EUS-guided Ablation of Pancreatic Cyst Neoplasms

NCT02422147 | Completed

• 1 other identifier: 723324
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

This is a registry that will maintain prospective data on the clinical outcomes of all patients with pancreatic cyst lesions who undergo EUS-guided alcohol ablation.

Conditions

Pancreatic Cyst

Outcome Measures

Primary Outcomes (1)

• This study will evaluate the clinical outcomes (effectiveness) of all patients with pancreatic cyst lesions undergoing EUS-guided ethanol ablation. This will include complete resolution of the pancreatic cyst lesion at the end of the treatment period.

  Clinical outcomes

  Up to 12 months

Study Arms (1)

Ablation of PCL

Patients with pancreatic cysts will undergo ablation using alcohol under EUS-guidance

Procedure: Ablation of PCL

Interventions

Ablation of PCL PROCEDURE

All procedures are standard of care and will be undertaken using a curvilinear echoendoscope. The cyst will be punctured using a 22G needle and after subtotal evacuation of the cyst, injection is performed with a volume of alcohol that is equal to the quantity aspirated, and the cyst will be lavaged for 3 to 5 minutes. The injected ethanol will then be evacuated at the end of lavage, leaving just enough fluid to outline the cavity. A second ablative agent such as paclitaxel is then injected and left in the cyst cavity. At the completion of the procedure, the needle will be removed from the cyst cavity.

Also known as: EUS-guided ablation of pancreatic cyst lesions (PCL)

Ablation of PCL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Any male or female presenting to Florida Hospital Center for Interventional Endoscopy with a pancreatic cyst will be considered for this registry pending he/she meets inclusion/exclusion criteria.

You may qualify if:

• Benign branch-duct intraductal papillary mucinous neoplasm (IPMN) or mucinous cyst neoplasm (MCN) measuring \>2 and up to 4cm in size and located in the head or body of the pancreas.
• Benign branch-duct IPMN or MCN measuring \> 2 and up to 4cm in size and located in the tail of the pancreas in a high-risk surgical candidate.
• A branch-duct IPMN or MCN with high-risk features (mural nodule or enlarging in size) in a high-risk surgical patient.
• Indeterminate cyst lesions

You may not qualify if:

• Cysts measuring \<2cm or \>4cm.
• Multiloculated cysts (\>4 locules).
• Cysts with vascular supply.
• Cysts communicating with the main pancreatic duct via an obvious side-branch measuring 2mm or more in diameter.
• Cysts with hypoechoic mass lesions that on fine needle aspiration (FNA)reveal malignant cells.
• Recent history of pancreatitis and EUS findings suggestive of a pseudocyst.
• Bleeding tendency; international normalized ratio (INR) \>1.4 or platelet count \<70,000.

Sponsors & Collaborators

• AdventHealth: lead

Study Sites (1)

AdventHealth

Orlando, Florida, 32803, United States

Location

MeSH Terms

Conditions

Pancreatic Cyst

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Pancreatic Diseases; Digestive System Diseases

Study Officials

• Muhammad Hasan, MD

  AdventHealth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2015
• First Posted: April 21, 2015
• Study Start: June 1, 2016
• Primary Completion: December 12, 2024
• Study Completion: December 12, 2024
• Last Updated: December 17, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)