MedTrace Logo

Biliary Metal Stent Study: Metal Stents for Management of Distal Malignant Biliary Obstruction

NCT00280709 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2011-08-10

No results posted yet for this study

Summary

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

Interventions

DEVICE

"Nitinella" ; SX-ELLA Stent Biliary (biliary metal stent)

Nitinella covered (arm 1) or uncovered (arm 2) biliary metal stent. Maximum diameter 10 mm, length 52 or 72 mm

Sponsors & Collaborators

  • University Hospital, Linkoeping

    lead OTHER

Principal Investigators

  • Eric P Kullman, M.D. · Department of Surgery, University Hostpital, Linkoping, Sweden.

  • Claes Soderlund, M.D. · Department of Surgery, Sodersjukhuset, Stockholm, Sweden.

  • Bo Ohlin, M.D. · Department of Surgery, Central Hospital of Blekinge, Karlskrona, Sweden.

  • Ervin Toth, M.D. · Department of Endoscopy, University Hospital MAS, Malmö, Sweden.

  • Carl-Eric Leijonmarck, M.D. · Department of Surgery, S:t Goran Hospital, Stockholm, Sweden.

  • Eduard Jonas, M.D. · Department of Surgery, Danderyd Hospital, Stockholm, Sweden.

  • Claes Rudberg, M.D. · Department of Surgery, Central Hospital, Vasteras, Sweden.

  • Kalev Teder, M.D. · Department of Surgery, Central Hospital, Norrkoping, Sweden.

  • Erik Svartholm, M.D. · Department of Surgery, Ryhov Hospital, Jonkoping, Sweden.

  • Mehmet Gozen, M.D. · Department of Surgery, Vastervik Hospital, Vastervik, Sweden.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2008-10-31
Completion
2010-08-31

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00280709 on ClinicalTrials.gov