Endoscopic Biliary Radiofrequency Ablation of Malignant Distal Common Bile Duct Strictures

Pancreatic Cancer Clinical Trial

Official title:

A Randomized Controlled Trial of Endoscopic Biliary Radiofrequency Ablation of Malignant Distal Common Bile Duct Strictures.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01721174
• Other study ID #: CRE 2012.153
• Status: Terminated
• Phase: N/A
• First received: October 31, 2012
• Last updated: January 24, 2018
• Start date: November 2012
• Est. completion date: December 2017

Study information

• Verified date: January 2018
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 42
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Procedure:
• SEMS only
The SEMS (Niti-S biliary uncovered metallic stent; Taewoong Medical, Korea) would be placed.
• EBRFA 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.

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital, Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stent patency rate		6 months
Secondary	Overall survival		3 years
Secondary	Serious adverse events		30 day
Secondary	Unscheduled readmission rates		1 year