Trial Outcomes & Findings for Endoscopic Ultrasound-guided Ethanol Injection of Pancreatic Cystic Neoplasms (NCT NCT02158039)

NCT ID: NCT02158039

Last Updated: 2018-02-05

Results Overview

Adverse events include pancreatitis, bleeding, perforation, any other occurrence resulting in hospitalization, medical treatment, surgery, death, or disability

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 33 participants
• Primary outcome timeframe: 1 year after final treatment
• Results posted on: 2018-02-05

Participant Flow

Participants were recruited in the Mayo Clinic Pancreas Clinic or the Mayo Clinic Interventional Endoscopy Unit in Rochester, Minnesota between April 2004 and August 2014.

Thirty-three subjects were enrolled, of whom 23 underwent study procedures and were considered accrued. Of the remaining 10, one withdrew and the other nine were excluded for a variety of per-protocol reasons including cysts found to communicate with pancreatic duct. Study was closed when an interim analysis showed low efficacy.

Participant milestones

Measure	Pancreatic Cyst Ethanol Injection Endoscopic ultrasound (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.
Overall Study STARTED	33
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Measure	Pancreatic Cyst Ethanol Injection Endoscopic ultrasound (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.
Overall Study Withdrawal by Subject	1
Overall Study Screen Failure	9

Baseline Characteristics

Endoscopic Ultrasound-guided Ethanol Injection of Pancreatic Cystic Neoplasms

Baseline characteristics by cohort

Measure	Pancreatic Cyst Ethanol Injection n=33 Participants 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.
Age, Continuous	70 years n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Region of Enrollment United States	33 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year after final treatment

Adverse events include pancreatitis, bleeding, perforation, any other occurrence resulting in hospitalization, medical treatment, surgery, death, or disability

Outcome measures

Measure	Pancreatic Cyst Ethanol Injection n=23 Participants 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.
Number of Participants With Adverse Events as a Measure of Safety and Tolerability Number of participants with adverse events	7 participants
Number of Participants With Adverse Events as a Measure of Safety and Tolerability Number of participants without adverse events	16 participants

PRIMARY outcome

Timeframe: 1 year after final treatment

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)

Outcome measures

Measure	Pancreatic Cyst Ethanol Injection n=23 Participants 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.
Number of Subjects With Complete or Partial Ablation of the Treated Cyst Complete ablation of treated cyst	2 participants
Number of Subjects With Complete or Partial Ablation of the Treated Cyst Greater than or equal to 80% cyst volume reduction	10 participants
Number of Subjects With Complete or Partial Ablation of the Treated Cyst Less than 80% cyst volume reduction	10 participants
Number of Subjects With Complete or Partial Ablation of the Treated Cyst Cyst volume increase	1 participants

Adverse Events

Pancreatic Cyst Ethanol Injection

Serious events: 6 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Pancreatic Cyst Ethanol Injection n=23 participants at risk 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.
Gastrointestinal disorders Acute interstitial pancreatitis	4.3% 1/23 • Number of events 1 • Participants were followed up at 3 days, 6 and 12 months, and then yearly after the last endoscopic ultrasound-guided ethanol lavage procedure, approximately 72 months.
Gastrointestinal disorders Death due to pancreatic adenocarcinoma	4.3% 1/23 • Number of events 1 • Participants were followed up at 3 days, 6 and 12 months, and then yearly after the last endoscopic ultrasound-guided ethanol lavage procedure, approximately 72 months.
Gastrointestinal disorders Death due to metastatic gallbladder carcinoma	4.3% 1/23 • Number of events 1 • Participants were followed up at 3 days, 6 and 12 months, and then yearly after the last endoscopic ultrasound-guided ethanol lavage procedure, approximately 72 months.
Cardiac disorders Death due to congestive heart failure	4.3% 1/23 • Number of events 1 • Participants were followed up at 3 days, 6 and 12 months, and then yearly after the last endoscopic ultrasound-guided ethanol lavage procedure, approximately 72 months.
Cardiac disorders Death due to biventricular systolic heart failure	4.3% 1/23 • Number of events 1 • Participants were followed up at 3 days, 6 and 12 months, and then yearly after the last endoscopic ultrasound-guided ethanol lavage procedure, approximately 72 months.
Social circumstances Death due to motor vehicle accident	4.3% 1/23 • Number of events 1 • Participants were followed up at 3 days, 6 and 12 months, and then yearly after the last endoscopic ultrasound-guided ethanol lavage procedure, approximately 72 months.

Other adverse events

Measure

Pancreatic Cyst Ethanol Injection n=23 participants at risk 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.

Gastrointestinal disorders Transient abdominal pain

4.3% 1/23 • Number of events 1 • Participants were followed up at 3 days, 6 and 12 months, and then yearly after the last endoscopic ultrasound-guided ethanol lavage procedure, approximately 72 months.

Additional Information

Dr. Mark Topazian

Mayo Clinic

Phone: 507-284-7602

Email: topazian.mark@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place