NCT04253249

Brief Summary

Pancreatic cysts (A cyst is a thin walled cavity containing fluid) were rarely reported previously, but have been on a rise due to advanced imaging for evaluating pancreatic lesions or other medical reasons has increased detection of pancreatic cysts. Study shows transformation of pancreatic cysts to be 10.8 for every 100,000 women and 13.8 for every 100,000 men. Pancreatic cysts are divided in two groups; serous and mucinous. Serous cysts are thin walled cysts and are not associated with precancer. On the other hand, mucinous cysts have a tendency to progress to pancreatic cancer. Radio frequency ablation (RFA) is an alternative method used for patients who could not or decided to not undergo surgical removal of the cyst. This study is a standard of care study and no changes in regards to the procedure scheduled with the physician will be changed.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started May 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2018

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 19, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2020

Completed
Last Updated

February 5, 2020

Status Verified

January 1, 2020

Enrollment Period

2.1 years

First QC Date

January 27, 2020

Last Update Submit

January 30, 2020

Conditions

Treatment Related Cancer

Outcome Measures

Primary Outcomes (1)

  • Treatment pancreatic cyst without surgery

    Efficacy of managing pancreatic cyst without open surgery

    Through study completion, an average of 1 year

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Groups to be recruited will include: Patients

You may qualify if:

  • Adult (18-64 yrs), Geriatric (65+ yrs)

You may not qualify if:

  • Pregnant woman
  • Neonates
  • Children

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Neoplasms, Second Primary

Condition Hierarchy (Ancestors)

Neoplasms

Study Officials

  • MOHAMED O. OTHMAN

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 27, 2020

First Posted

February 5, 2020

Study Start

May 1, 2018

Primary Completion

May 19, 2020

Study Completion

December 19, 2020

Last Updated

February 5, 2020

Record last verified: 2020-01

Locations

US(1)