Endoscopic Ethanol Ablation of Communicating Pancreatic Cystic Neoplasms

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cyst ethanol lavage

Subjects receiving the study intervention

Group Type EXPERIMENTAL

EUS and/or ERCP with ethanol injections of pancreatic cyst

Intervention Type PROCEDURE

Lavage of cyst with 80% ethanol

Interventions

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EUS and/or ERCP with ethanol injections of pancreatic cyst

Lavage of cyst with 80% ethanol

Intervention Type PROCEDURE

Other Intervention Names

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Alcohol lavage Alcohol injection Ethanol lavage Ethanol injection Endoscopic treatment Pancreas cyst ablation

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No