Endobiliary radiofrequency ablation of malignant hilar obstructio
- Conditions
- Neoplasms
- Registration Number
- KCT0004849
- Lead Sponsor
- Seoul National University Bundang Hospital
- Brief Summary
All procedures in the two groups were performed successfully in single session. In RFA group, the mean stricture length was 44.1 ± 12.2 mm from RAD to left IHD, which was ablated with 3 or 4 cycles from the left PTBD route. The stricture length from CBD to RPD was 48.7 ± 15.5 mm requiring 3–5 ablation cycles performed from the right PTBD route. In stent group, the mean stricture length was 41.8 ± 9.7 mm from RAD to left IHD and 43.7 ± 10.1 mm from CBD to RPD. The stricture lengths were not different between the two groups (p > 0.1). Two stents were successfully placed in criss-cross configuration in all patients. The stent patency was confirmed on completion cholangiogram in all patients. Bilateral drainage catheters were removed 2–5 days after the procedure. In all patients, cholangitis and fever were resolved within 3 days after the procedure. The value of laboratory tests significantly improved. The serum total bilirubin decreased after the procedure (from 7.4 ± 3.3 mg/dl to 1.6 ± 0.8 in the RFA group, p < 0.001, and from 6.9 ± 1.8 to 1.5 ± 0.9 mg/dl in the stent group, p < 0.001). The white blood cell count was normalized in all patients of the two groups (from 12.2 ± 4.1 mg/dl to 4.7 ± 2.2 in the RFA group, p < 0.001, and from 13.1 ± 4.1 to 5.1 ± 3.1 mg/dl in the stent group, p < 0.001). Procedure-related adverse events (AEs) included abdominal pain, skin infection at PTBD entry site, and mild hemobilia (Table 2). The pain and skin infection were resolved with oral analgesics and antibiotics. The hemobilia was suspected on cholangiogram during the procedure, but spontaneously disappeared on follow-up cholangiogram before PTBD removal. There was no difference in grade 1 or grade 2 AEs between the two groups. No AEs greater than grade 2 were observed in either group.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 25
radiologically or histologically proven malignant hilar obstruction
- patient who signed consent for biliary stent placement
- age 19-90
- possible curative resection
- inability to biliary access due to previous surgery
- life expectancy <3 months
- uncontrolled ascites, INR>2.0, platelet<5k
- pregnancy, inability to obtain written consent
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method stent patency
- Secondary Outcome Measures
Name Time Method survival