Cholecystokinin promotes regeneration of the injured common peroneal nerve：study protocol for a prospective, randomized, controlled clinical trial / 中国组织工程研究

ABSTRACT

BACKGROUND:Cholecystokinin as an endogenous neuroprotective factor in the nervous system has garnered increasing attention. Findings from previous animal studies show that cholecystokinin can effectively promote the regeneration of the injured peripheral nerve. On this basis, further clinical trials wil be performed to observe whether local application of cholecystokinin at nerve anastomosis can promote peripheral nerve regeneration. METHODS/DESIGN:As a prospective randomized controled trial, this study wil enrol 100 patients with complete rupture of the peroneal nerve, who wil be randomly divided into two groups: after nerve suture and partial gelatin sponge infiltration at nerve anastomosis, the patients wil be treated with 8 nmol/kg cholecystokinin (treatment group) or saline (control group). At 6, 12, 24 weeks after treatment, common peroneal nerve conduction velocity and electromyography and nerve fiber morphology wil be detected; the clinical efficacy at the last folow-up wil be assessed; and al adverse events during the folow-up wil be recorded to assess the therapeutic efficacy and safety. DISCUSSION:In this study, cholecystokinin as an inducing agent for nerve growth factor synthesis wil be observed and studied, with a view to providing a new idea for seeking peripheral nerve therapy. ETHICAL APPROVAL: The study protocol was approved by the Medical Ethics Committee of the Affiliated Hospital of Putian University (approval No. 2014116). Written informed consent wil be obtained from patients before treatment.