Cryotherapy for Locally Advanced Esophageal Cancer

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

February 11, 2020

Primary Completion Date

March 8, 2023

Study Completion Date

July 1, 2025

Conditions
Esophageal Cancer
Interventions
DEVICE

Cryotherapy

LNSC will be performed with low-pressure liquid nitrogen (\<5 psi) at 25 watts using a cryotherapy catheter passed through the working channel of the endoscope.We will plan to administer LNSC as follows: up to three cycles of 20 to 40 seconds each directed at the bulkiest aspect of the tumor. During each cycle, a surface area of approximately 2 to 3 cm2 is targeted. Up to three sites are treated during each session. Tissue thawing is verified between cycles by waiting at least 60 seconds before re-treatment, and by observing a return to baseline color of the tissue and complete disappearance of ice crystals after reperfusion. After the procedure is completed, patients will be monitored in the recovery unit for at least 30 minutes. Patients will be discharged after monitoring if they meet the endoscopy unit's standard discharge criteria.

Trial Locations (1)

23249

Hunter Holmes McGuire VA Medical Center, Richmond

Sponsors
All Listed Sponsors
collaborator

McGuire Research Institute

OTHER

lead

Hunter Holmes Mcguire Veteran Affairs Medical Center

FED