The Patency Period of the New Plastic Anti-reflux Biliary Stent

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Chinese University of Hong Kong.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01142921
First received: June 8, 2010
Last updated: February 8, 2011
Last verified: June 2010
  Purpose

The aim of this study is to determine the average patency period of the new anti-reflux biliary stent on patients with malignant bile duct strictures and to determine if this stent remains patent for a longer period of time comparing with the ordinary plastic Tannenbaum biliary stent.


Condition Intervention Phase
Pancreatitis
Cholangitis
Device: Anti-reflux Tannenbaum biliary stent
Device: Ordinary Tannenbaum biliary stent
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


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

Primary Outcome Measures:
  • time-to-occlusion or stent patency period in days [ Time Frame: within 25 weeks of device application ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bleeding associated with endoscopic retrograde cholangiopancreatography (ERCP) and stent placement [ Time Frame: within 25 weeks of device application ] [ Designated as safety issue: No ]
  • perforation associated with ERCP and stent placement [ Time Frame: within 25 weeks of device application ] [ Designated as safety issue: No ]
  • pancreatitis associated with ERCP and stent placement [ Time Frame: within 25 weeks of device application ] [ Designated as safety issue: No ]
  • cholangitis associated with ERCP and stent placement [ Time Frame: within 25 weeks of device application ] [ Designated as safety issue: No ]
  • stent migration associated with ERCP and stent placement [ Time Frame: within 25 weeks of device application ] [ Designated as safety issue: No ]
  • all cause mortality [ Time Frame: within 25 weeks of device application ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: November 2008
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ordinary Tannenbaum biliary stent
Ordinary Tannenbaum biliary stent
Device: Ordinary Tannenbaum biliary stent
Ordinary Tannenbaum biliary stent
Other Name: ST-2 Soehendra® Tannenbaum® Biliary Stent
Experimental: Anti-reflux Tannenbaum biliary stent
Anti-reflux Tannenbaum biliary stent
Device: Anti-reflux Tannenbaum biliary stent
Anti-reflux Tannenbaum biliary stent
Other Name: Fusion® Marathon™ Anti-Reflux Biliary Stent

Detailed Description:

Bile duct related cancer is a condition quite commonly seen among Asians. Predisposing conditions for primary bile duct cancer include recurrent infections and autoimmune diseases such as recurrent pyogenic cholangitis (RPC) and primary sclerosing cholangitis (PSC) as well as congenital problem such as choledochal cyst. Peri-ampullary tumour, pancreatic tumour and metastatic tumours with bile duct compression are other causes of bile duct obstruction. As many of these tumours are discovered at a late stage, curative treatment is usually not feasible. Palliative endoscopic stenting of the obstructed biliary system remains the treatment of choice for the majority.

The main problem with endoscopic stenting of the biliary system is the short stent patency period. There are some reports on modifications to plastic biliary stenting method in recent years including changes in stent designs, use of a different material or coating, administrating prophylactic antibiotics and the use of special drugs. All these have failed to show any conclusive effect on the stent patency period.

A preliminary study has demonstrated some promising results in the use of a stent with an anti-reflux property very similar to the stents the investigators are using in this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 years old
  • Patients who have cholangiographic evidence (on ERCP) consistent with a malignant extrahepatic biliary stricture (below bifurcation of the common hepatic duct) who require plastic stenting
  • Patients with peri-ampullary tumours, pancreatic tumours, gall bladder cancer and metastatic tumours with suspected extrinsic bile duct compression
  • Patients with stent or nasobiliary drain in-situ without previous sphincterotomy will qualify for the study if they satisfy the above inclusion criteria.

Exclusion Criteria:

  • Patients fit for surgery.
  • Patients who have dominant biliary strictures involving the hilum or more proximal biliary segments.
  • Previous sphincterotomy.
  • Other medical conditions that will result in a life expectancy of less then 3 months (ASA class >4)
  • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01142921

Contacts
Contact: Wai L Quan, Dr quanchan@live.com.sg
Contact: Kim W AU, MSc +85223622640 kimau@surgery.cuhk.edu.hk

Locations
China
Endoscopy Centre Recruiting
Hong Kong, China
Contact: Wai L Quan, Dr       quanchan@live.com.sg   
Contact: Kim W AU, MSc    +85226322640    kima@surgery.cuhk.edu.hk   
Sub-Investigator: Joseph J SUNG, MD         
Sub-Investigator: Francis K CHAN, MD         
Sub-Investigator: James Y LAU, MD         
Sub-Investigator: Derek LUO, Dr         
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Wai L Quan, Dr. Chinese University of Hong Kong
  More Information

No publications provided

Responsible Party: Dr. Wai Leong QUAN, The Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01142921     History of Changes
Other Study ID Numbers: ARBS
Study First Received: June 8, 2010
Last Updated: February 8, 2011
Health Authority: Hong Kong: Department of Health

Keywords provided by Chinese University of Hong Kong:
Stent Occlusion
Biliary Bleeding
Biliary Perforation

Additional relevant MeSH terms:
Cholangitis
Pancreatitis
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Pancreatic Diseases

ClinicalTrials.gov processed this record on October 22, 2014