Health TrialsbyHealthPanel

PERT in Acute Necrotizing Pancreatitis

ConditionsAcute Pancreatitis NecrotizingNutrition Assessment
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-60
SponsorAsian Institute of Gastroenterology, India

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Underlying chronic pancreatitis

Recurrent acute pancreatitis

Pancreatic cancer

Patients being discharged with NJ tubes

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pancreatic Enzyme Replacement Therapy

    Drug

    Enteric coated pancreatic enzyme preparation

  • Placebo

    Drug

    Similar appearing glucose capsules

Treatment groups

188 Participants
are divided into 2 treatment groups
Group A: PERTExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Body Mass Index (BMI)

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.

Time frame
3 months

Secondary outcomes

1

1. Change in Quality of Life

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.

Time frame
3 months
2

Change in pancreatic exocrine function

Exocrine function will be assessed by the Fecal elastase test.

Time frame
3 months
3

Change in nutritional status: Anthropometry

Skin fold thickness over the triceps muscle at the mid arm level.

Time frame
3 months
4

Change in nutritional status: Anthropometry

Mid-arm circumference

Time frame
3 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Asian Institute of Gastroenterology, India

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: