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Efficacy and Safety of Endobiliary Radiofrequency Ablation by Using a Novel RF Catheter (ELRA®) on Maintaining the Patency of Endobiliary Metal Drainage in Patients With Malignant Biliary Strictures : A Double-arm Comparable Study

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ClinicalTrials.gov Identifier: NCT02646514
Recruitment Status : Recruiting
First Posted : January 5, 2016
Last Update Posted : January 28, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:

Malignant obstructive jaundice is a common complication of advanced stage cholangiocarcinoma, gallbladder cancer, and pancreatic cancer. In biliary stricture by malignancy, biliary drainage with placement of self-expanding metal stent (SEMS) for palliation is the therapy of choice in these patients. When compared to plastic stents, SEMS present a significantly decreased risk of recurrent biliary obstruction. SEMS are also more cost-effective than plastic stents in patients with a life expectancy of longer than 4 months. However, despite their numerous benefits, SEMS become occluded in up to 50 % of patients in the first 6-8 months.

Radiofrequency ablation (RFA) has been used to treat malignancies of the liver since the early 1990s. Other studies have investigated its role in diseases of the colon and esophagus. More recently, this technique has been recognized for its potential in palliative treatment of malignant biliary strictures. RFA uses a high-frequency alternating current to generate heat and achieve coagulative necrosis when in contact with tissue. Within the bile duct, RFA appears to be safe and may result in decreased benign epithelial hyperplasia and tumor ingrowth. However, RFA along with placement of SEMS has not been well studied. On the other hand, newly developed RFA catheter (ELRA®) showed the feasibility and safety in south korea, recently.

The purpose of this study was to investigate the Efficacy and safety of endobiliary RFA by using a novel RF catheter (ELRA®) on maintaining the patency of endobiliary metal drainage in patients with malignant biliary strictures.


Condition or disease Intervention/treatment Phase
Cholangiocarcinoma, Gallbladder Cancer, Pancreatic Cancer Device: Radiofrequency ablation with stenting Device: stenting Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : September 2015
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019


Arm Intervention/treatment
Experimental: RFA with RF catheter (ELRA®) with stenting Device: Radiofrequency ablation with stenting

Side viewing endoscope or PTCS scope can be used for all procedures. Cholangiogram is performed to confirm the stricture location, length and diameter. And then, RF catheter (ELRA®) is advanced over a guide wire at the level of the biliary stricture and ablation at 7-10 watts for a time period of 60-120s according to the length is conducted.

After performance of RFA, metal stents are inserted to ensure adequate decompression and bile drainage.


Active Comparator: stenting Device: stenting
Metal stents are inserted to ensure adequate decompression and bile drainage. The diameter and stent lengths can be changed according to the lesion.




Primary Outcome Measures :
  1. Patency of metal stent [ Time Frame: 12 months ]
    Patency of metal stent (From stent insertion date to stent occlusion date or last follow up date if stent is patent)


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 12 months ]
  2. Complication rate [ Time Frame: 12 months ]


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologically confirmed malignant biliary obstruction or clinically defined malignant biliary obstruction
  • older than 19 years old
  • Life expectancy > 3 months
  • Inoperable case due to advanced stage or comorbidity
  • Informed consent

Exclusion Criteria:

  • Inadequate case for ERCP
  • Inadequate coagulation (platelet count < 60,000/µl, PT(INR)>1.5)
  • Abnormal biliary tract system due to previous operation
  • Failed endoscopic approach to duodenum or biliary tract
  • Pregnancy
  • No signed informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02646514


Locations
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Korea, Republic of
Severance Hospital, Yonsei University Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Seungmin Bang, MD    02-2228-5412    Bang7028@yuhs.ac   
Contact: Moonjae Chung, MD    82-10-5058-6865    mjchung@yuhs.ac   
Sponsors and Collaborators
Yonsei University

Publications:
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02646514     History of Changes
Other Study ID Numbers: 1-2015-0053
First Posted: January 5, 2016    Key Record Dates
Last Update Posted: January 28, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Yonsei University:
Cholangiocarcinoma, radiofrequency ablation, metal stent

Additional relevant MeSH terms:
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Cholangiocarcinoma
Pancreatic Neoplasms
Gallbladder Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Biliary Tract Neoplasms
Biliary Tract Diseases
Gallbladder Diseases