At a glance
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SOCCER: Study Of forCeps Cannulation During ERcp
In Brief
A clinical study evaluating Forceps for Post-ERCP Acute Pancreatitis. Completed, enrolled 152 participants across 1 site.
Detailed Summary
A difficult cannulation has been identified as one of the high risk factors for developing post-ERCP pancreatitis (PEP). The accessibility and morphology of the papilla influence the level of cannulation difficulty. The use of a forceps to assist in the cannulation is a demonstrated effective technique for cannulating papillae that are difficult to access. Thus, the objective of our study is to determine whether a forceps assisted cannulation leads to less difficult cannulation during ERCP. Because difficult cannulation is associated with increased risk of PEP, our study investigates whether the forceps assisted cannulation also reduces the incidence of PEP as a secondary outcome. Eligible patients who have consented will either be randomized to cannulation with forceps or cannulation with no forceps.
Study Details
Timeline
Interventions
The forceps clears the redundant tissue to enable access to the papilla, as well as stabilizes the ampullary position to permit an easier cannulation. The forceps is an FDA approved instrument and does not put the patient at any higher risk for any adverse event. Please note that for the explicit purpose of the study the forceps will be used to grab tissue and not take biopsies. The forceps may still be used to take biopsies if the physician believes it is indicated.