Pancreatic Exocrine Insufficiency in Acute Pancreatitis

NCT02563080 | Completed

• 1 other identifier: Exocrine insufficiency
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Severe pancreatitis induces more damage in the pancreas and might therefore result reduced exocrine function leading to the insufficiency. The aim of this prospective study is to investigate development of pancreatic exocrine insufficiency in patients recovering from first attack of moderately severe or severe acute pancreatitis.

Conditions

Exocrine Pancreatic Insufficiency; Acute Pancreatitis

Keywords

exocrine insufficiency; acute pancreatitis; severe; moderately severe

Outcome Measures

Primary Outcomes (1)

• Development of pancreatic exocrine insufficiency after first attack of moderately severe or severe acute pancreatitis confirmed by fecal elastase-1 test.

  fecal elastase-1 \<200 ug/g

  One year after discharging from hospital

Secondary Outcomes (2)

• Persistence of pancreatic exocrine insufficiency after first attack of moderately severe or severe acute pancreatitis

  One year after discharging from hospital

• New developments of pancreatic exocrine insufficiency after first attack of moderately severe or severe acute pancreatitis during the follow-up time

  One year after discharging from hospital

Other Outcomes (2)

• 30-day and hospital mortality after first attack of acute pancreatitis

  30 days, hospitalization time

• 5-year survival after first attack of acute pancreatitis

  5 years

Study Arms (1)

First attack of acute pancreatitis

50 patients with first attack of moderately severe or severe acute pancreatitis treated in Helsinki University Hospital.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with first attack of moderately severe or severe acute pancreatitis treated in Helsinki University Hospital.

You may qualify if:

• first episode of acute pancreatitis (diagnosis based on acute onset of characteristic symptoms and elevated plasma levels of amylase and/or typical findings on CT)
• severity of acute pancreatitis classified as moderately severe or severe by revised Atlanta classification of acute pancreatitis 2012

You may not qualify if:

• previous history of acute pancreatitis
• chronic pancreatitis
• known pancreatic exocrine insufficiency
• previous pancreatic surgery

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (1)

Helsinki University Hospital

Helsinki, 00029, Finland

Location

Related Publications (3)

• 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

• Boreham B, Ammori BJ. A prospective evaluation of pancreatic exocrine function in patients with acute pancreatitis: correlation with extent of necrosis and pancreatic endocrine insufficiency. Pancreatology. 2003;3(4):303-8. doi: 10.1159/000071768.

  PMID: 12890992 BACKGROUND

• Lindstrom O, Lietzen E, Mentula P, Tolonen M, Siironen P, Udd M, Puolakkainen P, Kylanpaa L. Development of pancreatic exocrine insufficiency after first moderately severe or severe acute pancreatitis. Scand J Gastroenterol. 2025 Sep;60(9):921-927. doi: 10.1080/00365521.2025.2533337. Epub 2025 Jul 17.

  PMID: 40673865 DERIVED

Biospecimen

Retention: NONE RETAINED

Fecal samples.

MeSH Terms

Conditions

Exocrine Pancreatic Insufficiency; Pancreatitis; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Leena Kylänpää, MD,PhD

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

• Outi Lindström, Md,PhD

  Helsinki University Central Hospital

  STUDY CHAIR

• Taija Korpela, MD

  Helsinki University Central Hospital

  STUDY CHAIR

• Marianne Udd, MD,PhD

  Helsinki University Central Hospital

  STUDY CHAIR

• Panu Mentula, MD,PhD

  Helsinki University Central Hospital

  STUDY CHAIR

• Päivi Siironen, MD,PhD

  Helsinki University Central Hospital

  STUDY CHAIR

• Matti Tolonen, MD

  Helsinki University Central Hospital

  STUDY CHAIR

• Elina Lietzen, MD

  Turku University Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: September 27, 2015
• First Posted: September 29, 2015
• Study Start: September 1, 2015
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: August 16, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)