Two Bilateral Metal Stenting in Hilar Malignancy

NCT01141088 | Unknown

• 1 other identifier: SCH-2010-02
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Malignant Hilar Stricture; Bilateral Stent Insertion

Outcome Measures

Primary Outcomes (1)

• 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.

  within 24 hr

Secondary Outcomes (4)

• Early complications

  within 30 days after stent insertion

• Late complications

  after 30 days following stent insertion

• Median stent patency

  up to 1 year, from stent insertion to the occlusion of the stent

• Median survival

  1 year, from stent insertion to the death of the patient

Study Arms (2)

Bilateral stent-in-stent insertion

EXPERIMENTAL

The passage of the bilateral metal stent across the stricture, stent-in-stent method.

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.

Procedure: Bilateral stent-in-stent insertion; Procedure: Bilateral side-by-side insertion

Interventions

Bilateral stent-in-stent insertion PROCEDURE

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.

Also known as: SIS

Bilateral side-by-side insertion; Bilateral stent-in-stent insertion

Bilateral side-by-side insertion PROCEDURE

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).

Also known as: SBS

Bilateral side-by-side insertion; Bilateral stent-in-stent insertion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Soon Chun Hyang University: lead

Study Sites (2)

Soon Chun Hyang University College of Medicine, Bucheon Hospital

Bucheon-si, 420-767, South Korea

RECRUITING

Soon Chun Hyang University College of Medicine, Cheonan Hospital

Cheonan, 330-721, South Korea

RECRUITING

Related Publications (1)

• 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.

  PMID: 30905729 DERIVED

Study Officials

• Jong Ho Moon, MD, PhD

  Soon Chun Hyang University College of Medicine, Bucheon Hospital, Bucheon, South Korea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jong Ho Moon, MD, PhD

CONTACT

+82-32-621-5083; jhmoon@schbc.ac.kr

Tae Hoon Lee, MD

CONTACT

+82-41-570-3662; thlee9@lycos.co.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 8, 2010
• First Posted: June 10, 2010
• Study Start: April 1, 2016
• Primary Completion: March 30, 2018
• Study Completion: September 30, 2018
• Last Updated: December 19, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)