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Endoscopic Ultrasound-guided Ethanol Injection of Pancreatic Cystic Neoplasms

NCT02158039 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2018-02-05

Study results available
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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.

Conditions

  • Neoplasms, Cystic, Mucinous, and Serous

Interventions

DRUG

Ethanol

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

DRUG

Lidocaine

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

Sponsors & Collaborators

Principal Investigators

  • Mark Topazian, MD · Mayo Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-06-30
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02158039 on ClinicalTrials.gov