Endoscopic Ultrasound-guided Ethanol Injection of Pancreatic Cystic Neoplasms

NCT02158039 | Completed Phase 1 Results DMC

• 1 other identifier: 498-04
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasms, Cystic, Mucinous, and Serous

Keywords

Intraductal Papillary Mucinous Neoplasm; Mucinous Cystic Neoplasm; Endoscopic Ultrasound; Ethanol

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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.

Drug: Ethanol; Drug: Lidocaine

Interventions

Ethanol DRUG

EUS-guided lavage of a pancreatic cystic neoplasm with ethanol solution. Ethanol was diluted to 80% using normal saline.

Pancreatic Cyst Ethanol Injection

Lidocaine DRUG

The final solution contained 1% lidocaine except in subjects allergic to local anesthetics.

Pancreatic Cyst Ethanol Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Subject's cyst does not meet consensus criteria for surgical resection, or
• Subject is deemed a poor operative candidate, or
• Ethanol ablation would allow a subtotal rather than total pancreatectomy, or
• Subject has decided not to undergo surgical treatment.

You may not qualify if:

• Known or suspected pregnancy, or nursing
• History of pancreatitis within past 3 months
• Main pancreatic duct is dilated to \> 4mm in neck, body, or tail
• Cyst is known to communicate with the pancreatic duct
• Cyst has a primarily microcystic architecture on EUS
• Cyst is immediately adjacent to the main pancreatic duct on EUS
• Cyst has a connection to the main pancreatic duct seen during EUS
• During initial cyst aspiration, more fluid is recovered than expected (suggesting communication to the main pancreatic duct)
• Pancreatic cytology has demonstrated cancer

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• 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.

  PMID: 26363331 BACKGROUND

MeSH Terms

Conditions

Neoplasms, Cystic, Mucinous, and Serous

Interventions

Ethanol; Lidocaine

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Mark Topazian
• Organization: Mayo Clinic

topazian.mark@mayo.edu

507-284-7602

Study Officials

• Mark Topazian, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: September 30, 2013
• First Posted: June 6, 2014
• Study Start: June 1, 2004
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: February 5, 2018
• Results First Posted: January 29, 2016

Record last verified: 2017-07

Locations

US (1)