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Endoscopic Treatment of Biliary Stricture Caused by Chronic Pancreatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01085747
Recruitment Status : Unknown
Verified August 2013 by Halttunen Jorma, Helsinki University Central Hospital.
Recruitment status was:  Active, not recruiting
First Posted : March 12, 2010
Last Update Posted : August 15, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:
Benign biliary strictures can be endoscopically treated with plastic or self-expandable metal stents (SEMS). The purpose of the prospective randomized study is to compare the safety and feasibility of covered SEMS with multiple plastic stents in the treatment of benign biliary stricture caused by chronic pancreatitis.

Condition or disease
Biliary Stricture Chronic Pancreatitis

Detailed Description:

All consecutive patients admitted for ERCP and treated for benign biliary stricture caused by chronic pancreatitis are prospectively enrolled in the study.

At the initial ERCP, an endoscopic sphincterotomy will be performed and one 10 Fr plastic stent will be inserted for the initial treatment of cholestasis in all patients.Pancreatic stent will be inserted if indicated. One to three months after the initial ERCP the patients will be randomized into two groups: those who receive cSEMS and those who receive multiple plastic stents into the bile duct. For the randomization, sealed envelopes will be used. As for cSEMSs, removable cSEMSs with diameter of 10 mm will be placed. A dilation with a 8-10mm balloon will be performed before and after the stent placement to secure the stent expansion. As for plastic stents, minimum three simultaneous 10 Fr stents will be inserted after 8-10 mm balloon dilation.

After three months a further ERCP will be performed. The number of plastic stents will be increased maximally to six 10 Fr stents after dilation if possible. In the group with cSEMS, the position of the stent will be controlled.

Once the cSEMS or plastic stents have been in place for minimum six months, the stents will be removed at the last ERCP.


Clinical response (adequate biliary drainage) is the primary endpoint of the study. Therefore, blood liver function tests (bilirubin, alkaline phosphatase) as well as the minimum diameter of the common bile duct in the area of the stricture, the maximum diameter of the common bile duct above the stricture and the length of the stricture are measured at ERCPs at the time of the initial plastic stent insertion (i.e. the first ERCP) and at removal of cSEMS or multiple plastic stents (the last ERCP). In addition, blood liver function tests are measured and abdominal ultrasonography performed in the follow-up six months and two years after the stent removal.

Morbidity and mortality are additional endpoints of the study. Therefore, complications (deaths, stent occlusions, dislodgements or migrations, cholangitis, hemobilia, stone formation above the stent), management of complications, admission times, surgical interventions and any additional care needed are monitored and recorded during the follow-up time. Patients are asked to contact the physician at any time if symptoms such as fever, abdominal pain or jaundice occur.

Study Design

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Covered Self-expandable Metal Stents Versus Multiple Plastic Stents for Benign Biliary Stricture Caused by Chronic Pancreatitis: a Prospective Randomized Study
Study Start Date : March 2008
Primary Completion Date : May 2013
Estimated Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis
U.S. FDA Resources

Groups and Cohorts

Plastic stent
Covered SEMS

Outcome Measures

Primary Outcome Measures :
  1. Stricture resolution of the common bile duct in the two study groups [ Time Frame: 2.5 years ]
    Stricture resolution during stenting and follow-up period, defined by normal liver function tests and abdominal ultrasonography

Secondary Outcome Measures :
  1. Stent removability [ Time Frame: Time from stent removal to 1 month post-stent removal ]
    Ability to remove stents endoscopically after six months without stent-removal related complications

  2. Occurrence of complications related to stents and procedure [ Time Frame: 2.5 years ]
  3. Length of endoscopic procedures in the two groups [ Time Frame: All endoscopic procedures ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All consecutive patients admitted for ERCP and treated for benign biliary stricture caused by chronic pancreatitis are prospectively enrolled in the study.

Inclusion Criteria:

  • Benign biliary stricture caused by chronic pancreatitis

Exclusion Criteria:

  • Malignancy, cirrhosis acute/chronic hepatitis or abnormal hepatic imaging. First attack of acute pancreatitis.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01085747

Helsinki University Central Hospital
Helsinki, Finland, 00290
Sponsors and Collaborators
Helsinki University Central Hospital
University of Turku
Oulu University Hospital
Principal Investigator: Jorma Halttunen, MD, PhD Helsinki University Central Hospital
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Halttunen Jorma, Jorma Halttunen, MD, PhD, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT01085747     History of Changes
Other Study ID Numbers: 98/13/03/03/08
First Posted: March 12, 2010    Key Record Dates
Last Update Posted: August 15, 2013
Last Verified: August 2013

Keywords provided by Halttunen Jorma, Helsinki University Central Hospital:
Chronic pancreatitis
Biliary stricture
Endoscopic treatment

Additional relevant MeSH terms:
Constriction, Pathologic
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases
Pathological Conditions, Anatomical
Bile Duct Diseases
Biliary Tract Diseases