Trial Title:
Treatment of Non-resectable Bile Duct Cancer With Radiofrequency Ablation or Photodynamic Therapy
NCT ID:
NCT05551299
Condition:
Hilar Cholangiocarcinoma
Conditions: Official terms:
Cholangiocarcinoma
Klatskin Tumor
Photosensitizing Agents
Conditions: Keywords:
Hilar Cholangiocarcinoma
Radiofrequency ablation (RFA)
Photodynamic therapy (PDT)
Photosensitizer
Klatskin Tumor
Bile Duct Cancer
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Photosensitizer
Description:
A photosensitizer, which is absorbed preferentially by tumour cells, is administered 24 -
48 hours prior to PDT. Light of a particular wavelength is then applied during endoscopic
retrograde cholangiopancreatography (ERCP) to kill primarily cancer cells locally within
the stenosis. Immediately after PDT treatment, new stents are inserted into all treated
segments if needed.
Arm group label:
Photodynamic therapy (PDT)
Other name:
Photodynamic therapy (PDT)
Intervention type:
Procedure
Intervention name:
Radiofrequency ablation (RFA)
Description:
RFA is also carried out as part of an ERCP. The RFA-probe is placed within the tumour
stenosis and electrical current is applied. New stents are inserted into all treated
segments if needed.
Arm group label:
Radiofrequency ablation (RFA)
Summary:
Bile duct cancer is often diagnosed after curative options are no longer available. Stent
therapy is used to keep the ducts open and can be combined with photodynamic therapy
(PDT) to extend life expectancy. PDT requires an injection of photosensitizer after which
light of a particular wavelength is applied endoscopically to kill the cancer cells.
Drawbacks include not only high costs and poor availability, but foremost that patients
have to avoid direct sunlight for a period of weeks. Radio frequency ablation (RFA)
together with stent implantation constitutes an alternative by which the cancer cells are
killed through heat, also applied endoscopically. The RFA technology is more widely
available and easier to deploy. However, it has not been studied extensively and no
randomized trials exist comparing the two methods. This trial will compare survival in
patients with a particular bile duct cancer depending on whether they receive PDT or RFA.
Moreover, data will be collected on side-effects and quality of life.
Detailed description:
Klatskin tumours are a form of bile duct cancer. They are generally not diagnosed until
quite late and a curative operation is rarely a possibility. Their anatomic location
usually results in bile duct obstruction and the aim of therapy is thus to keep the ducts
open. This is accomplished through endoscopic retrograde cholangiopancreatography (ERCP)
by implanting stents. Stent therapy combined with photodynamic therapy (PDT) extends life
expectancy. PDT requires an injection of photosensitizer that is absorbed primarily by
the cancer cells. Light of a particular wavelength is then applied with ERCP to kill the
cancer cells. Drawbacks include not only high costs and poor availability, but foremost
that patients have to avoid direct sunlight for a period of weeks. Radio frequency
ablation (RFA) together with stent implantation constitutes an alternative by which the
cancer cells are killed through heat applied during ERCP. The RFA technology is more
widely available and easier to deploy. However, it has not been studied extensively and
no randomized trials exist comparing the two methods. This trial will compare survival in
patients with Klatskin tumours depending on whether they receive PDT or RFA. Moreover,
data will be collected on side-effects and quality of life.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Hilar cholangiocarcinoma (cytological or histological confirmation)
2. Surgery is not planned
3. Age ≥ 18 years
4. Written informed consent
Exclusion Criteria:
1. Tumour not accessible endoscopically
2. Known hypersensitivity to porphyrins or to any of the other ingredients of the
photosensitizer chosen
3. Leukopenia (< 2000/mm3)
4. Thrombocytopenia (< 100,000 / mm³)
5. Severe, uncorrected coagulopathy (at the discretion of the physician)
6. Suspected erosion of major blood vessels, because of the risk of life-threatening
mass haemorrhage exists
7. Porphyria (clinician's assessment) or other light-exacerbated diseases
8. Severely impaired liver and or kidney function (at the discretion of the physician)
9. Bedridden for more than 50% of the time (similar to ECOG (Eastern Cooperative
Oncology Group) grade 3)
10. Planned surgical procedure within the next 30 days
11. Concurrent eye disease that will require a slit lamp examination within the next 30
days
12. Prior radiotherapy within the last four weeks
13. Previous PDT or RFA
14. Planned liver transplantation
15. Fertile women (within two years of their last menstruation) without appropriate
contraceptive measures (implanon, injections, oral contraceptives, intrauterine
devices, partner with vasectomy) while participating in the trial (participants
using a hormone-based method have to be informed of possible effects of the trial
medication on contraception)
16. Participation in other interventional trials
17. Patients under legal supervision or guardianship
18. Pregnant or nursing women
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Uniklinik RWTH Aachen, Medizinische Klinik III
Address:
City:
Aachen
Zip:
52074
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Karim Hamesch, PD Dr.
Phone:
+49 241 80 80861
Email:
khamesch@ukaachen.de
Facility:
Name:
Universitätsklinikum Augsburg; III. Med. Klinik
Address:
City:
Augsburg
Zip:
86156
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Tobias Weber, Dr.
Email:
tobias.weber@uk-augsburg.de
Facility:
Name:
Vivantes Netzwerk für Gesundheit GmbH, Klinikum Friedrichshain, Innere Medizin/Gastroenterologie
Address:
City:
Berlin
Zip:
10249
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Thomas Brunk, Dr.
Email:
thomas.brunk@vivantes.de
Facility:
Name:
Universitatsklinikum Bonn, Medizinische Klinik und Poliklinik I
Address:
City:
Bonn
Zip:
53127
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Dominik Kaczmarek, Dr.
Phone:
+49 228 287 -15263
Email:
Dominik.Kaczmarek@ukbonn.de
Facility:
Name:
Universitätsklinikum Frankfurt, Medizinische Klinik 1
Address:
City:
Frankfurt
Zip:
60590
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Jörg Trojan, Prof. Dr.
Facility:
Name:
Universitätsklinikum Freiburg, Medizinische Klinik II, Abteilung Gastroenterologie, Hepatologie, Endokrinologie & lnfektiologie
Address:
City:
Freiburg
Zip:
79106
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Armin Küllmer, Dr.
Facility:
Name:
Universitätsmedizin Greifswald Klinik für Innere Medizin A
Address:
City:
Greifswald
Zip:
17475
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Ali Aghdassi, Prof.
Email:
Ali.Aghdassi@med.uni-greifswald.de
Facility:
Name:
Site: Martin-Luther-Universitat Halle-Wittenberg, Universitätsklinik und Poliklinik für Innere Medizin I
Address:
City:
Halle
Zip:
06120
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Jonas Rosendahl, Prof. Dr.
Phone:
+49 345 557 2661
Email:
jonas.rosendahl@uk-halle.de
Facility:
Name:
Klinikum Hanau; Klinik für Gastroenterologie, Diabetologie und Infektiologie
Address:
City:
Hanau
Zip:
63450
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Likas Welsch, Dr.
Email:
Lukas_Welsch@klinikum-hanau.de
Facility:
Name:
KRH Klinikum Siloah, Klinik für Gastroenterologie
Address:
City:
Hannover
Zip:
30459
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Daniel Vidacek, Dr.
Phone:
+49 511 927 2102
Email:
Daniel.Vidacek@krh.de
Facility:
Name:
Klinikum St. Georg gGmbH; Klinik für Gastroenterologie, Hepatologie, Diabetologie und Endokrinologie
Address:
City:
Leipzig
Zip:
04109
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Ingolf Schiefke, Prof.
Email:
ingolf.schiefke@SanktGeorg.de
Facility:
Name:
University Hospital of Leipzig, Department of Gastroenterology
Address:
City:
Leipzig
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Albrecht Hoffmeister, Prof. Dr.
Phone:
++49 - 341 - 97 12240
Email:
Albrecht.Hoffmeister@medizin.uni-leipzig.de
Facility:
Name:
RKH Kliniken Ludwigsburg- Bietigheim gGmbH, Klinik für Innere Medizin, Gastroenterologie, Hämato-Onkologie, Diabetologie und Infektiologie
Address:
City:
Ludwigsburg
Zip:
71640
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Andreas Wannhoff, Dr.
Phone:
+4971419967201
Email:
andreas.wannhoff@rkh-kliniken.de
Facility:
Name:
Universitätsmedizin Mannheim, II. Medizinische Klinik
Address:
City:
Mannheim
Zip:
68167
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Sebastian Belle, PD Dr.
Phone:
+49 621 383-4642
Email:
sebastian.belle@umm.de
Facility:
Name:
Universitätsklinikum Gießen und Marburg GmbH (UKGM); Klinik für Innere Medizin mit den Schwerpunkten Gastroenterologie, Endokrinologie, Stoffwechsel und klinische Infektiologie
Address:
City:
Marburg
Zip:
35043
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Ulrike Denzer, Prof.
Email:
ulrike.denzer@uk-gm.de
Facility:
Name:
Klinikum der LMU München, Medizinische Klinik II, Campus Großhadern
Address:
City:
München
Zip:
81377
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Jörg Schirra, Prof. Dr.
Phone:
+49 89 4400 73031
Email:
joerg.schirra@med.uni-muenchen.de
Facility:
Name:
Universitlitsklinikum Munster Medizinische Klinik B (Gastroenterologie, Hepatologie, Endokrinologie, Klinische lnfektiologie)
Address:
City:
Münster
Zip:
48149
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Jonel Trebicka, Prof.
Phone:
+492518343330
Email:
Jonel.Trebicka@ukmuenster.de
Facility:
Name:
Klinikum Nürnberg Nord; Gastroenterologie/ Endokrinologie
Address:
City:
Nürnberg
Zip:
90419
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Alexander Dechêne, Prof.
Email:
Alexander.Dechene@klinikum-nuernberg.de
Facility:
Name:
Robert-Bosch-Krankenhaus (RBK) Stuttgart; Gastroenterologie, Hepatologie und Endokrinologie
Address:
City:
Stuttgart
Zip:
70376
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Arthur Schmidt
Email:
arthur.schmidt@rbk.de
Facility:
Name:
Universitätsklinikum Tübingen, Medizinische Klinik I
Address:
City:
Tübingen
Zip:
72076
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Christoph Werner, Dr.
Phone:
+49 7071 2982712
Email:
christoph.werner@med.uni-tuebingen.de
Start date:
February 10, 2023
Completion date:
April 2028
Lead sponsor:
Agency:
University of Leipzig
Agency class:
Other
Collaborator:
Agency:
Zentrum für Klinische Studien Leipzig
Agency class:
Other
Source:
University of Leipzig
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05551299
