ENDoscopic Assessment in Acute PANcreatitis Study (ENDOPAN Study)
ConditionAcute Pancreatitis (AP)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJan Kochanowski University
About this trial
This is a prospective observational cohort study designed to evaluate early upper gastrointestinal endoscopic findings in adult patients hospitalized with acute pancreatitis. The study aims to determine whether gastric and duodenal mucosal abnormalities detected during early hospitalization are associated with the severity and clinical course of acute pancreatitis.
Adult patients diagnosed with acute pancreatitis according to the revised Atlanta criteria will be enrolled after providing informed consent. Upper gastrointestinal endoscopy will be performed within 24-48 hours from hospital admission. In patients with moderately severe or severe acute pancreatitis, a follow-up endoscopy may be performed before discharge. Clinical, laboratory, imaging, microbiological, and endoscopic data will be collected prospectively during the index hospitalization.
The primary objective is to assess the association between early endoscopic mucosal abnormalities and acute pancreatitis severity according to the revised Atlanta classification. Secondary objectives include evaluation of the relationship between endoscopic findings and organ failure, local or systemic complications, inflammatory markers, nutritional tolerance, length of hospital stay, need for invasive interventions, and in-hospital mortality.
The study has received a positive opinion from the Bioethics Committee of Jan Kochanowski University in Kielce, Collegium Medicum, resolution no. 27/2026 dated May 20, 2026.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older.
Hospital admission due to acute pancreatitis to the study center.
Admission during the early phase of acute pancreatitis, allowing planned upper gastrointestinal endoscopy within 24-48 hours from hospital admission.
Ability to undergo diagnostic upper gastrointestinal endoscopy according to the investigator's and treating physician's assessment.
Disqualifiers
Age below 18 years.
Lack of written informed consent.
Inability to provide informed consent before enrollment.
Clinical condition precluding safe diagnostic upper gastrointestinal endoscopy, including hemodynamic instability, severe respiratory failure, or other unstable life-threatening condition.
Trial population
Adult patients hospitalized at the study center with acute pancreatitis diagnosed according to the revised Atlanta criteria. Eligible participants will be enrolled during the early phase of hospitalization after providing written informed consent. The study population will include patients with different etiologies of acute pancreatitis, including biliary, alcoholic, hypertriglyceridemic, post-ERCP, idiopathic, and other causes. Patients must be clinically stable enough to undergo diagnostic upper gastrointestinal endoscopy within 24-48 hours from hospital admission. Patients in whom endoscopy is unsafe or contraindicated will not be enrolled.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Percentage of Participants With Moderately Severe or Severe Acute Pancreatitis
Acute pancreatitis severity will be assessed according to the revised Atlanta classification during the index hospitalization. Participants will be classified as having mild, moderately severe, or severe acute pancreatitis. The primary outcome measure will be the percentage of participants who develop moderately severe or severe acute pancreatitis. Moderately severe acute pancreatitis is defined as transient organ failure lasting less than 48 hours and/or local or systemic complications without persistent organ failure. Severe acute pancreatitis is defined as persistent organ failure lasting more than 48 hours.
Time frame
During index hospitalization, from admission to hospital discharge, up to 30 daysSecondary outcomes
1
Percentage of Participants With Early Upper Gastrointestinal Mucosal Abnormalities
Upper gastrointestinal mucosal abnormalities will be assessed by diagnostic upper gastrointestinal endoscopy. The outcome measure will be the percentage of participants with at least one gastric or duodenal mucosal abnormality, including mucosal edema, erythema, erosions, ulcerations, hemorrhagic lesions, duodenitis, bile reflux, retained gastric contents, or other clinically relevant mucosal findings.
Time frame
Within 24-48 hours from hospital admissionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov