Clinical Outcomes of Endoscopic Bilateral Stent-in-stent Placement Followed by Side-by-side Method With Newly Designed Metallic Stent for Malignant Hilar Biliary Strictures

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Soon Chun Hyang University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Soon Chun Hyang University
ClinicalTrials.gov Identifier:
NCT01141088
First received: June 8, 2010
Last updated: March 9, 2011
Last verified: June 2010
  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
Device: Bona M-Hilar stent
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Soon Chun Hyang University:

Primary Outcome Measures:
  • Technical success of stent-in-stent method [ Time Frame: within 24 hr ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Median survival [ Time Frame: 1 year, from stent insertion to the death of the patient ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: June 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bilateral stent insertion
The passage of the bilateral metal stent across the stricture, stent-in-stent method
Device: Bona M-Hilar stent
After deployment of the first stent across the hilar stricture, the guidewire left across the primary stent was carefully withdrawn with an ERCP catheter, without pulling the guidewire back completely, and then was inserted, under fluoroscopic guidance, into the undrained contralateral hepatic duct through the central crossed mesh of the primary stent. Another uncovered metal stent was then introduced over the guidewire through the central crossed mesh and was deployed into the right hepatic duct.
Other Name: Bona M-hialr stent

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

No publications provided

Responsible Party: Tae Hoon Lee, Soon Chun Hyang University, Cheonan Hospital
ClinicalTrials.gov Identifier: NCT01141088     History of Changes
Other Study ID Numbers: SCH-2010-02
Study First Received: June 8, 2010
Last Updated: March 9, 2011
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Constriction, Pathologic
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 02, 2014