Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06274879 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Safety of Biliary Intraductal Radiofrequency Ablation in Patients With Unresectable Extrahepatic Biliary Tract Cancer

Study acronym: Ablatio
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial status: Not Yet Recruiting to Recruitingv7 Show 7 more changesShow less
    • Primary completion date: Dec 30, 2026 to Dec 30, 2029
    • Start date changed from estimate of Jun 1, 2025 to May 20, 2026
    • Primary endpoint revised
    • Study sites: 1 to 4
    • Study completion date: Dec 30, 2028 to Dec 30, 2030
    • Study description expanded, about 25 words
    • Eligibility criteria shortened, about 1 word
  2. Start date: Dec 1, 2024 to Jun 1, 2025v6
  3. Start date: Sep 1, 2024 to Dec 1, 2024v5
  4. Secondary endpoints revised (11)v4
  5. Primary completion date: Apr 30, 2026 to Dec 30, 2026v3 Show 5 more changesShow less
    • Start date: May 1, 2024 to Sep 1, 2024
    • Primary endpoint revised
    • Study completion date: Apr 30, 2026 to Dec 30, 2028
    • Eligibility criteria revised
    • Secondary endpoints: 8 to 11
  6. Eligibility criteria expanded, about 36 wordsv2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to provide evidence for the general tolerability of radiofrequency ablation (bRFA) in patients with unresectable bile duct cancer undergoing systemic palliative treatment consisting of systemic anti-tumor therapy with or without immune-checkpoint-inhibitor (ICI). The main question it aims to answer is whether it is safe to combine systemic anti-tumor therapy with or without ICI with and bRFA. Participants will be assigned to either the control group or the experimental group. In the control group, the standard of care consists of endoscopy with stent placement in the bile duct and systemic anti-tumor therapy, whereas in the experimental group, bRFA will be performed in addition to the standard of care. Participants will be followed up for 6 months, during the follow-up, the stage of the tumor, blood examination, the duration of the stent from the insertion until its failure, adverse events and quality of life will be examined. Researchers will compare the standard of care alone to the experimental group to see if the additional bRFA procedure causes higher or no difference in adverse events rate.
Trial Details
NCT Number NCT06274879
Lead Sponsor Insel Gruppe AG, University Hospital Bern
Collaborators: Swiss Cancer League
Conditions
(from sponsor)		 Bile Duct Cancer
Related terms Bile Duct Neoplasms
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov