EUS-Guided Pancreatic Injection of Cyst (EPIC) Trial

This study has been completed.
Sponsor:
Collaborator:
Indiana University School of Medicine
Information provided by (Responsible Party):
William R. Brugge, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00233038
First received: October 3, 2005
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

The purpose of the study is to learn about a new treatment for pancreatic cystic lesions. The injection of alcohol into cysts is a common way of treating cysts of the liver, kidney, and thyroid. We would like to find out if injection of alcohol would be useful for the treatment of pancreatic cystic lesions. The treatment with alcohol will use endoscopy and endoscopic ultrasound (procedures that use a scope that is placed through your mouth and into your stomach). We hypothesize that more than half of the cysts which are injected with ethanol will resolve.


Condition Intervention Phase
Pancreatic Cystadenoma
Procedure: Ethanol injection into a cyst
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: EUS-Guided Pancreatic Injection of Cyst (EPIC) Trial

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Enrollment: 50
Study Start Date: January 2005
Study Completion Date: March 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Detailed Description:

Cystic lesions of the kidney, thyroid, and liver are commonly treated with ethanol injections into the cyst cavity. The contact with ethanol results in rapid elimination of epithelial cells lining cyst cavities with few complications or pain. The majority of cysts become smaller and some are completely eliminated Depending on the type of cyst and tissue, some cysts can be completely ablated with ethanol. Although malignant masses arising from the pancreas have been safely injected with ethanol, there are no reports of injection of pancreatic cystadenomas. The ability to ablate cystadenomas of the pancreas would provide the first non-surgical treatment for these pre-malignant lesions of the pancreas.

Over the past two years we have conducted a pilot study of EUS-guided ethanol lavage of pancreatic cysts (2001-P-000358/5). 18 patients have undergone the procedure without evidence of pancreatitis, pain, or infection following the procedure. Initially, low concentrations of ethanol were used (5%) and over the course of the study, the concentration of the ethanol used for lavage has been increased to 60%. Although the patients have not undergone careful follow-up evaluations, it appears that at least 4 of the patients have had resolution of the cyst.

This is a prospective, randomized, blinded, controlled trial of ethanol ablation in 50 patients with a pancreatic cystadenoma. Patients with a pancreatic cyst (1-5cm in diameter) capable of safely undergoing endoscopy with conscious sedation will be candidates. Exclusion criteria include: coagulopathy (INR>1.5, PTT>100, platelets of< 50k), active infection of the cyst or unstable cardio-pulmonary disease (active angina, home O2, or pulmonary edema) will be excluded.

At the time of diagnostic cyst aspiration, the patient will be randomized to either saline lavage or ethanol (70%) lavage. During the exam, the cyst will be imaged with ultrasound, measured and aspirated. The cyst contents will be evaluated with cytologic evaluation, CEA, and amylase. After cyst aspiration, the cyst will be lavaged with either saline or ethanol for 5 minutes. At completion of the lavage, the cyst contents will be evacuated. The patient will be provided the results of the cyst fluid analysis and may elect to undergo surgical resection or additional lavage treatments. At the time of resection, the cyst and surrounding pancreas will be resected for histologic analysis. The degree of epithelial ablation will be determined with histologic sectioning and the cysts lavaged with ethanol will be compared to those cysts lavaged with saline. If the patient chooses not to have a surgical resection, the patient may return for a follow-up EUS exam at two additional monthly intervals with cyst aspiration and additional ethanol lavage. Those patients receiving saline during the initial treatment session will be crossed-over to ethanol.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a pancreatic cyst (1-5cm in diameter)
  • Capable of safely undergoing endoscopy with conscious sedation

Exclusion Criteria:

  • Coagulopathy (INR>1.5, PTT>100, platelets of< 50k)
  • Active infection of the cyst
  • Unstable cardio-pulmonary disease (active angina, home O2, or pulmonary edema)
  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: NCT00233038

Locations
United States, Indiana
Indiana University Medical Center
Indianapolis, Indiana, United States, 46202-5114
Sponsors and Collaborators
Massachusetts General Hospital
Indiana University School of Medicine
Investigators
Principal Investigator: William R. Brugge, MD Massachusetts General Hospital
  More Information

No publications provided by Massachusetts General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: William R. Brugge, MD, Director of Pancreas and Biliary Center, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00233038     History of Changes
Other Study ID Numbers: 2003-P-001745
Study First Received: October 3, 2005
Last Updated: October 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Pancreatic cancer
Pancreatic adenoma
Ethanol
Endoscopic ultrasound
Cyst ablation

Additional relevant MeSH terms:
Cystadenoma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Cystic, Mucinous, and Serous

ClinicalTrials.gov processed this record on September 29, 2014