Mucinous Cystic Tumor With Moderate DysplasiaPhase 1NCT01525706
Endoscopic Ultrasound (EUS) Guided Ethanol With Paclitaxel Ablation for Pancreatic Mucinous Cystic Neoplasm
A Phase 1 study testing Ethanol and Paclitaxel Injection in people with Mucinous Cystic Tumor With Moderate Dysplasia and Mucinous Cystadenoma of Pancreas, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Pancreatic cysts are becoming diagnosed more frequently due to the increased use and sensitivity of imaging. A subset of these cysts are pre-cancerous, therefore suggested treatment is surgery for removal. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Mucinous Cystic Tumor With Moderate Dysplasia, Mucinous Cystadenoma of Pancreas, Mucinous Cystadenocarcinoma of Pancreas
- What is being tested?
- Ethanol and Paclitaxel Injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2012to Nov 2016
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mucinous cystic neoplasm defined by cyst fluid analysis [23, 28]:
- CEA > 192ng/mL
- Amylase < 800 IU/L
- Cytology negative for malignant cells
- No communication of cyst with pancreatic duct on 2 imaging studies (EUS, CT, MRCP, or ERCP)
- Cyst size > 15mm but <50mm
- 3 or fewer cyst compartments
- Age ≥18 and ≤ 85
Who cannot join
- Inability to safely undergo EUS examination with standard conscious sedation
- Inability for safe FNA needle insertion into the cyst (eg: intervening vessel)
- Inability to undergo MRI (metal implants/cardiac pacemaker/defibrillator, claustrophobia)
- Coagulopathy (INR>1.5 or platelets<50)
- Active pancreatitis or pancreatic infection
- Active sepsis/bacteremia
Show all 9Show fewer
- Inability to provide informed consent
- Pregnancy
- Breastfeeding women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EUS Guided Ethanol With Paclitaxel Ablation for Pancreatic Mucinous Cystic Neoplasm
Pancreatic cysts are becoming diagnosed more frequently due to the increased use and sensitivity of imaging. A subset of these cysts are pre-cancerous, therefore suggested treatment is surgery for removal. However, surgery involves significant risks and emerging opinion suggests that not all cysts need to be surgically removed. An alternative therapy would be ideal, in particular for those where surgical risk outweighs the benefits of resection. Ethanol and paclitaxel ablation of pancreatic cysts may be a viable alternative to surgical resection.
Our hypothesis is that ethanol with paclitaxel ablation is a safe and effective method for treatment in those with per-cancerous, mucinous pancreatic cysts.
- Conditions
- Mucinous Cystic Tumor With Moderate Dysplasia, Mucinous Cystadenoma of Pancreas, Mucinous Cystadenocarcinoma of Pancreas, Benign Neoplasm of Pancreas
- Being tested
- Ethanol and Paclitaxel Injection
- Keywords
- Endoscopic Ultrasound, Pancreatic Mucinous Cystic Neoplasm, Fine Needle Injection, Ethanol Ablation, Paclitaxel Ablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ethanol and Paclitaxel InjectionDrug
Also called Ethanol, Paclitaxel
Endoscopic ultrasound will be used to locate and assess the pancreatic cyst. The fluid contents will be aspirated using a fine needle and sent for tumor marker analysis and cytology. With the needle maintained in the same position, 99% ethanol will be injected into the cyst. After 3-5 minutes of lavage, the entire volume of fluid will be removed from the cyst. The same volume of paclitaxel minus 1 mL [3mg/ml diluted in normal saline from original concentration of 6mg/mL] will be injected and left in the cyst. The needle is then retracted and the procedure completed. Patients will receive oral prophylactic antibiotics for 5 days after the procedure. Clinical follow up with MRI imaging with be done at 6, 12, 18, and 24 months. For those with a persistent cyst at 12 months, a repeat EUS FNI procedure will be done.
| Study group | Role | What they receive |
|---|---|---|
| Ethanol and Paclitaxel Injection | Experimental | All patients will receive at least one treatment with alcohol and paclitaxel. Receives: Drug: Ethanol and Paclitaxel Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Cyst Resolution
Proportion of patients without cysts at 6 months
Measured: 6 months
Efficacy: Degree of Ablation
Degree of cyst epithelial ablation in those undergoing resection
Measured: 6 months
Secondary outcomes (5)
Safety
Safety of ethanol/paclitaxel ablation
Measured: 30 day
Efficacy: Change of tumor markers
Change of CEA level in those with persistent/recurrent cyst
Measured: 12 month
Efficacy: Cyst Resolution
Proportion of patients without cysts at 12 months
Measured: 12 month
Efficacy: Cyst Resolution
Proportion of patients without cysts at 18 months
Measured: 18 months
Efficacy: Cyst Resolution
Proportion of patients with no cysts at 24 months
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2012 (estimated)
- Study startSep 2012
- Primary completionNov 2016
- Study completionNov 2016
Why it stopped: Poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Mucinous Cystic Tumor With Moderate DysplasiaStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- University of Western Ontario, Canada
- Responsible party
- Principal investigator, Brian Yan, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Brian M Yan, MD, FRCPC, Principal investigator, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01525706
- Sponsor's protocol ID
- UWO18494
- Status last verified
- Nov 2016
- First submitted
- 1 Feb 2012
- Last updated
- 2 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Oh HC, Seo DW, Song TJ, Moon SH, Park DH, Soo Lee S, Lee SK, Kim MH, Kim J. Endoscopic ultrasonography-guided ethanol lavage with paclitaxel injection treats patients with pancreatic cysts. Gastroenterology. 2011 Jan;140(1):172-9. doi: 10.1053/j.gastro.2010.10.001. Epub 2010 Oct 13.
PubMed 20950614Oh HC, Seo DW, Lee TY, Kim JY, Lee SS, Lee SK, Kim MH. New treatment for cystic tumors of the pancreas: EUS-guided ethanol lavage with paclitaxel injection. Gastrointest Endosc. 2008 Apr;67(4):636-42. doi: 10.1016/j.gie.2007.09.038. Epub 2008 Feb 11.
PubMed 18262182DeWitt J, DiMaio CJ, Brugge WR. Long-term follow-up of pancreatic cysts that resolve radiologically after EUS-guided ethanol ablation. Gastrointest Endosc. 2010 Oct;72(4):862-6. doi: 10.1016/j.gie.2010.02.039.
PubMed 20883866DeWitt J, McGreevy K, Schmidt CM, Brugge WR. EUS-guided ethanol versus saline solution lavage for pancreatic cysts: a randomized, double-blind study. Gastrointest Endosc. 2009 Oct;70(4):710-23. doi: 10.1016/j.gie.2009.03.1173. Epub 2009 Jul 4.
PubMed 19577745
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EUS Guided Ethanol With Paclitaxel Ablation for Pancreatic Mucinous Cystic Neoplasm
- ClinicalTrials.gov ID
- NCT01525706
- Acronym / sponsor ID
- UWO18494
- Conditions
- Mucinous Cystic Tumor With Moderate Dysplasia, Mucinous Cystadenoma of Pancreas, Mucinous Cystadenocarcinoma of Pancreas, Benign Neoplasm of Pancreas
- Keywords
- Endoscopic Ultrasound, Pancreatic Mucinous Cystic Neoplasm, Fine Needle Injection, Ethanol Ablation, Paclitaxel Ablation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor recruitment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- University of Western Ontario, Canada
- Study start
- Sep 2012
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 3 Feb 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.
Pancreatic cysts are becoming diagnosed more frequently due to the increased use and sensitivity of imaging. A subset of these cysts are pre-cancerous, therefore suggested treatment is surgery for removal. However, surgery involves significant risks and emerging opinion suggests that not all cysts need to be surgically removed. An alternative therapy would be ideal, in particular for those where surgical risk outweighs the benefits of resection. Ethanol and paclitaxel ablation of pancreatic cysts may be a viable alternative to surgical resection.
Our hypothesis is that ethanol with paclitaxel ablation is a safe and effective method for treatment in those with per-cancerous, mucinous pancreatic cysts.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ethanol and Paclitaxel Injection | Experimental | Drug: Ethanol and Paclitaxel InjectionAll patients will receive at least one treatment with alcohol and paclitaxel. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Mucinous cystic neoplasm defined by cyst fluid analysis [23, 28]:
- Cyst size > 15mm but <50mm
- 3 or fewer cyst compartments
- Age ≥18 and ≤ 85
Key exclusion criteria (9 listed)
- Inability to safely undergo EUS examination with standard conscious sedation
- Inability for safe FNA needle insertion into the cyst (eg: intervening vessel)
- Inability to undergo MRI (metal implants/cardiac pacemaker/defibrillator, claustrophobia)
- Coagulopathy (INR>1.5 or platelets<50)
- Active pancreatitis or pancreatic infection
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 and Paclitaxel InjectionAlso: Ethanol, PaclitaxelEndoscopic ultrasound will be used to locate and assess the pancreatic cyst. The fluid contents will be aspirated using a fine needle and sent for tumor marker analysis and cytology. With the needle maintained in the same position, 99% ethanol will be injected into the cyst. After 3-5 minutes of lavage, the entire volume of fluid will be removed from the cyst. The same volume of paclitaxel minus 1 mL [3mg/ml diluted in normal saline from original concentration of 6mg/mL] will be injected and left in the cyst. The needle is then retracted and the procedure completed. Patients will receive oral prophylactic antibiotics for 5 days after the procedure. Clinical follow up with MRI imaging with be done at 6, 12, 18, and 24 months. For those with a persistent cyst at 12 months, a repeat EUS FNI procedure will be done. | Drug | Ethanol and Paclitaxel Injection |
Primary outcome
Efficacy: Cyst Resolution
Time frame: 6 months
Proportion of patients without cysts at 6 months
Efficacy: Degree of Ablation
Time frame: 6 months
Degree of cyst epithelial ablation in those undergoing resection
5 secondary outcomes
Safety
Time frame: 30 day
Efficacy: Change of tumor markers
Time frame: 12 month
Efficacy: Cyst Resolution
Time frame: 12 month
Efficacy: Cyst Resolution
Time frame: 18 months
Efficacy: Cyst Resolution
Time frame: 24 months
Results and safety
The study was stopped early (reason given: Poor recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
- Results publication: PubMed 20950614Oh HC, Seo DW, Song TJ, Moon SH, Park DH, Soo Lee S, Lee SK, Kim MH, Kim J. Endoscopic ultrasonography-guided ethanol lavage with paclitaxel injection treats patients with pancreatic cysts. Gastroenterology. 2011 Jan;140(1):172-9. doi: 10.1053/j.gastro.2010.10.001. Epub 2010 Oct 13.
- Results publication: PubMed 18262182Oh HC, Seo DW, Lee TY, Kim JY, Lee SS, Lee SK, Kim MH. New treatment for cystic tumors of the pancreas: EUS-guided ethanol lavage with paclitaxel injection. Gastrointest Endosc. 2008 Apr;67(4):636-42. doi: 10.1016/j.gie.2007.09.038. Epub 2008 Feb 11.
- Results publication: PubMed 20883866DeWitt J, DiMaio CJ, Brugge WR. Long-term follow-up of pancreatic cysts that resolve radiologically after EUS-guided ethanol ablation. Gastrointest Endosc. 2010 Oct;72(4):862-6. doi: 10.1016/j.gie.2010.02.039.
- Results publication: PubMed 19577745DeWitt J, McGreevy K, Schmidt CM, Brugge WR. EUS-guided ethanol versus saline solution lavage for pancreatic cysts: a randomized, double-blind study. Gastrointest Endosc. 2009 Oct;70(4):710-23. doi: 10.1016/j.gie.2009.03.1173. Epub 2009 Jul 4.
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.
Brian M Yan, MD, FRCPC principal investigator
Western University, Canada
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 Paclitaxel Injection in people with Mucinous Cystic Tumor With Moderate Dysplasia and Mucinous Cystadenoma of Pancreas, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 8 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: stopped early, as of the sponsor's last update on 2 Nov 2016. 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 Canada. 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?
The study was stopped early (reason given: Poor recruitment). 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?
Efficacy: Cyst Resolution (time frame: 6 months). 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 NCT01525706, which also lists 4 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 2 Nov 2016.