Neoplasms, Cystic, Mucinous, and Serous
Conditions
Keywords
Intraductal Papillary Mucinous Neoplasm, Mucinous Cystic Neoplasm, Endoscopic Ultrasound, Ethanol
Brief summary
Cystic tumors of the pancreas are fluid-filled growths. They are often treated by surgical removal. A safe and effective non-surgical treatment is desirable. Ethanol (alcohol) injection may treat cysts by killing the lining cells of the cyst, and is an accepted treatment for cysts of other organs. In this study, participants with pancreatic cysts underwent endoscopic ultrasound (EUS) guided ethanol injection of pancreatic cysts. This was a pilot study to assess safety and efficacy. The hypotheses of this study were 1) complications of EUS guided ethanol injection requiring hospitalization will occur in \<10% of subjects, and 2) EUS guided ethanol injection, with retreatment as necessary, will ablate at least 50% of pancreatic cysts.
Detailed description
EUS is performed via the mouth under sedation. After a needle is placed into the pancreas cyst under EUS guidance, an ethanol solution is placed into the cyst via the needle. The ethanol solution is withdrawn and new ethanol injected, and this process is continued for 5 minutes, repeatedly washing the cyst with the ethanol solution. After this treatment, usual clinical follow-up is obtained including assessments of the cyst by CT or MRI scans. If a cyst of significant size persists, additional EUS-guided ethanol injections of the cyst were offered.
Interventions
DRUGEthanol
EUS-guided lavage of a pancreatic cystic neoplasm with ethanol solution. Ethanol was diluted to 80% using normal saline.
DRUGLidocaine
The final solution contained 1% lidocaine except in subjects allergic to local anesthetics.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Presence of a pancreatic cystic lesion, \> 1 cm in maximum diameter 2. Treatment of the cystic lesion is desired due to symptoms or concern for subsequent malignancy 3. Age \> or = 18 years 4. Able to give informed consent 5. Surgical treatment has been considered, and a surgical consultation offered to the patient, but: 1. Subject's cyst does not meet consensus criteria for surgical resection, or 2. Subject is deemed a poor operative candidate, or 3. Ethanol ablation would allow a subtotal rather than total pancreatectomy, or 4. Subject has decided not to undergo surgical treatment.
Exclusion criteria
1. Known or suspected pregnancy, or nursing 2. History of pancreatitis within past 3 months 3. Main pancreatic duct is dilated to \> 4mm in neck, body, or tail 4. Cyst is known to communicate with the pancreatic duct 5. Cyst has a primarily microcystic architecture on EUS 6. Cyst is immediately adjacent to the main pancreatic duct on EUS 7. Cyst has a connection to the main pancreatic duct seen during EUS 8. During initial cyst aspiration, more fluid is recovered than expected (suggesting communication to the main pancreatic duct) 9. Pancreatic cytology has demonstrated cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | 1 year after final treatment | Adverse events include pancreatitis, bleeding, perforation, any other occurrence resulting in hospitalization, medical treatment, surgery, death, or disability |
| Number of Subjects With Complete or Partial Ablation of the Treated Cyst | 1 year after final treatment | Complete or partial ablation of cysts will be defined by the presence of a persistent cystic structure, and its volume and maximum diameter, as determined by cross-sectional imaging studies (CT, MR) |
Countries
United States
Participant flow
Recruitment details
Participants were recruited in the Mayo Clinic Pancreas Clinic or the Mayo Clinic Interventional Endoscopy Unit in Rochester, Minnesota between April 2004 and August 2014.
Pre-assignment details
Thirty-three subjects were enrolled, of whom 23 underwent study procedures and were considered accrued. Of the remaining 10, one withdrew and the other nine were excluded for a variety of per-protocol reasons including cysts found to communicate with pancreatic duct. Study was closed when an interim analysis showed low efficacy.
Participants by arm
| Arm | Count |
|---|---|
| Pancreatic Cyst Ethanol Injection EUS-guided lavage of a pancreatic cyst with ethanol solution. The ethanol solution was diluted to 80% using normal saline. Final solution also contained 1% lidocaine except in patients allergic to local anesthetics. The ethanol solution was injected into pancreatic cysts at a volume equal to 90% of the aspirated cyst volume. In subjects undergoing re-treatment of a cyst, ethanol was diluted to 90% using normal saline, and injected in a volume equal to 100% of the aspirated cyst volume. | 33 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Screen Failure | 9 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Pancreatic Cyst Ethanol Injection |
|---|---|
| Age, Continuous | 70 years |
| Region of Enrollment United States | 33 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 23 |
| serious Total, serious adverse events | 6 / 23 |
Outcome results
Primary
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Adverse events include pancreatitis, bleeding, perforation, any other occurrence resulting in hospitalization, medical treatment, surgery, death, or disability
Time frame: 1 year after final treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pancreatic Cyst Ethanol Injection | Number of Participants With Adverse Events as a Measure of Safety and Tolerability | Number of participants with adverse events | 7 participants |
| Pancreatic Cyst Ethanol Injection | Number of Participants With Adverse Events as a Measure of Safety and Tolerability | Number of participants without adverse events | 16 participants |
Primary
Number of Subjects With Complete or Partial Ablation of the Treated Cyst
Complete or partial ablation of cysts will be defined by the presence of a persistent cystic structure, and its volume and maximum diameter, as determined by cross-sectional imaging studies (CT, MR)
Time frame: 1 year after final treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pancreatic Cyst Ethanol Injection | Number of Subjects With Complete or Partial Ablation of the Treated Cyst | Complete ablation of treated cyst | 2 participants |
| Pancreatic Cyst Ethanol Injection | Number of Subjects With Complete or Partial Ablation of the Treated Cyst | Greater than or equal to 80% cyst volume reduction | 10 participants |
| Pancreatic Cyst Ethanol Injection | Number of Subjects With Complete or Partial Ablation of the Treated Cyst | Less than 80% cyst volume reduction | 10 participants |
| Pancreatic Cyst Ethanol Injection | Number of Subjects With Complete or Partial Ablation of the Treated Cyst | Cyst volume increase | 1 participants |