Endoscopic Ethanol Ablation of Communicating Pancreatic Cystic Neoplasms

Pancreatic Neoplasms Clinical Trial

Official title:

Endoscopic Ethanol Ablation of Communicating Pancreatic Cystic Neoplasms

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01057355
• Other study ID #: 009-004705
• Status: Withdrawn
• Phase: Phase 1
• First received: January 26, 2010
• Last updated: September 17, 2014
• Start date: January 2010
• Est. completion date: June 2013

Study information

• Verified date: September 2014
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Other known NCT identifiers

• NCT01100229

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Procedure:
• EUS and/or ERCP with ethanol injections of pancreatic cyst
Lavage of cyst with 80% ethanol

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of adverse events requiring treatment or hospitalization		3 days, 30 days	Yes
Primary	Decrease in volume of the pancreatic cyst by cross-sectional imaging studies (CT or MR) performed before and after treatment		6 months, 12 months	No