Biliary Obstruction Clinical Trial
Official title:
Efficacy of Intraductal Radiofrequency Ablation in Combination With Metallic Biliary Stenting in Advanced Hilar Cholangiocarcinoma
Verified date | March 2020 |
Source | Rajavithi Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study aim to evaluate the efficacy of intraductal radiofrequency ablation for unresetable hilar cholangiocarcinoma in addition to biliary stenting. The patient would be randomized into 1:1 ratio of conventional group who received biliary stenting alone, and RFA group who receive intraductal RFA before biliary stenting. Immediate complications as well as long term stent patency and patient survival would be studied.
Status | Completed |
Enrollment | 70 |
Est. completion date | December 30, 2021 |
Est. primary completion date | December 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Hilar cholangiocarcinoma diagnosed by imaging or pathology - Considered unresectable or unfit for surgery - Presence of obstructive jaundice need endoscopic biliary drainage Exclusion Criteria: - History of unremovable metallic biliary stent placement - severe biliary stricture that the instrument was unable to pass through - unfit for endoscopic under conscious sedation - loss to follow up and loss contact within 6 months after intervention |
Country | Name | City | State |
---|---|---|---|
Thailand | Rajavithi Hospital | Bangkok |
Lead Sponsor | Collaborator |
---|---|
Rajavithi Hospital |
Thailand,
Doherty B, Nambudiri VE, Palmer WC. Update on the Diagnosis and Treatment of Cholangiocarcinoma. Curr Gastroenterol Rep. 2017 Jan;19(1):2. doi: 10.1007/s11894-017-0542-4. Review. — View Citation
Heimbach JK, Kulik LM, Finn RS, Sirlin CB, Abecassis MM, Roberts LR, Zhu AX, Murad MH, Marrero JA. AASLD guidelines for the treatment of hepatocellular carcinoma. Hepatology. 2018 Jan;67(1):358-380. doi: 10.1002/hep.29086. — View Citation
Kim JH, Won HJ, Shin YM, Kim PN, Lee SG, Hwang S. Radiofrequency ablation for recurrent intrahepatic cholangiocarcinoma after curative resection. Eur J Radiol. 2011 Dec;80(3):e221-5. doi: 10.1016/j.ejrad.2010.09.019. Epub 2010 Oct 14. — View Citation
Razumilava N, Gores GJ. Cholangiocarcinoma. Lancet. 2014 Jun 21;383(9935):2168-79. doi: 10.1016/S0140-6736(13)61903-0. Epub 2014 Feb 26. Review. — View Citation
Sripa B, Pairojkul C. Cholangiocarcinoma: lessons from Thailand. Curr Opin Gastroenterol. 2008 May;24(3):349-56. doi: 10.1097/MOG.0b013e3282fbf9b3. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Biliary stent patency | The duration between primary intervention and first recurrent increased in serum total bilirubin after intervention up to 6 months after the primary procedure | up to 6 months | |
Secondary | Patient survival | Survival time after primary intervention and documented patient death at 6 months after primary intervention | up to 6 months |
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