Study-group on Palliative ERCP And RFA-ablation in Metastatic and Inoperable Pancreatic Tumors

Summary

Pancreatic ductal adenocarcinoma (PDAC) is a very aggressive cancer and may become the second leading cause of cancer death by 2030. About half of the patients are diagnosed late, when the cancer has already spread (mPDAC), and the outlook is very poor. Chemotherapy is currently the only treatment for mPDAC. It can slow the disease and slightly extend life, but usually only by a few months. There are no other treatments that clearly improve survival. Radiofrequency ablation (RFA) is a minimally invasive technique that uses high-frequency electrical energy to generate heat and destroy tumor cells. Radiofrequency energy raises the temperature of the tissue, leading to coagulative necrosis and tumor cell death. RFA is commonly used to treat certain types of cancer and pre-cancerous lesions, including liver, kidney, lung, and bone tumors. In addition to directly destroying tumor tissue, RFA may also enhance the immune system's ability to recognize and attack cancer cells by exposing tumor antigens that were previously hidden within the tumor mass. Most research on radiofrequency ablation (RFA) to date has focused on Barrett's esophagus and liver cancer. However, RFA is increasingly being explored in palliative care, where early results suggest potential benefits. Advances in miniaturized endoscopic technology have enabled the application of RFA in anatomically challenging locations, such as the bile duct. Studies, including case series and clinical trials, have demonstrated that RFA is both feasible and safe. However, its impact on overall survival remains uncertain. Many previous studies are limited by small sample sizes and heterogeneous populations, often including patients with different cancer types and disease stages, which introduces bias and limits the generalizability of findings. We have therefore designed a prospective study focusing on patients with bile duct obstruction due to pancreatic ductal adenocarcinoma (PDAC) with limited metastatic spread (oligometastatic mPDAC). This study aims to provide more robust evidence on the potential role of RFA in improving clinical outcomes in a carefully selected subset of patients with advanced PDAC.

Interventions

• Habib™ EndoHPB · DEVICE

  This study will hold greater weight compared to previous ones, as it is randomized. It includes 178 patients, exclusively with pancreatic cancer, and is designed as a prospective investigation.

• ERCP · PROCEDURE

  Endoscopic retrograde cholangiopancreatography (ERCP) as part of clinical routine.

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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.

Sites (1)

• Department of Surgery, Umeå University Hospital, Umeå, Sweden · RECRUITING