ENDoscopic Assessment in Acute PANcreatitis Study (ENDOPAN Study)

NCT07714850 · tracked via the Priya Life Science Poland tracker

Sponsor

Jan Kochanowski University

Phase

Observational

Started

2026-09-01

Last updated

2026-09-24

Condition(s) studied

Acute Pancreatitis (AP)

Study summary

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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Age 18 years or older. * Diagnosis of acute pancreatitis according to the revised Atlanta criteria, defined by the presence of at least two of the following three features: typical abdominal pain consistent with acute pancreatitis; serum amylase and/or lipase activity at least three times the upper limit of normal; imaging findings consistent with acute pancreatitis. * 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. * Ability to provide written informed consent before enrollment and before any study-specific procedure. Exclusion Criteria: * 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. * Need for emergency therapeutic upper gastrointestinal endoscopy before planned study endoscopy, for example due to active upper gastrointestinal bleeding. * Known or suspected gastrointestinal perforation. * Previous gastric or duodenal surgery significantly altering upper gastrointestinal anatomy and preventing reliable assessment of gastric or duodenal mucosa. * Known advanced upper gastrointestinal malignancy affecting the stomach or duodenum. * Pregnancy. * Contraindication to upper gastrointestinal endoscopy or sedation according to the treating physician's or investigator's assessment. * Any condition that, in the investigator's opinion, would make participation unsafe or would prevent completion of study procedures.

Primary outcome measure(s)

Percentage of Participants With Moderately Severe or Severe Acute Pancreatitis — During index hospitalization, from admission to hospital discharge, up to 30 days
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.

Trial sites (1)

Facility	City	Region	Status
Department of General, Oncologic and Endocrine Surgery, Regional Hospital in Kielce	Kielce	Poland	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07714850 on ClinicalTrials.gov ↗ ← All trials in Poland