Long Term Outcomes After EUS-guided Ablation for Cystic Tumors of the Pancreas (EUS-EP)
Primary Purpose
Cystic Tumors of the Pancreas
Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Endoscopic ultrasonography-guided ethanol lavage with paclitaxel injection
Sponsored by
About this trial
This is an interventional treatment trial for Cystic Tumors of the Pancreas focused on measuring Cystic tumor, Pancreas, EUS
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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).
Sites / Locations
- Asan Medical Center, University of Ulsan College of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
EP
Arm Description
Single treatment arm
Outcomes
Primary Outcome Measures
Incidence of adverse events Treatment response by change of calculated cyst volume
recurrence during follow up
Secondary Outcome Measures
treatment response
predictive factors for complete resolution
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00689715
Brief Title
Long Term Outcomes After EUS-guided Ablation for Cystic Tumors of the Pancreas
Acronym
EUS-EP
Official Title
Long Term Outcomes After EUS-guided Ablation for Cystic Tumors of the Pancreas
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2006 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
August 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Tumors of the Pancreas
Keywords
Cystic tumor, Pancreas, EUS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EP
Arm Type
Experimental
Arm Description
Single treatment arm
Intervention Type
Procedure
Intervention Name(s)
Endoscopic ultrasonography-guided ethanol lavage with paclitaxel injection
Other Intervention Name(s)
paclitaxel (Taxol®, 6 mg/mL, Bristol-Myers Squibb Pharmaceutical Group)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of adverse events Treatment response by change of calculated cyst volume
Time Frame
early (< 7 days) and late (> 7days) adverse events
Title
recurrence during follow up
Time Frame
any recurrence of cyst after complete resolution during at least 3 years follow up
Secondary Outcome Measure Information:
Title
treatment response
Time Frame
1 year
Title
predictive factors for complete resolution
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong Wan Seo, M.D., Ph.D
Organizational Affiliation
Asan Medical Center, University of Ulsan Collge of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center, University of Ulsan College of Medicine
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
18262182
Citation
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.
Results Reference
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Long Term Outcomes After EUS-guided Ablation for Cystic Tumors of the Pancreas
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