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

T

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

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

Trial contacts and locations

13

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Data sourced from clinicaltrials.gov

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