Comparing Covered Self-expandable Metallic Stent (SEMS) Above/Across the Sphincter of Oddi

Taewoong Medical

Status and phase: Completed; Phase 4

Conditions: Cancer of Bile Duct; Pancreatic Cancer

Treatments: Device: PTFE Covered ComVi [full covered] Biliary Stent

Study type: Interventional

Funder types: Industry

Identifiers

NCT01041612

RaMM-BO 2.0

Details and patient eligibility

About

The purpose of this prospective, randomized multicenter study is to determine whether there is any difference in stent patency of covered metallic stents in terms of stent positioning, above and across the sphincter of Oddi, in malignant bile duct obstruction.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Inoperable and/or unresectable cases of malignant stenosis at distal common hepatic duct or CBD, >= 18 years old
• Bile duct or gallbladder cancer invading CBD or distal CHD
• Pancreatic cancer with mid or distal CBD invasion
• Cancer should be 1.5 cm apart from bifurcation and 2 cm apart from ampulla of Vater.
• First attempt of endoscopic biliary metallic stenting
• Negative history of biliary tract surgery
• Life expectancy at least longer than 4 months (Karnofsky score >60%)

Exclusion criteria

• Ampullary cancer
• Klatskin tumor
• Combined intrahepatic bile duct cancer
• Patient with hemobilia
• Previous history of biliary drainage (endoscopic, percutaneous, surgical) except plastic stent or endoscopic nasobiliary drainage smaller than 7 Fr within 14 days

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Group A: C-SEMS, inserted above SO

Active Comparator group

Description:

-In group A, SO should be preserved without sphincterotomy, but small infundibulotomy with needle knife can be accepted for cannulation.

Treatment:

Device: PTFE Covered ComVi [full covered] Biliary Stent

Device: PTFE Covered ComVi [full covered] Biliary Stent

Group B: C-SEMS, inserted across SO

Active Comparator group

Description:

-In group B, small sphincterotomy (50% incision) will be done after biliary cannulation.

Treatment:

Device: PTFE Covered ComVi [full covered] Biliary Stent

Device: PTFE Covered ComVi [full covered] Biliary Stent