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Endoscopic Ultrasound-guided Ethanol Injection of Pancreatic Cystic Neoplasms

Primary Purpose

Neoplasms, Cystic, Mucinous, and Serous

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Ethanol

Lidocaine

About this trial

This is an interventional treatment trial for Neoplasms, Cystic, Mucinous, and Serous focused on measuring Intraductal Papillary Mucinous Neoplasm, Mucinous Cystic Neoplasm, Endoscopic Ultrasound, Ethanol

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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:
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:

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

Sites / Locations

Mayo Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pancreatic Cyst Ethanol Injection

Arm Description

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.

Outcomes

Primary Outcome Measures

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

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)

Secondary Outcome Measures

Full Information

NCT ID

NCT02158039

First Posted

September 30, 2013

Last Updated

July 27, 2017

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT02158039

Brief Title

Endoscopic Ultrasound-guided Ethanol Injection of Pancreatic Cystic Neoplasms

Official Title

Endoscopic Ultrasound-guided Ethanol Injection of Pancreatic Cystic Neoplasms

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

June 2004 (undefined)

Primary Completion Date

September 2015 (Actual)

Study Completion Date

September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neoplasms, Cystic, Mucinous, and Serous

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

33 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pancreatic Cyst Ethanol Injection

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Ethanol

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Lidocaine

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of Participants With Adverse Events as a Measure of Safety and Tolerability

Description

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

Time Frame

1 year after final treatment

Title

Number of Subjects With Complete or Partial Ablation of the Treated Cyst

Description

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)

Time Frame

1 year after final treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark Topazian, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

Data sharing can be arranged and will require IRB approval

Citations:

PubMed Identifier

26363331

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.

Results Reference

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Endoscopic Ultrasound-guided Ethanol Injection of Pancreatic Cystic Neoplasms

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