PERT in Acute Necrotizing Pancreatitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

188 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-01

Study Completion Date

2027-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acute Pancreatitis Necrotizing Nutrition Assessment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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PERT

Enteric coated enzyme preparation containing: Lipase 25000U, Amylase 18000U, Protease 1000U. These medications are to be taken thrice daily with food (Breakfast, lunch and dinner)

Group Type EXPERIMENTAL

Pancreatic Enzyme Replacement Therapy

Intervention Type DRUG

Enteric coated pancreatic enzyme preparation

Placebo

Similar appearing glucose capsules will be provided three times a day along with food (breakfast, lunch and dinner)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Similar appearing glucose capsules

Interventions

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Pancreatic Enzyme Replacement Therapy

Enteric coated pancreatic enzyme preparation

Intervention Type DRUG

Placebo

Similar appearing glucose capsules

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No