Malignant Hilar StrictureNCT01141088
Two Bilateral Metal Stenting in Hilar Malignancy
A study testing Bilateral stent-in-stent insertion and Bilateral side-by-side insertion in people with Malignant Hilar Stricture and Bilateral Stent Insertion, run by Soon Chun Hyang University at 2 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Hilar Stricture, Bilateral Stent Insertion
- What is being tested?
- Bilateral stent-in-stent insertion and Bilateral side-by-side insertion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 1 Apr 2016to 30 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient over 18 years old
- patient with malignant hilar obstruction
Who cannot join
- refuse to participate in this study
- refuse to provide informed consent
- Karnofsky score < 60%
- physically unfit for endoscopic procedure
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites, 2 recruiting
- Recruiting
Soon Chun Hyang University College of Medicine, Bucheon Hospital
Bucheon-si, 420-767
Jong Ho Moon, MD, PhD, +82-32-621-5083, jhmoon@schbc.ac.kr
- Recruiting
Soon Chun Hyang University College of Medicine, Cheonan Hospital
Cheonan, 330-721
Tae Hoon Lee, MD, +82-41-570-3662, thlee9@lycos.co.kr
About this study
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
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.
Read the 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).
- Being tested
- Bilateral stent-in-stent insertion, Bilateral side-by-side insertion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral stent-in-stent insertionProcedure or surgery
Also called SIS
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.
Bilateral side-by-side insertionProcedure or surgery
Also called SBS
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).
| Study group | Role | What they receive |
|---|---|---|
| Bilateral stent-in-stent insertion | Experimental | The passage of the bilateral metal stent across the stricture, stent-in-stent method. Receives: Procedure: Bilateral stent-in-stent insertion; Procedure: Bilateral side-by-side insertion |
| Bilateral side-by-side insertion | Active comparator | The passage of the bilateral metal stent across the stricture, side-by-side method. Receives: Procedure: Bilateral stent-in-stent insertion; Procedure: Bilateral side-by-side insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 24 hr
Secondary outcomes (4)
Early complications
Early complications such as pancreatitis, cholecystitis, cholangitis, jaundice, or external or internal stent migration within 30 days after stent insertion.
Measured: 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.
Measured: after 30 days following stent insertion
Median stent patency
Measured: up to 1 year, from stent insertion to the occlusion of the stent
Median survival
Measured: 1 year, from stent insertion to the death of the patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2010 (estimated)
- Study start1 Apr 2016
- Primary completion30 Mar 2018 (estimated)
- Study completion30 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant Hilar StrictureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soon Chun Hyang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tae Hoon Lee, Soon Chun Hyang University
- Investigators
- Jong Ho Moon, MD, PhD, Principal investigator, Soon Chun Hyang University College of Medicine, Bucheon Hospital, Bucheon, South Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01141088
- Sponsor's protocol ID
- SCH-2010-02
- Status last verified
- Dec 2017
- First submitted
- 8 Jun 2010
- Last updated
- 19 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 30905729
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01141088
- Acronym / sponsor ID
- SCH-2010-02
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Soon Chun Hyang UniversityUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 30 Mar 2018 (estimated)
- Study completion
- 30 Sep 2018 (estimated)
- First posted
- 10 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bilateral stent-in-stent insertion | Experimental | Procedure: Bilateral stent-in-stent insertion, Procedure: Bilateral side-by-side insertionThe passage of the bilateral metal stent across the stricture, stent-in-stent method. |
| Bilateral side-by-side insertion | Active comparator | Procedure: Bilateral stent-in-stent insertion, Procedure: Bilateral side-by-side insertionThe passage of the bilateral metal stent across the stricture, side-by-side method. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient over 18 years old
- patient with malignant hilar obstruction
Key exclusion criteria (4 listed)
- refuse to participate in this study
- refuse to provide informed consent
- Karnofsky score < 60%
- physically unfit for endoscopic procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bilateral stent-in-stent insertionAlso: SISFollowing 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. | Procedure or surgery | Bilateral side-by-side insertion, Bilateral stent-in-stent insertion |
| Bilateral side-by-side insertionAlso: SBSFollowing 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). | Procedure or surgery | Bilateral side-by-side insertion, Bilateral stent-in-stent insertion |
Primary outcome
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.
4 secondary outcomes
Early complications
Time frame: within 30 days after stent insertion
Late complications
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2017.
- Derived from this study: PubMed 30905729Lee 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.
- Individual participant dataSharing planned: No
Related trials for Malignant Hilar Stricture
Not yet recruiting
Supra-papillary Versus Trans-papillary Biliary Stenting in Malignant Peri-hilar Stenosis
Biliary Disease Tract, Biliary Stenosis
Enrolling by invitationPhase 3
Primary Percutaneous Stenting Above the Ampulla Versus Endoscopic Drainage for Unresectable Malignant Hilar Biliary Obstruction
Cholangiocarcinoma Non-resectable, Gall Bladder Cancer
Recruiting
ERCP With and Without EUS Guided HGS for Bilateral Biliary Decompression in Malignant Hilar Biliary Obstruction
Malignant Hilar Stricture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jong Ho Moon, MD, PhD principal investigator
Soon Chun Hyang University College of Medicine, Bucheon Hospital, Bucheon, South Korea
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral stent-in-stent insertion and Bilateral side-by-side insertion in people with Malignant Hilar Stricture and Bilateral Stent Insertion, run by Soon Chun Hyang University at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jong Ho Moon, MD, PhD (+82-32-621-5083, jhmoon@schbc.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success (time frame: within 24 hr). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01141088, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2017.