Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00196105
Other study ID # 03-MOZ
Secondary ID
Status Completed
Phase N/A
First received September 12, 2005
Last updated September 28, 2011
Start date September 2003
Est. completion date December 2006

Study information

Verified date September 2011
Source Cook
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical DevicesCanada: Health Canada
Study type Interventional

Clinical Trial Summary

This study compares the 6 mm nitinol Zilver biliary endoprostheses and the 10 mm nitinol Zilver biliary endoprostheses to the 10 mm Wallstent in appropriate patients in need of palliative treatment of malignant obstructive jaundice.


Description:

This research is being done to determine if the new, FDA-cleared Zilver metal biliary stent is better than the conventional stents. The new Zilver stent may permit more accurate placement, may avoid some potential complications and last longer than the conventional stents. The study will also examine to find the best diameter of stent by comparing standard 10 mm stents to 6 mm Zilver stents.


Recruitment information / eligibility

Status Completed
Enrollment 241
Est. completion date December 2006
Est. primary completion date December 2006
Accepts healthy volunteers No
Gender Both
Age group 21 Years and older
Eligibility Inclusion Criteria:

- Unresectable malignancy of the extrahepatic bile duct

Exclusion Criteria:

- Age below 21 years

- Pregnancy

- Active alcohol or drug abuse

- Simultaneously participating in another investigational drug or device study.

- Allergy to stainless steel or nitinol

- Active cholangitis

- Brachytherapy

- Unable or unwilling to comply with follow up

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Device:
6 mm Nitinol Zilver Stent

10 mm Nitinol Zilver Stent

10 mm Stainless Steel Wallstent


Locations

Country Name City State
United States Maine Medical Center Portland Maine

Sponsors (1)

Lead Sponsor Collaborator
Cook

Country where clinical trial is conducted

United States, 

References & Publications (1)

Loew BJ, Howell DA, Sanders MK, Desilets DJ, Kortan PP, May GR, Shah RJ, Chen YK, Parsons WG, Hawes RH, Cotton PB, Slivka AA, Ahmad J, Lehman GA, Sherman S, Neuhaus H, Schumacher BM. Comparative performance of uncoated, self-expanding metal biliary stents — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Patency Number of days of stent patency: The time to stent occlusion requiring re-intervention, death, loss to follow-up, or patients alive at study end without an occlusion (>= 6 months after placement). up to 32 months No
Primary Closure or Blockage of the Stent (Occlusion) Biliary stents may become closed or blocked. This is also termed "Occlusion." Data for this outcome measure involve stent occlusions that required re-intervention. up to 32 months No
Primary Number of Days to Occlusion up to 32 months No
Primary Number of Deaths up to 32 months No
Primary Time to Death Overall Survival up to 32 months No
See also
  Status Clinical Trial Phase
Recruiting NCT04085055 - Fine Needle Biopsy of Solid Pancreatic Mass Lesions N/A
Recruiting NCT01950572 - Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma
Terminated NCT00529113 - Study With Gemcitabine and RTA 402 for Patients With Unresectable Pancreatic Cancer Phase 1
Recruiting NCT05351983 - Patient-derived Organoids Drug Screen in Pancreatic Cancer N/A
Recruiting NCT04809935 - EUS-Coeliac Plexus Block Versus Radiofrequency Ablation in Pain Relief of Patients With Malignancy Phase 4
Recruiting NCT05481476 - Surufatinib Combined With Sintilimab and AG in First-line Therapy of Patients With Locally Advanced or Metastatic Pancreatic Cancer Phase 2
Not yet recruiting NCT04652271 - International Pancreatic Surgery Outcomes Study - PancreasGroup.Org
Active, not recruiting NCT02950064 - A Study to Determine the Safety of BTP-114 for Treatment in Patients With Advanced Solid Tumors With BRCA Mutations Phase 1
Completed NCT03054987 - Endoscopic Ultrasound and Endoscopic Retrograde Cholangiopancreatography for Malignant Distal Biliary Obstruction N/A
Completed NCT02909530 - Comparison Between Olympus EZ Shot 3Plus 19G and EZ Shot 2 19G in EUS-guided FNB of Solid Pancreatic Masses N/A
Completed NCT02374411 - Knowledge, Attitudes, and Practice of Surgeons Toward Nutrition Support in HIPEC Patients N/A
Completed NCT01770405 - Clinical Registry of nCLE in Masses and Cystic Tumors of the Pancreas, Lymph Nodes, Submucosal Lesions of the GI Tract N/A
Terminated NCT01313416 - Gemcitabine and CT-011 for Resected Pancreatic Cancer Phase 2
Terminated NCT01515046 - Clinical Trial of High-dose Vitamin C for Advanced Pancreatic Cancer Phase 2
Enrolling by invitation NCT01465425 - Extracolonic Findings on Computed Tomography (CT) Colonography
Terminated NCT01434459 - Study of Gemcitabine With TheraSphere® (Yttrium-90)in Patients With Hepatic Tumors of Pancreatobiliary Origin Phase 1
Completed NCT00985777 - Vitamin E δ-Tocotrienol Administered to Subjects With Resectable Pancreatic Exocrine Neoplasia Phase 1
Completed NCT00385177 - Phase 1 Dose Escalation Study of SN2310 Injectable Emulsion in Patients With Advanced Solid Tumors Phase 1
Recruiting NCT00178763 - Hyperthermia With Chemotherapy for Locally Advanced or Metastatic Pancreas Cancer Phase 2
Completed NCT00136669 - Acupuncture For Pancreatic Cancer Pain Phase 3