Comparing Covered Self-expandable Metallic Stent (SEMS) Above/Across the Sphincter of Oddi
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ClinicalTrials.gov Identifier: NCT01041612 |
Recruitment Status
:
Completed
First Posted
: January 1, 2010
Last Update Posted
: October 21, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cancer of Bile Duct Pancreatic Cancer | Device: PTFE Covered ComVi [full covered] Biliary Stent | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Supportive Care |
Official Title: | Prospective Randomized Trial Comparing Covered Metal Stents Placed Above and Across the Sphincter of Oddi in Malignant Biliary Obstruction: A Multi-nation, Multi-center Study |
Study Start Date : | January 2010 |
Actual Primary Completion Date : | September 2012 |
Actual Study Completion Date : | September 2012 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Group A: C-SEMS, inserted above SO
-In group A, SO should be preserved without sphincterotomy, but small infundibulotomy with needle knife can be accepted for cannulation.
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Device: PTFE Covered ComVi [full covered] Biliary Stent
The stent is made of Nitinol wire. It is a flexible, fine mesh tubular prosthesis and it has 10 radiopaque markers; 4 in each end and 2 in the center.
Other Name: PTFE Covered ComVi [full covered] Biliary Stent, Taewoong Medical, Korea
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Active Comparator: Group B: C-SEMS, inserted across SO
-In group B, small sphincterotomy (50% incision) will be done after biliary cannulation.
|
Device: PTFE Covered ComVi [full covered] Biliary Stent
The stent is made of Nitinol wire. It is a flexible, fine mesh tubular prosthesis and it has 10 radiopaque markers; 4 in each end and 2 in the center.
Other Name: PTFE Covered ComVi [full covered] Biliary Stent, Taewoong Medical, Korea
|
- Obstruction of 1st C-SEMS or presence of jaundice at death without stent exchange [ Time Frame: one year ]
- Death of patients [ Time Frame: one year ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01041612
Japan | |
Gifu University | |
Gifu, Japan | |
Onomichi General Hospital | |
Onomichi, Japan | |
Teine-Keijinkai Hospital | |
Sapporo, Japan | |
The University of Tokyo | |
Tokyo, Japan | |
Toho University | |
Tokyo, Japan | |
Tokyo Medical University | |
Tokyo, Japan | |
Yamaguchi University | |
Ube, Japan | |
Korea, Republic of | |
Soon Chun Hyang University School of Medicine | |
Bucheon, Korea, Republic of | |
Soon Chun Hyang University School of Medicine | |
Cheonan, Korea, Republic of | |
Catholic University of Daegu School of Medicine | |
Daegu, Korea, Republic of | |
Inha University School of Medicine | |
Incheon, Korea, Republic of | |
Gangnam Severance Hospital | |
Seoul, Korea, Republic of, 135-720 | |
Ajou University School of Medicine | |
Suwon, Korea, Republic of |
Principal Investigator: | Dong Ki Lee, PH.D | Gangnam Severance Hospital |
Publications of Results:
Responsible Party: | Jong Taek, Lee, General manager, Taewoong Medical Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT01041612 History of Changes |
Other Study ID Numbers: |
RaMM-BO 2.0 |
First Posted: | January 1, 2010 Key Record Dates |
Last Update Posted: | October 21, 2016 |
Last Verified: | October 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Keywords provided by Jong Taek, Lee, Taewoong Medical Co., Ltd.:
CBD HBD cancer of bile duct pancreatic cancer |
Additional relevant MeSH terms:
Pancreatic Neoplasms Bile Duct Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms |
Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Biliary Tract Neoplasms Bile Duct Diseases Biliary Tract Diseases |