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

NCT07191418 | Not Yet Recruiting

• 2 other identifiers: SpearmintCIV-23-03-042680
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Cancer Metastatic to Liver

Outcome Measures

Primary Outcomes (1)

• The primary endpoint variable compares the Cancer Specific Survival between the two groups.

  6 months and 12 months

Study Arms (2)

Arm I: Endobiliary RFA + Biliary Stent Placement (Investigational Arm)

EXPERIMENTAL

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.

Device: Habib™ EndoHPB; Procedure: ERCP

Arm II: Biliary Stent Placement Alone (Control Arm)

ACTIVE COMPARATOR

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.

Procedure: ERCP

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.

Arm I: Endobiliary RFA + Biliary Stent Placement (Investigational Arm)

ERCP PROCEDURE

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

Arm I: Endobiliary RFA + Biliary Stent Placement (Investigational Arm); Arm II: Biliary Stent Placement Alone (Control Arm)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Roberto Valente: lead

Study Sites (1)

Department of Surgery, Umeå University Hospital

Umeå, 90185, Sweden

Location

MeSH Terms

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Central Study Contacts

Roberto Valente, MD, PHD, Head of Surgical Endo

CONTACT

+46764145826; roberto.valente@regionvasterbotten.se, roberto.valente@umu.se

Ira Sotirova, MD, GI surgeon

CONTACT

+46728422092; ira.sotirova@regionvasterbotten.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD, Senior Consultant Gastroenterologist

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 24, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 6, 2026

Record last verified: 2026-03

Locations

SE (1)