Endoscopic Ultrasonography-guided Double Ethanol Lavage for Pancreatic Cysts: a Prospective Cohort Study

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

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-08-31

Brief Summary

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Due to widespread use of cross-sectional imaging modalities, pancreatic cysts are common in abdominal image. These lesions encompass a wide spectrum, ranging from benign to malignant. The diagnosing specific type of cystic lesion is limited in spite of recent advances of diagnostic modalities. Surgical resection is generally recommended for malignant and potentially malignant lesions. However, surgical resection has significant morbidity and sometimes mortality. Recently, a few study of EUS-guided ethanol lavage for cystic tumors of the pancreas reported that complete resolution was achieved in only one-third of patients. Ethanol lavage of pancreatic cysts may be alternative method to surgical resection.

The purpose of this study is the double ethanol lavage is a safe and effective method for treatment in those with the indeterminate pancreas cysts.

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Detailed Description

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Conditions

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Pancreatic Mucinous-Cystic Neoplasm

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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ethanol double lavage

Endoscopic ultrasonography-guided double ethanol lavage

Group Type EXPERIMENTAL

Endoscopic ultrasonography-guided double ethanol lavage

Intervention Type DRUG

A radial echoendoscope and a 22 gauge needle were then used for cyst fluid aspiration and ethanol lavage.

The 80 percent volume of cyst fluid was aspirated, and the pure ethanol was injected into the collapsed cyst until the original shape was restored. After 3-5 minutes, the reaspiration of the injected ethanol was then performed. The pure ethanol was reinjected into the collapsed cyst, followed by reaspiration of maximal possible volume for 3-5 minutes.

Interventions

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Endoscopic ultrasonography-guided double ethanol lavage

A radial echoendoscope and a 22 gauge needle were then used for cyst fluid aspiration and ethanol lavage.

The 80 percent volume of cyst fluid was aspirated, and the pure ethanol was injected into the collapsed cyst until the original shape was restored. After 3-5 minutes, the reaspiration of the injected ethanol was then performed. The pure ethanol was reinjected into the collapsed cyst, followed by reaspiration of maximal possible volume for 3-5 minutes.

Intervention Type DRUG

Other Intervention Names

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Ethanol

Eligibility Criteria

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Inclusion Criteria

* Patients age 18 and older of any gender, ethnicity and race
* Voluntary enrollment and ability to give written informed consent
* Capable of safely undergoing endoscopy with deep sedation or general anesthesia
* Indeterminate cystic lesion which was diagnosed in cross-sectional image (CT and MRI)
* Pancreatic cystic lesion having uni- or oligo-locular (defined as having 2-6 locules within a cyst) and 2\~4 cm in diameter

Exclusion Criteria

* Pancreatic cystic lesions which had the typical morphology of serous cystadenomas (i.e., honeycomb appearance) and pseudocysts (i.e., recent history of acute pancreatitis or parenchymal changes)
* Pancreatic cystic lesions having communication between the cystic lesion and the main pancreatic duct according to endoscopic retrograde cholangiopancreatography and magnetic resonance cholangiopancreatography
* Pancreatic cystic lesions having overt evidence of carcinomas, such as peripancreatic invasion
* Patients with a bleeding tendency (prothrombin time \> 1.5 international normalized ratio \[INR\] or platelet count \< 50,000/μL).

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes