Clinical trial · Interventional
Biliary Metal Stent Study: Metal Stents for Management of Distal Malignant Biliary Obstruction
Covered Versus Uncovered Metal Stents for Management of Distal Malignant Biliary Obstruction? Results of a Randomized Prospective Study.
NCT00280709CI-TRIAL-00005344completedPhase 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 primary purpose is to compare patency of two different types of biliary metal stents, i.e. covered versus uncovered Nitinella metal stent. Secondary purposes are to determine frequency of complications in the two groups, e.g. cholecystitis, pancreatitis, and cholangitis.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bile Duct Cancer | Malignant Bile Duct Neoplasm | CURATED_BROADER | 0.80 |
| Bile Duct Obstruction | — | UNRESOLVED | — |
| Gallbladder Cancer | Malignant Gallbladder Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| "Nitinella" ; SX-ELLA Stent Biliary (biliary metal stent) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- Covered metal stent
- interventionNames
- Device: "Nitinella" ; SX-ELLA Stent Biliary (biliary metal stent)
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- Uncovered metal stent
- interventionNames
- Device: "Nitinella" ; SX-ELLA Stent Biliary (biliary metal stent)
Primary outcomes (1)
- measure
- Clinical follow-up every month, starting one month after stent insertion. Clinical and/or laboratory signs of stent dysfunction?
- timeFrame
- 12 months after stent insertion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * 20 years of age or older * oral and written information given and informed consent obtained * clinical data in accordance with malignant bile duct obstruction * ultrasonography signs of extrahepatic malignant common bile duct obstruction * typical radiological findings at ERCP of malignant common bile duct stenosis * proximal margin of the bile duct stenosis at least 2 cm from the hepatic confluence * bilirubin \> 50 micromol/L * radical surgery estimated not possible (temporary stenting with insertion of a plastic stent can be obtained but should be replaced by a metal stent within 4 weeks after the first ERCP procedure, and the patient is randomized at the time of insertion of the metal stent) Exclusion Criteria: * patients with active hepatitis or other hepatic diseases that may cause jaundice * informed consent not obtained * metastasis with numerous significant intrahepatic stenosis causing blockage of one or more segments of the liver (if no segment blockage, liver metastasis is not an exclusion criteria) * the patient is probably a candidate for surgical resection * suspicion of a non-malignant bile duct obstruction, e.g. stones or benign stenosis (should initiate further investigations) * the proximal end of the stenosis is located within 2 cm from the hepatic confluence * the patient has previously undergone BII or Roux-en-Y gastric resection, or has a significant duodenal obstruction making ERCP difficult * previously (more than 4 weeks earlier) treated with a bile duct stent * severe coagulation disturbance (PK-INR \> 1.6)
References
Publications (1)
- DERIVEDKullman E, Frozanpor F, Soderlund C, Linder S, Sandstrom P, Lindhoff-Larsson A, Toth E, Lindell G, Jonas E, Freedman J, Ljungman M, Rudberg C, Ohlin B, Zacharias R, Leijonmarck CE, Teder K, Ringman A, Persson G, Gozen M, Eriksson O. Covered versus uncovered self-expandable nitinol stents in the palliative treatment of malignant distal biliary obstruction: results from a randomized, multicenter study. Gastrointest Endosc. 2010 Nov;72(5):915-23. doi: 10.1016/j.gie.2010.07.036. PMID 21034892