: Using “cholangitis” and “cholecystitis” as the medical subject heading (MeSH; explode) or the key search words, approximately 17 200 items were selected from Medline (Ovid; 1966 to June 2003). These articles were subjected to a further screening with “human” as the “limiting word”. This screening provided 9618 items in English and in Japanese. A further 7093 literature publications were obtained from the Japana Centra Revuo Medicina (inter net version), using “cholangitis”, “cholecystitis”, and “biliary infection” as the key words, with further screening with “human” as the “limiting word”. This process provided 6141 items. After the titles and abstracts of a total of 15 759 works were examined by two committee members, 2494 were selected for a careful examination of their full texts.

Other literature quoted in these selected works, together with works suggested by the specialist committee members, were included in the examination.

To evaluate each article, a STARD (standards for reporting of diagnostic accuracy) checklist (Table 1)12 was considered important. The purpose of this checklist is to evaluate the format and study process, in order to improve the accuracy and completeness of the reporting of studies of diagnostic accuracy.

However, the STARD checklist is not suitable for classifying various categories (e.g., therapy, prevention, etiology, harm, prognosis, diagnosis, differential diagnosis, economic and decision analysis) and levels of evidence. Therefore, in the Guidelines, the science-based classification used by the Cochrane Library (Table 2) was adopted.

Table 2 Categories of evidence (refer to levels of evidence and grades of recommendations on the homepage of the Centre for Evidence-Based Medicine)
Full size table

The evidence obtained from each item of reference was evaluated in accordance with the science-based classification used by the Cochrane Library (Table 2), and the quality of evidence for each parameter associated with the diagnosis and treatment of acute biliary infection was determined. As stated above, the level of evidence presented by each article was determined in accordance with the Oxford Centre for Evidence-Based Medicine Levels of Evidence (May 2001), prepared by Phillips et al.13 (Table 2). The terms used in the categories are explained in the footnote to Table 2.

Categories of evidence and grading of recommendations

Based on the results obtained from these procedures, grades of recommendation were determined, according to the system for ranking recommendations in clinical guidelines14–16 shown in Table 3, and mentioned, as required, in the text of the Guidelines. The grades of recommendation in the Guidelines are based on the Kish14 method of classification and others.15,16 Recommendations graded “A” (that is, “do it”) and “B” (that is, “probably do it”), are based on a high level of evidence, whereas those graded “D” (that is, “probably don’t do it”) or “E” (that is, “don’t do it”) reflect a low level of evidence.

Table 3 Grading system for ranking recommendations in clinical guidelines14–16
Full size table

Discussion at the Tokyo International Consensus Meeting

Tadahiro Takada (Japan): “Dr. Strasberg, please explain the difference between a ‘Guidelines’ and ‘Standards’ in your mind?”

Steven Strasberg (USA): “To me, ‘guidelines’ represent a suggested course of action based on available evidence. They do not imply that other courses of action are below an acceptable level of care. Practice ‘standards’ are different, in that they imply that actions other than those listed as acceptable practice standards are below the level of acceptable care. It is particularly true that, in an area in which high levels of evidence are not available, that guidelines are not construed to be standards. Reliance on expert opinion to form guidelines may be useful, but even a consensus of experts may not be correct. For this reason a statement of the following type should be inserted in the introduction. ‘The practice guidelines promulgated in this work do not represent a standard of practice. They are a suggested plan of care based on best available evidence and a consensus of experts, but they do not exclude other approaches as being within the standard of practice’.”

The Members of Organizing Committee and Contributors for Tokyo Guidelines

Members of the Organizing Committee of Tokyo Guidelines for the Management of Acute Cholangitis and Cholecystitis

T. Takada

Department of Surgery, Teikyo University School of Medicine, Tokyo, Japan

Y. Nimura

Division of Surgical Oncology, Department of Surgery, Nagoya University, Graduate School of Medicine, Nagoya, Japan

Y. Kawarada

Mie University, Mie, Japan

K. Hirata

First Department of Surgery, Sapporo Medical University School of Medicine, Sapporo, Japan

H. Yasuda

Department of Surgery, Teikyo University Chiba Medical Center, Chiba, Japan

Y. Yamashita

Department of Surgery, Fukuoka University School of Medicine, Fukuoka, Japan

Y. Kimura

First Department of Surgery, Sapporo Medical University School of Medicine, Sapporo, Japan

M. Sekimoto

Department of Healthcare Economics and Quality Management, Kyoto University Graduate School of Medicine, Kyoto, Japan

T. Tsuyuguchi

Department of Medicine and Clinical Oncology, Graduate School of Medicine, Chiba University, Chiba, Japan

M. Nagino

Division of Surgical Oncology, Department of Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan

M. Hirota

Department of Gastroenterological Surgery, Kumamoto University Graduate School of Medical Sciences, Kumamoto, Japan

T. Mayumi

Department of Emergency Medicine and Critical Care, Nagoya University Graduate School of Medicine, Nagoya, Japan

F. Miura

Department of Surgery, Teikyo University School of Medicine, Tokyo, Japan

M. Yoshida

Department of Surgery, Teikyo University School of Medicine, Tokyo, Japan

Advisors and International Members of Tokyo Guidelines for the Management of Acute Cholangitis and Cholecystitis

N. Abe

Department of Surgery, Kyorin University School of Medicine, Tokyo, Japan

S. Arii

Department of Hepato-Biliary-Pancreatic / General Surgery, Tokyo Medical and Dental University, Tokyo, Japan

J. Belghiti

Department of Digestive Surgery & Transplantation, Hospital Beaujon, Clichy, France

G. Belli

Department of General and HPB Surgery, Loreto Nuovo Hospital, Naples, Italy

P.C. Bornman

Division of General Surgery, University of Cape Town, Cape Town, South Africa

M.W. Büchler

Department of General Surgery, University of Heidelberg, Germany

A.C.W. Chan

Director Endoscopy Centre, Specialist in General Surgery, Minimally Invastive Surgery Centre

M.F. Chen

Chang Gung Memorial Hospital, Chang Gung Medical University, Taiwan

X.P. Chen

Department of Surgery, Tongji Hunter College, Tongji Hospital Hepatic Surgery Centre, China

E.D. Santibanes

HPB and Liver Transplant Unit, Hospital Italiano de Buenos Aires, Argentina

C. Dervenis

First Department of Surgery, Agia Olga Hospital, Greece

S. Dowaki

Department of Digestive Surgery, Tokai University Tokyo Hospita, Kanagawa, Japan

S.T. Fan

Department of Surgery, The University of Hong Kong Medicak Centre, Queen Mary Hospital, Hong Kong

H. Fujii

1st Department of Surgery, University of Yamanashi Faculty of Medicine, Yamanashi, Japan

T.R. Gadacz

Gastrointestinal Surgery, Medical College of Georgia, USA

D.J. Gouma

Department of Surgery, Academic Medical Center, Amsterdam, The Netherlands

S.C. Hilvano

Department of Surgery, College of Medical & Philippine General Hospital, Philippines

S. Isaji

Department of Hepato-Biliary-Pancreatic Surgery, Mie University Graduate School of Medicine, Mie, Japan

M. I{sxto}

Department of Surgery, Fujita Health University, Nagoya, Japan

T. Kanematsu

Second Department of Surgery, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan

N. Kano

Special Adviser to the President, Chairman of Department of Surgery and Director of Endoscopic Surgical Center, Kameda Medical Center, Chiba, Japan

C.G. Ker

Division of HPB Surgery, Yuan’s General Hospital, Taiwan

M.H. Kim

Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Korea

S.W. Kim

Department of Surgery, Seoul National University College of Medicine, Korea

W. Kimura

First Department of Surgery, Yamagata University Faculty of Medicine, Yamagata, Japan

S. Kitano

First Department of Surgery, Oita University Faculty of Medicine, Oita, Japan

E.C.S. Lai

Pedder Medical Partners, Hong Kong

J.W.Y. Lau

Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong

K.H. Liau

Department of Surgery, Tan Tock Seng Hospital/Hepatobiliary Surgery, Singapore

S. Miyakawa

Department of Surgery, Fujita Health University, Nagoya, Japan

K. Miyazaki

Department of Surgery, Saga Medical School, Saga University Faculty of Medicine, Saga, Japan

H. Nagai

Department of Surgery, Jichi Medical School, Tokyo, Japan

T. Nakagohri

Department of Surgery, National Cancer Center Hospital East, Chiba, Japan

H. Neuhaus

Internal Medicine Evangelisches Krankenhaus Dusseldorf, Germany

T. Ohta

Department of Digestive Surgery, Kanazawa University Hospital, Ishikawa, Japan

K. Okamoto

First Department of Surgery, School of Medicine, University of Occupational and Environmental Health, Fukuoka, Japan

R.T. Padbury

Department of Surgery, The Flinders University of South Australia GPO, Australia)

B.B. Philippi

Department of Surgery, University of Indonesia, Cipto Mangunkusumo National Hospital, Jakarta, Indonesia

H.A. Pitt

Department of Surgery, Indiana University School of Medicine, USA

M. Ryu

Chiba Cancer Center, Chiba, Japan

V. Sachakul

Department of Surgery, Phramongkutklao College of Medecine, Thailand

M. Shimazu

Department of Surgery, Keio University School of Medicine, Tokyo, Japan

T. Shimizu

Department of Surgery, Nagaoka Chuo General Hospital, Niigata, Japan

K. Shiratori

Department of Digestive tract internal medicine, Tokyo Women’s Medical University, Tokyo, Japan

H. Singh

Department of HPB Surgery, Selayang Hospital, Malaysia

J.S. Solomkin

Department of Surgery, University of Cincinnati College of Medicine Cincinnati, Ohio, USA

S.M. Strasberg

Department of Surgery, Washington University in St Louis and Barnes-Jewish Hospital, USA

K. Suto

Department of Surgery, Yamagata University Faculty of Medicine, Yamagata, Japan

A.N. Supe

Department of Surgical Gastroenterology, Seth G S Medical College and K E M Hospital, India

M. Tada

Department of Digestive tract internal medicine, Graduate School of Medicine University of Tokyo, Tokyo, Japan

S. Takao

Research Center for life science resources, Kagoshima University Faculty of Medicine, Kagoshima, Japan

H. Takikawa

Teikyo University School of Medicine, Tokyo, Japan

M. Tanaka

Department of Surgery and Oncology, Graduate School of Medical Sciences Kyushu University, Fukuoka, Japan

S. Tashiro

Shikoku Central Hospital, Ehime, Japan

S. Tazuma

Department of Primary Care Medicine, Hiroshima University School of Medicine, Hiroshima, Japan

M. Unno

Department of Digestive Surgery, Tohoku University Graduate School of Medicine, Miyagi, Japan

G. Wanatabe

Department of Digestive Surgery, Toranomon Hospital Tokyo, Tokyo, Japan

J.A. Windsor

Department of General Surgery, Auckland Hospital, New Zealand

H. Yamaue

Second Department of Surgery, Wakayama Medical University School of Medicine, Wakayama, Japan

Working group of the Guidelines for the Management of Acute Cholangitis and Cholecystitis

M. Mayumi

Department of Emergency Medicine and Critical Care, Nagoya University School of Medicine, Nagoya, Japan

M. Y{acoshida}

Department of Surgery, Teikyo University School of Medicine, Tokyo, Japan

T. Sakai

Kyoto Katsura Hospital, General Internal Medicine, Kyoto, Japan

N. Abe

Department of Surgery, Kyorin University School of Medicine, Tokyo, Japan

M. Ito

Department of surgery, Fujita-Health University, Aichi, Japan

H. Ueno

Department of Emergency and Critical Care Medicine, Graduate School of Medicine, Chiba University, Chiba, Japan

M. Unno

Department of Surgery, Tohoku University Graduate School of Medical Science, Sendai, Japan

Y. Kimura

First Department of Surgery, Sapporo Medical University School of Medicine, Sapporo, Japan

M. Sekimoto

Department of Healthcare Economics and Quality Management, Kyoto University Graduate School of Medicine, Kyoto, Japan

S. Dowaki

Department of Surgery, Tokai University School of Medicine, Kanagawa, Japan

N. Nago

Japanese Association for Development of Community Medicine, Yokosuka Uwamachi Hospital, Yokosuka, Japan

J. Hata

Department of Laboratory Medicine, Kawasaki Medical School, Kurashiki, Japan

M. Hirota

Department of Gastroenterological Surgery, Kumamoto University Graduate School of Medical Sciences, Kumamoto, Japan

F. Miura

Department of Surgery, Teikyo University School of Medicine, Tokyo, Japan

Y. Ogura

Department of Pediatric Surgery, Nagoya University School of Medicine, Nagoya, Japan

A. Tanaka

Department of Medicine, Teikyo University School of Medicine, Tokyo, Japan

T. Tsuyuguchi

Department of Medicine and Clinical Oncology, Graduate School of Medicine, Chiba University, Chiba, Japan

M. Nagino

Division of Surgical Oncology, Department of Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan

K. Suto

Department of Gastroenterological and General Surgery, Course of Organ Functions and Controls, Yamagata University School of Medicine, Yamagata, Japan

T. Ohta

Department of Surgery, Institute of Gastroenterology, Tokyo Women’s Medical University, Tokyo, Japan

I. Endo

Department of Gastroenterological Surgery, Yokohama City University Graduate School of Medicine, Yokohama, Japan

Y. Yamashita

Department of Surgery, Fukuoka University Hospital, Fukuoka, Japan

S. Yokomuro

Nippon Medical School, Graduate School of Medicine Surgery for Organ Function and Biological Regulation, Tokyo, Japan

Members of the External Evaluation Committee

T. Fukui

St. Luke’s International Hospital, Tokyo, Japan

Y. Imanaka

Department of Healthcare Economics and Quality Management, Kyoto University Graduate School of Medicine, Kyoto, Japan

Y. Sumiyama

Third Department of Surgery, Toho University School of Medicine, Tokyo, Japan

T. Shimizu

Department of Surgery, Nagaoka chuo General Hospital, Nagaoka, Japan

H. Saisho

Department of Medicine and Clinical Oncology, Graduate School of Medicine, Chiba University, Chiba, Japan

K. Okamoto

First Department of Surgery, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan