Clinical trial NCT00280709: Biliary Metal Stent Study: Metal Stents for Management of Distal Malignant Biliary Obstruction
Official title: Covered Versus Uncovered Metal Stents for Management of Distal Malignant Biliary Obstruction? Results of a Randomized Prospective Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
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
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
First posted: 2006-01-23
Enrollment: 400
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
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
Secondary outcomes:
Other outcomes:
Locations:
city: Linkoping
country: Sweden
facility: Department of Surgery, University Hospital
Study officials:
affiliation: Department of Surgery, University Hostpital, Linkoping, Sweden.
name: Eric P Kullman, M.D.
role: STUDY_CHAIR
affiliation: Department of Surgery, Sodersjukhuset, Stockholm, Sweden.
name: Claes Soderlund, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Surgery, Central Hospital of Blekinge, Karlskrona, Sweden.
name: Bo Ohlin, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Endoscopy, University Hospital MAS, Malmö, Sweden.
name: Ervin Toth, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Surgery, S:t Goran Hospital, Stockholm, Sweden.
name: Carl-Eric Leijonmarck, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Surgery, Danderyd Hospital, Stockholm, Sweden.
name: Eduard Jonas, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Surgery, Central Hospital, Vasteras, Sweden.
name: Claes Rudberg, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Surgery, Central Hospital, Norrkoping, Sweden.
name: Kalev Teder, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Surgery, Ryhov Hospital, Jonkoping, Sweden.
name: Erik Svartholm, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Surgery, Vastervik Hospital, Vastervik, Sweden.
name: Mehmet Gozen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.