Pancreatic Enzyme Replacement in Acute Necrotizing Pancreatitis

ConditionsAcute Necrotizing Pancreatitis Pancreatic Exocrine Insufficiency

Trial statusRecruiting

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, the investigators propose to evaluate the impact of pancreatic exocrine replacement therapy on patients with acute necrotizing pancreatitis (ANP). The investigators will include patients of 18-60yrs age and both genders with \>50% pancreatic parenchymal necrosis and at least 5% loss of body weight.

The primary outcome measure is percent change in body weight 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 more than 50% pancreatic parenchymal necrosis and at least 5% loss of pre pancreatitis body weight at the time of screening

Within 6 weeks of onset of disease

Able to take food orally

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 capsules
Drug
Enteric coated pancreatic enzyme
Placebo
Drug
Similar appearing glucose capsules

Treatment groups

140 Participants

are divided into 2 treatment groups

Group A: Enteric coated enzyme preparation containing: Lipase 25000U, Amylase 18000U, Protease 1000U. These mExperimental treatment 1 intervention

Group B: Similar appearing glucose capsules will be provided three times a day along with foodPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Percent change in body weight

Body weight (in kg) will be measured at baseline and again at 3 months follow-up, and the difference between the two time points will be used to assess the effect of the intervention on patients' weight status. The change will be expressed as percent change of weight 3 months compared to baseline weight.

Time frame

3 months

Secondary outcomes

Change in quality of life

Quality of life will be assessed by the Short Form (SF)-36 tool. This is a standardised and validated questionnaire based scoring tool that contains 36 questions dealing with 8 domains of quality of life. 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

Change in pancreatic exocrine function

Exocrine function will be assessed by the Fecal elastase test and will be expressed as microgram of elastase per gram of stool. Higher value indicates better exocrine function. The cut-off value that will be used is 200mcg/gm elastase, below which exocrine insufficiency will be considered to be present.

Time frame

3 months

Change in nutritional status: Subjective Global Assesment (SGA)

This is a semiquantitative questionnaire based nutritional assessment tool which classifies the nutritional status as SGA A (normal nutrition), SGA B (mild/moderate malnutrition) and SGC C (severe malnutrition)

Time frame

3 months

Change in nuritional status: Anthropometry

Skin fold thickness (in mm) over the triceps muscle at the mid arm level.

Time frame

3 months

Other outcomes

Change in body composition (Bioimpedence analysis): Body fat mass (kg)

Total body fat will be assessed using Bioimpedence analysis (BIA) This is a non-invasive method that operates by sending a low-level, imperceptible electrical current through the body. The normal range is 10-20kg.

Time frame

3 months

Change in body composition (Bioimpedence analysis): Skeletal muscle mass (kg)

Skeletal muscle mass will be assessed using Bioimpedence analysis (BIA) This is a non-invasive method that operates by sending a low-level, imperceptible electrical current through the body.

Time frame

3 months

Change in body composition (Bioimpedence analysis): Total body water (litres)

Total body water will be quantified using Bioimpedence analysis (BIA) This is a non-invasive method that operates by sending a low-level, imperceptible electrical current through the body.

Time frame

3 months

Change in body composition (Bioimpedence analysis): Phase angle at 50kH (degrees)

Cell membrane integrity will be assessed using the phase angle function of Bioimpedence analysis (BIA) This is a non-invasive method that operates by sending a low-level, imperceptible electrical current through the body.

Time frame

3 months

Sponsors and contacts

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

Asian Institute of Gastroenterology, India

Lead sponsor

Source ClinicalTrials.gov

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