Clinical Trial: Pancreatic Exocrine Insufficiency in Acute Pancreatitis
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]
Official Title: Development of Pancreatic Exocrine Insufficiency After Moderately Severe or Severe Acute Pancreatitis
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.
Detailed Summary:
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 seve
Sponsor: Helsinki University Central Hospital
Current Primary Outcome: Development of pancreatic exocrine insufficiency after first attack of moderately severe or severe acute pancreatitis confirmed by fecal elastase-1 test. [ Time Frame: One year after discharging from hospital ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Persistence of pancreatic exocrine insufficiency after first attack of moderately severe or severe acute pancreatitis [ Time Frame: 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 [ Time Frame: One year after discharging from hospital ]
Original Secondary Outcome: Same as current
Information By: Helsinki University Central Hospital
Dates:
Date Received: September 27, 2015
Date Started: September 2015
Date Completion: December 2018
Last Updated: January 13, 2017
Last Verified: January 2017
