Endoscopic Ultrasound-guided Ethanol Injection of Pancreatic Cystic Neoplasms

NCT ID: NCT02158039

Last Updated: 2018-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30
• Study Completion Date: 2015-09-30

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 The ethanol solution is withdrawn and new ethanol injected, and this process is continued for 5 minutes, repeatedly washing the cyst with the ethanol solution.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

Conditions

Neoplasms, Cystic, Mucinous, and Serous

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Ethanol

Intervention Type: DRUG

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

Lidocaine

Intervention Type: DRUG

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

Interventions

Ethanol

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

Intervention Type: DRUG

Lidocaine

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Mark Topazian

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mark Topazian, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 26363331 (View on PubMed)

Other Identifiers

498-04

Identifier Type: -

Identifier Source: org_study_id