Common Hepatic Nerve Stimulation During Distal Pancreatectomy

• Research type

  Research Study

• Full title

  Safety and Feasibility of Common Hepatic Nerve Stimulation During Distal Pancreatectomy

• IRAS ID

  351087

• Contact name

  Shannon Springer

• Contact email

  Shannon.x.springer@galvani.bio

• Sponsor organisation

  Galvani Bioelectronics

• Duration of Study in the UK

  2 years, 0 months, 1 days

• Research summary

  The current study evaluates the feasibility and safety of placing, stimulating, and removing an instrument on the common hepatic artery (CHA) neurovascular bundle (NVB) during distal pancreatectomy. Stimulation of the nerves may reduce the inflammatory response to pancreatectomy and improve patients outcomes after the surgery. Up to 15 patients undergoing pancreatectomy will participate in the study. During minimally invasive pancreatectomy, the CHA is routinely exposed as part of the procedure
  Prior to any actions to conduct the standard distal pancreatectomy resection, the CHA NVB is identified and exposed and an implantable lead is placed laparoscopically on the CHA NVB and connected to an external pulse generator. An ultrasound transducer will be introduced to the abdomen and placed on the artery distally to the lead and used to evaluate blood flow during stimulation. The CHA NVB will be stimulated maximal three times using parameters selected to cause a change in arterial blood flow (a surrogate marker of CHA NVB activation). Stimulation parameters may be adjusted over the course of the study based on experience with prior study participants. Blood samples will be taken before, and at certain predefined time points after stimulation and recovery. The implantable lead and ultrasound transducer will be removed after completion of stimulation, and the standard surgery will continue. Surgeon user experience applying and removing the implantable lead will be documented, in addition to the physiological responses to CHA NVB stimulation. Post-operative safety will be followed through 30-days post-surgery or until all AEs are resolved.

  This instrument has not yet been tested on humans. It has been extensively tested on animals in the laboratory. Physicians can not yet use the instrument outside clinical research. The intention is to publish the results of this research in a scientific journal. These results may be necessary to market the instrument.

• REC name

  South East Scotland REC 02

• REC reference

  25/SS/0030

• Date of REC Opinion

  2 Jul 2025

• REC opinion

  Further Information Favourable Opinion