Endoscopic Ethanol Ablation of Communicating Pancreatic Cystic Neoplasms

Sponsor

Mayo Clinic (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01057355

Collaborator

(none)

Enrollment

Arm

Duration (Months)

Study Details

Study Description

Brief Summary

Pancreatic cysts are common, and some pancreas cysts have malignant potential. Usual treatment of these cysts is either observation or surgical removal of part or all of the pancreas. Minimally invasive treatment via endoscopy has been described, using endoscopic ultrasound (EUS) guided ethanol injections. Such studies exclude cysts that communicate with the main pancreatic duct, to avoid burning the main pancreatic duct with ethanol. In this study, pancreas cysts communicating with the main pancreas duct are treated with ethanol via endoscopic retrograde cholangiopancreatography (ERCP) and/or EUS.

Condition or Disease	Intervention/Treatment	Phase
Neoplasms, Cystic, Mucinous, and Serous Pancreatic Neoplasms Ultrasonography, Interventional	Procedure: EUS and/or ERCP with ethanol injections of pancreatic cyst	Phase 1

Detailed Description

Subjects will undergo EUS and/or ERCP as outpatients. For cysts shown to communicate with the main pancreas duct, a balloon catheter will be placed in the main pancreatic duct via ERCP. The balloon catheter will isolate the cyst from the main pancreatic duct, allowing ethanol injections of the cyst. A pancreatic duct stent will be placed in some patients, requiring repeat endoscopy for removal at another time.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Endoscopic Ethanol Ablation of Communicating Pancreatic Cystic Neoplasms

Study Start Date :

Jan 1, 2010

Actual Primary Completion Date :

Jun 1, 2013

Actual Study Completion Date :

Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cyst ethanol lavage Subjects receiving the study intervention	Procedure: EUS and/or ERCP with ethanol injections of pancreatic cyst Lavage of cyst with 80% ethanol Other Names: Alcohol lavage Alcohol injection Ethanol lavage Ethanol injection Endoscopic treatment Pancreas cyst ablation

Arm

Intervention/Treatment

Experimental: Cyst ethanol lavage

Subjects receiving the study intervention

Procedure: EUS and/or ERCP with ethanol injections of pancreatic cyst

Lavage of cyst with 80% ethanol

Other Names:

Alcohol lavage

Alcohol injection

Ethanol lavage

Ethanol injection

Endoscopic treatment

Pancreas cyst ablation

Outcome Measures

Primary Outcome Measures

Occurrence of adverse events requiring treatment or hospitalization [3 days, 30 days]
Decrease in volume of the pancreatic cyst by cross-sectional imaging studies (CT or MR) performed before and after treatment [6 months, 12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Presence of a pancreatic cystic lesion, at least 2 cm in maximum diameter
Cyst may communicate, or definitely communicates, with the pancreatic duct (based on prior CT, MR, ERCP, or EUS images)
Treatment of the cystic lesion is desired due to symptoms or concern for subsequent malignancy
Age at least 18 years
Able to give informed consent
Surgical treatment has been considered and a surgical consultation offered to the patient, OR the subject's cyst does not meet consensus criteria for surgical resection. (Current consensus criteria for resection are one or more of the following: cyst is symptomatic, ≥ 3 cm in diameter, contains a mural nodule, cytology of cyst fluid is positive for malignancy, or main pancreatic duct diameter is > 6 mm.)