CLINICAL TRIAL

Paclitaxel + Gemcitabine admixture for Pancreatic Cyst

Recruiting · 18+ · All Sexes · Indianapolis, IN

This study is evaluating whether a new procedure for treating pancreatic cysts may be effective.

See full description

About the trial for Pancreatic Cyst

Eligible Conditions
EUS-FNA · Pancreatic Cyst · Cysts

Treatment Groups

This trial involves 2 different treatments. Paclitaxel + Gemcitabine Admixture is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Paclitaxel + Gemcitabine admixture
DRUG
Normal saline
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Ethanol
DRUG
Paclitaxel + Gemcitabine admixture
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Normal saline
2013
Completed Phase 4
~2010

Eligibility

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Able to give written informed consent.
You are capable of safely undergoing endoscopy with deep sedation or general anesthesia. show original
You are eligible for the study if you are over the age of 18. show original
You have 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. show original
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
Similar Trials

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 12 months post initial treatment
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months post initial treatment
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 12 months post initial treatment.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Paclitaxel + Gemcitabine admixture will improve 2 primary outcomes in patients with Pancreatic Cyst. Measurement will happen over the course of 30 days post EUS-FNI procedure.

Incidence of serious and minor adverse events occurring within 30 days post ablation
30 DAYS POST EUS-FNI PROCEDURE
Based on definition of serious and minor adverse events, the two arms will be compared with respect to adverse events that took place within 30 days after the subject's procedure
30 DAYS POST EUS-FNI PROCEDURE
Percentage of subjects achieving complete cyst resolution at 12 months
12 MONTHS POST INITIAL TREATMENT
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

Who is running the study

Principal Investigator
M. T. M.
Prof. Matthew T. Moyer, Professor of Medicine
Milton S. Hershey Medical Center

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for pancreatic cyst?

The majority of pancreatic cystic lesions may be successfully treated with endoscopic procedures rather than surgical interventions, thus minimizing the need for post-procedure convalescence as well as cost.\n

Anonymous Patient Answer

What causes pancreatic cyst?

It has been hypothesized that pancreas and other organs may suffer cysts due to congenital defects and trauma. Though rare, the prevalence of cystic pancreas diseases and cysts in adults is high; the average age of cyst formation is around 40 years. The exact cause of most cysts remains undocumented; however, it is known that these masses are a result of a failure in the normal breakdown of mucus in the pancreas. Without knowing the root cause of these cysts, clinicians have no way to predict the progression of the condition. Currently, the treatment options for patients with cystic pancreatic diseases are surgical resection and drug therapy with cystic hydatidosis and hypercalcemia treatments.

Anonymous Patient Answer

How many people get pancreatic cyst a year in the United States?

Approximately 40% of all American adults will develop a pancreatic cyst throughout their life. Approximately 20% of patients with a pancreatic cyst will develop pancreatic cancer.

Anonymous Patient Answer

What is pancreatic cyst?

Pancreatic cysts can develop on the head of the pancreas or the body and are found in about 5% of the population. They are frequently discovered by ultrasound or CT scanning. They are usually benign and require no active intervention.

Anonymous Patient Answer

Can pancreatic cyst be cured?

Pancreatic cyst can be cured for the selected patients with careful evaluation. The recurrence rate of 1.9% and the mortality rate of 0.5% suggested that cure is a viable option in select cases.

Anonymous Patient Answer

What are the signs of pancreatic cyst?

The signs of pancreatic cyst depend on the structure of the cyst (simple or solid structure, fluid, or both fluids in a cyst) and can be distinguished by the presence or absence of solid content in cysts and if they contain either fluid or both fluid and solid content.

Anonymous Patient Answer

Is paclitaxel + gemcitabine admixture typically used in combination with any other treatments?

Paclitaxel has been extensively investigated in combination with gemcitabine. However the combination of gemcitabine and paclitaxel did not seem to be a commonly used combination.

Anonymous Patient Answer

Does paclitaxel + gemcitabine admixture improve quality of life for those with pancreatic cyst?

Those patients with pancreatic cyst receiving gemcitabine+taxol for pancreatic cancer had a longer QOL than those who received gemcitabine alone. Further studies are necessary to investigate clinical effects of gemcitabine admixture in patients with pancreatic cyst on QOL and cyst burden.

Anonymous Patient Answer

What is the latest research for pancreatic cyst?

Pancreatic cysts are common and are thought to occur with a biliary type predisposition. They may also be associated with an inflammatory condition, particularly sarcoidosis. A pancreatic cyst is likely to be associated with a benign condition. Older patients with sarcoidosis are especially at risk as the cysts usually become symptomatic by the late teens or early 20s.\n\nIn 2005, American Diabetes Association published the first set of diabetes control goals for type 2 diabetes in children and adolescents. One of the six goals is to HbA1c (glycated hemoglobin) < 7.1%. This goal is achievable for about two-thirds of patients aged 10–17 years old.

Anonymous Patient Answer

What are the common side effects of paclitaxel + gemcitabine admixture?

Paclitaxel/gemcitabine admixture resulted in the side effect profile seen. Although the side effect profiles observed were similar to those commonly experienced with paclitaxel monotherapy, tolerability and compliance merits consideration in adjuvant chemotherapy regimens combining paclitaxel with gemcitabine or gemcitabine alone.

Anonymous Patient Answer

Have there been any new discoveries for treating pancreatic cyst?

There are other medical possibilities for the treatment of pancreatic cyst but pancreatic cyst surgeries are not an option for the treatment of other pancreatic tumours. Thus, current medical guidelines recommend that all patients with a single pancreatic tumour treated conservatively with close follow-up should be performed as the current treatment.

Anonymous Patient Answer

How serious can pancreatic cyst be?

Pancreatic cysts can vary significantly in severity with respect to presenting symptoms, with cysts of less than 4 cm in diameter being most likely to undergo spontaneous resolution and no intervention requiring urgent surgery. Therefore, we recommend that the initial management of a symptomatic cyst consist of simple observational monitoring for symptom progression. Further intervention such as aspiration, or medical therapy should only be taken into consideration as appropriate depending on the severity of the patient's presentation.

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Pancreatic Cyst by sharing your contact details with the study coordinator.