Endoscopic Ultrasound-guided Ethanol Injection of Pancreatic Cystic Neoplasms

Neoplasms, Cystic, Mucinous, and Serous Clinical Trial

Official title:

Endoscopic Ultrasound-guided Ethanol Injection of Pancreatic Cystic Neoplasms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02158039
• Other study ID #: 498-04
• Status: Completed
• Phase: Phase 1
• First received: September 30, 2013
• Last updated: July 27, 2017
• Start date: June 2004
• Est. completion date: September 2015

Study information

• Verified date: July 2017
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 The ethanol solution is withdrawn and new ethanol injected, and this process is continued for 5 minutes, repeatedly washing the cyst with the ethanol solution.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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Neoplasms, Cystic, Mucinous, and Serous

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

References & Publications (1)

Gómez 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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	1 year after final treatment
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)	1 year after final treatment