CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 33 enrolled
Drug / intervention
Ethanol +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02158039
NCT02158039Phase 1Completed

Endoscopic Ultrasound-guided Ethanol Injection of Pancreatic Cystic Neoplasms

Mayo Clinic·interventional·Posted Jun 6, 2014·Updated Feb 5, 2018

In Brief

A Phase 1 clinical trial evaluating Ethanol and Lidocaine for Neoplasms, Cystic, Mucinous, and Serous. Completed, enrolled 33 participants across 1 site.

Detailed Summary

Cystic tumors of the pancreas are fluid-filled growths. They are often treated by surgical removal. A safe and effective non-surgical treatment is desirable. Ethanol (alcohol) injection may treat cysts by killing the lining cells of the cyst, and is an accepted treatment for cysts of other organs. In this study, participants with pancreatic cysts underwent endoscopic ultrasound (EUS) guided ethanol injection of pancreatic cysts. This was a pilot study to assess safety and efficacy. The hypotheses of this study were 1) complications of EUS guided ethanol injection requiring hospitalization will occur in \<10% of subjects, and 2) EUS guided ethanol injection, with retreatment as necessary, will ablate at least 50% of pancreatic cysts.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 6, 2014
Enrollment StartJun 1, 2004
Primary CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 11.3 yearsPosted 12.1 years ago

Interventions

Ethanoldrug

EUS-guided lavage of a pancreatic cystic neoplasm with ethanol solution. Ethanol was diluted to 80% using normal saline.

Lidocainedrug

The final solution contained 1% lidocaine except in subjects allergic to local anesthetics.