PRIMARY OBJECTIVE:
I. Evaluate the efficacy of pre-operative botulinum toxin type A (BTX) injection compared to no therapy for the prevention of clinically relevant POPF.
SECONDARY OBJECTIVES:
I. Evaluate the safety of pre-operative BTX injection into the Sphincter of Oddi.
II. Evaluate the efficacy of pre-operative BTX injection compared to no therapy for the prevention of all POPF.
EXPLORATORY OBJECTIVES:
I. Using a historical population matched for potential confounding clinicopathologic variables, evaluate differences in POPF.
II. Using a historical population matched for potential confounding clinicopathologic variables, evaluate differences in clinically relevant POPF (crPOPF).
III. Using a historical population matched for potential confounding clinicopathologic variables, evaluate differences in postoperative length of hospital stay.
IV. Using a historical population matched for potential confounding clinicopathologic variables, evaluate differences in rate of Clavien-Dindo grade III or greater complications.
V. Using a historical population matched for potential confounding clinicopathologic variables, evaluate differences in rate of percutaneous drainage.
VI. Using a historical population matched for potential confounding clinicopathologic variables, evaluate differences in rate of unplanned re-operation.
OUTLINE:
Patients receive botulinum toxin type A via endoscopic injection into intraduodenal sphincter of Oddi segment between 7-14 days prior to planned distal pancreas resection.
Patients are followed for 30 days following distal pancreas resection.
Source: View full study details on ClinicalTrials.gov
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