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Management of Incidentally Discovered Pancreatic Cysts

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ClinicalTrials.gov Identifier: NCT00550108
Recruitment Status : Terminated (Inability to enroll subjects.)
First Posted : October 26, 2007
Last Update Posted : June 26, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to determine the natural history of pancreatic cysts and to determine if these cysts can be effectively treated with a less invasive therapy (ethanol injection vs periodic imaging) rather than surgical resection

Condition or disease Intervention/treatment Phase
Pancreatic Cyst Other: Ethanol lavage Phase 3

Detailed Description:
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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective Study of the Management of Incidentally Discovered Pancreatic Cysts
Study Start Date : October 2007
Estimated Primary Completion Date : October 2012
Estimated Study Completion Date : October 2012
Arms and Interventions

Arm Intervention/treatment
No Intervention: A
Observation of pancreatic cysts
Experimental: B
Ethanol lavage of pancreatic cysts
Other: Ethanol lavage
Ethanol lavage of pancreatic cysts.


Outcome Measures

Primary Outcome Measures :
  1. Patients not progressing to operation due to the development of symptoms, growth to a maximum diameter of >3cm, or development of a mural nodule. [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. A decrease in size by >1 cm on MRCP Relative decrease in size of cyst after 1 or 2 injections with ethanol Is reduction in size durable (over what length of time)? [ Time Frame: 3 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00550108


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Cristina R Ferrone, MD Massachusetts General Hospital
More Information

Publications:
Responsible Party: Cristina R. Ferrone, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00550108     History of Changes
Other Study ID Numbers: 2007-P-000420
First Posted: October 26, 2007    Key Record Dates
Last Update Posted: June 26, 2008
Last Verified: June 2008

Keywords provided by Massachusetts General Hospital:
pancreatic cyst
ethanol injection

Additional relevant MeSH terms:
Cysts
Pancreatic Cyst
Neoplasms
Pathological Conditions, Anatomical
Pancreatic Diseases
Digestive System Diseases
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs