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
Recruitment status was Recruiting
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.
Malignant Hilar Stricture
Bilateral Stent Insertion
Device: Bona M-Hilar stent
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
- 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.
- 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 ]
|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)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01141088
|Contact: Jong Ho Moon, MD, PhDfirstname.lastname@example.org|
|Contact: Tae Hoon Lee, MDemail@example.com|
|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 firstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator:||Jong Ho Moon, MD, PhD||Soon Chun Hyang University College of Medicine, Bucheon Hospital, Bucheon, South Korea|