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Endoscopic Ultrasound (EUS)-Guided Ablation of Pancreatic Cysts

Primary Purpose

Pancreatic Cyst, Pancreatic Intraductal Papillary-Mucinous Neoplasm, Cystadenoma, Mucinous

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
98% Ethanol & Paclitaxel injection
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cyst focused on measuring Intraductal papillary mucinous neoplasms (IPMNs), Mucinous cystadenomas [MCN]), Invasive IPMNs or mucinous cystadenocarcinomas) tumors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. 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.
  2. Patient at least 18 years of age.

Exclusion Criteria:

  1. Investigator deems cyst does not meet safety or need for cyst ablation.
  2. Subject not competent to sign consent

Sites / Locations

  • Indiana University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

98% Ethanol with Paclitaxel injection

Arm Description

Outcomes

Primary Outcome Measures

Cyst resolution
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.

Secondary Outcome Measures

Full Information

First Posted
June 28, 2012
Last Updated
April 6, 2022
Sponsor
Indiana University
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1. Study Identification

Unique Protocol Identification Number
NCT01643460
Brief Title
Endoscopic Ultrasound (EUS)-Guided Ablation of Pancreatic Cysts
Official Title
Endoscopic Ultrasound (EUS)-Guided Ablation of Pancreatic Cysts
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
March 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cyst, Pancreatic Intraductal Papillary-Mucinous Neoplasm, Cystadenoma, Mucinous, Papillary Mucinous Cystadenoma, Borderline Malignancy
Keywords
Intraductal papillary mucinous neoplasms (IPMNs), Mucinous cystadenomas [MCN]), Invasive IPMNs or mucinous cystadenocarcinomas) tumors

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
98% Ethanol with Paclitaxel injection
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
98% Ethanol & Paclitaxel injection
Other Intervention Name(s)
Pancreatic cyst injection of Paclitaxel.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cyst resolution
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John M. DeWitt, MD
Organizational Affiliation
Indiana University Hospital, Indianapolis, IN 46202
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5121
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27650271
Citation
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.
Results Reference
derived
PubMed Identifier
24770971
Citation
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.
Results Reference
derived

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Endoscopic Ultrasound (EUS)-Guided Ablation of Pancreatic Cysts

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