Clinical trial · Interventional
Comparing Covered Self-expandable Metallic Stent (SEMS) Above/Across the Sphincter of Oddi
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
NCT01041612CI-TRIAL-00024380completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of Bile Duct | Malignant Bile Duct Neoplasm | ALIAS | 0.90 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PTFE Covered ComVi [full covered] Biliary Stent | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Group A: C-SEMS, inserted above SO
- description
- -In group A, SO should be preserved without sphincterotomy, but small infundibulotomy with needle knife can be accepted for cannulation.
- interventionNames
- Device: PTFE Covered ComVi [full covered] Biliary Stent
- type
- ACTIVE_COMPARATOR
- label
- Group B: C-SEMS, inserted across SO
- description
- -In group B, small sphincterotomy (50% incision) will be done after biliary cannulation.
- interventionNames
- Device: PTFE Covered ComVi [full covered] Biliary Stent
Primary outcomes (1)
- measure
- Obstruction of 1st C-SEMS or presence of jaundice at death without stent exchange
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTJung Nam Cho, Jimin Han, Ho Gak Kim, IM Hee Shin, Sang Heum Park, Jong Ho Moon, Jin Hong Kim, Don Haeng Lee, Iruru Maetani, Hiroyuki Maguchi, Keiji Hanada, Ichiro Yasuda, Takao Itoi, Hiroyuki Isayama, Dongki Lee. Prospective Randomized Trial Comparing Covered Metal Stent Placed Above and Across the Sphincter of Oddi in Malignant Biliary Obstruction. Gastrointestinal Endoscopy 77(58): AB139-AB140, 2013