Endoscopic Ethanol Ablation of Communicating Pancreatic Cystic Neoplasms

Mayo Clinic

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Neoplasms, Cystic, Mucinous, and Serous Pancreatic Neoplasms Ultrasonography, Interventional

Interventions

EUS and/or ERCP with ethanol injections of pancreatic cystPROCEDURE

Lavage of cyst with 80% ethanol

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Occurrence of adverse events requiring treatment or hospitalization

Time frame: 3 days, 30 days

Decrease in volume of the pancreatic cyst by cross-sectional imaging studies (CT or MR) performed before and after treatment

Time frame: 6 months, 12 months

Data from ClinicalTrials.gov

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