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Asan Medical Center |
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Information provided by: | Asan Medical Center |
ClinicalTrials.gov Identifier: | NCT00689715 |
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.
Condition | Intervention | Phase |
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Cystic Tumors of the Pancreas |
Procedure: Endoscopic ultrasonography-guided ethanol lavage with paclitaxel injection |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase 2/3 Study of EUS-Guided Ethanol Lavage With Paclitaxel Injection for Cystic Tumors of the Pancreas |
Estimated Enrollment: | 50 |
Study Start Date: | June 2006 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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EP: Experimental
Single treatment arm
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Procedure: Endoscopic ultrasonography-guided ethanol lavage with paclitaxel injection
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.
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Ages Eligible for Study: | 20 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Dong Wan Seo, M.D., Ph.D. | 82-2-3010-3192 | dwseoamc@amc.seoul.kr |
Contact: Hyoung-Chul Oh, M.D., Ph.D. | 82-2-748-9813 | ohcgi@cau.ac.kr |
Korea, Republic of | |
Asan Medical Center, University of Ulsan College of Medicine | Recruiting |
Seoul, Korea, Republic of, 138-736 | |
Contact: Dong Wan Seo 82-2-3010-3192 dwseoamc@amc.seoul.kr | |
Principal Investigator: Dong Wan Seo, M.D., Ph.D. | |
Sub-Investigator: Hyoung-Chul Oh, M.D., Ph.D. |
Principal Investigator: | Dong Wan Seo, M.D., Ph.D | Asan Medical Center, University of Ulsan Collge of Medicine |
Responsible Party: | Asan Medical Center, University of Ulsan College of Medicine ( Dong Wan Seo, Associate professor ) |
Study ID Numbers: | AMC0183 |
Study First Received: | June 2, 2008 |
Last Updated: | June 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00689715 |
Health Authority: | Korea: Food and Drug Administration |
Cystic tumor Pancreas EUS |
Digestive System Diseases Digestive System Neoplasms Paclitaxel Pancreatic Neoplasms Endocrine System Diseases Pancreatic Diseases |
Gastrointestinal Neoplasms Endocrinopathy Pancrelipase Ethanol Endocrine Gland Neoplasms |
Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Mitosis Modulators Gastrointestinal Agents Central Nervous System Depressants Antimitotic Agents |
Pharmacologic Actions Anti-Infective Agents, Local Neoplasms Neoplasms by Site Therapeutic Uses Tubulin Modulators Antineoplastic Agents, Phytogenic Central Nervous System Agents |