Endoscopic Ultrasound-guided Ethanol Injection of Pancreatic Cystic Neoplasms

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.

Study Overview

• Status: Completed
• Conditions: Neoplasms, Cystic, Mucinous, and Serous
• Intervention / Treatment: Drug: Ethanol; Drug: Lidocaine

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 The ethanol solution is withdrawn and new ethanol injected, and this process is continued for 5 minutes, repeatedly washing the cyst with the ethanol solution.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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Drug: Ethanol; EUS-guided lavage of a pancreatic cystic neoplasm with ethanol solution. Ethanol was diluted to 80% using normal saline.; Drug: Lidocaine; The final solution contained 1% lidocaine except in subjects allergic to local anesthetics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Mark Topazian, MD, Mayo Clinic

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2004
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: September 30, 2013
• First Submitted That Met QC Criteria: June 4, 2014
• First Posted (Estimate): June 6, 2014

Study Record Updates

• Last Update Posted (Actual): February 5, 2018
• Last Update Submitted That Met QC Criteria: July 27, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Ethanol; Endoscopic Ultrasound; Intraductal Papillary Mucinous Neoplasm; Mucinous Cystic Neoplasm
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms; Neoplasms, Cystic, Mucinous, and Serous; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Ethanol; Lidocaine
• Other Study ID Numbers: 498-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Data sharing can be arranged and will require IRB approval

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No