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Endoscopic Biliary Radiofrequency Ablation of Malignant Distal Common Bile Duct Strictures

This study is currently recruiting participants.
Verified November 2012 by Chinese University of Hong Kong
Sponsor:
Information provided by (Responsible Party):
Anthony Teoh, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01721174
First received: October 31, 2012
Last updated: November 6, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
Cholangiocarcinoma
 Procedure: SEMS only
Procedure: EBRFA and SEMS
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Endoscopic Biliary Radiofrequency Ablation of Malignant Distal Common Bile Duct Strictures.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Stent patency rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Serious adverse events [ Time Frame: 30 day ] [ Designated as safety issue: Yes ]
  • Unscheduled readmission rates [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 116
Study Start Date: November 2012
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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)
 Procedure: SEMS only
The SEMS (Niti-S biliary uncovered metallic stent; Taewoong Medical, Korea) would be placed.
Active Comparator: 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.
 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01721174

Contacts
Contact: Anthony Y Teoh, FRCSEd(Gen) 852-26326293 anthonyteoh@surgery.cuhk.edu.hk

Locations
Hong Kong
Prince of Wales Hospital, Chinese University of Hong Kong Recruiting
Hong Kong, Hong Kong
Contact: Anthony YB Teoh, FRCSEd(Gen)     85291661837     anthonyteoh@surgery.cuhk.edu.hk    
Principal Investigator: Anthony YB Teoh, FRCSEd(Gen)            
Sponsors and Collaborators
Chinese University of Hong Kong
  More Information

Publications:

Responsible Party: Anthony Teoh, Honorary Assistant Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01721174     History of Changes
Other Study ID Numbers: CRE 2012.153
Study First Received: October 31, 2012
Last Updated: November 6, 2012
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Keywords provided by Chinese University of Hong Kong:
Pancreatic cancer
Cholangiocarcinoma
Endoscopic radiofrequency ablation

Additional relevant MeSH terms:
Pancreatic Neoplasms
Cholangiocarcinoma
Cholestasis
Constriction, Pathologic
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
 Pancreatic Diseases
Endocrine System Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Bile Duct Diseases
Biliary Tract Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 19, 2013