J

UOEH 35 4 : 2492572013

249

Review

Progression of Tokyo Guidelines and Japanese Guidelines for Management

of Acute Cholangitis and Cholecystitis
Toshihiko Mayumi1*, Kazuki Someya1, Hiroki Ootubo1, Tatsuo Takama1, Takashi Kido1, Fumihiko Kamezaki1,
Masahiro Yoshida2 and Tadahiro Takada3
1

Department of Emergency Medicine, School of Medicine, University of Occupational and Environmental Health,
Japan. Yahatanishi-ku Kitakyushu 807-8555, Japan
2
Clinical Research Center Kaken Hospital, International University of Health and Welfare, Koufudai Ichikawa 272-0827, Japan
3
Department of Surgery, School of Medicine, Teikyo University, Kaga, Itabashi-ku 173-0003, Japan

Abstract : The Japanese Guidelines for management of acute cholangitis and cholecystitis were published in 2005 as
the first practical guidelines presenting diagnostic and severity assessment criteria for these diseases. After the Japanese version, the Tokyo Guidelines (TG07) were reported in 2007 as the first international practical guidelines. There
were some differences between the two guidelines, and some weak points in TG07 were pointed out, such as low
sensitivity for diagnosis and the presence of divergence between severity assessment and clinical judgment for acute
cholangitis. Therefore, revisions were started to not only make them up to date but also concurrent with the same
diagnostic and severity assessment criteria. The Revision Committee for the revision of TG07 (TGRC) performed
validation studies of TG07 and new diagnostic and severity assessment criteria of acute cholangitis and cholecystitis. These were retrospective multi-institutional studies that collected cases of acute cholangitis, cholecystitis, and
non-inflammatory biliary disease. TGRC held 35 meetings as well as international email exchanges with co-authors
abroad and held three International Meetings. Through these efforts, TG13 improved the diagnostic sensitivity for
acute cholangitis and cholecystitis, and presented criteria with extremely low false positive rates. Furthermore, severity assessment criteria adapted for clinical use, flowcharts, and many new diagnostic and therapeutic modalities
were presented. The worlds first management bundles of acute cholangitis and cholecystitis were also presented.
The revised Japanese version was published with the same content as TG13. An electronic application of TG13 that
can help to diagnose and assess the severity of these diseases using the criteria of TG13 was made for free download.
Keywords : practice guidelines, acute cholangitis, acute cholecystitis, management bundles, antibiotics.
Received July 8, 2013, accepted October 18, 2013

What are practice guidelines?

If all interventions were standardized, there would
be no need for practice guidelines, but, in any medical fields, when new diagnostic and therapeutic methods are developed some controversy over them may
occur. If there were a best practice, discrepancies in

these interventions might result in poor medical care

for patients.
Practice guidelines are made to improve patients
outcome, disseminating current good practices, but
some medical staff fear that if they did not follow the
guidelines they might be sued. Although medical staff
need to explain the contents of the guidelines to patients

*Corresponding Author: Toshihiko Mayumi, MD, Department of Emergency Medicine, School of Medicine, University of Occupational and Environmental
Health, Yahatanishi-ku, Kitakyushu, Fukuoka 807-8555, Japan. Tel:+81-93-691-7516, Fax: +81-93-691-7579, Email: mtoshi@med.uoeh-u.ac.jp

250

T Mayumi et al

and patients family, interventions should be chosen not

only by evidence, but also with the approval of the patients/family and by the medical circumstance of the
institution. Therefore, following the guidelines in any
and all situations is not necessarily the best practice.

The Japanese Guidelines for management of acute

cholangitis and cholecystitis 2003
There were no practical guidelines, evidence-basedcriteria for diagnosis, or severity assessment of treatment of acute cholecystitis or acute cholangitis before
2003. Although Charcots triad and Reynolds pentad
are well known, the full complement of symptoms and
signs described in these criteria are infrequent and not
useful in clinical management strategies [1].
In these circumstances, a project committee began to
prepare evidence-based guidelines for the management
of acute cholangitis and cholecystitis. This work was
funded by the Japanese Ministry of Health, Labour, and
Welfare, in cooperation with the Japanese Society for
Abdominal Emergency Medicine, the Japan Biliary Association, and the Japanese Society of Hepato-BiliaryPancreatic Surgery. The working group, consisting of
46 experts in gastroenterology, surgery, internal medicine, emergency medicine, intensive care, and clinical
epidemiology, analyzed and examined the literature on
patients with acute cholangitis and cholecystitis in order to produce evidence-based guidelines.
There was a lack of high-level evidence in these
fields, and the working group formulated the guidelines by obtaining consensus, based on best evidence.
This work required more than 20 meetings to obtain a
consensus within the working group on each item. Following that, four forums were held to permit examination of the Guideline details in Japan to an audience in
order to collect public comments. After these efforts,
the Japanese Guidelines for management of acute cholangitis and cholecystitis and diagnostic and severity assessment criteria for these diseases were published in
2005 as the first practice guidelines in the world.

Tokyo Guidelines for management of acute cholangitis and cholecystitis 2007

As a next step, we attempted to make worldwide

practice guidelines for acute cholangitis and cholecystitis. Since the diagnosis and management of acute
biliary infection may differ from country to country,
we appointed a publication committee and held 12
meetings to prepare draft guidelines in English. We
then had several discussions on these draft guidelines
with leading experts in the field throughout the world,
via e-mail. Finally, an International Consensus Meeting took place in Tokyo, on April 1st2nd, 2006, to
obtain international agreement on diagnostic criteria,
severity assessment, and management strategies [2].
With minor modifications after the international meeting, the Tokyo Guidelines for the management of acute
cholangitis and cholecystitis (TG07) were published in
2007 as the first international practice guidelines for
these diseases [3-6]. TG07 has not only diagnostic and
severity assessment criteria, but also flowcharts, epidemiology, and several kinds of techniques of biliary
drainage and surgical methods [6-10].

Distribution of Tokyo Guidelines for management

of acute cholangitis and cholecystitis 2007
After the publication of TG07, the criteria for diagnosis and severity assessment criteria were frequently
used in new clinical studies of acute cholangitis and
cholecystitis, and citations of TG07 increased [11].
These were referred to in a text book [12, 13], in a
review in the New England Journal of Medicine [14],
and in the Guidelines for Diagnosis and management
of complicated intra-abdominal infection by the Surgical Infection Society and the Infectious Diseases
Society of America [15]. Also, it was reported that
compliance with the TG07 was correlated with good
outcomes of patients with acute cholangitis [16].

Japanese Guidelines 2005 (JG05) and Tokyo

Guidelines 2007 (TG07) in clinical practice
On the other hand, critical appraisal of TG07 showed
problems in applying it in clinical settings. First, the
sensitivity of acute cholangitis was low [17]. Second,
since mild and moderate acute cholangitis can be distinguished only 24 hrs after initial medical treatment in
TG07, the criteria is impractical for deciding the timing of biliary drainage [18, 19].

Progression of Tokyo Guidelines

Since the diagnostic and severity assessment criteria and the flowchart were different between the two
guidelines, these discrepancies led to confusion and
misinterpretation in Japan.

Tokyo Guidelines 2013 (TG13)

To update and correct these defects in the Japanese
Guidelines 2005 (JG05) and the Tokyo Guidelines
2007 (TG07), we set up the Tokyo Guidelines Revision Committee for the revision of TG07 (TGRC) in
June 2010 and started the validation of TG07. We also
set up new diagnostic criteria and severity assessment
criteria by retrospectively analyzing cases of acute
cholangitis and cholecystitis, including cases of noninflammatory biliary disease, collected from multiple
institutions [1, 20]. TGRC held 35 committee meetings, and three International Meetings for the Clinical Assessment and Revision of Tokyo Guidelines in
2011-2012. Through these meetings, the final draft
of the updated Tokyo Guidelines (TG13) was prepared
on the basis of evidence from retrospective multi-cen-

251

ter analyses and were published in 2013 [11]. To be

specific, discussion took place involving the revised
new diagnostic and severity assessment criteria, new
flowcharts of the management of acute cholangitis and
cholecystitis, recommended medical care for which
new evidence had been added, new recommendations
for gallbladder drainage and antimicrobial therapy,
and the role of surgical intervention (Table 1, 2) (Fig.
1, 2) [21-27].
TG13 improved the diagnostic sensitivity for acute
cholangitis and cholecystitis, and presented criteria
with extremely low false positive rates adapted for
clinical practice [21, 22]. The sensitivity improved
from 82.8% (TG07) to 91.8% (TG13). While the
specificity was similar to TG07, the false positive rate
in cases of acute cholecystitis was reduced from 15.5
(TG07) to 5.9% (TG13). Furthermore, severity assessment criteria adapted for clinical use, f lowcharts,
and many new diagnostic and therapeutic modalities
were presented. Free full-text articles and a mobile application of TG13 are available via http://www.jshbps.
jp/en/guideline/tg13.html (Fig. 3).

Table 1. TG13 diagnostic criteria for acute cholangitis

A. Systemic inflammation
A-1. Fever and/or shaking chills
A-2. Laboratory data: evidence of inflammatory response
B. Cholestasis
B-1. Jaundice
B-2. Laboratory data: abnormal liver function tests
C. Imaging
C-1. Biliary dilatation
C-2. Evidence of the etiology on imaging (stricture, stone, stent etc.)
Suspected diagnosis: One item in A + one item in either B or C
Definite diagnosis: One item in A, one item in B and one item in C
Thresholds
A-1 Fever
A-2 Evidence of inflammatory response
B-1 Jaundice
B-2 Abnormal liver function tests

BT
> 38
WBC (1000/l ) < 4, or > 10
CRP (mg/dl ) 1
T-Bil 2 (g/dl)
ALP (IU) > 1.5STD
GTP (IU) > 1.5STD
AST (IU) > 1.5STD
ALT (IU) > 1.5STD

Note: A-2: Abnormal white blood cell counts, increase of serum C-reactive protein levels, and other changes indicating inf lammation.
B-2: Increased serum ALP,GTP (GGT), AST and ALT levels. Other factors which are helpful in diagnosis of acute cholangitis include
abdominal pain [right upper quadrant (RUQ) or upper abdominal] and a history of biliary disease such as gallstones, previous biliary
procedures, and placement of a biliary stent. In acute hepatitis, marked systematic inf lammatory response is observed infrequently. Virological and serological tests are required when differential diagnosis is difficult. STD: upper limit of normal value, BT: body temparature,
WBC: white blood cell count, CRP: C-reactive protein, T-Bil: toital birirubin, ALP: alkaline phosphatase, cGTP (GGT): c-glutamyltransferase, AST: aspartate aminotransferase, ALT: alanine aminotransferase, Reproduced from ref. Kiriyama S et al (2013): J Hepatobiliary
Pancreat Sci 20: 24-34 [21] with permission of the Springer Science

T Mayumi et al

252

Table 2. TG13 severity assessment criteria for acute cholangitis

Grade III (Severe) acute cholangitis
Grade III acute cholangitis is defined as cholangitis that is associated with the onset of dysfunction in at least one of any of
the following organs/systems:
1. Cardiovascular dysfunction
Hypotension requiring dopamine > 5 g/kg per min, or any dose of norepinephrine
2. Neurological dysfunction
Disturbance of consciousness
3. Respiratory dysfunction
PaO2/FiO2 ratio < 300
4. Renal dysfunction
Oliguria, serum creatinine > 2.0 mg/dl
5. Hepatic dysfunction
PT-INR > 1.5
6. Hematological dysfunction
Platelet count < 100,000 / mm3
Grade II (moderate) acute cholangitis
Grade II acute cholangitis is associated with any two of the following conditions:
1. Abnormal WBC count ( > 12,000 / mm3, < 4,000 / mm3)
2. High fever ( 39C)
3. Age ( 75 years old)
4. Hyperbilirubinemia (total bilirubin 5 mg/dl)
5. Hypoalbuminemia ( < STD 0.7)
Grade I (mild) acute cholangitis
Grade I acute cholangitis does not meet the criteria of Grade III (severe) or Grade II (moderate) acute cholangitis at
initial diagnosis.
Notes: Early diagnosis, early biliary drainage and/or treatment for etiology, and antimicrobial administration are fundamental treatments
for acute cholangitis classified not only as Grade III (severe) and Grade II (moderate) but also Grade I (mild). Therefore, it is recommended that patients with acute cholangitis who do not respond to the initial medical treatment (general supportive care and antimicrobial
therapy) undergo early biliary drainage or treatment for etiology (see f lowchart). STD: lower limit of normal value, Reproduced from ref.
Kiriyama S et al (2013): J Hepatobiliary Pancreat Sci 20: 24-34 [21] with permission of the Springer Science.

Diagnosis and
Severity
Assessment by
TG13
Guidelines
Grade I
(Mild)

Treatment According to Grade, According to Response,

and According to Need for Additional Therapy

Antibiotics
and General
Supportive Care

Grade II
(Moderate)

Finish course
of antibiotics

Biliary
Drainage

Early Biliary Drainage

Antibiotics
General Supportive Care

if still needed
percutaneous treatment,

Urgent Biliary Drainage

Organ Support
Antibiotics

Fig. 1. Flowchart for the management of acute cholangitis: TG13.

for etiology
(Endoscopic treatment,

Grade III
(Severe)

Treatment

or surgery)

Performance of a blood culture should be taken into consideration before initiation of

administration of antibiotics. A bile culture should be performed during biliary drainage, : Principle
of treatment for acute cholangitis consists of antimicrobial administration and billary drainage
including treatment for etiology. For patient with choledocholithiasis, treatment for etiology might
be performed simultaneously, if possible, with biliary drainage. Reproduced from ref. Miura F et al
(2013): J Hepatobiliary Pancreat Sci 20: 47-54 [23] with permission of the Springer Science.

Progression of Tokyo Guidelines

Diagnosis and
Severity
Assessment by
TG13
Guidelines
Grade I
(Mild)

Treatment According to Grade and According to Response

Observation
Antibiotics
and General
Supportive Care

Grade II
(Moderate)

Antibiotics
and General
Supportive Care

Grade III
(Severe)

253

Antibiotics
and General
Organ Support

Early LC
Advanced laparoscopic
technique
available

Emergency
Surgery

Successful therapy
Failure
therapy

Urgent/early
GB drainage

Delayed/
Elective
LC

Fig. 2. Flowchart for the management of acute cholangitis: TG13.

LC: laparoscopic cholecystectomy, GB: gallbladder, : Performance of a blood culture should be
taken into consideration before initiation of administration of antibiotics, : A bile culture should
be performed during GB drainage. Reproduced from ref. Miura F et al (2013): J Hepatobiliary
Pancreat Sci 20: 47-54 [23] with permission of the Springer Science.

PDF are downloadable for free from

http://link.springer.com/journal/534/20/1/page/1 (Springer Link) or
http://www.jshbps.jp/en/guideline/tg13.html (JSHBPS HP)

Fig. 3. Download of Application and Tokyo Guidelines.

254

T Mayumi et al

Management bundles for acute cholangitis and

cholecystitis in TG13
Management bundles for acute cholangitis and cholecystitis were introduced for effective dissemination
of the guidelines recommendations for the first time in
the world (Table 3, 4) [28]. Adherence to these bundles
is a great indicator of the distribution of the guidelines,
and the correlations with adherence to these bundles
and the patients prognosis are also good indicators
of the effectiveness of the guidelines. For the conve-

Table 3. Management bundle of acute cholangitis

1. When acute cholangitis is suspected, diagnostic assessment is made using TG13 diagnostic criteria every 6-12 h
2. 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, within 24 h after diagnosis, and during the time zone of 24-48 h
4. As soon as a diagnosis has been made, the initial treatment
is provided. The 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 with Grade I (mild), when no response to the
initial treatment is observed within 24 h, biliary tract drainage is carried out immediately
6. For patients with Grade II (moderate), biliary tract drainage is immediately performed along with the initial treatment. If early drainage cannot be performed due to the
lack of facilities or skilled personnel, transfer of the patient
is considered
7. For patients with Grade III (severe), urgent biliary tract
drainage is performed along with the initial treatment and
general supportive care. If urgent drainage cannot be performed due to the lack of facilities or skilled personnel,
transfer of the patient is considered
8. For patient with 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 cholangitis with endoscopic, percutaneous, or operative intervention is considered
once acute illness has resolved. Cholecystectomy should
be performed for cholecystolithiasis after acute cholangitis
has resolved
KUB: kidneyureterbladder, US: ultrasonography, CT: computed
tomography, MRI: magnetic resonance imaging, MRCP: magnetic
resonance cholangiopancreatography, HIDA: hepatobiliary iminodiacetic acid. Reproduced from ref. Okamoto K et al (2013): J
Hepatobiliary Pancreat Sci 20: 55-59 [28] with permission of the
Springer Science.

nience of clinicians, a checklist of the bundles has also

been prepared to confirm compliance with the bundles
of TG13.

Table 4. Management bundle of acute cholecystitis

1. When acute cholecystitis is suspected, diagnostic assessment is made using TG13 diagnostic criteria every
6-12 h
2. Abdominal US is carried out, followed by HIDA scan
and CT scan if needed to make the diagnosis
3. Severity is repeatedly assessed using severity assessment criteria; at diagnosis, within 24 h after diagnosis,
and during the time zone of 24-48 h
4. Taking into consideration that cholecystectomy is performed, as soon as a diagnosis has been made, the initial treatment takes place involving the replacement of
sufficient f luid after fasting, electrolyte compensation,
intravenous injection of analgesics and full dose antimicrobial agents
5. For patients with Grade I (mild), cholecystectomy at an
early stage within 72 h of onset of symptoms is recommended
6. If conservative treatment patients with Grade I (mild)
is selected and no response to the initial treatment is
observed within 24 h, reconsider early cholecystectomy
if still within 72 h of onset of symptoms or biliary tract
drainage
7. For patients with Grade II (moderate), perform immediate biliary drainage or drainage if no early improvement
(or cholecystectomy in experienced centers) along with
the initial treatment
8. For patients with Grade II (moderate) and III (severe) at
high 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 with Grade II (moderate), for those
with serious local complications including biliary
peritonitis, pericholecystic abscess, liver abscess or
for those with gallbladder torsion, emphysematous
cholecystitis, gangrenous cholecystitis, and purulent
cholecystitis, emergency surgery is conducted (open or
laparoscopic depending on experience) along with the
general supportive care of the patient. If surgery cannot
be performed due to the lack of facilities or skilled personnel, transfer of the patient is considered
11. For patients with Grade III (severe) with jaundice and
those in poor general conditions, emergency gallbladder
drainage is considered with initial therapy with antibiotics and general support measures. For patients who are
found to have gallbladder stones during biliary drainage, cholecystectomy is performed at after 3 month interval after the patients general conditions are improved
US: ultrasonography, CT: computed tomography, HIDA: hepatobiliary iminodiacetic acid. Reproduced from ref. Okamoto K et al
(2013): J Hepatobiliary Pancreat Sci 20: 55-59 [28] with permission
of the Springer Science.

Progression of Tokyo Guidelines

The Japanese Guidelines 2013 (JG13)

255

cholangitis and cholecystitis. J Hepatobiliary Pancreat

Surg 14: 1-10

After finishing the final draft of TG13, a revision of

the Japanese Guidelines 2013 (JG13) was begun with
TGRC. To avoid making double standards, as between
JG05 and TG07, main schema, such as diagnostic and
severity assessment criteria, flow charts, and recommendations were set the same as TG13. Little was
modified from TG13 according to Japanese medical
situations, such as the availability of antibiotics. JG13
was published in Japanese in March 2013 as a book.

4 . Wada K, Takada T, Kawarada Y et al (2007): Diagnostic criteria and severity assessment of acute cholangitis: Tokyo Guidelines. J Hepatobiliary Pancreat Surg
14: 52-58
5 . Hirota M, Takada T, Kawarada Y et al (2007): Diagnostic criteria and severity assessment of acute cholecystitis: Tokyo Guidelines. J Hepatobiliary Pancreat
Surg 14: 78-82
6 . Miura F, Takada T, Kawarada Y et al (2007): Flowcharts for the diagnosis and treatment of acute cholan-

Computer Application for TG13

gitis and cholecystitis: Tokyo Guidelines. J Hepatobiliary Pancreat Surg 14: 27-34

To distribute TG13, we made a computer application that can help to diagnose and assess the severity
of acute cholangitis and cholecystitis using the criteria
of TG13. This Application also shows f lowcharts and
recommended antibiotics, and can be downloaded for
free (Fig. 3).

7 . Sekimoto M, Takada T, Kawarada Y et al (2007): Need

for criteria for the diagnosis and severity assessment of
acute cholangitis and cholecystitis: Tokyo Guidelines.
J Hepatobiliary Pancreat Surg 14: 11-14
8 . Tsuyuguchi T, Takada T, Kawarada Y et al (2007):
Techniques of biliary drainage for acute cholangitis:
Tokyo Guidelines. J Hepatobiliary Pancreat Surg 14:

Conclusions

35-45
9 . Tsuyuguchi T, Takada T, Kawarada Y et al (2007):

The Japanese and Tokyo Guidelines for acute cholangitis and cholecystitis were revised in 2013 with a
retrospective multi-center analysis of these disease
and non-inf lammatory biliary disease. These studies
and many revised international meetings lead to the
adaption of these guidelines to clinical management of
these disease. We hope that the management bundles
and computer application of these guidelines will be
distributed to medical staff and will aid the diagnosis
and severity assessment of acute cholangitis and cholecystitis and improve the outcome of patients.

Techniques of biliary drainage for acute cholecystitis:

Tokyo Guidelines. J Hepatobiliary Pancreat Surg 14:
46-51
10 . Yamashita Y, Takada T, Kawarada Y et al (2007): Surgical treatment of patients with acute cholecystitis:
Tokyo Guidelines. J Hepatobiliary Pancreat Surg 14:
91-97
11 . Takada T, Strasberg SM, Solomkin JS et al (2013):
TG13: Updated Tokyo Guidelines for the management
of acute cholangitis and cholecystitis. J Hepatobiliary
Pancreat Sci 20: 1-7
12 . Cameron JL & Cameron AM (2011): Current Surgical

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TG07
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TG13

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