Clinical trial NCT01721174: Endoscopic Biliary Radiofrequency Ablation of Malignant Distal Common Bile Duct Strictures
Official title: A Randomized Controlled Trial of Endoscopic Biliary Radiofrequency Ablation of Malignant Distal Common Bile Duct Strictures.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pancreatic Cancer
Cholangiocarcinoma
Keywords: Pancreatic cancer
Cholangiocarcinoma
Endoscopic radiofrequency ablation
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2012-11-04
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 exclusion criteria)
3. Presence of main portal vein thrombosis
4. Prior SEMS placement
5. Prior Billroth II or roux-en Y reconstruction
6. History of bleeding disorder or use of anticoagulation
7. Child's B/C cirrhosis
8. Pregnancy
9. Performance status ECOG ≥3 (confined to bed / chair \> 50% waking hours)
10. Presence of other malignancy
11. Presence of gastric outlet obstruction
12. Life expectancy \< 3months

Primary outcomes:
measure: Stent patency rate
timeFrame: 6 months
Secondary outcomes:
measure: Overall survival
timeFrame: 3 years
measure: Serious adverse events
timeFrame: 30 day
measure: Unscheduled readmission rates
timeFrame: 1 year
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital, Chinese University of Hong Kong
Study officials:
References:
citation: Steel AW, Postgate AJ, Khorsandi S, Nicholls J, Jiao L, Vlavianos P, Habib N, Westaby D. Endoscopically applied radiofrequency ablation appears to be safe in the treatment of malignant biliary obstruction. Gastrointest Endosc. 2011 Jan;73(1):149-53. doi: 10.1016/j.gie.2010.09.031.