Cholangiocarcinoma Clinical Trial
Official title:
Investigation of the Effect of Intraductal Radiofrequency Ablation in Inoperable Biliopancreatic Tumors Complicated With Obstructive Jaundice
This phase-2 study aims to evaluate feasibility, safety and efficacy of thermal ablation of biliary obstructive malignancies by means of radiofrequency ablation (RFA, ELRA, StarMed) during endoscopic retrograde cholangio-pancreaticography (ERCP) with primary intent to obtain palliative biliary drainage via stenting
INTRODUCTION
Biliary obstruction is the most relevant factor for survival and quality of life in patients
suffering from primary bile duct malignancies or pancreatic head carcinoma. Due to their
insidious course, these cancers are often diagnosed at an advanced stage. Thus, therapy is
frequently restricted to palliative management. Within this setting, the
prevention/treatment of biliary complications such as jaundice, cholangitis, or sepsis is
one of the key therapeutic factors to extend survival and maintain quality of life (1-3).
Endoscopic stenting of the biliary tract is now generally accepted as the primary approach
to reestablish sufficient biliary drainage, provided approximately 50% of the liver
parenchyma is drained (4). As the tumor grows, unfortunately, it often occurs that jaundice
reappears despite primary stenting. Most oftenly this relates to unbridled tumor expansion
leading to either stent-dysfunction by tumor ingrowth (through the mesh in case of metallic
stenting of or via clogging of plastic stents) or either to extension in more proximal bile
ducts/branches shutting of sufficient/adequate biliary drainage.
Given the context of incurable disease, a minimally-invasive strategy that could reduce the
tumor burden in addition to stenting might be considered beneficial in terms of longer
sustained bile duct drainage, and as such improve quality of life, more efficiently
administered and better tolerated courses chemotherapy and delayed disease progression.
An example of such a potential minimal invasive strategy is RadioFrequency Ablation (RFA).
It involves a modified electrocautery technique that has emerged among the many choices for
local, minimally invasive tissue ablation. It has proven effective, versatile, and
relatively inexpensive. RFA has been used for years in the treatment of cardiac dysrhythmias
from aberrant conduction pathways, osteoid osteoma, prostate hypertrophy, and chronic pain
(5-8). Recent clinical applications include tumor ablation in the liver (9-11), kidney
(12,13) adrenal gland (14,15), bone (16), lung (17), and breast (18) as well as soft tissue
debulking and pain palliation (19).
In the context of gastro-intestinal endoscopy, RFA has taken its place in the reduction of
neoplastic progression of Barrett esophagus over 3 years of follow-up (20).
With regard to biliopancreatic endoscopy and oncology in particular, this approach has only
recently been introduced. A primary experience using an alternative endoscopically
applicable RFA-system for bile duct lesions, has shown to be feasible and safe ex vivo in
resected fresh pig livers and in an open-label pilot study involving 22 patients with
malignant biliary obstruction (21,22). Similar results have been obtained in animal testing
for the ELRA-system (StarMed, Taewoong Medical, Seoul, Korea).
The presumed theoretical advantage of the current system (ELRA system, StarMed, Taewoong
Medical, Seoul, Korea) is the capacity to better control the locally applied temperature at
all times and to maintain temperature continuous, as such preventing tissue adjacent to an
active tip from carbonization during the procedure. Additionally the 4-ring appliance of
thermal ablation allows a better thermal spreading and therefore appliance of ablation
STUDY OBJECTIVE & DESIGN
This project involves a single center investigator-driven prospective non-randomized
non-controlled trial evaluating feasibility, safety and efficacy of thermal ablation of
biliary obstructive malignancies by means of the ELRA RF during ERCP with primary intent to
obtain palliative biliary drainage via stenting .
STUDY METHODOLOGY : POPULATION & INTERVENTION
ELIGIBLE PATIENT POPULATION
All patients with an inoperable biliopancreatic tumor with obstructive jaundice and
therefore in need of biliary drainage via ERCP, eligible and consenting for inclusion (cfr
infra), will be considered for entry in the study. This is a non-randomized non-controlled
investigator-driven trial.
ENDOSCOPIC INTERVENTION
All procedures will be performed under general anesthesia, according to standard good
clinical practice. After performing an endoscopic sphincterotomy with/without balloon
dilatation of the stenosis (conventional approach) in preparation of stenting, a RFA
catheter (ELRA, Taewoong, Seoul, Korea), suitable for endoscopic delivery into the biliary
tree over a 0.035-inch guide wire, will be advanced up to the level of the malignant
stenosis.
The "end of follow−up" is defined as the end of the follow−up period (designated at 3 months
after index procedure) or failure of treatment or death.
The outcome parameters will be compared to those of a historically matched control group
(i.e. stented without RFA).
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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