S3-Leitlinie – Diagnostik und Therapie biliärer Karzinome

1. Informationen zu dieser Leitlinie

1.1. Herausgeber

Leitlinienprogramm Onkologie der Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften e. V. (AWMF), der Deutschen Krebsgesellschaft e. V. (DKG) und der Deutschen Krebshilfe (DKH).

1.2. Federführende Fachgesellschaft(en)

Deutsche Gesellschaft für Gastroenterologie, Verdauungs- und Stoffwechselkrankheiten

1.3. Finanzierung der Leitlinie

Diese Leitlinie wurde von der Deutschen Krebshilfe im Rahmen des Leitlinienprogramms Onkologie gefördert.

1.4. Kontakt

Office Leitlinienprogramm Onkologie
c/o Deutsche Krebsgesellschaft e. V.
Kuno-Fischer-Straße 8
14 057 Berlin

[e-mail]
www.leitlinienprogramm-onkologie.de

1.5. Zitierweise

Leitlinienprogramm Onkologie (Deutsche Krebsgesellschaft, Deutsche Krebshilfe, AWMF): Diagnostik und Therapie des Hepatozellulären Karzinoms und biliärer Karziome, Langversion 2.0, Juni 2021, AWMF Registernummer: 032/-053OL, https://www.leitlinienprogramm-onkologie.de/leitlinien/hepatozellulaeres-karzinom-hcc/ (Zugriff am: TT.MM.JJJJ)

1.6. Besonderer Hinweis

Die Medizin unterliegt einem fortwährenden Entwicklungsprozess, sodass alle Angaben, insbesondere zu diagnostischen und therapeutischen Verfahren, immer nur dem Wissensstand zur Zeit der Drucklegung der Leitlinie entsprechen können. Hinsichtlich der angegebenen Empfehlungen zur Therapie und der Auswahl sowie Dosierung von Medikamenten wurde die größtmögliche Sorgfalt beachtet. Gleichwohl werden die Benutzer aufgefordert, die Beipackzettel und Fachinformationen der Hersteller zur Kontrolle heranzuziehen und im Zweifelsfall einen Spezialisten zu konsultieren. Fragliche Unstimmigkeiten sollen bitte im allgemeinen Interesse der OL-Redaktion mitgeteilt werden.

Der Benutzer selbst bleibt verantwortlich für jede diagnostische und therapeutische Applikation, Medikation und Dosierung. 

In dieser Leitlinie sind eingetragene Warenzeichen (geschützte Warennamen) nicht besonders kenntlich gemacht. Es kann also aus dem Fehlen eines entsprechenden Hinweises nicht geschlossen werden, dass es sich um einen freien Warennamen handelt.

Das Werk ist in allen seinen Teilen urheberrechtlich geschützt. Jede Verwertung außerhalb der Bestimmung des Urhebergesetzes ist ohne schriftliche Zustimmung der OL-Redaktion unzulässig und strafbar. Kein Teil des Werks darf in irgendeiner Form ohne schriftliche Genehmigung der OL-Redaktion reproduziert werden. Dies gilt insbesondere für Vervielfältigungen, Übersetzungen, Mikroverfilmungen und die Einspeicherung, Nutzung und Verwertung in elektronischen Systemen, Intranets und dem Internet.

In dieser Leitlinie wird aus Gründen der Lesbarkeit die männliche Form verwendet, dessenungeachtet beziehen sich die Angaben auf Angehörige aller Geschlechter.

1.7. Ziele des Leitlinienprogramms Onkologie

Die Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften e. V., die Deutsche Krebsgesellschaft e. V. und die Deutsche Krebshilfe haben sich mit dem Leitlinienprogramm Onkologie (OL) das Ziel gesetzt, gemeinsam die Entwicklung und Fortschreibung und den Einsatz wissenschaftlich begründeter und praktikabler Leitlinien in der Onkologie zu fördern und zu unterstützen. Die Basis dieses Programms beruht auf den medizinisch-wissenschaftlichen Erkenntnissen der Fachgesellschaften und der DKG, dem Konsens der medizinischen Fachexperten, Anwender und Patienten sowie auf dem Regelwerk für die Leitlinienerstellung der AWMF und der fachlichen Unterstützung und Finanzierung durch die Deutsche Krebshilfe. Um den aktuellen Stand des medizinischen Wissens abzubilden und den medizinischen Fortschritt zu berücksichtigen, müssen Leitlinien regelmäßig überprüft und fortgeschrieben werden. Die Anwendung des AWMF-Regelwerks soll dabei Grundlage zur Entwicklung qualitativ hochwertiger onkologischer Leitlinien sein. Da Leitlinien ein wichtiges Instrument der Qualitätssicherung und des Qualitätsmanagements in der Onkologie darstellen, sollten sie gezielt und nachhaltig in den Versorgungsalltag eingebracht werden. So sind aktive Implementierungsmaßnahmen und auch Evaluationsprogramme ein wichtiger Bestandteil der Förderung des Leitlinienprogramms Onkologie. Ziel des Programms ist es, in Deutschland professionelle und mittelfristig finanziell gesicherte Voraussetzungen für die Entwicklung und Bereitstellung hochwertiger Leitlinien zu schaffen. Diese hochwertigen Leitlinien dienen nicht nur dem strukturierten Wissenstransfer, sondern können auch in der Gestaltung der Strukturen des Gesundheitssystems ihren Platz finden. Zu erwähnen sind in diesem Zusammenhang evidenzbasierte Leitlinien als Grundlage zum Erstellen und Aktualisieren von Disease-Management-Programmen oder die Verwendung von aus Leitlinien extrahierten Qualitätsindikatoren im Rahmen der Zertifizierung von Organtumorzentren.

1.8. Weitere Dokumente zu dieser Leitlinie

Bei diesem Dokument handelt es sich um die Langversion der S3-Leitlinie „Diagnostik und Therapie des Hepatozellulären Karzinoms und biliärer Karzinome“. Neben der Langversion wird es folgende ergänzende Dokumente zu dieser Leitlinie geben:

• Kurzversion der Leitlinie

• Laienversion (Patientenleitlinie)

• Leitlinienreport zum Erstellungsprozess der Leitlinie

• Evidenztabellen

Diese Leitlinie und alle Zusatzdokumente sind über die folgenden Seiten zugänglich.

• Leitlinienprogramm Onkologie (https://www.leitlinienprogramm-onkologie.de/leitlinien/hepatozellulaeres-karzinom-hcc/)

• AWMF (www.leitlinien.net)

• Deutsche Gesellschaft für Gastroenterologie, Verdauungs- und Stoffwechselkrankheiten (www.dgvs.de)

• Guidelines International Network (www.g-i-n.net)

Die Leitlinie ist außerdem in der App des Leitlinienprogramms Onkologie enthalten.

Weitere Informationen unter: https://www.leitlinienprogramm-onkologie.de/app/

1.9. Zusammensetzung der Leitliniengruppe

1.9.1. Koordination und Redaktion

Prof. Dr. Nisar P. Malek
Ärztlicher Direktor Medizinische Klinik Universitätsklinikum Tübingen

Prof. Dr. Michael Bitzer
Stellvertretener Ärztlicher Direktor Medizinische Klinik Universitätsklinikum Tübingen

Prof. Dr. Peter R. Galle
Ärztlicher Direktor Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Sabrina Voesch
Ärztin in Weiterbildung Medizinische Klinik Universitätsklinikum Tübingen

1.9.2. Beteiligte Fachgesellschaften und Organisationen

In [Tab. 1] sind die an der Leitlinienerstellung beteiligten medizinischen Fachgesellschaften und sonstigen Organisationen sowie deren mandatierte Vertreter aufgeführt.

Tab. 1 Beteiligte Fachgesellschaften und Organisationen.

Beteiligte Fachgesellschaften und Organisationen	Mandatsträger
Deutsche Gesellschaft für Allgemein- und Viszeralchirurgie (DGAV)	Oldhafer K., Seehofer D. (Stellv.)
Deutsche Gesellschaft für Chirurgie (DGCH)	Lang H.
Deutsche Gesellschaft für Ernährungsmedizin (DGEM)	Plauth M., Ockenga J. (Stellv.)
Deutsche Gesellschaft für Endoskopie und bildgebende Verfahren (DGE-BV)	Meining A.
Deutsche Gesellschaft für Hämatologie und Onkologie (DGHO)	Sinn M.
Deutsche Gesellschaft für Innere Medizin (DGIM)	Bitzer M., Trojan J.
Deutsche Gesellschaft für interventionelle Radiologie und minimalinvasive Therapie (DeGIR)	Pereira P., Mahnken A. (Stellv.), Huppert P. (Stellv.)
Deutsche Gesellschaft für Nuklearmedizin (DGN)	Bartenstein P., La Fougère Ch. (Stellv.)
Deutsche Gesellschaft für Pädiatrische Onkologie und Hämatologie (GPOH)	Schmid I., v. Schweinitz D. (Stellv.)
Deutsche Gesellschaft für Palliativmedizin (DGPall)	Lenz P.
Deutsche Gesellschaft für Pathologie (DGP)	Schirmacher P., Evert M.
Berufsverband deutscher Pathologen (BDP)	Schirmacher P., Evert M.
Deutsche Gesellschaft für Radioonkologie (DEGRO)	Vorwerk, H., Krug D. (Stellv.)
Deutsche Gesellschaft für Ultraschall in der Medizin (DEGUM)	Schuler, A., Wildner D. (Stellv.)
Deutscher Verband für Physiotherapie (ZKV)	Tholen, R.
Deutsche Röntgengesellschaft e. V. (DRG)	Vogl, T., Paprottka P., Wacker F., Helmberger T.
Deutsche Gesellschaft für Gastroenterologie, Verdauungs- und Stoffwechselkrankheiten (DGVS)	Malek N., Galle P., Götz M., Lammert F., Plentz R.
Deutsche Transplantationsgesellschaft (DTG)	Nadalin S.
Deutsche Gesellschaft für Humangenetik (GfH)	Nguyen H. P.
Deutsche Leberhilfe e. V.	van Thiel I., Kautz A. (Stellv.)
Deutsche Leberstiftung	Schirmacher P.
Lebertransplantierte Deutschland e. V.	Hammes E. bis 10.08.2020 Riemer J. ab 11.08.2020
Arbeitsgemeinschaft Internistische Onkologie (AIO)	Vogel A., Wege H.
Arbeitsgemeinschaft Onkologische Pathologie	Dombrowski F.
Arbeitsgemeinschaft Radiologische Onkologie (ARO)	Brunner T., Gkika E. (Stellv.)
Arbeitsgemeinschaft Tumorklassifikation in der Onkologie (ATO)	Tannapfel A., Wittekind Ch. (Stellv.)
Arbeitsgemeinschaft Supportive Maßnahmen in der Onkologie (AGSMO)	Stein A.
Arbeitsgemeinschaft Onkologische Rehabilitation und Sozialmedizin (AGORS)	Körber J.
Chirurgische Arbeitsgemeinschaft Onkologie (CAO-V)	Bechstein W.
Arbeitsgemeinschaft Psychoonkologie (PSO)	Stengel, A., Ringwald J. (Stellv.)
Konferenz Onkologischer Kranken- und Kinderkrankenpflege (KOK)	Knötgen G., Paradies K. (Stellv.)
Arbeitsgemeinschaft Palliativmedizin (APM)	Ritterbusch U.
Arbeitsgemeinschaft Bildgebung in der Onkologie (ABO)	Persigehl Th.
Arbeitsgemeinschaft Prävention und Integrative Medizin in der Onkologie (AG PRIO)	Stoll Ch., Micke O. (Stellv.)
Arbeitsgemeinschaft Soziale Arbeit in der Onkologie (ASO)	Taubert A.

Außerdem wurden folgende Fachgesellschaften für den Leitlinienprozess angeschrieben, diese haben jedoch keinen Mandatsträger benannt:

• Deutsche Gesellschaft für Allgemeinmedizin und Familienmedizin

• Deutsche Gesellschaft für Pflegewissenschaft e. V.

• Arbeitsgemeinschaft Pädiatrische Onkologie

• Arbeitsgemeinschaft Onkologische Thoraxchiurgie

• Deutsche Gesellschaft für Ernährung e. V.

• Deutsche Gesellschaft für Klinische Chemie und Laboratoriumsmedizin ([Tab. 2], [3])

Tab. 2 Arbeitsgruppen und deren Mitglieder.

Arbeitsgruppe	Mitglieder der Arbeitsgruppe (AG-Leiter hervorgehoben)
AG I. Risikofaktoren, Prävention und Früherkennung	Trojan J., Schuler A., van Thiel I., Kautz A., Wedemeyer H., Lammert F., Roeb E., Geier A., Wildner D., Hofmann, W. P., Schmid I.
AG II.I Histopathologische und molekulare Diagnostik	Schirmacher P, Nguyen H. P., Dombrowski F., Evert M., Tannapfel A.
AG II.II Bildgebende Diagnostik	Götz M., Paprottka P., Persigehl T., Vogl T.J., Meining A., Wacker F., Pohl J., Reimer P., Schellhaas B.
AG III.I Operative und Interventionelle Therapieverfahren	Nadalin S., Pereira P., Bechstein W., Oldhafer K., Lang H., Bartenstein P., Vorwerk H., Brunner T., Hammes E., Vogel A., Helmberger T., Seehofer D., La Fougère Ch., Albert J., Hoffmann R.-T., Mahnken A., Huppert P., Gkika E., Krug D.
AG III.II Systemtherapie	Bitzer M., Galle P., Sinn M., Stein A., Plentz R., Schmid I., Wörns M.-A., Wege H.
AG IV Supportivtherapie	Lenz P., Ritterbusch U., Tholen R., Körber J., Stoll Ch., Taubert A., Stengel A., Knötgen G., Plauth M., Waidmann O.

Tab. 3 Beteiligte Experten.

Beteiligte Experten	Arbeitsgruppe
Wedemeyer, H.	AG I Risikofaktoren, Prävention und Früherkennung
Roeb, E.	AG I Risikofaktoren, Prävention und Früherkennung
Geier, A.	AG I Risikofaktoren, Prävention und Früherkennung
Pohl, J.	AG II. II Bildgebende Diagnostik
Reimer, P.	AG II. II Bildgebende Diagnostik
Schellhaas, B.	AG II. II Bildgebende Diagnostik
Albert, J.	AG III.I. Operative und Interventionelle Therapieverfahren
Hoffmann, R.-T.	AG III.I. Operative und Interventionelle Therapieverfahren
Hofmann, W. P.	AG I Risikofaktoren, Prävention und Früherkennung
Wörns, M.-A.	AG III.II. Systemtherapie
Waidmann, O.	AG IV. Supportivtherapie

Die Zuordnung der beteiligten Mandatsträger und Experten finden Sie in den [Tab. 2], [3].

1.9.3. Patientenbeteiligung

Die Leitlinie wurde unter direkter Beteiligung von 4 Patientenvertretern erstellt.

Herr Ingo van Thiel, Herr Achim Kautz und Frau Elke Hammes waren von Beginn an in die Erstellung der Leitlinie eingebunden und nahmen mit eigenem Stimmrecht an der Konsensuskonferenz teil. Herr Kautz war der Stellvertreter von Herrn Thiel und hat daher nicht abgestimmt. Frau Riemer ersetzte Frau Hammes ab der Videokonsensuskonferenz 08/2020.

1.9.4. Methodische Begleitung

1. Durch das Leitlinienprogramm Onkologie:

   • Dr. med. Markus Follmann, MPH, MSc (OL Office c/o Deutsche Krebsgesellschaft)

   • Thomas Langer, Dipl.-Soz.-Wiss. (OL Office c/o Deutsche Krebsgesellschaft)

2. Durch die Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften e. V.:

   • Dr. rer. medic. Susanne Blödt, MScPH (AWMF-IMWI)

3. Durch die Firma Clinical Guideline Service – User Group:

   • Dr. Nadine Steubesand

   • Dr. Paul Freudenberger

4. Durch die DGVS

   • Pia Lorenz

   • PD Dr. med. Petra Lynen Jansen

1.10. Verwendete Abkürzungen

Abkürzung	Erläuterung
3D-CRT	Three-dimensional Conformal Radiation Therapy
5-FU	5-Fluorouracil
AASLD	American Association for the Study of Liver Diseases
ACG	American College of Gastroenterology
AFIP	Armed Forces Institute of Pathology
AFP	Alpha-Fetoprotein
AFP-L3	Lektin reaktives Alpha-Fetoprotein
AG	Arbeitsgruppe
ALT	Alanin-Aminotransferase
APASL	Asian Pacific Association for the Study of the Liver
APRI	AST/Thrombozyten-Ratio-Index
ARFI	Acoustic Radiation Force Impulse Imaging
AST	Aspartat-Aminotransferase
ATG	Antithymozytenglobulin
AUC	Area under the Curve
AWMF	Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften e. V.
ÄZQ	Ärztliches Zentrum für Qualität in der Medizin
BÄK	Bundesärztekammer
BCLC	Barcelona Clinic Liver Cancer
Bds	Beiderseits
BilIN	Biliäre intraepitheliale Neoplasie
BMI	Body-Mass-Index
BSC	Best Supportive Care
BSG	British Society of Gastroenterology
CA 19-9	Carbohydrate-Antigen 19-9
CCA	Cholangiokarzinom
iCCA	Intrahepatisches Cholangiokarzinom
dCCA	Distales Cholangiokarzinom
eCCA	Extrahepatisches Cholangiokarzinom
pCCA	Perihiläres Cholangiokarzinom
CD	Cluster of Differentiation
CEUS	Kontrastmittel-Ultraschall
CI	Konfidenzintervall
CIPN	Chemotherapie-induzierte periphere Neuropathie
CLIP	Cancer of the Liver Italian Program
CNI	Calcineurininhibitor
CR	Complete Remission
CT	Computertomografie
CTCEA	Common Terminology Criteria for Adverse Events
CTLA-4	Cytotoxic T-lymphocyte-associated Protein 4
CU-HCC	Chinese University-HCC (Risikoscore)
CUP	Cancer of Unkown Primary
DAAD	Direct-acting antiviral Drugs
DCP	des-Gamma-Carboxyprothrombin
DGCH	Deutsche Gesellschaft für Chirurgie
DGEM	Deutsche Gesellschaft für Ernährungsmedizin
DGVS	Deutsche Gesellschaft für Gastroenterologie, Verdauungs- und Stoffwechselkrankheiten
DHC	Ductus Choledochus
DKG	Deutsche Krebsgesellschaft e. V.
DKH	Deutsche Krebshilfe e. V.
EASL	European Association for the Study of the Liver
ECOG	Eastern Cooperative Oncology Group
EG	Empfehlungsgrad, A = starke Empfehlung, B = Empfehlung, 0 = offene Empfehlung
EK	Expertenkonsens
ELTR	European Liver Transplant Registry
EORTC	European Organisation for Research and Treatment of Cancer
EORTIC-QLQ	European Organisation for Research and Treatment of Cancer – Quality of Life Questionnaire
EQD2	Equivalenzdosis von 2 Gy
ERC(P)	Endoskopische retrograde Cholangio(pankreatiko)grafie
ESCULAP	Erlanger Synopsis for Contrast-enhanced Ultrasound for Liver Lesion Assessment in Patients at Risk
ESMO	European Society of Medical Oncology
ETC	Extended Toronto Criteria
EUS-(FNA)	Endosonografischer Ultraschall – (Feinnadelaspiration)
FACT-H	Functional Assessment of Cancer Therapy- Hepatobiliary
FDG-PET	Fluordeoxyglukose-Positronen-Emissionstomografie
FIB-4	Fibrosis-4
GAG-HCC	Guide with Age, Gender, HBV DNA, Core Promoter Mutations and Cirrhosis-HCC
GB-CA	Gallenblasenkarzinom
Gd-DTPA	Gadolinium-Diethylene-Triamine Pentaacetic Acid
Gd-EOB-DTPA	Gadolinium-Ethoxybenzyl-Diethylentriamin-Penta-Essigsäure
GEKID	Gesellschaft der epidemiologischen Krebsregister in Deutschland e. V.
G-I-N	Guidelines International Network
GLOBOCAN	Global Cancer Incidence, Mortality and Prevalence
GOT	Glutamat-Oxalacetat-Transaminase
GPT	Glutamat-Pyruvat-Transaminase
HAI	Hepatische arterielle Infusion
HBsAg	Hepatitis-B-surface-Antigen
HBeAg	Hepatitis-B-envelope-Antigen
HBV	Hepatitis B
HCC	Hepatozelluläres Karzinom
HCV	Hepatitis C
HepPar1	Hepatocyte Paraffin 1
HR	Hazard Ratio
HSP70	Hitzeschockprotein 70
hTERT	Human Telomerase Reverse Transcriptase
ICCR	International Collaboration on Cancer Reporting
ICD	International Statistical Classification of Diseases and Related Health Problems
IGRT	Image Guided Radiotherapy
ILCA	International Liver Cancer Association
IPMN	Intraduktale papillär-muzinösen Neoplasie
IRE	Irreversible Elektroporation
IQWiG	Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen
ITT	Intention to Treat
JIS	Japan Integrated Staging Score
KASL	Korean Association for the Study of the Liver
LA	Leitlinienadaptation
LAASL	Latin American Association for the Study of the Liver (LAASL)
LiMax	Maximum liver function capacity
LiRADS	Liver Imaging Reporting and Data System
LL	Leitlinie
LoE	Level of Evidence
LTx	Lebertransplantation
MARS	Molecular-Adsorbent-Recirculating-System
MCN	Muzinös-zystische Neoplasie
MRCP	Magnetresonanz-Cholangiopankreatikografie
MR(T)	Magnetresonanz(tomografie)
MWA	Mikrowellenablation
NAFLD	Non-alcoholic fatty Liver Disease
NASH	Nichtalkoholische Steatohepatitis
NCI	National Cancer Institute
NCCN	The National Comprehensive Cancer Network
NGC	National Guideline Clearinghouse
NICE	National Institute for Health and Clinical Excellence
NRS	Nutrition Risk Screening
NT	Nicht transplantabel
OL	Leitlinienprogramm Onkologie
OP	Operation
ORN	Osteoradionekrose
OS	Overall Survival
PBC	Primär biliäre Zirrhose
PBD	Präoperative biliäre Drainage
PD	Progressive Disease
PDT	Photodynamische Therapie
PEI/PAI	Perkutane Ethanol Injektion
PET	Positronen-Emissions-Tomografie
PFS	Progression Free Survival
PICO	Population Intervention Comparison Outcome
PR	Partial Remission
PS	Progressive Disease
PSC	Primär sklerosierende Cholangitis
PV	Portalvene
PZK	Patientenzentrierte Kommunikation
QI	Qualitätsindikatoren
QoL	Quality of Life
RFA	Radiofrequenzablation
iRFA	Intraduktale Radiofrequenzablation
RILD	Radiation induced Liver Disease
RR	Relatives Risiko
SBRT	Stereotactic Body Radiotherapy
SD	Stable Disease
SEOM	Spanish Society of Medical Oncology
SEMS	Selbstexpandierender Metallstent
SGA	Subjective Global Assessment
SGB	Sozialgesetzbuch
SR	Systematische Recherche
STIKO	Ständige Impfkomission
SVR	Substained Virological Response
TACE	Transarterielle Chemoembolisation
DEB-TACE	Drug-eluting Bead TACE
TARE	Transarterielle Radioembolisation
TNM	Tumor Nodus Metastase
TTD	Time to Deterioration
TTP	Time to Progression
UICC	Union for International Cancer Control
UCSF	University of California, San Francisco
UNOS	United Network of Organ Sharing
US	Ultraschall
VEGF(R)	Vascular Endothelial Growth Factor (Receptor)
WHO	Wold Health Organisation

Publication History

Article published online:
11 February 2022

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