RecruitingPhase 4NCT05551299

Treatment of Non-resectable Bile Duct Cancer with Radiofrequency Ablation or Photodynamic Therapy

Cholangiocarcinoma Treatment with Radiofrequency Ablation or Photodynamic Therapy: a Randomized Controlled Trial

Sponsor

University of Leipzig

Enrollment

258 participants

Start Date

Feb 10, 2023

Study Type

INTERVENTIONAL

Conditions

Hilar Cholangiocarcinoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two treatments — radiofrequency ablation (using heat to destroy tumor tissue) and photodynamic therapy (using light-activated drugs to kill cancer cells) — delivered through an endoscope into the bile duct, for people with inoperable bile duct cancer (cholangiocarcinoma). **You may be eligible if...** - You have been diagnosed with bile duct cancer (hilar cholangiocarcinoma) confirmed by cytology or tissue biopsy - Surgery is not planned for your cancer - You are 18 or older - You have given written informed consent **You may NOT be eligible if...** - Your tumor cannot be reached by endoscope - You are allergic to porphyrins (a component of the photodynamic therapy drug) - You have very low blood counts (low white cells or platelets) - You have severe uncorrected blood clotting problems - Your liver or kidney function is severely impaired - You are mostly bedridden (ECOG 3 or higher) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPhotosensitizer

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.

PROCEDURERadiofrequency ablation (RFA)

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.

Locations(20)

Uniklinik RWTH Aachen, Medizinische Klinik III

Aachen, Germany

Universitätsklinikum Augsburg; III. Med. Klinik

Augsburg, Germany

Vivantes Netzwerk für Gesundheit GmbH, Klinikum Friedrichshain, Innere Medizin/Gastroenterologie

Berlin, Germany

Universitatsklinikum Bonn, Medizinische Klinik und Poliklinik I

Bonn, Germany

Universitätsklinikum Frankfurt, Medizinische Klinik 1

Frankfurt, Germany

Universitätsklinikum Freiburg, Medizinische Klinik II, Abteilung Gastroenterologie, Hepatologie, Endokrinologie & lnfektiologie

Freiburg im Breisgau, Germany

Universitätsmedizin Greifswald Klinik für Innere Medizin A

Greifswald, Germany

Site: Martin-Luther-Universitat Halle-Wittenberg, Universitätsklinik und Poliklinik für Innere Medizin I

Halle, Germany

Klinikum Hanau; Klinik für Gastroenterologie, Diabetologie und Infektiologie

Hanau, Germany

KRH Klinikum Siloah, Klinik für Gastroenterologie

Hanover, Germany

Klinikum St. Georg gGmbH; Klinik für Gastroenterologie, Hepatologie, Diabetologie und Endokrinologie

Leipzig, Germany

University Hospital of Leipzig, Department of Gastroenterology

Leipzig, Germany

RKH Kliniken Ludwigsburg- Bietigheim gGmbH, Klinik für Innere Medizin, Gastroenterologie, Hämato-Onkologie, Diabetologie und Infektiologie

Ludwigsburg, Germany

Universitätsmedizin Mannheim, II. Medizinische Klinik

Mannheim, Germany

Universitätsklinikum Gießen und Marburg GmbH (UKGM); Klinik für Innere Medizin mit den Schwerpunkten Gastroenterologie, Endokrinologie, Stoffwechsel und klinische Infektiologie

Marburg, Germany

Klinikum der LMU München, Medizinische Klinik II, Campus Großhadern

München, Germany

Universitlitsklinikum Munster Medizinische Klinik B (Gastroenterologie, Hepatologie, Endokrinologie, Klinische lnfektiologie)

Münster, Germany

Klinikum Nürnberg Nord; Gastroenterologie/ Endokrinologie

Nuremberg, Germany

Robert-Bosch-Krankenhaus (RBK) Stuttgart; Gastroenterologie, Hepatologie und Endokrinologie

Stuttgart, Germany

Universitätsklinikum Tübingen, Medizinische Klinik I

Tübingen, Germany

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NCT05551299

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