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

NCT02213419 | Unknown Phase 1 DMC

• 1 other identifier: 2014-06-058-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Mucinous-Cystic Neoplasm

Keywords

Cystic Tumors of the Pancreas; Endoscopic Ultrasound; Ethanol

Outcome Measures

Primary Outcomes (1)

• Rate of Subjects with Complete or Partial response of treatment

  Complete or partial response of treatment will be defined by the presence of a treated cystic structure, and its volume and maximum diameter in cross-sectional imaging studies (CT, MR)

  1 year after final treatment

Secondary Outcomes (1)

• Incidence rate of adverse events after treatment

  1 year after final treatment

Study Arms (1)

ethanol double lavage

EXPERIMENTAL

Endoscopic ultrasonography-guided double ethanol lavage

Drug: Endoscopic ultrasonography-guided double ethanol lavage

Interventions

Endoscopic ultrasonography-guided double ethanol lavage 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.

Also known as: Ethanol

ethanol double lavage

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Cencer

Seoul, 135-710, South Korea

RECRUITING

MeSH Terms

Interventions

Ethanol

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Jong-Kyun Lee, M.D., Ph.D.

  Division of Gastroenterology, Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jong-Kyun Lee, M.D., Ph.D.

CONTACT

82-2-3410-3407; jongk.lee@samsung.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2014
• First Posted: August 11, 2014
• Study Start: October 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: February 12, 2015

Record last verified: 2014-07

Locations

KR (1)