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

NCT ID: NCT02646514

Last Updated: 2019-01-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2019-09-30

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.

Conditions

Cholangiocarcinoma, Gallbladder Cancer, Pancreatic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RFA with RF catheter (ELRA®) with stenting

Group Type: EXPERIMENTAL

Radiofrequency ablation with stenting

Intervention Type: DEVICE

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.

stenting

Group Type: ACTIVE_COMPARATOR

stenting

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Severance Hospital, Yonsei University

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Facility Contacts

Seungmin Bang, MD

Role: primary

Bang7028@yuhs.ac

02-2228-5412

Moonjae Chung, MD

Role: backup

mjchung@yuhs.ac

82-10-5058-6865

References

Sharaiha RZ, Natov N, Glockenberg KS, Widmer J, Gaidhane M, Kahaleh M. Comparison of metal stenting with radiofrequency ablation versus stenting alone for treating malignant biliary strictures: is there an added benefit? Dig Dis Sci. 2014 Dec;59(12):3099-102. doi: 10.1007/s10620-014-3264-6. Epub 2014 Jul 18.

Reference Type: BACKGROUND

PMID: 25033929 (View on PubMed)

Ortner ME, Caca K, Berr F, Liebetruth J, Mansmann U, Huster D, Voderholzer W, Schachschal G, Mossner J, Lochs H. Successful photodynamic therapy for nonresectable cholangiocarcinoma: a randomized prospective study. Gastroenterology. 2003 Nov;125(5):1355-63. doi: 10.1016/j.gastro.2003.07.015.

Reference Type: BACKGROUND

PMID: 14598251 (View on PubMed)

Kang H, Chung MJ, Cho IR, Jo JH, Lee HS, Park JY, Park SW, Song SY, Bang S. Efficacy and safety of palliative endobiliary radiofrequency ablation using a novel temperature-controlled catheter for malignant biliary stricture: a single-center prospective randomized phase II TRIAL. Surg Endosc. 2021 Jan;35(1):63-73. doi: 10.1007/s00464-020-07689-z. Epub 2020 Jun 2.

Reference Type: DERIVED

PMID: 32488654 (View on PubMed)

Other Identifiers

1-2015-0053

Identifier Type: -

Identifier Source: org_study_id