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IRS(Irradiation Stent) vs. CS(Conventional Stent) Insertion in Inoperable Malignant Biliary Obstruction (IRCSMBO)

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ClinicalTrials.gov Identifier: NCT02001779
Recruitment Status : Completed
First Posted : December 5, 2013
Last Update Posted : February 14, 2017
Sponsor:
Information provided by (Responsible Party):
Gao-jun Teng, Zhongda Hospital

Brief Summary:
Stenting the malignant biliary obstruction is considered to be the preferred palliation modality to relieve pruritus,cholangitis,pain and jaundice in patients without surgical indications of malignant biliary obstruction.An unicentral clinical trial has demonstrated the safety and technical feasibility of an irradiation biliary stent insertion in patients with biliary obstruction caused by adenocarcinomas, such a treatment seems have benefits in relieving jaundice and extending survival when compared to a conventional biliary stent.However,the small sample size,the population distribution of two groups will influence the final results in obtaining a powerful statistical conclusion.Therefore,a multicentric study was designed to prospectively compared the responses to the treatment with this irradiation biliary stent versus the conventional biliary self-expandable stent in patients with inoperable malignant biliary obstruction.

Condition or disease Intervention/treatment Phase
Malignant Biliary Obstruction Device: Biliary SEMS loaded with 125I seeds Device: Conventional biliary SEMS Not Applicable

Detailed Description:
Malignant biliary obstruction is a common condition caused by various carcinomas.The clinical process is usually silent and insidious,only 10-20% patients can be surgically removed once obstructive jaundice occurred.The long-term survival rate after resection remain dismal.Relief of obstructive jaundice plays major role on prognosis in patients without surgical indications.For unresectable patients,stenting the biliary obstruction is considered to be the preferred palliation modality to relieve pruritus,cholangitis,pain and jaundice.Although a number of new techniques for treatment of malignant biliary obstruction have been developed,there have been no significant differences in survival or quality of life comparing surgery bypass versus plastic stent insertion,metal stent insertion versus plastic stents insertion,or covered stent versus uncovered stents insertion in such patients.Our previous unicentric clinical trial has demonstrated the safety and technical feasibility of a biliary intraluminal irradiation stent insertion in patients with biliary obstruction caused by adenocarcinomas, such a treatment seems have benefits in relieving jaundice and extending survival when compared to a conventional biliary stent.However,the small sample size,the population distribution of two groups will influence the final results in obtaining a powerful statistical conclusion in the overall survival and stent patency between two groups.Therefore,a multicentric study was designed to prospectively compared the responses to the treatment with this irradiation biliary stent versus the conventional biliary self-expandable stent in patients with inoperable malignant biliary obstruction.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 328 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of Stent Insertion Combined With or Without Brachytherapy in Patients With Inoperable Malignant Biliary Obstruction
Actual Study Start Date : October 2013
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Arm Intervention/treatment
Experimental: Biliary SEMS loaded with 125I seeds
A self-expandable metallic biliary stent loaded with 125 iodine seeds is inserted in patients with inoperable malignant biliary obstruction.
Device: Biliary SEMS loaded with 125I seeds
A self-expandable metallic biliary stent loaded with 125 iodine seeds is inserted in patients with inoperable malignant biliary obstruction.

Active Comparator: Conventional biliary SEMS
A self-expandable metallic biliary stent is inserted in patients with inoperable malignant biliary obstruction.
Device: Conventional biliary SEMS
A self-expandable metallic stent is inserted in patients with inoperable malignant biliary obstruction.




Primary Outcome Measures :
  1. Patency [ Time Frame: Participants will be followed till die or lost to follow-up,an expected average of a year. ]
    Time from stenting to the day when stricture/obstruction of the stent occured or restricture/reobstruction after recanalization the obstructed stent.


Secondary Outcome Measures :
  1. Over survival [ Time Frame: Participants will be followed till die or lost to follow-up,an expected average of a year. ]
    Time from stenting to the day when the patients died or lost to the follow-up.

  2. Clinical success [ Time Frame: Participants will be followed till die or lost to follow-up,an expected average of a year. ]
    The rate of relief of the symptoms and signs of the patients.

  3. Safety [ Time Frame: Participants will be followed till die or lost to follow-up,an expected average of a year. ]
    Including technique success rate,side effect/complication,radioactive safety.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical,histological or pathological diagnosis of malignant biliary obstruction
  • Unresectability or refusal to be surgically treated
  • The Eastern Cooperative Oncology Group(ECOG) scores from 0 to 3
  • With symptoms such as jaundice related to biliary obstruction
  • Willing and able to comply with the study procedures and provide written informed consent to participate in the study
  • Biliary obstruction of Bismuthe-Corlette,type I and II

Exclusion Criteria:

  • Benign biliary obstruction
  • The Eastern Cooperative Oncology Group(ECOG) score of 4
  • Biliary tract stricture that could not be dilated enough to pass the delivery system
  • Presence of metallic biliary stent or bile duct surgery
  • Percutaneous transhepatic cholangiography(PTC) procedure was contraindicated
  • Active hepatitis
  • Biliary obstruction of Bismuthe-Corlette,type Ⅲ and Ⅳ
  • Uncooperative or could not provide authorization and signature

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02001779


Locations
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China, Jiangsu
Zhongda Hospital,Southeast University
Nanjing, Jiangsu, China, 210009
Sponsors and Collaborators
Zhongda Hospital
Investigators
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Principal Investigator: Gao-jun Teng, Ph.D,MD Zhongda Hospital Southeast University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gao-jun Teng, Professor of Radiology & Chair,Department of Radiology, Zhongda Hospital
ClinicalTrials.gov Identifier: NCT02001779    
Other Study ID Numbers: IR-C-STENT-MBO-83272121
First Posted: December 5, 2013    Key Record Dates
Last Update Posted: February 14, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Gao-jun Teng, Zhongda Hospital:
Malignant biliary obstruction
Obstruction/stricture
Stent
Brachytherapy
Bile duct