Endoscopic Ethanol Ablation of Communicating Pancreatic Cystic Neoplasms

Phase 1

Withdrawn

• Conditions: Ultrasonography, Interventional; Neoplasms, Cystic, Mucinous, and Serous; Pancreatic Neoplasms
• Interventions: Procedure: EUS and/or ERCP with ethanol injections of pancreatic cyst

• Registration Number: NCT01057355
• Lead Sponsor: Mayo Clinic

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.

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 Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-26
• Study First Submitted QC: 2010-01-26
• Study First Posted: 2010-01-27
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-17
• Last Update Posted: 2014-09-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.)

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Exclusion Criteria

• Known or suspected pregnancy, or nursing
• History of pancreatitis within 3 months prior to study endoscopy procedures
• Cyst has a primarily microcystic architecture on EUS

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cyst ethanol lavage	EUS and/or ERCP with ethanol injections of pancreatic cyst	Subjects receiving the study intervention

Primary Outcome Measures

Name	Time	Method
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