Clinical trial NCT02158039: Endoscopic Ultrasound-guided Ethanol Injection of Pancreatic Cystic Neoplasms
Official title: Endoscopic Ultrasound-guided Ethanol Injection of Pancreatic Cystic Neoplasms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms, Cystic, Mucinous, and Serous
Keywords: Intraductal Papillary Mucinous Neoplasm
Mucinous Cystic Neoplasm
Endoscopic Ultrasound
Ethanol
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2014-06-06
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 The ethanol solution is withdrawn and new ethanol injected, and this process is continued for 5 minutes, repeatedly washing the cyst with the ethanol solution.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

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

Primary outcomes:
measure: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
timeFrame: 1 year after final treatment
measure: Number of Subjects With Complete or Partial Ablation of the Treated Cyst
timeFrame: 1 year after final treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Mark Topazian, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.