Neoplasms, Cystic, Mucinous, and SerousPhase 1NCT02158039
Endoscopic Ultrasound-guided Ethanol Injection of Pancreatic Cystic Neoplasms
A Phase 1 study testing Ethanol and Lidocaine in people with Neoplasms, Cystic, Mucinous, and Serous, run by Mayo Clinic at 1 site in United States.
Trial summary
Cystic tumors of the pancreas are fluid-filled growths. They are often treated by surgical removal. A safe and effective non-surgical treatment is desirable. Ethanol (alcohol) injection may treat cysts by killing the lining cells of the cyst, and is an accepted treatment for cysts of other organs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Cystic, Mucinous, and Serous
- What is being tested?
- Ethanol and Lidocaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to Sep 2015
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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, > 1 cm in maximum diameter
- Treatment of the cystic lesion is desired due to symptoms or concern for subsequent malignancy
- Age > or = 18 years
- Able to give informed consent
- Surgical treatment has been considered, and a surgical consultation offered to the patient, but:
- Subject's cyst does not meet consensus criteria for surgical resection, or
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- Subject is deemed a poor operative candidate, or
- Ethanol ablation would allow a subtotal rather than total pancreatectomy, or
- Subject has decided not to undergo surgical treatment.
Who cannot join
- Known or suspected pregnancy, or nursing
- History of pancreatitis within past 3 months
- Main pancreatic duct is dilated to > 4mm in neck, body, or tail
- Cyst is known to communicate with the pancreatic duct
- Cyst has a primarily microcystic architecture on EUS
- Cyst is immediately adjacent to the main pancreatic duct on EUS
Show all 9Show fewer
- Cyst has a connection to the main pancreatic duct seen during EUS
- During initial cyst aspiration, more fluid is recovered than expected (suggesting communication to the main pancreatic duct)
- Pancreatic cytology has demonstrated cancer
Trial locations and contacts
1 site in 1 country.
About this study
Cystic tumors of the pancreas are fluid-filled growths. They are often treated by surgical removal. A safe and effective non-surgical treatment is desirable. Ethanol (alcohol) injection may treat cysts by killing the lining cells of the cyst, and is an accepted treatment for cysts of other organs. In this study, participants with pancreatic cysts underwent endoscopic ultrasound (EUS) guided ethanol injection of pancreatic cysts. This was a pilot study to assess safety and efficacy.
The hypotheses of this study were 1) complications of EUS guided ethanol injection requiring hospitalization will occur in <10% of subjects, and 2) EUS guided ethanol injection, with retreatment as necessary, will ablate at least 50% of pancreatic cysts.
Read the detailed description
EUS is performed via the mouth under sedation. After a needle is placed into the pancreas cyst under EUS guidance, an ethanol solution is placed into the cyst via the needle. The ethanol solution is withdrawn and new ethanol injected, and this process is continued for 5 minutes, repeatedly washing the cyst with the ethanol solution.
After this treatment, usual clinical follow-up is obtained including assessments of the cyst by CT or MRI scans. If a cyst of significant size persists, additional EUS-guided ethanol injections of the cyst were offered.
- Conditions
- Neoplasms, Cystic, Mucinous, and Serous
- Being tested
- Ethanol, Lidocaine
- Keywords
- Intraductal Papillary Mucinous Neoplasm, Mucinous Cystic Neoplasm, Endoscopic Ultrasound, Ethanol
- Medical subject headings
- Neoplasms, Cystic, Mucinous, and Serous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EthanolDrug
EUS-guided lavage of a pancreatic cystic neoplasm with ethanol solution. Ethanol was diluted to 80% using normal saline.
LidocaineDrug
The final solution contained 1% lidocaine except in subjects allergic to local anesthetics.
| Study group | Role | What they receive |
|---|---|---|
| Pancreatic Cyst Ethanol Injection | Experimental | EUS-guided lavage of a pancreatic cyst with ethanol solution. The ethanol solution was diluted to 80% using normal saline. Final solution also contained 1% lidocaine except in patients allergic to local anesthetics. The ethanol solution was injected into pancreatic cysts at a volume equal to 90% of the aspirated cyst volume. In subjects undergoing re-treatment of a cyst, ethanol was diluted to 90% using normal saline, and injected in a volume equal to 100% of the aspirated cyst volume. Receives: Drug: Ethanol; Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Adverse events include pancreatitis, bleeding, perforation, any other occurrence resulting in hospitalization, medical treatment, surgery, death, or disability
Measured: 1 year after final treatment
Number of Subjects With Complete or Partial Ablation of the Treated Cyst
Complete or partial ablation of cysts will be defined by the presence of a persistent cystic structure, and its volume and maximum diameter, as determined by cross-sectional imaging studies (CT, MR)
Measured: 1 year after final treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2014 (estimated)
- Study startJun 2004
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 33 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, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02158039
- Sponsor's protocol ID
- 498-04
- Status last verified
- Jul 2017
- First submitted
- 30 Sep 2013
- Last updated
- 5 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: Data sharing can be arranged and will require IRB approval
Publications
Gomez V, Takahashi N, Levy MJ, McGee KP, Jones A, Huang Y, Chari ST, Clain JE, Gleeson FC, Pearson RK, Petersen BT, Rajan E, Vege SS, Topazian MD. EUS-guided ethanol lavage does not reliably ablate pancreatic cystic neoplasms (with video). Gastrointest Endosc. 2016 May;83(5):914-20. doi: 10.1016/j.gie.2015.08.069. Epub 2015 Sep 9.
PubMed 26363331
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Ultrasound-guided Ethanol Injection of Pancreatic Cystic Neoplasms
- ClinicalTrials.gov ID
- NCT02158039
- Acronym / sponsor ID
- 498-04
- Conditions
- Neoplasms, Cystic, Mucinous, and Serous
- Keywords
- Intraductal Papillary Mucinous Neoplasm, Mucinous Cystic Neoplasm, Endoscopic Ultrasound, Ethanol
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jun 2004
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 6 Jun 2014 (estimated)
- Results
- Posted 29 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cystic tumors of the pancreas are fluid-filled growths. They are often treated by surgical removal. A safe and effective non-surgical treatment is desirable. Ethanol (alcohol) injection may treat cysts by killing the lining cells of the cyst, and is an accepted treatment for cysts of other organs. In this study, participants with pancreatic cysts underwent endoscopic ultrasound (EUS) guided ethanol injection of pancreatic cysts. This was a pilot study to assess safety and efficacy.
The hypotheses of this study were 1) complications of EUS guided ethanol injection requiring hospitalization will occur in <10% of subjects, and 2) EUS guided ethanol injection, with retreatment as necessary, will ablate at least 50% of pancreatic cysts.
Detailed description
EUS is performed via the mouth under sedation. After a needle is placed into the pancreas cyst under EUS guidance, an ethanol solution is placed into the cyst via the needle. The ethanol solution is withdrawn and new ethanol injected, and this process is continued for 5 minutes, repeatedly washing the cyst with the ethanol solution.
After this treatment, usual clinical follow-up is obtained including assessments of the cyst by CT or MRI scans. If a cyst of significant size persists, additional EUS-guided ethanol injections of the cyst were offered.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pancreatic Cyst Ethanol Injection | Experimental | Drug: Ethanol, Drug: LidocaineEUS-guided lavage of a pancreatic cyst with ethanol solution. The ethanol solution was diluted to 80% using normal saline. Final solution also contained 1% lidocaine except in patients allergic to local anesthetics. The ethanol solution was injected into pancreatic cysts at a volume equal to 90% of the aspirated cyst volume. In subjects undergoing re-treatment of a cyst, ethanol was diluted to 90% using normal saline, and injected in a volume equal to 100% of the aspirated cyst volume. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Presence of a pancreatic cystic lesion, > 1 cm in maximum diameter
- Treatment of the cystic lesion is desired due to symptoms or concern for subsequent malignancy
- Age > or = 18 years
- Able to give informed consent
- Surgical treatment has been considered, and a surgical consultation offered to the patient, but:
Key exclusion criteria (9 listed)
- Known or suspected pregnancy, or nursing
- History of pancreatitis within past 3 months
- Main pancreatic duct is dilated to > 4mm in neck, body, or tail
- Cyst is known to communicate with the pancreatic duct
- 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 |
|---|---|---|
| EthanolEUS-guided lavage of a pancreatic cystic neoplasm with ethanol solution. Ethanol was diluted to 80% using normal saline. | Drug | Pancreatic Cyst Ethanol Injection |
| LidocaineThe final solution contained 1% lidocaine except in subjects allergic to local anesthetics. | Drug | Pancreatic Cyst Ethanol Injection |
Primary outcome
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time frame: 1 year after final treatment
Adverse events include pancreatitis, bleeding, perforation, any other occurrence resulting in hospitalization, medical treatment, surgery, death, or disability
Number of Subjects With Complete or Partial Ablation of the Treated Cyst
Time frame: 1 year after final treatment
Complete or partial ablation of cysts will be defined by the presence of a persistent cystic structure, and its volume and maximum diameter, as determined by cross-sectional imaging studies (CT, MR)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26363331Gomez V, Takahashi N, Levy MJ, McGee KP, Jones A, Huang Y, Chari ST, Clain JE, Gleeson FC, Pearson RK, Petersen BT, Rajan E, Vege SS, Topazian MD. EUS-guided ethanol lavage does not reliably ablate pancreatic cystic neoplasms (with video). Gastrointest Endosc. 2016 May;83(5):914-20. doi: 10.1016/j.gie.2015.08.069. Epub 2015 Sep 9.
- Individual participant dataSharing planned: Undecided. Data sharing can be arranged and will require IRB approval
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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, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ethanol and Lidocaine in people with Neoplasms, Cystic, Mucinous, and Serous, run by Mayo Clinic 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 9 inclusion and 9 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 5 Feb 2018. 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.
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?
Yes. Results are posted in the registry (first posted 29 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Adverse Events as a Measure of Safety and Tolerability (time frame: 1 year after final treatment). 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?
On the ClinicalTrials.gov record for NCT02158039, which also lists 1 linked publication.
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 5 Feb 2018.