Acute Necrotizing PancreatitisPhase 3PERiANPNCT07441824
Pancreatic Enzyme Replacement in Acute Necrotizing Pancreatitis
A Phase 3 study testing Pancreatic enzyme capsules in people with Acute Necrotizing Pancreatitis and Pancreatic Exocrine Insufficiency, run by Asian Institute of Gastroenterology, India at 4 sites in India.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acute Necrotizing Pancreatitis, Pancreatic Exocrine Insufficiency
- What is being tested?
- Pancreatic enzyme capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 4 sitesIndia
- Study dates
- 10 Apr 2026to Jun 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
- Age 18-60 years
- Both genders
Who cannot join
- Underlying chronic pancreatitis
- Recurrent acute pancreatitis
- Pancreatic cancer
- Patients being discharged with NJ tubes
- Pregnancy and lactation
- Inability to give informed consent.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
India4 sites, 4 recruiting
- Recruiting
Gauhati Medical College
Guwahati, Assam, 781032
Mallika Bhattacharyya, MD, +918135848141, mallikabhattacharyya@gmail.com
- Recruiting
Asian Institute of Gastroenterology Hospitals, Gachibowli
Hyderabad, Telangana, 500032
Rupjyoti Talukdar, MD, +917032804231, rup_talukdar@yahoo.com
- Recruiting
Asian Institute of Gastroenterology, Banjara Hills
Hyderabad, Telangana, 500082
Jahangeer Basha, DM, 9000199577, dr.jahangeer@aighospitals.com
- Recruiting
ILS Hospital, Dum Dum
Kolkata, West Bengal, 700080
Sanjay Banerjee, DM, +919830129866, drsanjaygastro@gmail.com
About this study
Official title: Effect of Pancreatic Enzyme Replacement Therapy in Patients With Acute Necrotizing Pancreatitis: A Multicenter Double Blinded Randomised Placebo Controlled 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.
Read the 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 complications.
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 necrosectomy.
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 deficiencies. The risk of PEI after ANP is about 25% over 3 years. According to two meta-analysis, 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, the investigators 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, 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.
- Being tested
- Pancreatic enzyme capsules, Placebo
- Keywords
- acute pancreatitis, pancrearic exocrine insufficiency, pancreatic enzyme replacement therapy
- Medical subject headings
- Pancreatitis, Acute Necrotizing, Exocrine Pancreatic Insufficiency, Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pancreatic enzyme capsulesDrug
Enteric coated pancreatic enzyme
PlaceboDrug
Similar appearing glucose capsules
| Study group | Role | What they receive |
|---|---|---|
| Enteric coated enzyme preparation containing: Lipase 25000U, Amylase 18000U, Protease 1000U. These m | Experimental | Not described Receives: Drug: Pancreatic enzyme capsules |
| Similar appearing glucose capsules will be provided three times a day along with food | Placebo comparator | Drug: Placebo Similar appearing glucose capsules Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (16)
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.
Measured: 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.
Measured: 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)
Measured: 3 months
Change in nuritional status: Anthropometry
Skin fold thickness (in mm) over the triceps muscle at the mid arm level.
Measured: 3 months
Change in nutritional change: Anthropometry
Mid-arm circumference (MAC) in cm.
Measured: 3 months
Change in nutritional status: Anthropometry
Mid-upper arm muscle circumference (MAMC) in cm.
Measured: 3 months
Change in nutritional status: Anthropomentry
Mid-arm muscle area (MAMA) in cm square.
Measured: 3 months
Change in nutritional status: Biochemical assessment
Hemoglobin in gm/dL
Measured: 3 months
Change in nutritional status: Biochemical assessment
Serum prealbumin in mg/dL
Measured: 3 months
Change in nutritional status: Biochemical assessment
Vitamin D
Measured: 3 months
Change in nutritional status: Biochemical assessment
Vitamin B12
Measured: 3 months
Change in the endocrine status
Fasting blood glucose (FBS)
Measured: 3 months
Change in the endocrine status
HbA1c
Measured: 3 months
Change in the endocrine status
Stimulated C-peptide
Measured: 3 months
Change in patient's impression of change after treatment
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
Measured: 3 months
Readmission after onset of treatment
Readmission to hospital
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start10 Apr 2026
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute Necrotizing PancreatitisStudies of the same condition, open and under way.
- More trials run by Asian Institute of Gastroenterology, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rupjyoti Talukdar, Asian Institute of Gastroenterology, India
- Investigators
- Rupjyoti Talukdar, MD, Study director, Asian Institute of Gastroenterology Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07441824
- Sponsor's protocol ID
- PERiANP
- Acronym
- PERiANP
- Status last verified
- Apr 2026
- First submitted
- 15 Feb 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wang GJ, Gao CF, Wei D, Wang C, Ding SQ. Acute pancreatitis: etiology and common pathogenesis. World J Gastroenterol. 2009 Mar 28;15(12):1427-30. doi: 10.3748/wjg.15.1427.
PubMed 19322914Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25.
PubMed 23100216Lee PJ, Papachristou GI. New insights into acute pancreatitis. Nat Rev Gastroenterol Hepatol. 2019 Aug;16(8):479-496. doi: 10.1038/s41575-019-0158-2.
PubMed 31138897Umapathy C, Raina A, Saligram S, Tang G, Papachristou GI, Rabinovitz M, Chennat J, Zeh H, Zureikat AH, Hogg ME, Lee KK, Saul MI, Whitcomb DC, Slivka A, Yadav D. Natural History After Acute Necrotizing Pancreatitis: a Large US Tertiary Care Experience. J Gastrointest Surg. 2016 Nov;20(11):1844-1853. doi: 10.1007/s11605-016-3264-2. Epub 2016 Sep 12.
PubMed 27619808Huang W, de la Iglesia-Garcia D, Baston-Rey I, Calvino-Suarez C, Larino-Noia J, Iglesias-Garcia J, Shi N, Zhang X, Cai W, Deng L, Moore D, Singh VK, Xia Q, Windsor JA, Dominguez-Munoz JE, Sutton R. Exocrine Pancreatic Insufficiency Following Acute Pancreatitis: Systematic Review and Meta-Analysis. Dig Dis Sci. 2019 Jul;64(7):1985-2005. doi: 10.1007/s10620-019-05568-9. Epub 2019 Jun 4.
PubMed 31161524
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pancreatic Enzyme Replacement Therapy in Patients With Acute Necrotizing Pancreatitis: A Multicenter Double Blinded Randomised Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT07441824
- Acronym / sponsor ID
- PERiANP / PERiANP
- Keywords
- acute pancreatitis, pancrearic exocrine insufficiency, pancreatic enzyme replacement therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 10 Apr 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 complications.
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 necrosectomy.
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 deficiencies. The risk of PEI after ANP is about 25% over 3 years. According to two meta-analysis, 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, the investigators 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, 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enteric coated enzyme preparation containing: Lipase 25000U, Amylase 18000U, Protease 1000U. These m | Experimental | Drug: Pancreatic enzyme capsules |
| Similar appearing glucose capsules will be provided three times a day along with food | Placebo comparator | Drug: PlaceboDrug: Placebo Similar appearing glucose capsules |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
- Age 18-60 years
Key exclusion criteria (6 listed)
- Underlying chronic pancreatitis
- Recurrent acute pancreatitis
- Pancreatic cancer
- Patients being discharged with NJ tubes
- Pregnancy and lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pancreatic enzyme capsulesEnteric coated pancreatic enzyme | Drug | Enteric coated enzyme preparation containing: Lipase 25000U, Amylase 18000U, Protease 1000U. These m |
| PlaceboSimilar appearing glucose capsules | Drug | Similar appearing glucose capsules will be provided three times a day along with food |
Primary outcome
Percent change in body weight
Time frame: 3 months
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.
16 secondary outcomes
Change in quality of life
Time frame: 3 months
Change in pancreatic exocrine function
Time frame: 3 months
Change in nutritional status: Subjective Global Assesment (SGA)
Time frame: 3 months
Change in nuritional status: Anthropometry
Time frame: 3 months
Change in nutritional change: Anthropometry
Time frame: 3 months
Change in nutritional status: Anthropometry
Time frame: 3 months
Change in nutritional status: Anthropomentry
Time frame: 3 months
Change in nutritional status: Biochemical assessment
Time frame: 3 months
Change in nutritional status: Biochemical assessment
Time frame: 3 months
Change in nutritional status: Biochemical assessment
Time frame: 3 months
Change in nutritional status: Biochemical assessment
Time frame: 3 months
Change in the endocrine status
Time frame: 3 months
Change in the endocrine status
Time frame: 3 months
Change in the endocrine status
Time frame: 3 months
Change in patient's impression of change after treatment
Time frame: 3 months
Readmission after onset of treatment
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Background: PubMed 19322914Wang GJ, Gao CF, Wei D, Wang C, Ding SQ. Acute pancreatitis: etiology and common pathogenesis. World J Gastroenterol. 2009 Mar 28;15(12):1427-30. doi: 10.3748/wjg.15.1427.
- Background: PubMed 23100216Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25.
- Background: PubMed 31138897Lee PJ, Papachristou GI. New insights into acute pancreatitis. Nat Rev Gastroenterol Hepatol. 2019 Aug;16(8):479-496. doi: 10.1038/s41575-019-0158-2.
- Background: PubMed 27619808Umapathy C, Raina A, Saligram S, Tang G, Papachristou GI, Rabinovitz M, Chennat J, Zeh H, Zureikat AH, Hogg ME, Lee KK, Saul MI, Whitcomb DC, Slivka A, Yadav D. Natural History After Acute Necrotizing Pancreatitis: a Large US Tertiary Care Experience. J Gastrointest Surg. 2016 Nov;20(11):1844-1853. doi: 10.1007/s11605-016-3264-2. Epub 2016 Sep 12.
- Background: PubMed 31161524Huang W, de la Iglesia-Garcia D, Baston-Rey I, Calvino-Suarez C, Larino-Noia J, Iglesias-Garcia J, Shi N, Zhang X, Cai W, Deng L, Moore D, Singh VK, Xia Q, Windsor JA, Dominguez-Munoz JE, Sutton R. Exocrine Pancreatic Insufficiency Following Acute Pancreatitis: Systematic Review and Meta-Analysis. Dig Dis Sci. 2019 Jul;64(7):1985-2005. doi: 10.1007/s10620-019-05568-9. Epub 2019 Jun 4.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rupjyoti Talukdar, MD study director
Asian Institute of Gastroenterology Hospitals
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pancreatic enzyme capsules in people with Acute Necrotizing Pancreatitis and Pancreatic Exocrine Insufficiency, run by Asian Institute of Gastroenterology, India at 4 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abdul Rasheed, PharmD (+919652104726, abdulrasheedmd1223@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in body weight (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07441824, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.