Endoscopic Treatment of Biliary Stricture Caused by Chronic Pancreatitis

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Brief Title

Endoscopic Treatment of Biliary Stricture Caused by Chronic Pancreatitis

Official Title

Covered Self-expandable Metal Stents Versus Multiple Plastic Stents for Benign Biliary Stricture Caused by Chronic Pancreatitis: a Prospective Randomized Study

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.
    

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.

      Follow-up

      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 Type

Observational


Primary Outcome

Stricture resolution of the common bile duct in the two study groups

Secondary Outcome

 Stent removability

Condition

Biliary Stricture


Study Arms / Comparison Groups

 Plastic stent
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

60

Start Date

March 2008

Completion Date

May 2015

Primary Completion Date

May 2013

Eligibility Criteria

        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.
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Jorma Halttunen, MD, PhD, , 

Location Countries

Finland

Location Countries

Finland

Administrative Informations


NCT ID

NCT01085747

Organization ID

98/13/03/03/08


Responsible Party

Principal Investigator

Study Sponsor

Helsinki University Central Hospital

Collaborators

 University of Turku

Study Sponsor

Jorma Halttunen, MD, PhD, Principal Investigator, Helsinki University Central Hospital


Verification Date

August 2013