Pancreatic CystNCT01643460
Endoscopic Ultrasound (EUS)-Guided Ablation of Pancreatic Cysts
A study testing 98% Ethanol & Paclitaxel injection in people with Pancreatic Cyst and Pancreatic Intraductal Papillary-Mucinous Neoplasm, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Cyst, Pancreatic Intraductal Papillary-Mucinous Neoplasm, Cystadenoma, Mucinous
- What is being tested?
- 98% Ethanol & Paclitaxel injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Investigator deems cyst does not meet safety or need for cyst ablation.
- Subject not competent to sign consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Hospital
Indianapolis, Indiana, 46202-5121
About this study
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
Read the 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.
- Conditions
- Pancreatic Cyst, Pancreatic Intraductal Papillary-Mucinous Neoplasm, Cystadenoma, Mucinous, Papillary Mucinous Cystadenoma, Borderline Malignancy
- Being tested
- 98% Ethanol & Paclitaxel injection
- Keywords
- Intraductal papillary mucinous neoplasms (IPMNs), Mucinous cystadenomas [MCN]), Invasive IPMNs or mucinous cystadenocarcinomas) tumors
- Medical subject headings
- Pancreatic Cyst, Pancreatic Intraductal Neoplasms, Cystadenoma, Mucinous, Cystadenocarcinoma, Mucinous, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
98% Ethanol & Paclitaxel injectionProcedure or surgery
Also called Pancreatic cyst injection of Paclitaxel.
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.
| Study group | Role | What they receive |
|---|---|---|
| 98% Ethanol with Paclitaxel injection | Experimental | Not described Receives: Procedure: 98% Ethanol & Paclitaxel injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cyst resolution
- 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2012 (estimated)
- Study startSep 2009
- Primary completion31 Dec 2020
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CystStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John DeWitt, Indiana University
- Investigators
- John M. DeWitt, MD, Principal investigator, Indiana University Hospital, Indianapolis, IN 46202
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01643460
- Sponsor's protocol ID
- 0812-57
- Status last verified
- Apr 2022
- First submitted
- 28 Jun 2012
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 27650271DeWitt 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.
PubMed 24770971
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Ultrasound (EUS)-Guided Ablation of Pancreatic Cysts
- ClinicalTrials.gov ID
- NCT01643460
- Acronym / sponsor ID
- 0812-57
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 18 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 98% Ethanol with Paclitaxel injection | Experimental | Procedure: 98% Ethanol & Paclitaxel injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Investigator deems cyst does not meet safety or need for cyst ablation.
- Subject not competent to sign consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 98% Ethanol & Paclitaxel injectionAlso: Pancreatic cyst injection of Paclitaxel.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. | Procedure or surgery | 98% Ethanol with Paclitaxel injection |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
- Derived from this study: PubMed 27650271Kim 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.
- Derived from this study: PubMed 24770971DeWitt 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John M. DeWitt, MD principal investigator
Indiana University Hospital, Indianapolis, IN 46202
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 98% Ethanol & Paclitaxel injection in people with Pancreatic Cyst and Pancreatic Intraductal Papillary-Mucinous Neoplasm, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cyst resolution (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01643460, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2022.