NCT01643460

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2009

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

June 28, 2012

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 18, 2012

Completed
8.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

April 14, 2022

Status Verified

April 1, 2022

Enrollment Period

11.3 years

First QC Date

June 28, 2012

Last Update Submit

April 6, 2022

Conditions

Pancreatic CystPancreatic Intraductal Papillary-Mucinous NeoplasmCystadenoma, MucinousPapillary Mucinous Cystadenoma, Borderline Malignancy

Keywords

Intraductal papillary mucinous neoplasms (IPMNs)Mucinous cystadenomas [MCN])Invasive IPMNs or mucinous cystadenocarcinomas) tumors

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Study Arms (1)

98% Ethanol with Paclitaxel injection

EXPERIMENTAL
Procedure: 98% Ethanol & Paclitaxel injection

Interventions

98% Ethanol & Paclitaxel injectionPROCEDURE

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.

Also known as: Pancreatic cyst injection of Paclitaxel.
98% Ethanol with Paclitaxel injection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University Hospital

Indianapolis, Indiana, 46202-5121, United States

Location

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: 27650271DERIVED

  • 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.

    PMID: 24770971DERIVED

MeSH Terms

Conditions

Pancreatic CystPancreatic Intraductal NeoplasmsCystadenoma, MucinousCystadenocarcinoma, MucinousNeoplasms

Interventions

EthanolPaclitaxel

Condition Hierarchy (Ancestors)

CystsPancreatic DiseasesDigestive System DiseasesNeoplasms, Ductal, Lobular, and MedullaryNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypePancreatic NeoplasmsDigestive System NeoplasmsNeoplasms by SiteEndocrine Gland NeoplasmsEndocrine System DiseasesCystadenomaAdenomaNeoplasms, Cystic, Mucinous, and SerousCystadenocarcinomaAdenocarcinomaCarcinoma

Intervention Hierarchy (Ancestors)

AlcoholsOrganic ChemicalsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenes

Study Officials

  • John M. DeWitt, MD

    Indiana University Hospital, Indianapolis, IN 46202

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Endoscopic Ultrasound

Study Record Dates

First Submitted

June 28, 2012

First Posted

July 18, 2012

Study Start

September 1, 2009

Primary Completion

December 31, 2020

Study Completion

March 31, 2022

Last Updated

April 14, 2022

Record last verified: 2022-04

Locations

US(1)