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

NCT00280709 | Completed Phase 4 DMC

• 1 other identifier: ELLA
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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

Bile Duct Obstruction; Pancreatic Cancer; Gallbladder Cancer; Bile Duct Cancer

Keywords

Bile duct; Bile duct obstruction; Biliary stent; Metal stent; ERCP; Patency; Complication; Stent occlusion

Outcome Measures

Primary Outcomes (1)

• Clinical follow-up every month, starting one month after stent insertion. Clinical and/or laboratory signs of stent dysfunction?

  12 months after stent insertion

Study Arms (2)

1

ACTIVE COMPARATOR

Covered metal stent

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

2

ACTIVE COMPARATOR

Uncovered metal stent

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

Interventions

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

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

1; 2

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• patients with active hepatitis or other hepatic diseases that may cause jaundice
• informed consent not obtained
• 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)

Sponsors & Collaborators

• University Hospital, Linkoeping: lead

Study Sites (1)

Department of Surgery, University Hospital

Linköping, 58185, Sweden

Location

Related Publications (1)

• Kullman 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 DERIVED

MeSH Terms

Conditions

Cholestasis; Pancreatic Neoplasms; Gallbladder Neoplasms; Bile Duct Neoplasms

Condition Hierarchy (Ancestors)

Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Biliary Tract Neoplasms; Gallbladder Diseases

Study Officials

• Eric P Kullman, M.D.

  Department of Surgery, University Hostpital, Linkoping, Sweden.

  STUDY CHAIR

• Claes Soderlund, M.D.

  Department of Surgery, Sodersjukhuset, Stockholm, Sweden.

  PRINCIPAL INVESTIGATOR

• Bo Ohlin, M.D.

  Department of Surgery, Central Hospital of Blekinge, Karlskrona, Sweden.

  PRINCIPAL INVESTIGATOR

• Ervin Toth, M.D.

  Department of Endoscopy, University Hospital MAS, Malmö, Sweden.

  PRINCIPAL INVESTIGATOR

• Carl-Eric Leijonmarck, M.D.

  Department of Surgery, S:t Goran Hospital, Stockholm, Sweden.

  PRINCIPAL INVESTIGATOR

• Eduard Jonas, M.D.

  Department of Surgery, Danderyd Hospital, Stockholm, Sweden.

  PRINCIPAL INVESTIGATOR

• Claes Rudberg, M.D.

  Department of Surgery, Central Hospital, Vasteras, Sweden.

  PRINCIPAL INVESTIGATOR

• Kalev Teder, M.D.

  Department of Surgery, Central Hospital, Norrkoping, Sweden.

  PRINCIPAL INVESTIGATOR

• Erik Svartholm, M.D.

  Department of Surgery, Ryhov Hospital, Jonkoping, Sweden.

  PRINCIPAL INVESTIGATOR

• Mehmet Gozen, M.D.

  Department of Surgery, Vastervik Hospital, Vastervik, Sweden.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 20, 2006
• First Posted: January 23, 2006
• Study Start: January 1, 2006
• Primary Completion: October 1, 2008
• Study Completion: August 1, 2010
• Last Updated: August 10, 2011

Record last verified: 2010-12

Locations

SE (1)