ENDoscopic Assessment in Acute PANcreatitis Study (ENDOPAN Study)

NCT07714850 | Not Yet Recruiting

• 1 other identifier: 27/2026
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Acute Pancreatitis (AP)

Keywords

Acute pancreatitis; Upper gastrointestinal endoscopy; Gastroscopy; Disease severity; Gastroduodenal mucosal injury; Helicobacter pylori

Outcome Measures

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.

  During index hospitalization, from admission to hospital discharge, up to 30 days

Secondary Outcomes (1)

• Percentage of Participants With Early Upper Gastrointestinal Mucosal Abnormalities

  Within 24-48 hours from hospital admission

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jan Kochanowski University: lead

Related Publications (16)

• Baron TH, DiMaio CJ, Wang AY, Morgan KA. American Gastroenterological Association Clinical Practice Update: Management of Pancreatic Necrosis. Gastroenterology. 2020 Jan;158(1):67-75.e1. doi: 10.1053/j.gastro.2019.07.064. Epub 2019 Aug 31.

  PMID: 31479658 BACKGROUND

• Jablonska B, Mrowiec S. Nutritional Support in Patients with Severe Acute Pancreatitis-Current Standards. Nutrients. 2021 Apr 28;13(5):1498. doi: 10.3390/nu13051498.

  PMID: 33925138 BACKGROUND

• Demcsak A, Soos A, Kincses L, Capunge I, Minkov G, Kovacheva-Slavova M, Nakov R, Wu D, Huang W, Xia Q, Deng L, Hollenbach M, Schneider A, Hirth M, Ioannidis O, Vincze A, Bajor J, Sarlos P, Czako L, Illes D, Izbeki F, Gajdan L, Papp M, Hamvas J, Varga M, Kanizsai P, Bona E, Miko A, Vancsa S, Juhasz MF, Ocskay K, Darvasi E, Miklos E, Eross B, Szentesi A, Parniczky A, Casadei R, Ricci C, Ingaldi C, Mastrangelo L, Jovine E, Cennamo V, Marino MV, Barauskas G, Ignatavicius P, Pelaez-Luna M, Rios AS, Turcan S, Tcaciuc E, Malecka-Panas E, Zatorski H, Nunes V, Gomes A, Goncalves TC, Freitas M, Constantino J, Sa M, Pereira J, Mateescu B, Constantinescu G, Sandru V, Negoi I, Ciubotaru C, Negoita V, Bunduc S, Gheorghe C, Barbu S, Tantau A, Tantau M, Dumitru E, Suceveanu AI, Tocia C, Gherbon A, Litvin A, Shirinskaya N, Rabotyagova Y, Bezmarevic M, Hegyi PJ, Han J, Rodriguez-Oballe JA, Salas IM, Comas EP, Garcia DI, Cuadrado AJ, Castineira AQ, Chang YT, Chang MC, Kchaou A, Tlili A, Kacar S, Gokbulut V, Duman D, Kani HT, Altintas E, Chooklin S, Chuklin S, Gougol A, Papachristou G, Hegyi P. Acid suppression therapy, gastrointestinal bleeding and infection in acute pancreatitis - An international cohort study. Pancreatology. 2020 Oct;20(7):1323-1331. doi: 10.1016/j.pan.2020.08.009. Epub 2020 Aug 22.

  PMID: 32948430 BACKGROUND

• Lee KM, Paik CN, Chung WC, Yang JM. Association between acute pancreatitis and peptic ulcer disease. World J Gastroenterol. 2011 Feb 28;17(8):1058-62. doi: 10.3748/wjg.v17.i8.1058.

  PMID: 21448359 BACKGROUND

• Lin CK, Wang ZS, Lai KH, Lo GH, Hsu PI. Gastrointestinal mucosal lesions in patients with acute pancreatitis. Zhonghua Yi Xue Za Zhi (Taipei). 2002 Jun;65(6):275-8.

  PMID: 12201568 BACKGROUND

• Chen TA, Lo GH, Lin CK, Lai KH, Wong HY, Yu HC, Hsu PI, Chen HH, Tsai WL, Chen WC. Acute pancreatitis-associated acute gastrointestinal mucosal lesions: incidence, characteristics, and clinical significance. J Clin Gastroenterol. 2007 Jul;41(6):630-4. doi: 10.1097/01.mcg.0000225638.37533.8c.

  PMID: 17577121 BACKGROUND

• Jaber S, Garnier M, Asehnoune K, Bounes F, Buscail L, Chevaux JB, Dahyot-Fizelier C, Darrivere L, Jabaudon M, Joannes-Boyau O, Launey Y, Levesque E, Levy P, Montravers P, Muller L, Rimmele T, Roger C, Savoye-Collet C, Seguin P, Tasu JP, Thibault R, Vanbiervliet G, Weiss E, De Jong A. Guidelines for the management of patients with severe acute pancreatitis, 2021. Anaesth Crit Care Pain Med. 2022 Jun;41(3):101060. doi: 10.1016/j.accpm.2022.101060. Epub 2022 May 25.

  PMID: 35636304 BACKGROUND

• Leppaniemi A, Tolonen M, Tarasconi A, Segovia-Lohse H, Gamberini E, Kirkpatrick AW, Ball CG, Parry N, Sartelli M, Wolbrink D, van Goor H, Baiocchi G, Ansaloni L, Biffl W, Coccolini F, Di Saverio S, Kluger Y, Moore E, Catena F. 2019 WSES guidelines for the management of severe acute pancreatitis. World J Emerg Surg. 2019 Jun 13;14:27. doi: 10.1186/s13017-019-0247-0. eCollection 2019.

  PMID: 31210778 BACKGROUND

• Crockett SD, Wani S, Gardner TB, Falck-Ytter Y, Barkun AN; American Gastroenterological Association Institute Clinical Guidelines Committee. American Gastroenterological Association Institute Guideline on Initial Management of Acute Pancreatitis. Gastroenterology. 2018 Mar;154(4):1096-1101. doi: 10.1053/j.gastro.2018.01.032. Epub 2018 Feb 3. No abstract available.

  PMID: 29409760 BACKGROUND

• Working Group IAP/APA Acute Pancreatitis Guidelines. IAP/APA evidence-based guidelines for the management of acute pancreatitis. Pancreatology. 2013 Jul-Aug;13(4 Suppl 2):e1-15. doi: 10.1016/j.pan.2013.07.063.

  PMID: 24054878 BACKGROUND

• Tenner S, Vege SS, Sheth SG, Sauer B, Yang A, Conwell DL, Yadlapati RH, Gardner TB. American College of Gastroenterology Guidelines: Management of Acute Pancreatitis. Am J Gastroenterol. 2024 Mar 1;119(3):419-437. doi: 10.14309/ajg.0000000000002645. Epub 2023 Nov 7.

  PMID: 38857482 BACKGROUND

• Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25.

  PMID: 23100216 BACKGROUND

• Nawacki L, Bociek A, Bielejewska A, Gorczyca-Glowacka I, Gluszek S. More Than Just a Complication: Post-ERCP Pancreatitis and Its Clinical Determinants in over 800 Procedures. J Clin Med. 2025 Sep 29;14(19):6916. doi: 10.3390/jcm14196916.

  PMID: 41095997 BACKGROUND

• Nawacki L, Gluszek S. Hospital mortality rate and predictors in acute pancreatitis in Poland: A single-center experience. Asian J Surg. 2024 Jan;47(1):208-215. doi: 10.1016/j.asjsur.2023.07.063. Epub 2023 Aug 3.

  PMID: 37541899 BACKGROUND

• Nawacki L, Matykiewicz J, Stochmal E, Gluszek S. Splanchnic Vein Thrombosis in Acute Pancreatitis and Its Consequences. Clin Appl Thromb Hemost. 2021 Jan-Dec;27:10760296211010260. doi: 10.1177/10760296211010260.

  PMID: 33887991 BACKGROUND

• Nawacki L, Kolomanska M, Bryk P, Gluszek S. Endoscopic changes in patients diagnosed with acute pancreatitis. Minerva Gastroenterol (Torino). 2023 Sep;69(3):359-364. doi: 10.23736/S2724-5985.21.02826-9. Epub 2021 Apr 15.

  PMID: 33856142 BACKGROUND

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Study Officials

• Łukasz Nawacki

  Jan Kochanowski University in Kielce, Poland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Łukasz Nawacki, PhD habilitated

CONTACT

+4841349 69 09; lukasz.nawacki@ujk.edu.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD habilitated

Study Record Dates

• First Submitted: July 5, 2026
• First Posted: July 20, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): February 28, 2029
• Study Completion (Estimated): September 30, 2029
• Last Updated: July 22, 2026

Record last verified: 2026-07