NCT06179459

Brief Summary

Acute pancreatitis is one of the most common gastrointestinal disorders requiring hospitalization worldwide. Pancreatic fluid collections can occur as a consequence of acute and chronic pancreatitis and can result in significant morbidity and mortality, including significant abdominal pain, gastric outlet obstruction, biliary obstruction, organ failure, persistent unwellness, infection and sepsis. Symptomatic pancreatic fluid collections require treatment, and endoscopic drainage is considered standard of care. The aim of this study is to evaluate the treatment outcomes in patients undergoing standard of care, endoscopic treatment of pancreatic fluid collections.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
80mo left

Started May 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress43%
May 2021Dec 2032

Study Start

First participant enrolled

May 1, 2021

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

December 12, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 21, 2023

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2032

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2032

Last Updated

November 4, 2025

Status Verified

November 1, 2025

Enrollment Period

11.6 years

First QC Date

December 12, 2023

Last Update Submit

November 3, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Treatment outcomes in patients undergoing endoscopic treatment of pancreatic fluid collections.

    Treatment outcomes in patients undergoing endoscopic treatment of pancreatic fluid collections.

    3 years

Secondary Outcomes (15)

  • Treatment success

    6 months

  • Number and type of interventions performed

    6 months

  • Need for surgical intervention

    6 months

  • Technical success of endoscopic interventions in pancreatic fluid collections.

    6 months

  • Inflammatory response and organ failure in patients undergoing endoscopic therapy for pancreatic fluid collections.

    6 months

  • +10 more secondary outcomes

Interventions

Patients with pancreatic fluid collections will be undergoing EUS-guided drainage and/or endoscopic necrosectomy

Eligibility Criteria

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

Patients with pancreatic fluid collections

You may qualify if:

  • Age ≥ 18 years
  • All patients undergoing endoscopic treatment of pancreatic fluid collections

You may not qualify if:

  • Age \< 18 years
  • Patients who did not receive endoscopic treatment of pancreatic fluid collections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orlando Health

Orlando, Florida, 21806, United States

RECRUITING

MeSH Terms

Conditions

PancreatitisPancreatic PseudocystPancreatitis, Acute Necrotizing

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesPancreatic CystCystsNeoplasms

Study Officials

  • Ji Young Bang, MD MPH

    Orlando Health, Digestive Health Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2023

First Posted

December 21, 2023

Study Start

May 1, 2021

Primary Completion (Estimated)

December 1, 2032

Study Completion (Estimated)

December 1, 2032

Last Updated

November 4, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations