Long Term Outcomes After EUS-guided Ablation for Cystic Tumors of the Pancreas

PHASE2/PHASE3UnknownINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

June 30, 2006

Primary Completion Date

August 31, 2016

Study Completion Date

August 31, 2016

Conditions
Cystic Tumors of the Pancreas
Interventions
PROCEDURE

Endoscopic ultrasonography-guided ethanol lavage with paclitaxel injection

A curvilinear-array echoendoscope and a 22 gauge needle were then used for cyst fluid aspiration, ethanol lavage and paclitaxel injection. The maximum possible volume of cyst fluid was aspirated, and the needle tip was carefully maintained inside the cyst to avoid parenchymal injury. Ethanol was injected into the collapsed cyst until the original shape was restored, and a lavage was then performed for 3-5 minutes. Pure ethanol (99%) was used for all patients except the first 2 in whom 88% ethanol was used. After reaspiration of the injected ethanol, the cyst cavity was injected with a solution containing 3 mg/mL paclitaxel and the needle then carefully retracted. The high viscosity of paclitaxel necessitated dilution in 0.9% normal saline for administration via a 22G needle. The volume of the paclitaxel solution administered was the same as the volume of the cyst fluid aspirated.

Trial Locations (1)

138-736

Asan Medical Center, University of Ulsan College of Medicine, Seoul

Sponsors
All Listed Sponsors
lead

Asan Medical Center

OTHER

NCT00689715 - Long Term Outcomes After EUS-guided Ablation for Cystic Tumors of the Pancreas | Biotech Hunter | Biotech Hunter