Pancreatic CystPhase 3NCT00550108
Management of Incidentally Discovered Pancreatic Cysts
A Phase 3 study testing Ethanol lavage in people with Pancreatic Cyst, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this study is to determine the natural history of pancreatic cysts and to determine if these cysts can be effectively treated with a less invasive therapy (ethanol injection vs periodic imaging) rather than surgical resection Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pancreatic Cyst
- What is being tested?
- Ethanol lavage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Oct 2012
- Phase
- Phase 3
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cyst between 1-3cm
- No evidence of a mural nodule, solid component, or septations in the cyst
- For patients with multiple cysts, the largest will be evaluated
Who cannot join
- Any imaging or cytology concerning for malignancy
- Pancreatic Pseudocyst
- Gross Cyst >3cm as measured on MRCP
- Clinically active pancreatitis or serum amylase or lipase >3x upper limit of normal
- Coagulopathy (INR>1.5, PTT>100, Platelets<50K)
- Inability to tolerate conscious sedation and endoscopy
Show all 10Show fewer
- Rated ASA IV or greater
- Prior EUS and aspiration of the pancreatic cyst
- Breast feeding
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: A Prospective Study of the Management of Incidentally Discovered Pancreatic Cysts
The purpose of this study is to determine the natural history of pancreatic cysts and to determine if these cysts can be effectively treated with a less invasive therapy (ethanol injection vs periodic imaging) rather than surgical resection
Read the detailed description
The appropriate management of patients with cystic lesions of the pancreas is controversial. The identification of small asymptomatic pancreatic cysts is increasing due to an improvement in the quality of radiologic imaging and the frequency that imaging is obtained. However, the natural history of these lesions is unknown1. The current consensus guidelines established at the International Consensus Conference in Sendai, Japan in 2005 suggest that branch chain IPMNs and mucinous cystic neoplasms that cause no symptoms, measure <3cm, and have no nodules can be observed with periodic imaging. However, the time course of these pre malignant mucinous lesions, intraductal papillary mucinous neoplasms (IPMN) or mucinous cystadenomas, from benign to malignant has not been determined. Due to the unknown natural history, and diagnostic uncertainty, some authors have recommended routine resection2, 3. Resection, despite improvements in surgical outcomes after pancreatectomy at high volume centers, carries a mortality and morbidity of 1-6% and 35-51%, respectively4-6. More recently studies are reporting a more selective approach to avoid the risk of operation in patients with benign lesions7. Improved radiographic and endoscopic studies have been able to identify some lesions with increased malignant potential8, 9. Thus, most patients will undergo pancreas specific radiologic imaging and endoscopic ultrasound with cyst aspiration. Since the natural history of cystic lesions is poorly understood no clear guidelines for surgical resection have been established. Some of the cysts will grow over time, with an increase in the cumulative risk of malignancy. Therefore, the therapeutic alternatives are to wait and watch for a change in the cyst morphology or to treat preemptively, which has been restricted to surgical resection. Based on the pilot study performed by Dr. William Brugge, at Massachusetts General Hospital, ethanol lavage of pancreatic cysts is safe and will result in a decrease in cyst diameter in 61% of patients. Additionally, if patients elect to not be treated preemptively it is unclear how to best follow these patients in terms of the type and the frequency of follow up studies.
- Conditions
- Pancreatic Cyst
- Being tested
- Ethanol lavage
- Keywords
- pancreatic cyst, ethanol injection
- Medical subject headings
- Pancreatic Cyst
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ethanol lavageOther
Ethanol lavage of pancreatic cysts.
| Study group | Role | What they receive |
|---|---|---|
| A | No intervention | Observation of pancreatic cysts |
| B | Experimental | Ethanol lavage of pancreatic cysts Receives: Other: Ethanol lavage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients not progressing to operation due to the development of symptoms, growth to a maximum diameter of >3cm, or development of a mural nodule.
Measured: 3 years
Secondary outcomes (1)
A decrease in size by >1 cm on MRCP Relative decrease in size of cyst after 1 or 2 injections with ethanol Is reduction in size durable (over what length of time)?
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionOct 2012 (estimated)
- Study completionOct 2012 (estimated)
Why it stopped: Inability to enroll subjects.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Massachusetts General HospitalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Cristina R Ferrone, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00550108
- Sponsor's protocol ID
- 2007-P-000420
- Status last verified
- Jun 2008
- First submitted
- 24 Oct 2007
- Last updated
- 26 Jun 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fernandez-del Castillo C, Targarona J, Thayer SP, Rattner DW, Brugge WR, Warshaw AL. Incidental pancreatic cysts: clinicopathologic characteristics and comparison with symptomatic patients. Arch Surg. 2003 Apr;138(4):427-3; discussion 433-4. doi: 10.1001/archsurg.138.4.427.
PubMed 12686529
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of the Management of Incidentally Discovered Pancreatic Cysts
- ClinicalTrials.gov ID
- NCT00550108
- Acronym / sponsor ID
- 2007-P-000420
- Conditions
- Pancreatic Cyst
- Keywords
- pancreatic cyst, ethanol injection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inability to enroll subjects.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 26 Oct 2007 (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 determine the natural history of pancreatic cysts and to determine if these cysts can be effectively treated with a less invasive therapy (ethanol injection vs periodic imaging) rather than surgical resection
Detailed description
The appropriate management of patients with cystic lesions of the pancreas is controversial. The identification of small asymptomatic pancreatic cysts is increasing due to an improvement in the quality of radiologic imaging and the frequency that imaging is obtained. However, the natural history of these lesions is unknown1. The current consensus guidelines established at the International Consensus Conference in Sendai, Japan in 2005 suggest that branch chain IPMNs and mucinous cystic neoplasms that cause no symptoms, measure <3cm, and have no nodules can be observed with periodic imaging. However, the time course of these pre malignant mucinous lesions, intraductal papillary mucinous neoplasms (IPMN) or mucinous cystadenomas, from benign to malignant has not been determined. Due to the unknown natural history, and diagnostic uncertainty, some authors have recommended routine resection2, 3. Resection, despite improvements in surgical outcomes after pancreatectomy at high volume centers, carries a mortality and morbidity of 1-6% and 35-51%, respectively4-6. More recently studies are reporting a more selective approach to avoid the risk of operation in patients with benign lesions7. Improved radiographic and endoscopic studies have been able to identify some lesions with increased malignant potential8, 9. Thus, most patients will undergo pancreas specific radiologic imaging and endoscopic ultrasound with cyst aspiration. Since the natural history of cystic lesions is poorly understood no clear guidelines for surgical resection have been established. Some of the cysts will grow over time, with an increase in the cumulative risk of malignancy. Therefore, the therapeutic alternatives are to wait and watch for a change in the cyst morphology or to treat preemptively, which has been restricted to surgical resection. Based on the pilot study performed by Dr. William Brugge, at Massachusetts General Hospital, ethanol lavage of pancreatic cysts is safe and will result in a decrease in cyst diameter in 61% of patients. Additionally, if patients elect to not be treated preemptively it is unclear how to best follow these patients in terms of the type and the frequency of follow up studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | No intervention | –Observation of pancreatic cysts |
| B | Experimental | Other: Ethanol lavageEthanol lavage of pancreatic cysts |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Cyst between 1-3cm
- No evidence of a mural nodule, solid component, or septations in the cyst
- For patients with multiple cysts, the largest will be evaluated
Key exclusion criteria (10 listed)
- Any imaging or cytology concerning for malignancy
- Pancreatic Pseudocyst
- Gross Cyst >3cm as measured on MRCP
- Clinically active pancreatitis or serum amylase or lipase >3x upper limit of normal
- Coagulopathy (INR>1.5, PTT>100, Platelets<50K)
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 |
|---|---|---|
| Ethanol lavageEthanol lavage of pancreatic cysts. | Other | B |
Primary outcome
Patients not progressing to operation due to the development of symptoms, growth to a maximum diameter of >3cm, or development of a mural nodule.
Time frame: 3 years
1 secondary outcome
A decrease in size by >1 cm on MRCP Relative decrease in size of cyst after 1 or 2 injections with ethanol Is reduction in size durable (over what length of time)?
Time frame: 3 years
Results and safety
The study was stopped early (reason given: Inability to enroll subjects.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2008.
- Background: PubMed 12686529Fernandez-del Castillo C, Targarona J, Thayer SP, Rattner DW, Brugge WR, Warshaw AL. Incidental pancreatic cysts: clinicopathologic characteristics and comparison with symptomatic patients. Arch Surg. 2003 Apr;138(4):427-3; discussion 433-4. doi: 10.1001/archsurg.138.4.427.
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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.
Cristina R Ferrone, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ethanol lavage in people with Pancreatic Cyst, run by Massachusetts General Hospital 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 3 inclusion and 10 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: stopped early, as of the sponsor's last update on 26 Jun 2008. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 stopped early (reason given: Inability to enroll subjects.). Results are not available in the source record.
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?
Patients not progressing to operation due to the development of symptoms, growth to a maximum diameter of >3cm, or development of a mural nodule. (time frame: 3 years). 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 NCT00550108, 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 26 Jun 2008.