Cholangiocarcinoma, Pancreatic Cancer
Conditions
Keywords
Pancreatic cancer, Cholangiocarcinoma, Endoscopic radiofrequency ablation
Brief summary
Malignant bile duct obstruction is a common sequela of pancreatic cancers or distal bile duct cancers, and its development can hinder the use of chemotherapy, decrease patient quality of life, and decrease survival. To relieve obstructive jaundice as a result of the obstruction, endoscopic stent placement is usually required. The use self-expandable metal stents (SEMSs) have been shown to result in a longer patency times as compared with plastic stents. However, despite improvements in materials and stent design, stent obstruction still occurs in 13% to 44% of the patients. Tumor in-growth is the most common mechanism of stent obstruction. Recently, the use of endoscopic biliary radiofrequency ablation (EBRFA) have been described in patients suffering from inoperable malignant distal common bile duct (CBD) obstruction. The procedure uses heat energy to cause local tumour tissue death, resulting in re-opening of the bile duct lumen. The procedure has the potential of reducing the rate of stent obstruction after SEMS and also prolonging survival. The safety profile appears to be comparable that of placement of SEMS alone without added complications (\<10%). The aim of the current study is to compare the efficacy of EBRFA with the addition of SEMS to SEMS alone in a randomized controlled trial.We hypothesize that the application of EBRFA can reduce recurrent biliary obstruction after SEMS.
Interventions
PROCEDURESEMS only
The SEMS (Niti-S biliary uncovered metallic stent; Taewoong Medical, Korea) would be placed.
PROCEDUREEBRFA and SEMS
The radiofrequency ablation (RFA) catheter would be placed under fluoroscopic guidance across the biliary stricture. The Habib EndoHPB (EMcision UK, London, United Kingdom) radiofrequency ablation catheter is a bipolar RFA probe that is 8F (2.6 mm), 1.8 m long, compatible with standard (3.2-mm working channel) side-viewing endoscopes, and passes over 0.035-inch guidewires. The catheter has 2 ring electrodes 8 mm apart with the distal electrode 5 mm from the leading edge, providing local coagulative necrosis over a 2.5-cm length. Depending on the length of the stricture, sequential applications would be applied to complete treatment throughout the length of the stricture without significant overlap of treated areas. An uncovered SEMSs (Niti-S biliary uncovered metallic stent; Taewoong Medical, Gimpo City, Korea) would be placed after 2 sessions of EBRFA.
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years old with informed consent 2. Histologically (preferred) or radiologically confirmed distal malignant bile duct tumors 3. Inoperability by staging, comorbidities or patient wishes 4. Distal tumors 2cm away from the portal hilum 5. Bilirubin \> 50umol/L at diagnosis
Exclusion criteria
1. Periampullary tumours 2. Multiple hepatic metastases with significant blockage of one or more liver segments (if no segment blockage, metastasis is not an
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stent patency rate | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival | 3 years |
| Serious adverse events | 30 day |
| Unscheduled readmission rates | 1 year |
Countries
Hong Kong
Outcome results
None listed