Cystic Tumors of the PancreasPhase 2/3EUS-EPNCT00689715
Long Term Outcomes After EUS-guided Ablation for Cystic Tumors of the Pancreas
A Phase 2/3 study testing Endoscopic ultrasonography-guided ethanol lavage with paclitaxel injection in people with Cystic Tumors of the Pancreas, run by Asan Medical Center at 1 site in South Korea.
Trial summary
Cystic lesions of the pancreas are defined as round, fluid-filled structures within the pancreas detected by radiologic imaging. With widespread use of cross-sectional imaging modalities for various indications, such lesions are now detected in nearly 20% of abdominal imagings, with the majority discovered… Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Cystic Tumors of the Pancreas
- What is being tested?
- Endoscopic ultrasonography-guided ethanol lavage with 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
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2006to Aug 2016
- Phase
- Phase 2/3
- 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- uni- or oligo-locular cystic tumors
- indeterminate cystic tumors for which EUS-guided fine needle aspiration (FNA) was required to obtain additional information
- cystic tumors that increased in size during the observation period
Who cannot join
- cystic tumors which had the typical morphology of serous cystadenomas (i.e., honeycomb appearance) and pseudocysts (i.e., parenchymal changes)
- evidence of communication between the cystic lesion and the main pancreatic duct according to endoscopic retrograde pancreatograms
- overt carcinomas with peripancreatic invasion
- patients with a bleeding tendency (prothrombin time > 1.5 international normalized ratio [INR] or platelet count < 50,000/μL).
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Asan Medical Center, University of Ulsan College of Medicine
Seoul, 138-736
About this study
Cystic lesions of the pancreas are defined as round, fluid-filled structures within the pancreas detected by radiologic imaging. With widespread use of cross-sectional imaging modalities for various indications, such lesions are now detected in nearly 20% of abdominal imagings, with the majority discovered incidentally. These lesions encompass a wide spectrum of histopathologic entities and biologic behavior, ranging from benign to malignant. Substantial morphologic overlap restricts the accuracy in diagnosing specific type of cystic lesion in spite of recent advances in diagnostic modalities. It is a challenging issue to differentiate each cystic lesion and make a management plan since cystic lesions that are relatively common and asymptomatic may possess malignant potential. Although inflammatory pseudocysts were thought to account for 80-90% of cystic lesions of the pancreas, with cystic tumors accounting for the remaining,10 the latter may occur much more frequently than traditionally estimated.
To date, surgical resection is generally recommended for malignant and potentially malignant lesions. However, surgical resection of the pancreas still carries substantial morbidity and sometimes mortality, especially for the cystic lesion located in the head portion. Therefore, management should be individualized by risk-benefit analysis for each patient.
Read more
Recently, a pilot study of EUS-guided ethanol lavage for cystic tumors of the pancreas reported that complete resolution was achieved in only one-third of patients even though epithelial lining ablation was demonstrated in all resected specimens. Therefore, more effective treatment modalities or ablation agents are required to improve treatment responses. Intratumoral or intraperitoneal injection of chemotherapeutic agent has been used for endobronchial lesions of lung cancer, brain tumors and advanced ovarian cancer.13-16 EUS-guided injection of antitumor material has been reported in advanced pancreatic cancer. Although local injection of chemotherapeutic agents into pancreatic cystic tumors has not yet been reported, it is reasonable to suggest that such an approach may have an additive effect on ablation of the epithelial lining of cystic tumor when combined with ethanol lavage.
Paclitaxel, a widely used chemotherapeutic agent, inhibits cell processes that are dependent on microtubule turnover. Due to its highly hydrophobic nature,19 paclitaxel is expected to exert its effect longer when instilled within a closed cavity such as a cyst. The hydrophobic and viscous nature of paclitaxel may reduce the possibility of it leaking through a puncture site and causing complications.
The present study evaluated safety, feasibility and response following EUS-guided ethanol lavage with paclitaxel injection (EUS-EP) for treating cystic tumors of the pancreas.
- Conditions
- Cystic Tumors of the Pancreas
- Being tested
- Endoscopic ultrasonography-guided ethanol lavage with paclitaxel injection
- Keywords
- Cystic tumor, Pancreas, EUS
- 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.
Endoscopic ultrasonography-guided ethanol lavage with paclitaxel injectionProcedure or surgery
Also called paclitaxel (Taxol®, 6 mg/mL, Bristol-Myers Squibb Pharmaceutical Group)
A curvilinear-array echoendoscope and a 22 gauge needle were then used for cyst fluid aspiration, ethanol lavage and paclitaxel injection. The maximum possible volume of cyst fluid was aspirated, and the needle tip was carefully maintained inside the cyst to avoid parenchymal injury. Ethanol was injected into the collapsed cyst until the original shape was restored, and a lavage was then performed for 3-5 minutes. Pure ethanol (99%) was used for all patients except the first 2 in whom 88% ethanol was used. After reaspiration of the injected ethanol, the cyst cavity was injected with a solution containing 3 mg/mL paclitaxel and the needle then carefully retracted. The high viscosity of paclitaxel necessitated dilution in 0.9% normal saline for administration via a 22G needle. The volume of the paclitaxel solution administered was the same as the volume of the cyst fluid aspirated.
| Study group | Role | What they receive |
|---|---|---|
| EP | Experimental | Single treatment arm Receives: Procedure: Endoscopic ultrasonography-guided ethanol lavage with paclitaxel injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events Treatment response by change of calculated cyst volume
Measured: early (< 7 days) and late (> 7days) adverse events
recurrence during follow up
Measured: any recurrence of cyst after complete resolution during at least 3 years follow up
Secondary outcomes (2)
treatment response
Measured: 1 year
predictive factors for complete resolution
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2008 (estimated)
- Study startJun 2006
- Primary completionAug 2016 (estimated)
- Study completionAug 2016 (estimated)
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 Cystic Tumors of the PancreasStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Wan Seo, Asan Medical Center
- Investigators
- Dong Wan Seo, M.D., Ph.D, Principal investigator, Asan Medical Center, University of Ulsan Collge of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00689715
- Sponsor's protocol ID
- AMC0183
- Acronym
- EUS-EP
- Status last verified
- Jul 2016
- First submitted
- 2 Jun 2008
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Oh 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 18262182
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Outcomes After EUS-guided Ablation for Cystic Tumors of the Pancreas
- ClinicalTrials.gov ID
- NCT00689715
- Acronym / sponsor ID
- EUS-EP / AMC0183
- Conditions
- Cystic Tumors of the Pancreas
- Keywords
- Cystic tumor, Pancreas, EUS
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 4 Jun 2008 (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.
Cystic lesions of the pancreas are defined as round, fluid-filled structures within the pancreas detected by radiologic imaging. With widespread use of cross-sectional imaging modalities for various indications, such lesions are now detected in nearly 20% of abdominal imagings, with the majority discovered incidentally. These lesions encompass a wide spectrum of histopathologic entities and biologic behavior, ranging from benign to malignant. Substantial morphologic overlap restricts the accuracy in diagnosing specific type of cystic lesion in spite of recent advances in diagnostic modalities. It is a challenging issue to differentiate each cystic lesion and make a management plan since cystic lesions that are relatively common and asymptomatic may possess malignant potential. Although inflammatory pseudocysts were thought to account for 80-90% of cystic lesions of the pancreas, with cystic tumors accounting for the remaining,10 the latter may occur much more frequently than traditionally estimated.
To date, surgical resection is generally recommended for malignant and potentially malignant lesions. However, surgical resection of the pancreas still carries substantial morbidity and sometimes mortality, especially for the cystic lesion located in the head portion. Therefore, management should be individualized by risk-benefit analysis for each patient.
Recently, a pilot study of EUS-guided ethanol lavage for cystic tumors of the pancreas reported that complete resolution was achieved in only one-third of patients even though epithelial lining ablation was demonstrated in all resected specimens. Therefore, more effective treatment modalities or ablation agents are required to improve treatment responses. Intratumoral or intraperitoneal injection of chemotherapeutic agent has been used for endobronchial lesions of lung cancer, brain tumors and advanced ovarian cancer.13-16 EUS-guided injection of antitumor material has been reported in advanced pancreatic cancer. Although local injection of chemotherapeutic agents into pancreatic cystic tumors has not yet been reported, it is reasonable to suggest that such an approach may have an additive effect on ablation of the epithelial lining of cystic tumor when combined with ethanol lavage.
Paclitaxel, a widely used chemotherapeutic agent, inhibits cell processes that are dependent on microtubule turnover. Due to its highly hydrophobic nature,19 paclitaxel is expected to exert its effect longer when instilled within a closed cavity such as a cyst. The hydrophobic and viscous nature of paclitaxel may reduce the possibility of it leaking through a puncture site and causing complications.
The present study evaluated safety, feasibility and response following EUS-guided ethanol lavage with paclitaxel injection (EUS-EP) for treating cystic tumors of the pancreas.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EP | Experimental | Procedure: Endoscopic ultrasonography-guided ethanol lavage with paclitaxel injectionSingle treatment arm |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- uni- or oligo-locular cystic tumors
- indeterminate cystic tumors for which EUS-guided fine needle aspiration (FNA) was required to obtain additional information
- cystic tumors that increased in size during the observation period
Key exclusion criteria (4 listed)
- cystic tumors which had the typical morphology of serous cystadenomas (i.e., honeycomb appearance) and pseudocysts (i.e., parenchymal changes)
- evidence of communication between the cystic lesion and the main pancreatic duct according to endoscopic retrograde pancreatograms
- overt carcinomas with peripancreatic invasion
- patients with a bleeding tendency (prothrombin time > 1.5 international normalized ratio [INR] or platelet count < 50,000/μL).
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 |
|---|---|---|
| Endoscopic ultrasonography-guided ethanol lavage with paclitaxel injectionAlso: paclitaxel (Taxol®, 6 mg/mL, Bristol-Myers Squibb Pharmaceutical Group)A curvilinear-array echoendoscope and a 22 gauge needle were then used for cyst fluid aspiration, ethanol lavage and paclitaxel injection. The maximum possible volume of cyst fluid was aspirated, and the needle tip was carefully maintained inside the cyst to avoid parenchymal injury. Ethanol was injected into the collapsed cyst until the original shape was restored, and a lavage was then performed for 3-5 minutes. Pure ethanol (99%) was used for all patients except the first 2 in whom 88% ethanol was used. After reaspiration of the injected ethanol, the cyst cavity was injected with a solution containing 3 mg/mL paclitaxel and the needle then carefully retracted. The high viscosity of paclitaxel necessitated dilution in 0.9% normal saline for administration via a 22G needle. The volume of the paclitaxel solution administered was the same as the volume of the cyst fluid aspirated. | Procedure or surgery | EP |
Primary outcome
Incidence of adverse events Treatment response by change of calculated cyst volume
Time frame: early (< 7 days) and late (> 7days) adverse events
recurrence during follow up
Time frame: any recurrence of cyst after complete resolution during at least 3 years follow up
2 secondary outcomes
treatment response
Time frame: 1 year
predictive factors for complete resolution
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
- Background: 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.
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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.
Dong Wan Seo, M.D., Ph.D principal investigator
Asan Medical Center, University of Ulsan Collge of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Endoscopic ultrasonography-guided ethanol lavage with paclitaxel injection in people with Cystic Tumors of the Pancreas, run by Asan Medical Center at 1 site in South Korea.
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 4 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: status not confirmed, as of the sponsor's last update on 26 Jul 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 South Korea. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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?
Incidence of adverse events Treatment response by change of calculated cyst volume (time frame: early (< 7 days) and late (> 7days) adverse events). 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 NCT00689715, 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 Jul 2016.