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

NCT05551299 | Recruiting Phase 4 DMC

• 3 other identifiers: CARP2022-500107-50-00434336116
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 20

Brief 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.

Conditions

Hilar Cholangiocarcinoma

Keywords

Hilar Cholangiocarcinoma; Radiofrequency ablation (RFA); Photodynamic therapy (PDT); Photosensitizer; Klatskin Tumor; Bile Duct Cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Hazard ratio from a Cox regression model will be used to compare randomization arms. Covariates will be stratification variables, classification of local inoperability, use of prophylactic antibiotics, Bismuth type and time between diagnosis and beginning RFA/PDT.

  through study completion, an average of 1 year

Secondary Outcomes (18)

• Overall survival (complementary perspective: median survival time)

  through study completion, an average of 1 year

• Overall survival (complementary perspective: two-year overall survival)

  up to two years

• Overall survival (complementary perspective: restricted mean survival on a time horizon of two-years)

  through study completion, an average of 1 year

• Days alive and out of hospital up to two years

  up to two years

• Quality of Life (QoL) measured using QLQ-C30 at various points in time after randomization (V2 (14 days), V3 (ca. 3 months), as a function of time after 6 months, adjusting for the baseline value)

  through study completion, an average of 1 year

Study Arms (2)

Photodynamic therapy (PDT)

EXPERIMENTAL

The index procedure in all patients at baseline includes stenting, using an endoscopic retrograde cholangio-pancreatography (ERCP) procedure. The Intervention is at least one PDT at baseline according to the clinical routine of the trial site.

Drug: Photosensitizer

Radiofrequency ablation (RFA)

EXPERIMENTAL

The index procedure in all patients at baseline includes stenting, using an endoscopic retrograde cholangio-pancreatography (ERCP) procedure. The Intervention is at least one RFA at baseline according to the clinical routine of the trial site.

Procedure: Radiofrequency ablation (RFA)

Interventions

Photosensitizer DRUG

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.

Also known as: Photodynamic therapy (PDT)

Photodynamic therapy (PDT)

Radiofrequency ablation (RFA) PROCEDURE

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.

Radiofrequency ablation (RFA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hilar cholangiocarcinoma (cytological or histological confirmation)
• Surgery is not planned
• Age ≥ 18 years
• Written informed consent

You may not qualify if:

• Tumour not accessible endoscopically
• Known hypersensitivity to porphyrins or to any of the other ingredients of the photosensitizer chosen
• Leukopenia (\< 2000/mm3)
• Thrombocytopenia (\< 100,000 / mm³)
• Severe, uncorrected coagulopathy (at the discretion of the physician)
• Suspected erosion of major blood vessels, because of the risk of life-threatening mass haemorrhage exists
• Porphyria (clinician's assessment) or other light-exacerbated diseases
• Severely impaired liver and or kidney function (at the discretion of the physician)
• Bedridden for more than 50% of the time (similar to ECOG (Eastern Cooperative Oncology Group) grade 3)
• Planned surgical procedure within the next 30 days
• Concurrent eye disease that will require a slit lamp examination within the next 30 days
• Prior radiotherapy within the last four weeks
• Previous PDT or RFA
• Planned liver transplantation
• 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)

Sponsors & Collaborators

• University of Leipzig: lead
• Zentrum für Klinische Studien Leipzig: collaborator

Study Sites (20)

Uniklinik RWTH Aachen, Medizinische Klinik III

Aachen, 52074, Germany

RECRUITING

Universitätsklinikum Augsburg; III. Med. Klinik

Augsburg, 86156, Germany

RECRUITING

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

Berlin, 10249, Germany

NOT YET RECRUITING

Universitatsklinikum Bonn, Medizinische Klinik und Poliklinik I

Bonn, 53127, Germany

RECRUITING

Universitätsklinikum Frankfurt, Medizinische Klinik 1

Frankfurt, 60590, Germany

NOT YET RECRUITING

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

Freiburg im Breisgau, 79106, Germany

RECRUITING

Universitätsmedizin Greifswald Klinik für Innere Medizin A

Greifswald, 17475, Germany

RECRUITING

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

Halle, 06120, Germany

RECRUITING

Klinikum Hanau; Klinik für Gastroenterologie, Diabetologie und Infektiologie

Hanau, 63450, Germany

RECRUITING

KRH Klinikum Siloah, Klinik für Gastroenterologie

Hanover, 30459, Germany

RECRUITING

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

Leipzig, 04109, Germany

RECRUITING

University Hospital of Leipzig, Department of Gastroenterology

Leipzig, Germany

RECRUITING

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

Ludwigsburg, 71640, Germany

RECRUITING

Universitätsmedizin Mannheim, II. Medizinische Klinik

Mannheim, 68167, Germany

WITHDRAWN

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

Marburg, 35043, Germany

RECRUITING

Klinikum der LMU München, Medizinische Klinik II, Campus Großhadern

München, 81377, Germany

RECRUITING

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

Münster, 48149, Germany

RECRUITING

Klinikum Nürnberg Nord; Gastroenterologie/ Endokrinologie

Nuremberg, 90419, Germany

RECRUITING

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

Stuttgart, 70376, Germany

RECRUITING

Universitätsklinikum Tübingen, Medizinische Klinik I

Tübingen, 72076, Germany

RECRUITING

MeSH Terms

Conditions

Klatskin Tumor; Bile Duct Neoplasms

Interventions

Photosensitizing Agents; Photochemotherapy; Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Cholangiocarcinoma; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Dermatologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Radiation-Sensitizing Agents; Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy; Radiofrequency Therapy; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Albrecht Hoffmeister, Prof.Dr.med.

  Universitätsklinikum Leipzig; Bereich Gastroenterologie

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Albrecht Hoffmeister, Prof.Dr.med.

CONTACT

+49-341-97-12240; albrecht.hoffmeister@medizin.uni-leipzig.de

Marcus Hollenbach, Dr. med.

CONTACT

+49-341-97-12362; marcus.hollenbach@medizin.uni-leipzig.de

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: September 8, 2022
• First Posted: September 22, 2022
• Study Start: February 10, 2023
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (20)