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Two Bilateral Metal Stenting in Hilar Malignancy

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2017 by Soon Chun Hyang University
Sponsor:
Information provided by (Responsible Party):
Tae Hoon Lee, Soon Chun Hyang University
ClinicalTrials.gov Identifier:
NCT01141088
First received: June 8, 2010
Last updated: February 27, 2017
Last verified: February 2017
  Purpose
The overall median survival of nonresectable malignant hilar obstruction in most series has been less than 6 months. Most patients with malignant hilar obstruction present with advanced disease, making allative endoscopic drainage the principal therapeutic option. However, the optimal endoscopic management strategy is contentious. In malignant hilar obstruction, exclusively endoscopic placement of bilateral metal stents has been considered very difficult and complex, and it may require multiple procedures, with an increased risk of complications and mortality. To overcome this difficulty and strategize plan of management, the investigators evaluated the technical and clinical efficacy of endoscopic bilateral placement of newly designed stents, Y-configuration, followed by side-by-side insertion in failure of stent-in-stent method for the management of malignant hilar obstruction.

Condition Intervention Phase
Malignant Hilar Stricture
Bilateral Stent Insertion
Procedure: Bilateral stent-in-stent insertion
Procedure: Bilateral side-by-side insertion
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Official Title: Clinical Outcomes of Endoscopic Bilateral Stent-in-stent Placement Versus Side-by-side Method With Newly Designed Metallic Stent for Malignant Hilar Biliary

Further study details as provided by Soon Chun Hyang University:

Primary Outcome Measures:
  • Technical success [ Time Frame: within 24 hr ]

    Passage of the double stent across the stricture,along with flow of contrast medium and/or bile through the stent.

    Adequate expansion: 70% of maximal expanded diameter was dilated within 24 hr.



Secondary Outcome Measures:
  • Early complications [ Time Frame: within 30 days after stent insertion ]
    Early complications such as pancreatitis, cholecystitis, cholangitis, jaundice, or external or internal stent migration within 30 days after stent insertion.

  • Late complications [ Time Frame: after 30 days following stent insertion ]
    Late complications were defines as complications such as pancreatitis, cholecystitis, cholangitis, jaundice, or stent migration after 30 days following stent insertion.

  • Median stent patency [ Time Frame: up to 1 year, from stent insertion to the occlusion of the stent ]
  • Median survival [ Time Frame: 1 year, from stent insertion to the death of the patient ]

Estimated Enrollment: 80
Actual Study Start Date: April 1, 2016
Estimated Study Completion Date: December 31, 2017
Estimated Primary Completion Date: November 30, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bilateral stent-in-stent insertion
The passage of the bilateral metal stent across the stricture, stent-in-stent method.
Procedure: Bilateral stent-in-stent insertion
Following negotiation of both IHD by two guidewires, inserted 1st stent to left IHD side. After deployment of the 1st stent across the hilar stricture, the remaining guide wire across the 1st stent was carefully withdrawn using an ERCP catheter without pulling it back completely. Then that guidewie was inserted under fluoroscopic guidance into the undrained right IHD through the central portion of the 1st stent. The 2nd cross-wired stent was then introduced over a guidewire through the central open mesh and then was deployed into the right IHD, so that the central portion of the 2nd stent overlapped the central portion of the 1st stent, forming a Y-shape.
Other Name: SIS
Procedure: Bilateral side-by-side insertion
Following the introduction of two guidewires, the first stent was pushed and deployed into the left hepatic duct as possible, and then subsequently the second stent was pushed and deployed into the right hepatic duct, using the same method. In tight stricture during a guidewire manipulation, pneumatic biliary balloon dilation prior to insertion of first stent was performed. All stents were positioned above the level of the papilla, with their distal ends at the same level as possible. The diameter of the stent used in each case (8 or 10 mm) depended on the maximum diameter of the common bile duct (CBD).
Other Name: SBS
Active Comparator: Bilateral side-by-side insertion
The passage of the bilateral metal stent across the stricture, side-by-side method.
Procedure: Bilateral stent-in-stent insertion
Following negotiation of both IHD by two guidewires, inserted 1st stent to left IHD side. After deployment of the 1st stent across the hilar stricture, the remaining guide wire across the 1st stent was carefully withdrawn using an ERCP catheter without pulling it back completely. Then that guidewie was inserted under fluoroscopic guidance into the undrained right IHD through the central portion of the 1st stent. The 2nd cross-wired stent was then introduced over a guidewire through the central open mesh and then was deployed into the right IHD, so that the central portion of the 2nd stent overlapped the central portion of the 1st stent, forming a Y-shape.
Other Name: SIS
Procedure: Bilateral side-by-side insertion
Following the introduction of two guidewires, the first stent was pushed and deployed into the left hepatic duct as possible, and then subsequently the second stent was pushed and deployed into the right hepatic duct, using the same method. In tight stricture during a guidewire manipulation, pneumatic biliary balloon dilation prior to insertion of first stent was performed. All stents were positioned above the level of the papilla, with their distal ends at the same level as possible. The diameter of the stent used in each case (8 or 10 mm) depended on the maximum diameter of the common bile duct (CBD).
Other Name: SBS

Detailed Description:
  1. Stent-in-stent (SIS) placement Following negotiation of both intrahepatic bile ducts (IHD) by two guidewires, inserted 1st stent to left IHD side. The central portion of the 1st stent was crossed over the right-side guide wire to access the contralateral ductal system across the central cross-wired portion using the right-side guide wire as a target. After deployment of the 1st stent across the hilar stricture, the remaining guide wire across the 1st stent was carefully withdrawn using an ERCP catheter without pulling it back completely. Then that guidewie was inserted under fluoroscopic guidance into the undrained right IHD through the central portion of the 1st stent. The 2nd cross-wired stent was then introduced over a guidewire through the central open mesh and then was deployed into the right IHD, so that the central portion of the 2nd stent overlapped the central portion of the 1st stent, forming a Y-shape. If selective insertion of a guide wire into the left IHD was difficult at first, the guidewire and the 1st stent were inserted into the right IHD first and then attempts were made to insert the guide wire and a stent into the left IHD. If contralateral guide wire cannulation failed after the 1st stent placement, the stricture was dilated up to 4 or 6 mm using a balloon catheter (Hurricane biliary balloon dilatation catheter; Boston Scientific) over the guide wire. Alternatively, a second intervention for contralateral stent placement was allowed 2-3 days after expansion of the 1st endoscopic stent.
  2. Side-by-side (SBS) placement Bilateral SBS stent placement was performed as follows. The stricture was first negotiated by inserting a guidewire into both IHD using the same method. Following the introduction of these two guidewires, the first stent was pushed and deployed into the left hepatic duct as possible, and then subsequently the second stent was pushed and deployed into the right hepatic duct, using the same method. During the deployment of the first stent, the second stent was preloaded on a guidewire to facilitate the bilateral SBS stent placement. Endoscopic dilatation of stricture before deployment of stents has not been routinely performed in primary procedures. In tight stricture during a guidewire manipulation, pneumatic biliary balloon dilation prior to insertion of first stent was performed. All stents were positioned above the level of the papilla, with their distal ends at the same level as possible. The diameter of the stent used in each case (8 or 10 mm) depended on the maximum diameter of the common bile duct (CBD).
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient over 18 years old
  • patient with malignant hilar obstruction

Exclusion Criteria:

  • refuse to participate in this study
  • refuse to provide informed consent
  • Karnofsky score < 60%
  • physically unfit for endoscopic procedure
  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: NCT01141088

Contacts
Contact: Jong Ho Moon, MD, PhD +82-32-621-5083 jhmoon@schbc.ac.kr
Contact: Tae Hoon Lee, MD +82-41-570-3662 thlee9@lycos.co.kr

Locations
Korea, Republic of
Soon Chun Hyang University College of Medicine, Bucheon Hospital Recruiting
Bucheon, Korea, Republic of, 420-767
Contact: Jong Ho Moon, MD, PhD    +82-32-621-5083    jhmoon@schbc.ac.kr   
Soon Chun Hyang University College of Medicine, Cheonan Hospital Recruiting
Cheonan, Korea, Republic of, 330-721
Contact: Tae Hoon Lee, MD    +82-41-570-3662    thlee9@lycos.co.kr   
Sponsors and Collaborators
Soon Chun Hyang University
Investigators
Principal Investigator: Jong Ho Moon, MD, PhD Soon Chun Hyang University College of Medicine, Bucheon Hospital, Bucheon, South Korea
  More Information

Responsible Party: Tae Hoon Lee, MD, PhD, Soon Chun Hyang University
ClinicalTrials.gov Identifier: NCT01141088     History of Changes
Other Study ID Numbers: SCH-2010-02
Study First Received: June 8, 2010
Last Updated: February 27, 2017
Individual Participant Data  
Plan to Share IPD: No

ClinicalTrials.gov processed this record on March 23, 2017