Two Bilateral Metal Stenting in Hilar Malignancy
Primary Purpose
Malignant Hilar Stricture, Bilateral Stent Insertion
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Bilateral stent-in-stent insertion
Bilateral side-by-side insertion
Sponsored by
About this trial
This is an interventional treatment trial for Malignant Hilar Stricture
Eligibility 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
Sites / Locations
- Soon Chun Hyang University College of Medicine, Bucheon HospitalRecruiting
- Soon Chun Hyang University College of Medicine, Cheonan HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Bilateral stent-in-stent insertion
Bilateral side-by-side insertion
Arm Description
The passage of the bilateral metal stent across the stricture, stent-in-stent method.
The passage of the bilateral metal stent across the stricture, side-by-side method.
Outcomes
Primary Outcome Measures
Technical success
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
Early complications such as pancreatitis, cholecystitis, cholangitis, jaundice, or external or internal stent migration within 30 days after stent insertion.
Late complications
Late complications were defines as complications such as pancreatitis, cholecystitis, cholangitis, jaundice, or stent migration after 30 days following stent insertion.
Median stent patency
Median survival
Full Information
NCT ID
NCT01141088
First Posted
June 8, 2010
Last Updated
December 15, 2017
Sponsor
Soon Chun Hyang University
1. Study Identification
Unique Protocol Identification Number
NCT01141088
Brief Title
Two Bilateral Metal Stenting in Hilar Malignancy
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2016 (Actual)
Primary Completion Date
March 30, 2018 (Anticipated)
Study Completion Date
September 30, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Soon Chun Hyang University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Hilar Stricture, Bilateral Stent Insertion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bilateral stent-in-stent insertion
Arm Type
Experimental
Arm Description
The passage of the bilateral metal stent across the stricture, stent-in-stent method.
Arm Title
Bilateral side-by-side insertion
Arm Type
Active Comparator
Arm Description
The passage of the bilateral metal stent across the stricture, side-by-side method.
Intervention Type
Procedure
Intervention Name(s)
Bilateral stent-in-stent insertion
Other Intervention Name(s)
SIS
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Bilateral side-by-side insertion
Other Intervention Name(s)
SBS
Intervention Description
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).
Primary Outcome Measure Information:
Title
Technical success
Description
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.
Time Frame
within 24 hr
Secondary Outcome Measure Information:
Title
Early complications
Description
Early complications such as pancreatitis, cholecystitis, cholangitis, jaundice, or external or internal stent migration within 30 days after stent insertion.
Time Frame
within 30 days after stent insertion
Title
Late complications
Description
Late complications were defines as complications such as pancreatitis, cholecystitis, cholangitis, jaundice, or stent migration after 30 days following stent insertion.
Time Frame
after 30 days following stent insertion
Title
Median stent patency
Time Frame
up to 1 year, from stent insertion to the occlusion of the stent
Title
Median survival
Time Frame
1 year, from stent insertion to the death of the patient
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jong Ho Moon, MD, PhD
Phone
+82-32-621-5083
Email
jhmoon@schbc.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Tae Hoon Lee, MD
Phone
+82-41-570-3662
Email
thlee9@lycos.co.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jong Ho Moon, MD, PhD
Organizational Affiliation
Soon Chun Hyang University College of Medicine, Bucheon Hospital, Bucheon, South Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Soon Chun Hyang University College of Medicine, Bucheon Hospital
City
Bucheon
ZIP/Postal Code
420-767
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jong Ho Moon, MD, PhD
Phone
+82-32-621-5083
Email
jhmoon@schbc.ac.kr
Facility Name
Soon Chun Hyang University College of Medicine, Cheonan Hospital
City
Cheonan
ZIP/Postal Code
330-721
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tae Hoon Lee, MD
Phone
+82-41-570-3662
Email
thlee9@lycos.co.kr
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30905729
Citation
Lee TH, Moon JH, Choi JH, Lee SH, Lee YN, Paik WH, Jang DK, Cho BW, Yang JK, Hwangbo Y, Park SH. Prospective comparison of endoscopic bilateral stent-in-stent versus stent-by-stent deployment for inoperable advanced malignant hilar biliary stricture. Gastrointest Endosc. 2019 Aug;90(2):222-230. doi: 10.1016/j.gie.2019.03.011. Epub 2019 Mar 21.
Results Reference
derived
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Two Bilateral Metal Stenting in Hilar Malignancy
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