Clinical trial · Interventional
Covered Versus Uncovered SEMS for Palliation of Malignant Biliary Strictures.
Covered Versus Uncovered Self-conformable Metal Stent for Palliation of Primary Malignant Extra-hepatic Biliary Strictures: a Randomized Multicenter Study
NCT02930252CI-TRIAL-00024251SEMScompletedN/AClinicalTrials.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 study is to compare the duration of stent patency of a covered vs. an uncovered biliary self-expandable metal stents (SEMS) placed to relieve biliary obstruction in patients with inoperable extrahepatic malignant biliary obstruction.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Niti-S Biliary ComVi Stent | Device | — | UNRESOLVED |
| Niti-S stent (D type) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Niti-S Biliary ComVi Stent
- description
- Device: Niti-S Biliary ComVi Stent is a hollow cylindrical stent fabricated by knitting first and second super-elastic shape memory alloy wires to make a net-like structure. A plurality of interlocked points allow each of the inside and outside stent bodies to contract and expand in the longitudinal direction and to apply a force against the longitudinal contraction. A hollow polytetrafluoroethylene (PTFE) membrane tube is closely fitted between the inside and outside stent bodies, with each of overlapped ends of the PTFE membrane tube and the inside and outside stent bodies integrated into a single structure.
- interventionNames
- Device: Niti-S Biliary ComVi Stent
- type
- ACTIVE_COMPARATOR
- label
- Niti-S Stent (D-type)
- description
- Device: The Niti-S Stent (D-type) maintains a desired bent shape corresponding to the specific target lesion. It is comprised of a hollow cylindrical stent body fabricated by knitting first and second super-elastic shape memory alloy wires to make a net-like structure with a plurality of interlocked points capable of allowing the stent body to contract and expand in the longitudinal direction and to apply a force against the longitudinal contraction of the stent body. The wires are made of a shape memory alloy through a process of shaping the alloy then heat-treating the wires to allow restoration of the original shape at a predetermined temperature.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Malignant obstructive disease at the level of the extrahepatic bile duct (CBD) * Serum bilirubin \>50 micromol/L * Inoperability due to a poor medical condition and/or unresectable disease * ≥ 18 years of age * Willing and able to comply with study procedures and provide written informed consent Exclusion Criteria: * Benign obstruction of the CBD * Malignancy involving intrahepatic ducts or duodenum * Prior gastric bypass or Billroth type I or type II gastric resection * Prior biliary surgery * World Health Organization (WHO) performance score of 4 (100% of time in bed) * international normalized ratio (INR)\> 1.5 * Life expectancy of \< 90 days
References
Publications (15)
- BACKGROUNDWarshaw AL, Fernandez-del Castillo C. Pancreatic carcinoma. N Engl J Med. 1992 Feb 13;326(7):455-65. doi: 10.1056/NEJM199202133260706. No abstract available. PMID 1732772
- BACKGROUNDCubiella J, Castells A, Fondevila C, Sans M, Sabater L, Navarro S, Fernandez-Cruz L. Prognostic factors in nonresectable pancreatic adenocarcinoma: a rationale to design therapeutic trials. Am J Gastroenterol. 1999 May;94(5):1271-8. doi: 10.1111/j.1572-0241.1999.01018.x. PMID 10235206
- BACKGROUNDDumonceau JM, Cremer M, Auroux J, Delhaye M, Deviere J. A comparison of Ultraflex Diamond stents and Wallstents for palliation of distal malignant biliary strictures. Am J Gastroenterol. 2000 Mar;95(3):670-6. doi: 10.1111/j.1572-0241.2000.01844.x. PMID 10710055
- BACKGROUNDFerlitsch A, Oesterreicher C, Dumonceau JM, Deviere J, Leban T, Born P, Rosch T, Suter W, Binek J, Meyenberger C, Mullner M, Schneider B, Schofl R. Diamond stents for palliation of malignant bile duct obstruction: a prospective multicenter evaluation. Endoscopy. 2001 Aug;33(8):645-50. doi: 10.1055/s-2001-16214. PMID 11490378
- BACKGROUNDAhmad J, Siqueira E, Martin J, Slivka A. Effectiveness of the Ultraflex Diamond stent for the palliation of malignant biliary obstruction. Endoscopy. 2002 Oct;34(10):793-6. doi: 10.1055/s-2002-34269. PMID 12244500
- BACKGROUNDShah RJ, Howell DA, Desilets DJ, Sheth SG, Parsons WG, Okolo P 3rd, Lehman GA, Sherman S, Baillie J, Branch MS, Pleskow D, Chuttani R, Bosco JJ. Multicenter randomized trial of the spiral Z-stent compared with the Wallstent for malignant biliary obstruction. Gastrointest Endosc. 2003 Jun;57(7):830-6. doi: 10.1016/s0016-5107(03)70016-9. PMID 12776028
- BACKGROUNDKaassis M, Boyer J, Dumas R, Ponchon T, Coumaros D, Delcenserie R, Canard JM, Fritsch J, Rey JF, Burtin P. Plastic or metal stents for malignant stricture of the common bile duct? Results of a randomized prospective study. Gastrointest Endosc. 2003 Feb;57(2):178-82. doi: 10.1067/mge.2003.66.