Cholangiocarcinoma, Gallbladder Cancer, Pancreatic Cancer Clinical Trial
| Verified date | January 2019 |
| Source | Yonsei University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Recruiting |
| Enrollment | 48 |
| Est. completion date | September 2019 |
| Est. primary completion date | September 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 19 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Severance Hospital, Yonsei University | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Yonsei University |
Korea, Republic of,
Ortner ME, Caca K, Berr F, Liebetruth J, Mansmann U, Huster D, Voderholzer W, Schachschal G, Mössner J, Lochs H. Successful photodynamic therapy for nonresectable cholangiocarcinoma: a randomized prospective study. Gastroenterology. 2003 Nov;125(5):1355-63. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Patency of metal stent | Patency of metal stent (From stent insertion date to stent occlusion date or last follow up date if stent is patent) | 12 months | |
| Secondary | Overall Survival | 12 months | ||
| Secondary | Complication rate | 12 months |