Acute Pancreatitis Necrotizing, Nutrition Assessment
Conditions
Keywords
Nutrition in AP, PERT in AP, pancreatic exocrine insufficiency
Brief summary
In this multicenter, double blinded, placebo-controlled, 1:1 parallel group RCT, we propose to evaluate the impact of pancreatic exocrine replacement therapy on patients with acute necrotizing pancreatitis (ANP). We will include patients of 18-60yrs age and both genders with \>50% pancreatic parenchymal necrosis and \>10% loss of body weight. The primary outcome measure is change in BMI at 3 months after enrolment. The intervention will include pancreatic enzyme consisting of 25000 IU of lipase and similar appearing placebo.
Detailed description
Acute pancreatitis (AP), an inflammatory disorder of the pancreas, is mild and self-limiting in most patients. Around 10-20% of AP patients develop acute necrotizing pancreatitis (ANP) which is characterized by destruction of both pancreatic and peripancreatic tissue and is associated with high rate of morbidity and mortality due to both local and systemic complications1,2,3. Early recognition and close monitoring of affected patients is crucial. Treatment consists of goal-directed intravenous fluid resuscitation, pain control, and enteral nutrition as early as possible. While sterile necrosis might resolve with above conservative measures, infected necrosis requires antibiotics and further interventions such as percutaneous drainage, minimally invasive surgeries, and endoscopic necrosectomy4. In ANP patients there is direct destruction of acinar tissue that results in pancreatic exocrine insufficiency (PEI). In PEI there is insufficient secretion of pancreatic enzymes that causes inadequate nutrient digestion and absorption resulting in weight loss, malnutrition, metabolic bone disease and fat-soluble vitamins and mineral deficiencies5. The risk of PEI after ANP is about 25% over 3 years6. According to two meta-analysis5,7, PEI was found to be more prevalent during the index AP episode and it remained persistent in about half of the study population at follow-ups. They also reported that the risk of developing PEI is more in those with alcoholic etiology and severe and necrotizing pancreatitis. Hence, management of PEI following ANP is important to improve nutritional status and quality of life. Pancreatic enzyme replacement therapy (PERT) is the mainstay of treatment for PEI. While the use of PERT is well-established in chronic pancreatitis, its efficacy in patients with ANP is still unclear. Hence, in this study, we aim to provide insights into the potential benefits of enzyme supplementation in patients with ANP by evaluating nutritional status, clinical outcomes, and quality of life. This is a multicenter, double blinded, placebo-controlled, 1:1 parallel group RCT, we propose to evaluate the impact of pancreatic exocrine replacement therapy on patients with acute necrotizing pancreatitis (ANP). We will include patients of 18-60yrs age and both genders with \>50% pancreatic parenchymal necrosis and \>10% loss of body weight. The primary outcome measure is change in BMI at 3 months after enrolment. The intervention will include pancreatic enzyme consisting of 25000 IU of lipase and similar appearing placebo.
Interventions
Enteric coated pancreatic enzyme preparation
DRUGPlacebo
Similar appearing glucose capsules
Sponsors
Asian Institute of Gastroenterology, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed with AP according to the Revised Atlanta Classification diagnostic criteria * Index episode of acute pancreatitis with at least 50% pancreatic parenchymal necrosis and greater than at least 10% loss of pre pancreatitis body weight at the time of screening * Within 28 days of onset of disease * Age 18-60 years * Both genders
Exclusion criteria
* Underlying chronic pancreatitis * Recurrent acute pancreatitis * Pancreatic cancer * Patients being discharged with NJ tubes * Pregnancy and lactation * Inability to give informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Mass Index (BMI) | 3 months | BMI will be measured at baseline and again at 3 months follow-up, with the difference between the two time points used to assess the effect of the intervention on patients' weight status. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in pancreatic exocrine function | 3 months | Exocrine function will be assessed by the Fecal elastase test. |
| Change in nutritional status: Anthropometry | 3 months | Skin fold thickness over the triceps muscle at the mid arm level. |
| Change in nutritional status: Biochemical assessment | 3 months | Serum prealbumin levels (gm/dL) |
| 1. Change in Quality of Life | 3 months | Quality of life will be assessed by the Short Form (SF)-36 tool. The lowest score in this tool is 0 and the highest score is 100, a higher score indicating better quality of life. |
| Change in patient's impression of change after treatment | 3 months | This will be evaluated using the Patient's Global Impression of Change (PGIC). The score ranges from 1-7, with a score of 1 indicating very much improved and 7 indicating very much worse. |
| Readmission after onset of treatment | 3 months | Readmission to hospital |
| Change in the endocrine status | 3 months | HbA1c and C-peptide |
Contacts
Primary ContactAbdul Rasheed, PharmD
Backup ContactRupjyoti Talukdar, MD
Outcome results
None listed