Symptoms and General Pathology

All Conditions

Constriction, Pathologic

Pathological Conditions, Anatomical

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.

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deployment of the 1st stent across the hilar stricture, the remaining guide wire across the 1st stent was carefully withdrawn using an ERCP catheter without pulling it back completely.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 stent-in-stent insertion

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).

Bilateral side-by-side insertion

Jong Ho Moon, MD, PhD

Tae Hoon Lee, MD

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.

1. 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.
2. 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).

Two Bilateral Metal Stenting in Hilar Malignancy

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

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 such as pancreatitis, cholecystitis, cholangitis, jaundice, or external or internal stent migration within 30 days after stent insertion.

Late complications were defines as complications such as pancreatitis, cholecystitis, cholangitis, jaundice, or stent migration after 30 days following stent insertion.

Soon Chun Hyang University

MD, PhD

Neoplasms

Digestive System Diseases

Rare Diseases

Klatskin Tumor

Cholestasis

Bile Duct Diseases

Biliary Tract Diseases

Gastrointestinal Diseases

Cholangiocarcinoma

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Bile Duct Cancer

Self-expandable metallic stent will be inserted for the malignant hilar obstruction.

DoubleLayer plastic stent (Olympus) will be inserted for malignant hilar obstruction.

Self-expandable metallic stent will be inserted for malignant hilar obstruction.

SEMS insertion

DoubleLayer plastic stent will be inserted for malignant hilar obstruction.

DLS insertion

Do Hyun Park, MD

Jung Sik Choi, MD

Sang Woo Cha, MD

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 palliative endoscopic drainage the principal therapeutic option. However, the optimal endoscopic management strategy is contentious. Almost all of the published data comparing plastic and metallic stents relate to distal tumors (those of the pancreas, common bile duct and ampulla). Stent patency, complication rates, and cost-effectiveness have favored metallic stents when compared with plastic stents in patients with distal malignant obstruction expected to live at least 3 to 6 months.

There are few comparative study as to whether self-expanding metallic or plastic stent, especially DLS (double layer plastic stent) are preferable in the technical success, stent patency, and cost-effectiveness for palliating malignant hilar obstruction.

The study was designed to compare the the technical success, stent patency, and cost-effectiveness of self-expandable metal stent and DLS in patients with malignant hilar obstruction.

Uncovered Self-expandable Metal Stent Versus Double Layer Plastic Stent for Malignant Hilar Stricture

Uncovered Self-expandable Metal Stent Versus DoubleLayer Plastic Stent for Malignant Hilar Stricture: a Prospective Randomized Multicenter Trial

Interval time (d) from stent insertion to occlusion

Early or Late complications

* asymptomatic hyperamylasemia
* pancreatitis (mild/moderate/severe)
* cholecystitis
* cholangitis
* recurrent jaundice
* Internal migration
* external migration
* occlusion

Total Cost for SEMS and DLS group

* ERCP cost
* Total ERBD cost (DLS or metal)
* Total hospitalization cost
* Cost for session x No. of session
* Total (DLS vs. metal)cost /session

* Successful insertion of bilateral or unilateral stent insertion.
* Time to adequate expansion (70% of maximal expanded diameter was dilated state) in metal stent ≤ 24 hrs
* No stent migration within 24 hrs

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Two Bilateral Metal Stenting in Hilar Malignancy	NCT01141088	Malignant Hilar... Bilateral Stent...	Bilateral stent... Bilateral side-...	18 Years -	Soon Chun Hyang University
Uncovered Self-expandable Metal Stent Versus Double Layer Plastic Stent for Malignant Hilar Stricture	NCT01125865	Bile Duct Obstr... Klatskin's Tumo...	SEMS insertion DLS insertion	18 Years -	Soon Chun Hyang University

Spots Global Cancer Trial Database for malignant hilar stricture