Covered Metal Stent for Benign Biliary Stricture Caused by Chronic Pancreatitis

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Brief Title

Covered Metal Stent for Benign Biliary Stricture Caused by Chronic Pancreatitis

Official Title

Covered Self-expandable Metal Stent, 6 Versus 12 Months, for Benign Biliary Stricture Caused by Chronic Pancreatitis: a Prospective Randomized Study

Brief Summary

      Benign biliary strictures caused by chronic pancreatitis can be endoscopically treated with
      covered self-expandable metal stents (cSEMS).The purpose of the prospective randomized study
      is to define the optimal duration of stenting and the diameter of the cSEMS.
    

Detailed Description

      All consecutive patients admitted for ERCP and treated for benign biliary stricture caused by
      chronic pancreatitis with or without acute pancreatitis are prospectively enrolled in the
      study. The age and gender of the patients and the aetiology of the pancreatitis will be
      recorded.

      At initial presentation, clinical and laboratory findings recorded include liver function
      tests, abdominal pain, jaundice and cholangitis. Pancreatic calcifications are documented in
      abdominal computed tomography. Patients with malignancies, cirrhosis, acute/chronic hepatitis
      or abnormal hepatic imaging studies are excluded. Patients with first attack of acute
      pancreatitis will be excluded.

      The approval of the ethics committee of the hospital has been obtained. An informed consent
      will be obtained from all patients.

      All patients are prepared and sedated for ERCP as per standard medical practice of the
      hospital. At the initial ERCP, an endoscopic sphincterotomy will be performed and the
      presence/absence of bile duct stones above the stricture and the treatment of stones are
      recorded. A pancreatic stent will be inserted if indicated. For the initial ERCP the patients
      will be randomized into two groups: those who receive 10 mm diameter cSEMS and those who
      receive 12 mm diameter cSEMS into the bile duct. For the randomization, sealed envelopes will
      be used. The length of the cSEMS is recorded.

      Further ERCP for stent removal will be performed after six months for the patients with 12 mm
      diameter cSEMS and after twelve months for the patients with 10 mm diameter cSEMS. In case of
      stent migration during the follow-up, the stent will be replaced by a similar new cSEMS. If a
      pancreatic stent will be placed, the removal or replacement will be handled according to the
      hospital practice.

      After each ERCP procedure, all patients will stay in hospital for monitoring the occurrence
      of primary complications such as acute pancreatitis and cholangitis, bile leak, bleeding or
      perforation. Plasma amylase activity is measured same day > 4h after ERCP. Post-ERCP
      pancreatitis is defined as the presence of abdominal pain attributable to acute pancreatitis
      and plasma amylase level at least three times above the upper limit of the reference
      interval. The treatment of primary complications is recorded.

      Follow-up

      Clinical response (adequate biliary drainage) and recurrent stricture formation are the
      primary endpoints 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 ERCP and at removal of cSEMS.
      Blood liver function tests are measured in the morning before ERCPs; the exact widths and
      lengths in mm:s are obtained by comparison the widths and lengths with the diameter of the
      scope. 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

Interventional


Primary Outcome

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

Secondary Outcome

 Stent removability

Condition

Biliary Stricture

Intervention

ERCP

Study Arms / Comparison Groups

 Covered biliary metal stent, 12 mm
Description:  ERCP and placement of a covered self-expanding biliary metal stent, 12mm in diameter

Publications

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

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

30

Start Date

August 2013

Completion Date

December 2021

Primary Completion Date

December 2020

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

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Leena Kylänpää, MD, PhD, +358-50-4272869, [email protected]

Location Countries

Finland

Location Countries

Finland

Administrative Informations


NCT ID

NCT01929538

Organization ID

175/13/03/02/2013


Responsible Party

Principal Investigator

Study Sponsor

Helsinki University Central Hospital


Study Sponsor

Leena Kylänpää, MD, PhD, Principal Investigator, Helsinki University Central Hospital


Verification Date

February 2019