Neoplasms, Cystic, Mucinous, and SerousPhase 1NCT01057355
Endoscopic Ethanol Ablation of Communicating Pancreatic Cystic Neoplasms
A Phase 1 study testing EUS and/or ERCP with ethanol injections of pancreatic cyst in people with Neoplasms, Cystic, Mucinous, and Serous and Pancreatic Neoplasms, run by Mayo Clinic.
Trial summary
Pancreatic cysts are common, and some pancreas cysts have malignant potential. Usual treatment of these cysts is either observation or surgical removal of part or all of the pancreas. Minimally invasive treatment via endoscopy has been described, using endoscopic ultrasound (EUS) guided ethanol injections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Cystic, Mucinous, and Serous, Pancreatic Neoplasms, Ultrasonography, Interventional
- What is being tested?
- EUS and/or ERCP with ethanol injections of pancreatic cyst
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Jun 2013
- Phase
- Phase 1
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of a pancreatic cystic lesion, at least 2 cm in maximum diameter
- Cyst may communicate, or definitely communicates, with the pancreatic duct (based on prior CT, MR, ERCP, or EUS images)
- Treatment of the cystic lesion is desired due to symptoms or concern for subsequent malignancy
- Age at least 18 years
- Able to give informed consent
- Surgical treatment has been considered and a surgical consultation offered to the patient, OR the subject's cyst does not meet consensus criteria for surgical resection. (Current consensus criteria for resection are one or more of the following: cyst is symptomatic, ≥ 3 cm in diameter, contains a mural nodule, cytology of cyst fluid is positive for malignancy, or main pancreatic duct diameter is > 6 mm.)
Who cannot join
- Known or suspected pregnancy, or nursing
- History of pancreatitis within 3 months prior to study endoscopy procedures
- Cyst has a primarily microcystic architecture on EUS
About this study
Pancreatic cysts are common, and some pancreas cysts have malignant potential. Usual treatment of these cysts is either observation or surgical removal of part or all of the pancreas. Minimally invasive treatment via endoscopy has been described, using endoscopic ultrasound (EUS) guided ethanol injections. Such studies exclude cysts that communicate with the main pancreatic duct, to avoid burning the main pancreatic duct with ethanol. In this study, pancreas cysts communicating with the main pancreas duct are treated with ethanol via endoscopic retrograde cholangiopancreatography (ERCP) and/or EUS.
Read the detailed description
Subjects will undergo EUS and/or ERCP as outpatients. For cysts shown to communicate with the main pancreas duct, a balloon catheter will be placed in the main pancreatic duct via ERCP. The balloon catheter will isolate the cyst from the main pancreatic duct, allowing ethanol injections of the cyst. A pancreatic duct stent will be placed in some patients, requiring repeat endoscopy for removal at another time.
- Conditions
- Neoplasms, Cystic, Mucinous, and Serous, Pancreatic Neoplasms, Ultrasonography, Interventional
- Being tested
- EUS and/or ERCP with ethanol injections of pancreatic cyst
- Keywords
- Intraductal papillary mucinous neoplasm, Mucinous cystic neoplasm, Endoscopic ultrasound, Endoscopic retrograde cholangiopancreatography, Pancreatic cyst, Pancreas cyst, Alcohol
- Medical subject headings
- Neoplasms, Cystic, Mucinous, and Serous, Pancreatic Neoplasms, Pancreatic Cyst
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS and/or ERCP with ethanol injections of pancreatic cystProcedure or surgery
Also called Alcohol lavage, Alcohol injection, Ethanol lavage, Ethanol injection
Lavage of cyst with 80% ethanol
| Study group | Role | What they receive |
|---|---|---|
| Cyst ethanol lavage | Experimental | Subjects receiving the study intervention Receives: Procedure: EUS and/or ERCP with ethanol injections of pancreatic cyst |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of adverse events requiring treatment or hospitalization
Measured: 3 days, 30 days
Decrease in volume of the pancreatic cyst by cross-sectional imaging studies (CT or MR) performed before and after treatment
Measured: 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionJun 2013
- Study completionJun 2013
Why it stopped: slow accural
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasms, Cystic, Mucinous, and SerousStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Topazian, Mayo Clinic
- Investigators
- Mark Topazian, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01057355
- Sponsor's protocol ID
- 009-004705
- Status last verified
- Sep 2014
- First submitted
- 26 Jan 2010
- Last updated
- 19 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Ethanol Ablation of Communicating Pancreatic Cystic Neoplasms
- ClinicalTrials.gov ID
- NCT01057355
- Acronym / sponsor ID
- 009-004705
- Conditions
- Neoplasms, Cystic, Mucinous, and Serous, Pancreatic Neoplasms, Ultrasonography, Interventional
- Keywords
- Intraductal papillary mucinous neoplasm, Mucinous cystic neoplasm, Endoscopic ultrasound, Endoscopic retrograde cholangiopancreatography, Pancreatic cyst, Pancreas cyst, Alcohol
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: slow accural
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 27 Jan 2010 (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.
Pancreatic cysts are common, and some pancreas cysts have malignant potential. Usual treatment of these cysts is either observation or surgical removal of part or all of the pancreas. Minimally invasive treatment via endoscopy has been described, using endoscopic ultrasound (EUS) guided ethanol injections. Such studies exclude cysts that communicate with the main pancreatic duct, to avoid burning the main pancreatic duct with ethanol. In this study, pancreas cysts communicating with the main pancreas duct are treated with ethanol via endoscopic retrograde cholangiopancreatography (ERCP) and/or EUS.
Detailed description
Subjects will undergo EUS and/or ERCP as outpatients. For cysts shown to communicate with the main pancreas duct, a balloon catheter will be placed in the main pancreatic duct via ERCP. The balloon catheter will isolate the cyst from the main pancreatic duct, allowing ethanol injections of the cyst. A pancreatic duct stent will be placed in some patients, requiring repeat endoscopy for removal at another time.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cyst ethanol lavage | Experimental | Procedure: EUS and/or ERCP with ethanol injections of pancreatic cystSubjects receiving the study intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Presence of a pancreatic cystic lesion, at least 2 cm in maximum diameter
- Cyst may communicate, or definitely communicates, with the pancreatic duct (based on prior CT, MR, ERCP, or EUS images)
- Treatment of the cystic lesion is desired due to symptoms or concern for subsequent malignancy
- Age at least 18 years
- Able to give informed consent
Key exclusion criteria (3 listed)
- Known or suspected pregnancy, or nursing
- History of pancreatitis within 3 months prior to study endoscopy procedures
- Cyst has a primarily microcystic architecture on EUS
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 |
|---|---|---|
| EUS and/or ERCP with ethanol injections of pancreatic cystAlso: Alcohol lavage, Alcohol injection, Ethanol lavage, Ethanol injectionLavage of cyst with 80% ethanol | Procedure or surgery | Cyst ethanol lavage |
Primary outcome
Occurrence of adverse events requiring treatment or hospitalization
Time frame: 3 days, 30 days
Decrease in volume of the pancreatic cyst by cross-sectional imaging studies (CT or MR) performed before and after treatment
Time frame: 6 months, 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2014.
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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.
Mark Topazian, M.D. principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EUS and/or ERCP with ethanol injections of pancreatic cyst in people with Neoplasms, Cystic, Mucinous, and Serous and Pancreatic Neoplasms, run by Mayo Clinic.
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 6 inclusion and 3 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: withdrawn, as of the sponsor's last update on 19 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Occurrence of adverse events requiring treatment or hospitalization (time frame: 3 days, 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2014.