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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.
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 The ethanol solution is withdrawn and new ethanol injected, and this process is continued for 5 minutes, repeatedly washing the cyst with the ethanol solution.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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pancreatic Cyst Ethanol Injection | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ethanol | Drug | EUS-guided lavage of a pancreatic cystic neoplasm with ethanol solution. Ethanol was diluted to 80% using normal saline. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 year after final treatment |
| 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) | 1 year after final treatment |
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Inclusion Criteria:
Presence of a pancreatic cystic lesion, > 1 cm in maximum diameter
Treatment of the cystic lesion is desired due to symptoms or concern for subsequent malignancy
Age > or = 18 years
Able to give informed consent
Surgical treatment has been considered, and a surgical consultation offered to the patient, but:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Topazian, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26363331 | Background | Gomez V, Takahashi N, Levy MJ, McGee KP, Jones A, Huang Y, Chari ST, Clain JE, Gleeson FC, Pearson RK, Petersen BT, Rajan E, Vege SS, Topazian MD. EUS-guided ethanol lavage does not reliably ablate pancreatic cystic neoplasms (with video). Gastrointest Endosc. 2016 May;83(5):914-20. doi: 10.1016/j.gie.2015.08.069. Epub 2015 Sep 9. |
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Data sharing can be arranged and will require IRB approval
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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 were recruited in the Mayo Clinic Pancreas Clinic or the Mayo Clinic Interventional Endoscopy Unit in Rochester, Minnesota between April 2004 and August 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pancreatic Cyst Ethanol Injection | Endoscopic ultrasound (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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Only subjects who received the study intervention, endoscopic ultra sound (EUS)- guided ethanol lavage were included in the baseline analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Number | participants | 1 year after final treatment |
|
Participants were followed up at 3 days, 6 and 12 months, and then yearly after the last endoscopic ultrasound-guided ethanol lavage procedure, approximately 72 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute interstitial pancreatitis | Gastrointestinal disorders | Systematic Assessment | Required hospitalization |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Transient abdominal pain | Gastrointestinal disorders | Systematic Assessment |
Sample size was small, and a control group was not included. Neither cyst histology not degree of epithelial ablation was assessed by surgical resection in any of the study participants.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mark Topazian | Mayo Clinic | 507-284-7602 | topazian.mark@mayo.edu |
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| ID | Term |
|---|---|
| D018297 | Neoplasms, Cystic, Mucinous, and Serous |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 |
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| Lidocaine | Drug | The final solution contained 1% lidocaine except in subjects allergic to local anesthetics. |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| 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) | Posted | Number | participants | 1 year after final treatment |
|
|
|
| 6 |
| 23 |
| 1 |
| 23 |
|
| Death due to pancreatic adenocarcinoma | Gastrointestinal disorders | Systematic Assessment |
|
| Death due to metastatic gallbladder carcinoma | Gastrointestinal disorders | Systematic Assessment |
|
| Death due to congestive heart failure | Cardiac disorders | Systematic Assessment |
|
| Death due to biventricular systolic heart failure | Cardiac disorders | Systematic Assessment |
|
| Death due to motor vehicle accident | Social circumstances | Systematic Assessment |
|
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| Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| Title | Measurements |
|---|---|
|
| Cyst volume increase |
|