Does Pancreatic Stent Decrease the Risk of Pancreatitis After Pancreatic Sphincterotomy for Difficult Cannulation?

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorHelsinki University Central Hospital

About this trial

The purpose of the study is to compare the risk of PEP after pancreatic sphincterotomy performed for difficult cannulation in a group of patients with and in a group of patients without placement of a prophylactic pancreatic stent. The definition of difficult cannulation is defined according to the literature.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Consecutive patients with naïve papilla presenting to ERCP with indication of common bile duct (CBD) cannulation will be considered to the study.

Disqualifiers

Exclusion criteria are age below 18 years, acute pancreatitis and no consent to the study.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Biliary cannulation

    Device

    Cannulation of biliary duct by sphincterotome

Treatment groups

268 Participants
are divided into 2 treatment groups
Group A: Pancreatic sphincterotomyActive comparator 1 intervention
Group B: Pancreatic sphincterotomy + pancreatic stentActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Post-ERCP pancreatitis rate

Time frame
30 days

Secondary outcomes

Other outcomes

Sponsors and contacts

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