Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00233038
Status:
COMPLETED
Last Update Posted:
2013-10-29
First Post:
2005-10-03
Brief Title:
EUS-Guided Pancreatic Injection of Cyst EPIC Trial
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
EUS-Guided Pancreatic Injection of Cyst EPIC Trial
Status:
COMPLETED
Status Verified Date:
2013-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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-0003585 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 INR15 PTT100 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
Over the past two years we have conducted a pilot study of EUS-guided ethanol lavage of pancreatic cysts 2001-P-0003585 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 INR15 PTT100 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None