Endobiliary Radiofrequency Ablation With S-1 for Unresectable Cholangiocarcinoma

NACompletedINTERVENTIONAL
Enrollment

66

Participants

Timeline

Start Date

December 31, 2015

Primary Completion Date

August 31, 2018

Study Completion Date

March 31, 2019

Conditions
Cholangiocarcinoma
Interventions
DEVICE

radiofrequency ablation

All patients underwent biliary sphincterotomy. Cholangiogram was performed to confirm stricture location, length and diameter. The Habib Endo HPB (Hepatobiliary) probe (EMcision, HitchinHerts, UK) was then advanced over a wire at the level of the biliary stricture and ablation using ERBE generator set at 7-10 watts for a time period of 90-120 s was conducted. A 1- to 2-min resting period after energy delivery was allowed before moving the catheter along the length of the stricture to ablate the rest of the stricture.

DRUG

S-1

In the RFA plus S-1 group, treatment with S-1 began within 1 month after RFA. Based on the patient's body surface area, S-1 was administered as follows: when the level of total bilirubin was less than 2 mg/dl. Based on the body surface area, S-1 was administered if \<1.25 m2, 80 mg/day; if 1.25-1.5 m2, 100 mg/day; if≥1.5 m2, 120 mg/day. S-1 was administered orally twice daily for 14 days, followed by 7 days without treatment.

DEVICE

Stent

Plastic stent(s) were placed after RFA depending on the location of the malignant obstruction

Trial Locations (1)

31006

Hangzhou First People's Hospital, Hangzhou

All Listed Sponsors
lead

First People's Hospital of Hangzhou

OTHER

NCT02592538 - Endobiliary Radiofrequency Ablation With S-1 for Unresectable Cholangiocarcinoma | Biotech Hunter | Biotech Hunter