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A Prospective Study of the Management of Incidentally Discovered Pancreatic Cysts

Phase 3
18 Years
90 Years
Not Enrolling
Pancreatic Cyst

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Trial Information

A Prospective Study of the Management of Incidentally Discovered Pancreatic Cysts

The appropriate management of patients with cystic lesions of the pancreas is controversial.
The identification of small asymptomatic pancreatic cysts is increasing due to an
improvement in the quality of radiologic imaging and the frequency that imaging is obtained.
However, the natural history of these lesions is unknown1. The current consensus
guidelines established at the International Consensus Conference in Sendai, Japan in 2005
suggest that branch chain IPMNs and mucinous cystic neoplasms that cause no symptoms,
measure <3cm, and have no nodules can be observed with periodic imaging. However, the time
course of these pre malignant mucinous lesions, intraductal papillary mucinous neoplasms
(IPMN) or mucinous cystadenomas, from benign to malignant has not been determined. Due to
the unknown natural history, and diagnostic uncertainty, some authors have recommended
routine resection2, 3. Resection, despite improvements in surgical outcomes after
pancreatectomy at high volume centers, carries a mortality and morbidity of 1-6% and 35-51%,
respectively4-6. More recently studies are reporting a more selective approach to avoid the
risk of operation in patients with benign lesions7. Improved radiographic and endoscopic
studies have been able to identify some lesions with increased malignant potential8, 9.
Thus, most patients will undergo pancreas specific radiologic imaging and endoscopic
ultrasound with cyst aspiration. Since the natural history of cystic lesions is poorly
understood no clear guidelines for surgical resection have been established. Some of the
cysts will grow over time, with an increase in the cumulative risk of malignancy.
Therefore, the therapeutic alternatives are to wait and watch for a change in the cyst
morphology or to treat preemptively, which has been restricted to surgical resection. Based
on the pilot study performed by Dr. William Brugge, at Massachusetts General Hospital,
ethanol lavage of pancreatic cysts is safe and will result in a decrease in cyst diameter in
61% of patients. Additionally, if patients elect to not be treated preemptively it is
unclear how to best follow these patients in terms of the type and the frequency of follow
up studies.

Inclusion Criteria:

- Cyst between 1-3cm

- No evidence of a mural nodule, solid component, or septations in the cyst

- For patients with multiple cysts, the largest will be evaluated

Exclusion Criteria:

- Any imaging or cytology concerning for malignancy

- Pancreatic Pseudocyst

- Gross Cyst >3cm as measured on MRCP

- Clinically active pancreatitis or serum amylase or lipase >3x upper limit of normal

- Coagulopathy (INR>1.5, PTT>100, Platelets<50K)

- Inability to tolerate conscious sedation and endoscopy

- Rated ASA IV or greater

- Prior EUS and aspiration of the pancreatic cyst

- Breast feeding

- Pregnancy

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Patients not progressing to operation due to the development of symptoms, growth to a maximum diameter of >3cm, or development of a mural nodule.

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Cristina R Ferrone, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Institutional Review Board

Study ID:




Start Date:

October 2007

Completion Date:

October 2012

Related Keywords:

  • Pancreatic Cyst
  • pancreatic cyst
  • ethanol injection
  • Cysts
  • Pancreatic Cyst



Massachusetts General HospitalBoston, Massachusetts  02114-2617