- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01643460
Endoscopic Ultrasound (EUS)-Guided Ablation of Pancreatic Cysts
April 6, 2022 updated by: John DeWitt, Indiana University
The purpose of this study is to track outcomes and complications of patients at IUMC referred by physicians for EUS-guided pancreatic cyst ablation.
This information is essential in order to disseminate future published information to physicians about this technique.
A database will be created to track these patients undergoing an already scheduled/planned procedure.
Phone calls at selected intervals will be made following the procedure to track any complications that occur
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Pancreatic cysts represent a wide spectrum of lesions.
Many cysts are uniformly benign (pseudocysts) or have negligible malignant potential (serous cystadenomas).
However, others represent premalignant (i.e.
intraductal papillary mucinous neoplasms (IPMNs) or mucinous cystadenomas [MCN]), or malignant (i.e.
invasive IPMNs or mucinous cystadenocarcinomas) tumors.
Management of pancreatic cysts is challenging but surgery is generally recommended for cysts that are symptomatic, premalignant (except possibly branch duct IPMNs) or demonstrate malignancy by imaging features and/or biopsy.
However, even in experienced hospitals, surgical resection or enucleation of pancreatic cystic tumors is associated with significant perioperative morbidity and mortality rates of 20-40% and up to 2%, respectively.
Study Type
Interventional
Enrollment (Actual)
33
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202-5121
- Indiana University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients referred between January 2009 and February 2016 to EUS at IUMC for pancreatic cyst ablation and with no contraindications for anticipated safe and successful performance of the procedure.
- Patient at least 18 years of age.
Exclusion Criteria:
- Investigator deems cyst does not meet safety or need for cyst ablation.
- Subject not competent to sign consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 98% Ethanol with Paclitaxel injection
|
Pancreatic cyst injection via Endoscopic Ultrasound (EUS)of 98% Ethanol with Paclitaxel (dose determined in relation to cyst size & amount of fluid aspirated from the cyst.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cyst resolution
Time Frame: 6 months
|
1. Patients will undergo EUS-guided cyst ablation with ethanol +/- paclitaxel as indicated for their scheduled procedure.
2. Patients will return 3 months after initial ablation for a repeat EUS, and ablation will be repeated if cyst size is >10mm in diameter.
3. CT or MRI imaging will be performed 3 months after the second procedure to assess for cyst resolution.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: John M. DeWitt, MD, Indiana University Hospital, Indianapolis, IN 46202
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- DeWitt JM, Al-Haddad M, Sherman S, LeBlanc J, Schmidt CM, Sandrasegaran K, Finkelstein SD. Alterations in cyst fluid genetics following endoscopic ultrasound-guided pancreatic cyst ablation with ethanol and paclitaxel. Endoscopy. 2014 Jun;46(6):457-64. doi: 10.1055/s-0034-1365496. Epub 2014 Apr 25.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (Actual)
December 31, 2020
Study Completion (Actual)
March 31, 2022
Study Registration Dates
First Submitted
June 28, 2012
First Submitted That Met QC Criteria
July 17, 2012
First Posted (Estimate)
July 18, 2012
Study Record Updates
Last Update Posted (Actual)
April 14, 2022
Last Update Submitted That Met QC Criteria
April 6, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Pathological Conditions, Anatomical
- Pancreatic Diseases
- Neoplasms, Cystic, Mucinous, and Serous
- Adenoma
- Neoplasms, Ductal, Lobular, and Medullary
- Pancreatic Neoplasms
- Pancreatic Cyst
- Cysts
- Cystadenoma
- Pancreatic Intraductal Neoplasms
- Cystadenoma, Mucinous
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents, Local
- Anti-Infective Agents
- Central Nervous System Depressants
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Ethanol
- Paclitaxel
- Albumin-Bound Paclitaxel
Other Study ID Numbers
- 0812-57
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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