Endoscopic Ethanol Ablation of Communicating Pancreatic Cystic Neoplasms

NCT01057355 | Withdrawn Phase 1 DMC

• 1 other identifier: 009-004705
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

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

Keywords

Intraductal papillary mucinous neoplasm; Mucinous cystic neoplasm; Endoscopic ultrasound; Endoscopic retrograde cholangiopancreatography; Pancreatic cyst; Pancreas cyst; Alcohol

Outcome Measures

Primary Outcomes (2)

• Occurrence of adverse events requiring treatment or hospitalization

  3 days, 30 days

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

  6 months, 12 months

Study Arms (1)

Cyst ethanol lavage

EXPERIMENTAL

Subjects receiving the study intervention

Procedure: EUS and/or ERCP with ethanol injections of pancreatic cyst

Interventions

EUS and/or ERCP with ethanol injections of pancreatic cyst PROCEDURE

Lavage of cyst with 80% ethanol

Also known as: Alcohol lavage, Alcohol injection, Ethanol lavage, Ethanol injection, Endoscopic treatment, Pancreas cyst ablation

Cyst ethanol lavage

Eligibility Criteria

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

You may qualify if:

• 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.)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

MeSH Terms

Conditions

Neoplasms, Cystic, Mucinous, and Serous; Pancreatic Neoplasms; Pancreatic Cyst

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Cysts

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Mark Topazian, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: January 26, 2010
• First Posted: January 27, 2010
• Study Start: January 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: September 19, 2014

Record last verified: 2014-09