Efficacy Study of EUS-guided Ethanol Lavage With Paclitaxel Injection for Cystic Tumors of the Pancreas (EUS-EP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Asan Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Dong Wan Seo, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT00689715
First received: June 2, 2008
Last updated: February 2, 2012
Last verified: February 2012
  Purpose

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
Cystic Tumors of the Pancreas
Procedure: Endoscopic ultrasonography-guided ethanol lavage with paclitaxel injection
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2/3 Study of EUS-guided Ethanol Lavage With Paclitaxel Injection for Cystic Tumors of the Pancreas

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: June 2006
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EP
Single treatment arm
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.
Other Name: paclitaxel (Taxol®, 6 mg/mL, Bristol-Myers Squibb Pharmaceutical Group)

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00689715

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

Locations
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.         
Sponsors and Collaborators
Asan Medical Center
Investigators
Principal Investigator: Dong Wan Seo, M.D., Ph.D Asan Medical Center, University of Ulsan Collge of Medicine
  More Information

Publications:
Responsible Party: Dong Wan Seo, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT00689715     History of Changes
Other Study ID Numbers: AMC0183
Study First Received: June 2, 2008
Last Updated: February 2, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Asan Medical Center:
Cystic tumor
Pancreas
EUS

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Ethanol
Pancreatin
Pancrelipase
Paclitaxel
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 26, 2014