EUS-Guided Pancreatic Injection of Cyst (EPIC) Trial
1 other identifier
interventional
50
1 country
1
Brief Summary
The purpose of the study is to learn about a new treatment for pancreatic cystic lesions. The injection of alcohol into cysts is a common way of treating cysts of the liver, kidney, and thyroid. We would like to find out if injection of alcohol would be useful for the treatment of pancreatic cystic lesions. The treatment with alcohol will use endoscopy and endoscopic ultrasound (procedures that use a scope that is placed through your mouth and into your stomach). We hypothesize that more than half of the cysts which are injected with ethanol will resolve.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2005
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 3, 2005
CompletedFirst Posted
Study publicly available on registry
October 5, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedOctober 29, 2013
October 1, 2013
2.9 years
October 3, 2005
October 28, 2013
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients with a pancreatic cyst (1-5cm in diameter)
- Capable of safely undergoing endoscopy with conscious sedation
You may not qualify if:
- Coagulopathy (INR\>1.5, PTT\>100, platelets of\< 50k)
- Active infection of the cyst
- Unstable cardio-pulmonary disease (active angina, home O2, or pulmonary edema)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Indiana University Medical Center
Indianapolis, Indiana, 46202-5114, United States
Related Publications (2)
Kim KH, McGreevy K, La Fortune K, Cramer H, DeWitt J. Sonographic and cyst fluid cytologic changes after EUS-guided pancreatic cyst ablation. Gastrointest Endosc. 2017 Jun;85(6):1233-1242. doi: 10.1016/j.gie.2016.09.011. Epub 2016 Sep 17.
PMID: 27650271DERIVEDDeWitt J, McGreevy K, Schmidt CM, Brugge WR. EUS-guided ethanol versus saline solution lavage for pancreatic cysts: a randomized, double-blind study. Gastrointest Endosc. 2009 Oct;70(4):710-23. doi: 10.1016/j.gie.2009.03.1173. Epub 2009 Jul 4.
PMID: 19577745DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William R. Brugge, MD
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Pancreas and Biliary Center
Study Record Dates
First Submitted
October 3, 2005
First Posted
October 5, 2005
Study Start
January 1, 2005
Primary Completion
December 1, 2007
Study Completion
March 1, 2008
Last Updated
October 29, 2013
Record last verified: 2013-10