Endoscopic Ethanol Ablation of Communicating Pancreatic Cystic Neoplasms

Mayo Clinic

Status and phase: Withdrawn; Phase 1

Conditions: Ultrasonography, Interventional; Neoplasms, Cystic, Mucinous, and Serous; Pancreatic Neoplasms

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01057355

009-004705

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No 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.)

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Cyst ethanol lavage

Experimental group

Description:

Subjects receiving the study intervention

Treatment:

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