Bile Duct Obstruction Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Device, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Sweden
Department of Surgery, Umeå University Hospital
RECRUITING
Umeå
Contact Information
Primary
Roberto Valente, MD, PHD, Head of Surgical Endo
roberto.valente@regionvasterbotten.se, roberto.valente@umu.se
+46764145826
Backup
Ira Sotirova, MD, GI surgeon
ira.sotirova@regionvasterbotten.se
+46728422092
Time Frame
Start Date: 2026-04-09
Estimated Completion Date: 2027-09
Participants
Target number of participants: 178
Treatments
Experimental: Arm I: Endobiliary RFA + Biliary Stent Placement (Investigational Arm)
Patients randomized to this arm will undergo:~Endobiliary RFA Procedure:~Performed via endoscopic retrograde cholangiopancreatography (ERCP). A radiofrequency ablation catheter, Habib™ EndoHPB is introduced into the biliary tract.~Controlled thermal energy is applied to the malignant biliary stricture to ablate tumor tissue intraductally. RFA energy settings, duration of application, and number of applications will be standardized per protocol. Biliary Stent Placement: Immediately following RFA, a self-expandable metal stent (SEMS) or plastic stent will be deployed across the stricture to maintain biliary patency. The type and size of the stent will be based on clinical standard and anatomy.~Supporting Treatment:~Patients will receive standard systemic chemotherapy per national guidelines for metastatic pancreatic cancer (e.g., FOLFIRINOX or gemcitabine + nab-paclitaxel).~Supportive care includes antibiotics peri-ERCP, analgesics, antiemetics, and biliary drainage monitoring.
Active_comparator: Arm II: Biliary Stent Placement Alone (Control Arm)
Patients randomized to the control group will receive:~Biliary Stent Placement Only:~Performed via ERCP as above, without RFA. A SEMS or plastic stent will be placed across the malignant stricture.~Supporting Treatment:~Identical systemic chemotherapy regimens and supportive care protocols as in Arm I.
Sponsors
Leads: Roberto Valente

This content was sourced from clinicaltrials.gov