Palliative ERCP and RFA ablation for metastatic, inoperable pancreatic tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study uses palliative chemotherapy plus a locoregional therapy approach combining ERCP-guided radiofrequency ablation (RFA) with the Habib EndoHPB device to target liver metastases from pancreatic cancer. Eligible participants have pancreatic head tumors causing bile duct compression, limited liver metastases (up to five lesions, each ≤1 cm), and measurable disease, with good performance status. The study seeks to determine whether this multimodal approach can improve local tumor control and potentially extend survival in a difficult-to-treat population. Primary outcomes focus on safety and feasibility, with secondary considerations on disease control and progression-free survival. The trial is led by Roberto Valente at Umeå University Hospital, with no listed collaborators at this time.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Individuals with newly diagnosed pancreatic cancer in the head of the pancreas causing compression on the bile duct.
* Metastatic stage to the liver
* Histologically or cytologically confirmed mPDAC.
* Cancer burden limited to maximum 5 metastases in the liver, each of them maximum 1 cm in the larger diameter.
* Patients must be under palliative chemotherapy treatment.
* Cancer should be radiologically measurable (in an area not previously irradiated).
* WHO performance status 0-2.
* Age 18-85 years.

Exclusion Criteria:

* Intellectual disability, unwillingness or language difficulties
* which hinders the ability to give informed consent.
* Ongoing extensive immunosuppression and/or severe leuko- or
* thrombocytopenia.
* Ongoing acute cholangitis.
* Ongoing sepsis.
* Acute kidney failure.
* Uncompensated heart failure or unstable coronary insufficiency
* (symptomatic/uncompensated).
* Pregnancy or breastfeeding.
* Any metastases outside the liver.
* Cardiac pacemakers/cardioverter defibrillators.
* Severe coagulopathy.

Where it's running

• Department of Surgery, Umeå University Hospital
  Umeå, Sweden Recruiting

Study contacts

• Study coordinator: Roberto Valente, MD, PHD, Head of Surgical Endo
• Email: roberto.valente@regionvasterbotten.se, roberto.valente@umu.se
• Phone: +46764145826

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.