Radiofrequency Ablation for Biliopancreatic Malignancy

Brief Title

Radiofrequency Ablation for Biliopancreatic Malignancy

Official Title

Investigation of the Effect of Intraductal Radiofrequency Ablation in Inoperable Biliopancreatic Tumors Complicated With Obstructive Jaundice

Brief Summary

      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
    

Detailed Description

      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).
    

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Feasibility (ratio of technically successful RFA-applications to all examinations in which RFA-use was intended)

Secondary Outcome

 Efficacy measured by progression-free survival at 3 months upon standard follow-up imaging study and duration of stent patency (days) after the RFA-performed procedure

Condition

Pancreas Cancer

Intervention

Radiofrequency ablation (StarMed)

Study Arms / Comparison Groups

 Radiofrequency ablation (StarMed)

Description:  Radiofrequency ablation catheter

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Device

Estimated Enrollment

18

Start Date

November 2014

Completion Date

March 2016

Primary Completion Date

March 2016

Eligibility Criteria

        Inclusion Criteria:

          1. Male or female subjects with age above 18 years old

          2. A confirmed diagnosis (endoscopic radiology, histology etc) of pancreatic or
             cholangiocarcinoma with obstructive jaundice considered inoperable according to
             multidisciplinary assessment

          3. Willing and able to give written informed consent

        Exclusion Criteria:

          1. Refusal to consent or undergo ERCP

          2. Less than 50% of liver parenchyma potentially drainable on pre-intervention imaging

          3. Platelets < 40 x 109 mm3, an international normalized ratio (INR) > 1.5

          4. Other concomitant disease or condition likely to significantly decrease life
             expectancy (e.g., moderate to severe congestive heart failure, severe COPD)

          5. Portal vein thrombosis

        18 patients to be included : Hilar cholangiocarcinoma : n=9 Distal
        cholangiocarcinoma/pancreatic cancer n=9
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Laleman Wim, MD PhD, , 

Location Countries

Belgium

Location Countries

Belgium

NCT ID

NCT02468076

Organization ID

IGNITE-1

Responsible Party

Sponsor

Study Sponsor

Universitaire Ziekenhuizen KU Leuven

Study Sponsor

Laleman Wim, MD PhD, Principal Investigator, Universitaire Ziekenhuizen KU Leuven

Verification Date

November 2014