ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Efficacy Study of Endoscopic Ultrasonography (EUS)-Guided Ethanol Lavage With Paclitaxel Injection for Cystic Tumors of the Pancreas (EUS-EP)

This study is currently recruiting participants.
Study NCT00689715.   Last updated on June 3, 2008.   Information provided by Asan Medical Center

This Tabular View shows the required WHO registration data elements as marked by

Descriptive Information Fields
Brief Title  Efficacy Study of Endoscopic Ultrasonography (EUS)-Guided Ethanol Lavage With Paclitaxel Injection for Cystic Tumors of the Pancreas
Official Title  Phase 2/3 Study of EUS-Guided Ethanol Lavage With Paclitaxel Injection for Cystic Tumors of the Pancreas
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.

Detailed Description
Study Phase Phase II, Phase III
Study Type  Interventional
Study Design  Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary Outcome Measure  Incidence of complications Treatment response by change of calculated cyst volume [ Time Frame: 30-days for complication and at least 6 months for treatment response ] [ Designated as safety issue: Yes ]
Secondary Outcome Measure 
Condition  Cystic Tumors of the Pancreas
Intervention  Procedure: Endoscopic ultrasonography-guided ethanol lavage with paclitaxel injection
MEDLINE PMIDs 18262182
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  50
Start Date  June 2006
Completion Date
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).
Gender Both
Ages 20 Years to 85 Years
Accepts Healthy Volunteers No
Contacts ††
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    
Location Countries  Korea, Republic of
Administrative Information Fields
NCT ID  NCT00689715
Organization ID AMC0183
Secondary IDs ††
Study Sponsor  Asan Medical Center
Collaborators ††
Investigators 
Principal Investigator:     Dong Wan Seo, M.D., Ph.D     Asan Medical Center, University of Ulsan Collge of Medicine    
Information Provided By Asan Medical Center
Verification Date June 2008
First Received Date  June 2, 2008
Last Updated Date June 3, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




Links to all studies - primarily for crawlers