NCT03085004

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of chemotherapeutic pancreatic cyst ablation using ethanol lavage followed by the infusion of a dual-agent chemotherapeutic cocktail (paclitaxel + gemcitabine) compared with alcohol-free saline lavage followed by infusion of the same dual-agent chemotherapeutic cocktail (paclitaxel + gemcitabine) for the ablation of pancreatic cystic neoplasms using endoscopic ultrasound guided fine needle infusion (EUS-FNI) for agent delivery.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2019

Longer than P75 for phase_3

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 21, 2017

Completed
2.1 years until next milestone

Study Start

First participant enrolled

April 12, 2019

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

6.7 years

First QC Date

March 9, 2017

Last Update Submit

March 25, 2026

Conditions

Pancreatic CystEUS-FNA

Keywords

Pancreatic cystEUS-FNAChemotherapyEndoscopic ultrasound-guided fine needle infusionpaclitaxelgemcitabinecyst ablation

Outcome Measures

Primary Outcomes (2)

  • Percentage of subjects achieving complete cyst resolution at 12 months

    This is defined as Complete response greater than or equal to 95% reduction in cyst volume and measured by "r" as cyst volume 4/3×π×r3 at 12 months post initial treatment

    12 months post initial treatment

  • Percentage of subjects achieving complete cyst resolution at 24 months of long term follow up

    This is defined as Complete response greater than or equal to 95% reduction in cyst volume and measured by "r" as cyst volume 4/3×π×r3 at 24 months post initial treatment

    24 months post initial treatment

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Cyst will be lavaged for 3 to 5 minutes with \>/=99% ethanol. Following lavage with \>/=99% ethanol, the cyst will be infused with an admixture of (3mg/ml paclitaxel + 19mg/ml gemcitabine).

Drug: EthanolDrug: Paclitaxel + Gemcitabine admixture

Study group

EXPERIMENTAL

Cyst will be lavaged for 3 to 5 minutes with normal saline. Following lavage with normal saline, the cyst will be infused with an admixture of (3mg/ml paclitaxel + 19mg/ml gemcitabine).

Drug: Normal salineDrug: Paclitaxel + Gemcitabine admixture

Interventions

EthanolDRUG

The cyst will be lavaged for 3 to 5 minutes using \>/=99% ethanol as the lavage agent prior to infusing the cyst with the paclitaxel + gemcitabine admixture.

Control Group
Normal salineDRUG

The cyst will be lavaged for 3 to 5 minutes using normal saline as the lavage agent prior to infusing the cyst with the paclitaxel + gemcitabine admixture.

Study group
Paclitaxel + Gemcitabine admixtureDRUG

Following lavage, cysts will be infused with an admixture of 3mg/ml paclitaxel and 19mg/ml gemcitabine.

Control GroupStudy group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult subjects over the age of 18.
  • Patients with a previously-detected pancreatic cyst(s) 2-5 cm in diameter which is consistent with a mucinous type cyst as per ASGE guidelines, including indeterminate type cysts.
  • Able to give written informed consent.
  • Capable of safely undergoing endoscopy with deep sedation or general anesthesia.

You may not qualify if:

  • Lesions which are consistent with a benign cyst by clinical, cytological, chemical, and radiographic evaluation as per ASGE guidelines (i.e., consistent with a pseudocyst or serous cystadenoma).
  • Known or suspected pancreatic cancer or pathologic lymphadenopathy.
  • Cysts with the following high-risk features: main pancreatic duct dilation of \> 5mm, epithelial type mural nodules (\> 2mm)33, pathologically thick wall/septation (\> 2mm), cytology showing high grade dysplasia or "suspicious for malignancy", signs of common bile duct or pancreatic duct obstruction, solid mass component within or associated with the cyst (\> 2mm), pancreatic duct stricture associated with tail atrophy, or previous fine needle aspiration failure due to excessive cyst fluid viscosity. (Of note, the following higher-risk features ARE eligible: recent growth in size, atypical cells on cytology, and symptoms referable to the pancreas.)
  • Septated cysts with \> 4 compartments.
  • Confirmed acute pancreatitis within the last 6 months.
  • Baseline lab values (must be within 6 months of consent date) in the following ranges: white blood cells \> 14 or \< 2 K/uL, hematocrit \<30%, platelets \<30 K/uL, non-pharmacologic INR \>1.7, CA19-9 \>2x ULN, lipase \>2x ULN, creatinine \>3.0 mg/dl (unless stable on renal replacement therapy), ALT \>500 U/L, total bilirubin \>2.5 mg/dl.
  • Any pre-existing or discovered medical condition that would, at the discretion of the investigator, interfere with the completion of and/or participation in the existing protocol. This includes severe pre-existing medical conditions which would preclude a reasonable 5 year life expectancy (and thus neutralize the patient's benefit from ablating a premalignant type pancreatic cyst).
  • Pregnancy, breastfeeding, or incarcerated individual.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Indiana University Health University Hospital

Indianapolis, Indiana, 46202, United States

Location

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Pancreatic Cyst

Interventions

EthanolSaline SolutionPaclitaxel

Condition Hierarchy (Ancestors)

CystsNeoplasmsPancreatic DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

AlcoholsOrganic ChemicalsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenes

Study Officials

  • Matthew T. Moyer, MD, MS

    Penn State Health Milton S Hershey Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

March 9, 2017

First Posted

March 21, 2017

Study Start

April 12, 2019

Primary Completion

December 31, 2025

Study Completion

February 1, 2026

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(2)