Endoscopic Biliary Radiofrequency Ablation of Malignant Distal Common Bile Duct Strictures

NCT ID: NCT01721174

Last Updated: 2018-01-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2017-12-31

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.

Conditions

Pancreatic Cancer; Cholangiocarcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SEMS only

Endoscopic retrograde cholangiopancreatography (ERCP) would be performed under standard operating conditions to confirm the length of the biliary stricture, diameter, and position. An uncovered self expanding metallic stent (SEMS) would be inserted to bypass the site of narrowing (Niti-S biliary uncovered metallic stent; Taewoong Medical, Gimpo City, Korea)

Group Type: ACTIVE_COMPARATOR

SEMS only

Intervention Type: PROCEDURE

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

EBRFA and SEMS

Endoscopic retrograde cholangiopancreatography (ERCP) would be performed under standard operating conditions to confirm the length of the biliary stricture, diameter, and position. The radiofrequency ablation (EBRFA) catheter would be placed under fluoroscopic guidance across the biliary stricture. The Habib EndoHPB (EMcision UK, London, United Kingdom) radiofrequency ablation catheter with energy delivered by an RFA generator would be used to apply RFA to the entire length of the stricture, sequential applications would be applied to complete treatment throughout the length of the stricture without significant overlap of treated areas. Patients would undergo 2 sessions of EBRFA 2 weeks apart. A plastic stent would be inserted in between the 2 sessions. An uncovered SEMSs (Niti-S biliary uncovered metallic stent; Taewoong Medical, Gimpo City, Korea) would be placed after the second EBRFA.

Group Type: ACTIVE_COMPARATOR

EBRFA and SEMS

Intervention Type: PROCEDURE

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.

Interventions

SEMS only

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

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Anthony Teoh

Honorary Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Prince of Wales Hospital, Chinese University of Hong Kong

Hong Kong, , Hong Kong

Countries

Hong Kong

References

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.

Reference Type: BACKGROUND

PMID: 21184881 (View on PubMed)

Other Identifiers

CRE 2012.153

Identifier Type: -

Identifier Source: org_study_id