Efficacy Study of Endoscopic Ultrasonography (EUS)-Guided Ethanol Lavage With Paclitaxel Injection for Cystic Tumors of the Pancreas
Information source: Asan Medical Center
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cystic Tumors of the Pancreas
Intervention: Endoscopic ultrasonography-guided ethanol lavage with paclitaxel injection (Procedure)
Phase: Phase 2/Phase 3
Status: Recruiting
Sponsored by: Asan Medical Center Official(s) and/or principal investigator(s):
Dong Wan Seo, M.D., Ph.D, Principal Investigator, Affiliation: Asan Medical Center, University of Ulsan Collge of Medicine
Overall contact:
Dong Wan Seo, M.D., Ph.D., Phone: 82-2-3010-3192, Email: dwseoamc@amc.seoul.kr
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.
Clinical Details
Official title: Phase 2/3 Study of EUS-Guided Ethanol Lavage With Paclitaxel Injection for Cystic Tumors of the Pancreas
Study design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Incidence of complications
Treatment response by change of calculated cyst volume
Eligibility
Minimum age: 20 Years.
Maximum age: 85 Years.
Gender(s): Both.
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).
Locations and Contacts
Dong Wan Seo, M.D., Ph.D., Phone: 82-2-3010-3192, Email: dwseoamc@amc.seoul.kr
Asan Medical Center, University of Ulsan College of Medicine, Seoul 138-736, Korea, Republic of; Recruiting
Dong Wan Seo, Phone: 82-2-3010-3192, Email: dwseoamc@amc.seoul.kr
Dong Wan Seo, M.D., Ph.D., Principal Investigator
Hyoung-Chul Oh, M.D., Ph.D., Sub-Investigator
Additional Information
Related 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. Epub 2008 Feb 11.
Starting date: June 2006
Last updated: June 3, 2008
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