APPEI: Pancreatic Exocrine Insufficiency in Acute Pancreatitis

Sponsor

Helsinki University Central Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02563080

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Exocrine Pancreatic Insufficiency Acute Pancreatitis

Detailed Description

This is a prospective pilot study of 50 patients with first attack of moderately severe or severe acute pancreatitis (AP) classified by the new revised criteria for AP 2012 treated in Helsinki University Hospital. The included patients are treated according to the existing hospital practice and current guidelines for AP (American Pancreatic Association guidelines). The development of pancreatic exocrine insufficiency is determined by measuring the fecal elastase-1 test. The test is measured during the hospitalization time (baseline testing), and in the follow-up period 1-2 months and 12 months after discharging from hospital. The baseline test will be measured as soon as the severity of AP is known and patient is included in the study, and the first stool sample is available. Patients with previous history of AP, chronic pancreatitis, known pancreatic exocrine insufficiency or previous pancreatic surgery will be excluded.

The patients' characteristics (age, gender, comorbidities) and etiology of AP, laboratory values on admission, imaging findings and data of given treatments and interventional therapies and length of hospital stays are collected from hospital charts. Also the 30-day and hospital mortality will be recorded. Patients' symptoms (weight loss, diarrhea, abdominal pain) and BMIs are recorded with physical examinations in the 1-2 months follow-up visit. 12 months after discharging from hospital the patients' symptoms and BMIs are recorded with phone inquiries. 5-year survival after the first AP attack will be determined from hospital records.

The approval of the ethics committee of the hospital has been obtained. An informed consent will be obtained from all patients.

Development of pancreatic exocrine insufficiency after first attack of moderately severe or severe AP confirmed by fecal elastase-1 test is the primary endpoint of this study. Also, the persistence pancreatic exocrine insufficiency and probable new developments of it during the follow-up will be assessed (secondary endpoints). 30-day and hospital mortality and 5-year survival after first attack of moderately severe or severe AP will be determined as well (secondary endpoints).

The aim in this study (during the study period) is not to change the existing management of AP. The existing guidelines for treatment of severe AP patients do not include enzyme supplementation therapy. However, if the patients have low fecal elastase-1 levels indicating pancreatic exocrine insufficiency after the follow-up period of 12 months, they will be informed about the enzyme supplementation therapy. And if the patients are willing to start the therapy, it can be administrated.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

50 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Development of Pancreatic Exocrine Insufficiency After Moderately Severe or Severe Acute Pancreatitis

Study Start Date :

Sep 1, 2015

Actual Primary Completion Date :

Feb 1, 2022

Actual Study Completion Date :

Feb 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
First attack of acute pancreatitis 50 patients with first attack of moderately severe or severe acute pancreatitis treated in Helsinki University Hospital.

Outcome Measures

Primary Outcome Measures

Development of pancreatic exocrine insufficiency after first attack of moderately severe or severe acute pancreatitis confirmed by fecal elastase-1 test. [One year after discharging from hospital]
fecal elastase-1 <200 ug/g

Secondary Outcome Measures

Persistence of pancreatic exocrine insufficiency after first attack of moderately severe or severe acute pancreatitis [One year after discharging from hospital]
fecal elastase-1 <200 ug/g
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]
fecal elastase-1 <200 ug/g

Other Outcome Measures

30-day and hospital mortality after first attack of acute pancreatitis [30 days, hospitalization time]
mortality
5-year survival after first attack of acute pancreatitis [5 years]
survival

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Helsinki University Hospital	Helsinki		Finland	00029

Sponsors and Collaborators

Helsinki University Central Hospital

Investigators

Principal Investigator: Leena Kylänpää, MD,PhD, Helsinki University Central Hospital
Study Chair: 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