Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Pancreatic Cancer
Type
Interventional
Phase
Early Phase 1
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: A prospective randomized placebo-controlled double blinded trial design will be used for the proposed study.Masking: Double (Participant, Care Provider)Masking Description: Both patients and the physicians performing the cases will be unaware of who receives lidocaine or placebo.Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

The primary objective of this study is to determine the effect of IV lidocaine infusion on various enzymatic activities and associated pathways in isolated CTCs as well as the number of CTCs during the perioperative period in patients undergoing robotic pancreatectomy for pancreatic cancer. It is ex...

The primary objective of this study is to determine the effect of IV lidocaine infusion on various enzymatic activities and associated pathways in isolated CTCs as well as the number of CTCs during the perioperative period in patients undergoing robotic pancreatectomy for pancreatic cancer. It is expected that by downregulating the pathways by lidocaine might affect the enzymatic activity in those CTCs as well as the number of CTCs in the circulation. A prospective randomized controlled double blinded trial design will be used for the proposed study. Patients undergoing robotic pancreatectomy for pancreatic cancer will be randomized (ratio 1:1) into two groups: one group will receive a 24-h normal saline infusion and the second group will receive a 24-h lidocaine infusion. Blood samples will be collected in different times perioperatively in order to evaluate the objectives of the study.

Tracking Information

NCT #
NCT04048278
Collaborators
Not Provided
Investigators
Principal Investigator: Gina E. Votta-Velis, MD PhD Associate Professor