Acute Pancreatitis (AP)NCT07643961
Outpatient Versus Inpatient Management of Mild Acute Pancreatitis
A study testing Outpatient Management (Group A) and Standard Inpatient Management (Group B) in people with Acute Pancreatitis (AP) and Biliary Pancreatitis, run by Center for Traumatology and Major Burns, Ben Arous at 1 site in Tunisia.
Trial summary
Acute pancreatitis is a sudden inflammation of the pancreas that causes severe abdominal pain. Most cases are mild and get better within a few days with basic supportive treatment such as fluids and pain relief. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pancreatitis (AP), Biliary Pancreatitis
- What is being tested?
- Outpatient Management (Group A) and Standard Inpatient Management (Group B)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Jul 2026to 31 Mar 2027
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older Diagnosis of acute pancreatitis based on at least two of three revised Atlanta (2012) criteria: characteristic abdominal pain; serum lipase or amylase ≥3× upper limit of normal; or characteristic imaging findings Classification as mild acute pancreatitis: SIRS score = 0 and HAPS score = 0 at emergency department presentation Ability to tolerate oral intake at the time of randomisation Provision of written informed consent Presence of a competent caregiver at home Residence within 30-45 minutes' travel time from the hospital Ability to communicate by telephone
Who cannot join
- Pregnancy or breastfeeding Inability to maintain oral intake for reasons unrelated to acute pancreatitis Acute pancreatitis attributable to tumour, post-ERCP intervention, or abdominal trauma Concurrent choledocholithiasis with or without cholangitis Chronic pancreatitis or history of recurrent acute pancreatitis (≥2 prior episodes) ASA physical status classification ≥ 3 Clinical or radiological features suggesting moderately severe or severe acute pancreatitis Alcohol withdrawal syndrome No competent caregiver at home Residence more than 30-45 minutes from the hospital Inability to communicate by telephone or equivalent means
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tunisia1 site
Traumatology and great burns center
Ben Arous, Tunisia, 2074
Imen Ben Ismail, 26196121434, imen.benismail@fmt.utm.tn
About this study
Official title: Outpatient Versus Inpatient Management of Mild Acute Pancreatitis: A Randomised Controlled Non-Inferiority Trial
Acute pancreatitis is a sudden inflammation of the pancreas that causes severe abdominal pain. Most cases are mild and get better within a few days with basic supportive treatment such as fluids and pain relief. Currently, all patients with acute pancreatitis are admitted to hospital, even those with a very low risk of complications. This study will test whether patients with mild acute pancreatitis can be safely sent home with close follow-up (telephone calls on days 1, 2, and 3 after discharge and a clinic visit on day 4) instead of staying in hospital. Patients will be randomly assigned to either home management or standard hospitalization. We will compare the rate of treatment failure at 30 days between the two groups. We expect that home management will be as safe as hospitalization, while being more convenient for patients and less costly for the health system.
Read the detailed description
Acute pancreatitis (AP) is one of the most common gastrointestinal causes of emergency hospital admission worldwide. Approximately 80% of cases are classified as mild according to the revised Atlanta Classification (2012) and resolve without organ failure or local complications within three to five days. Despite this favorable prognosis, current practice mandates universal inpatient admission. Only two small studies have explored outpatient management of mild AP, reporting treatment failure rates of 4-12% in the ambulatory arm; however, neither was prospectively randomized nor adequately powered for non-inferiority.
This trial is a prospective, single-center, open-label, two-arm, parallel-group, randomized controlled non-inferiority trial. Patients presenting with mild AP, confirmed by at least two revised Atlanta (2012) criteria and classified as mild by a SIRS score of 0 and a Harmless Acute Pancreatitis Score (HAPS) of 0, will be randomly allocated in a 1:1 ratio to outpatient management (Group A) or standard inpatient care (Group B). Randomization will use a table of random numbers with a block size of four. Group A patients will receive an initial 4-6 hour supervised observation period in the emergency department, followed by daily teleconsultation on days 1-3 and an in-person clinic visit on day 4. Group B patients will be admitted to hospital per standard institutional protocol. All patients will receive IAP/APA-compliant supportive care and a final 30-day outcome assessment. The primary endpoint is the 30-day treatment failure rate. Non-inferiority will be declared if the upper bound of the one-sided 95% confidence interval for the between-group difference does not exceed 10%.
- Conditions
- Acute Pancreatitis (AP), Biliary Pancreatitis
- Being tested
- Outpatient Management (Group A), Standard Inpatient Management (Group B)
- Keywords
- acute pancreatitis, outpatient, ambulatory, non-inferiority, randomised controlled trial, HAPS, SIRS
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outpatient Management (Group A)Other
Early discharge from the emergency department after 4-6 hours of observation, with structured teleconsultation follow-up on Days 1, 2, and 3, in-person review on Day 4, unrestricted emergency department access, and 30-day outcome assessment.
Standard Inpatient Management (Group B)Other
Conventional ward admission with daily monitoring, intravenous supportive care, and discharge based on clinical improvement.
| Study group | Role | What they receive |
|---|---|---|
| Outpatient Management (Group A) | Experimental | Patients receive a 4-6 hour supervised observation in the emergency department, then are discharged with structured ambulatory follow-up: daily teleconsultation on Days 1, 2, and 3; in-person clinic visit with blood sampling on Day 4; open-access emergency readmission at any time; and a 30-day final consultation. All patients receive IAP/APA-compliant supportive care. Receives: Other: Outpatient Management (Group A) |
| Standard Inpatient Management (Group B) | Active comparator | Patients are admitted to the gastroenterology or surgical ward for conventional inpatient care with daily clinical and biological monitoring, intravenous fluids, analgesia, antiemetics, and early oral refeeding per IAP/APA guidelines. Discharge is determined by clinical improvement and full oral diet tolerance. A 30-day follow-up consultation is arranged at discharge. Receives: Other: Standard Inpatient Management (Group B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Failure Rate at 30 Days
Proportion of patients experiencing at least one of the following: food intolerance (<50% of a standard meal), persistent nausea or vomiting refractory to antiemetics, uncontrolled pain requiring parenteral analgesia or emergency attendance, new-onset SIRS or HAPS deterioration, or (Group A only) any unplanned hospital admission.
Measured: 30 days from randomisation
Secondary outcomes (6)
Recurrence of abdominal pain Assessed by Numeric Rating Scale (NRS)
Recurrence of abdominal pain during the 30-day follow-up period, assessed at each contact point (teleconsultation Days 1, 2, 3; clinic visit Day 4; final visit Day 30) using the Numeric Rating Scale (NRS) from 0 (no pain) to 10 (worst imaginable pain). Recurrence is defined as any new episode of abdominal pain scoring ≥4/10 after an initial pain-free interval following discharge or hospital admission.
Measured: 30 days
SIRS score at 48 hours
Measured: 48 hours
Organ failure Assessed by the Modified Marshall Scoring System
Rate of organ failure occurring within 30 days of randomisation, assessed using the Modified Marshall Scoring System. Organ failure is defined as a score of ≥2 in any of the three organ systems evaluated: respiratory (PaO₂/FiO₂ ratio), renal (serum creatinine), and cardiovascular (systolic blood pressure). Transient organ failure (resolving within 48 hours) and persistent organ failure (lasting >48 hours) will be recorded separately.
Measured: 30 days
Unplanned hospital readmission
Measured: 30 days
ICU admission rate
Measured: 30 days
Patient satisfaction Assessed by the Patient Satisfaction Questionnaire Short Form (PSQ-18)
Patient satisfaction with the allocated management strategy, assessed at the 30-day follow-up visit using the Patient Satisfaction Questionnaire Short Form (PSQ-18), a validated 18-item instrument evaluating satisfaction across seven domains: general satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with doctor, and accessibility. Each item is rated on a 5-point Likert scale (1 = strongly agree to 5 = strongly disagree). Domain scores are transformed to a 0-100 scale, with higher scores indicating greater satisfaction.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Pancreatitis (AP)Studies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center for Traumatology and Major Burns, Ben Arous
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Imen Ben Ismail, Center for Traumatology and Major Burns, Ben Arous
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07643961
- Sponsor's protocol ID
- CTGBA/EC/2025/07-03
- Status last verified
- Jul 2026
- First submitted
- 8 Jun 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Nardiello C, Morty RE. World No Tobacco Day 2020. Am J Physiol Lung Cell Mol Physiol. 2020 May 1;318(5):L1010-L1015. doi: 10.1152/ajplung.00110.2020. Epub 2020 Apr 1. No abstract available.
PubMed 32233793Working Group IAP/APA Acute Pancreatitis Guidelines. IAP/APA evidence-based guidelines for the management of acute pancreatitis. Pancreatology. 2013 Jul-Aug;13(4 Suppl 2):e1-15. doi: 10.1016/j.pan.2013.07.063.
PubMed 24054878Lankisch PG, Weber-Dany B, Hebel K, Maisonneuve P, Lowenfels AB. The harmless acute pancreatitis score: a clinical algorithm for rapid initial stratification of nonsevere disease. Clin Gastroenterol Hepatol. 2009 Jun;7(6):702-5; quiz 607. doi: 10.1016/j.cgh.2009.02.020. Epub 2009 Feb 24.
PubMed 19245846Banks 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 23100216
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient Versus Inpatient Management of Mild Acute Pancreatitis: A Randomised Controlled Non-Inferiority Trial
- ClinicalTrials.gov ID
- NCT07643961
- Acronym / sponsor ID
- CTGBA/EC/2025/07-03
- Conditions
- Acute Pancreatitis (AP), Biliary Pancreatitis
- Keywords
- acute pancreatitis, outpatient, ambulatory, non-inferiority, randomised controlled trial, HAPS, SIRS
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Center for Traumatology and Major Burns, Ben ArousUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 12 Jun 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.
Acute pancreatitis is a sudden inflammation of the pancreas that causes severe abdominal pain. Most cases are mild and get better within a few days with basic supportive treatment such as fluids and pain relief. Currently, all patients with acute pancreatitis are admitted to hospital, even those with a very low risk of complications. This study will test whether patients with mild acute pancreatitis can be safely sent home with close follow-up (telephone calls on days 1, 2, and 3 after discharge and a clinic visit on day 4) instead of staying in hospital. Patients will be randomly assigned to either home management or standard hospitalization. We will compare the rate of treatment failure at 30 days between the two groups. We expect that home management will be as safe as hospitalization, while being more convenient for patients and less costly for the health system.
Detailed description
Acute pancreatitis (AP) is one of the most common gastrointestinal causes of emergency hospital admission worldwide. Approximately 80% of cases are classified as mild according to the revised Atlanta Classification (2012) and resolve without organ failure or local complications within three to five days. Despite this favorable prognosis, current practice mandates universal inpatient admission. Only two small studies have explored outpatient management of mild AP, reporting treatment failure rates of 4-12% in the ambulatory arm; however, neither was prospectively randomized nor adequately powered for non-inferiority.
This trial is a prospective, single-center, open-label, two-arm, parallel-group, randomized controlled non-inferiority trial. Patients presenting with mild AP, confirmed by at least two revised Atlanta (2012) criteria and classified as mild by a SIRS score of 0 and a Harmless Acute Pancreatitis Score (HAPS) of 0, will be randomly allocated in a 1:1 ratio to outpatient management (Group A) or standard inpatient care (Group B). Randomization will use a table of random numbers with a block size of four. Group A patients will receive an initial 4-6 hour supervised observation period in the emergency department, followed by daily teleconsultation on days 1-3 and an in-person clinic visit on day 4. Group B patients will be admitted to hospital per standard institutional protocol. All patients will receive IAP/APA-compliant supportive care and a final 30-day outcome assessment. The primary endpoint is the 30-day treatment failure rate. Non-inferiority will be declared if the upper bound of the one-sided 95% confidence interval for the between-group difference does not exceed 10%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Outpatient Management (Group A) | Experimental | Other: Outpatient Management (Group A)Patients receive a 4-6 hour supervised observation in the emergency department, then are discharged with structured ambulatory follow-up: daily teleconsultation on Days 1, 2, and 3; in-person clinic visit with blood sampling on Day 4; open-access emergency readmission at any time; and a 30-day final consultation. All patients receive IAP/APA-compliant supportive care. |
| Standard Inpatient Management (Group B) | Active comparator | Other: Standard Inpatient Management (Group B)Patients are admitted to the gastroenterology or surgical ward for conventional inpatient care with daily clinical and biological monitoring, intravenous fluids, analgesia, antiemetics, and early oral refeeding per IAP/APA guidelines. Discharge is determined by clinical improvement and full oral diet tolerance. A 30-day follow-up consultation is arranged at discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18 years or older Diagnosis of acute pancreatitis based on at least two of three revised Atlanta (2012) criteria: characteristic abdominal pain; serum lipase or amylase ≥3× upper limit of normal; or characteristic imaging findings Classification as mild acute pancreatitis: SIRS score = 0 and HAPS score = 0 at emergency department presentation Ability to tolerate oral intake at the time of randomisation Provision of written informed consent Presence of a competent caregiver at home Residence within 30-45 minutes' travel time from the hospital Ability to communicate by telephone
Key exclusion criteria (1 listed)
- Pregnancy or breastfeeding Inability to maintain oral intake for reasons unrelated to acute pancreatitis Acute pancreatitis attributable to tumour, post-ERCP intervention, or abdominal trauma Concurrent choledocholithiasis with or without cholangitis Chronic pancreatitis or history of recurrent acute pancreatitis (≥2 prior episodes) ASA physical status classification ≥ 3 Clinical or radiological features suggesting moderately severe or severe acute pancreatitis Alcohol withdrawal syndrome No competent caregiver at home Residence more than 30-45 minutes from the hospital Inability to communicate by telephone or equivalent means
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 |
|---|---|---|
| Outpatient Management (Group A)Early discharge from the emergency department after 4-6 hours of observation, with structured teleconsultation follow-up on Days 1, 2, and 3, in-person review on Day 4, unrestricted emergency department access, and 30-day outcome assessment. | Other | Outpatient Management (Group A) |
| Standard Inpatient Management (Group B)Conventional ward admission with daily monitoring, intravenous supportive care, and discharge based on clinical improvement. | Other | Standard Inpatient Management (Group B) |
Primary outcome
Treatment Failure Rate at 30 Days
Time frame: 30 days from randomisation
Proportion of patients experiencing at least one of the following: food intolerance (<50% of a standard meal), persistent nausea or vomiting refractory to antiemetics, uncontrolled pain requiring parenteral analgesia or emergency attendance, new-onset SIRS or HAPS deterioration, or (Group A only) any unplanned hospital admission.
6 secondary outcomes
Recurrence of abdominal pain Assessed by Numeric Rating Scale (NRS)
Time frame: 30 days
SIRS score at 48 hours
Time frame: 48 hours
Organ failure Assessed by the Modified Marshall Scoring System
Time frame: 30 days
Unplanned hospital readmission
Time frame: 30 days
ICU admission rate
Time frame: 30 days
Patient satisfaction Assessed by the Patient Satisfaction Questionnaire Short Form (PSQ-18)
Time frame: 30 days
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 10 Jul 2026.
- Results publication: PubMed 32233793Nardiello C, Morty RE. World No Tobacco Day 2020. Am J Physiol Lung Cell Mol Physiol. 2020 May 1;318(5):L1010-L1015. doi: 10.1152/ajplung.00110.2020. Epub 2020 Apr 1. No abstract available.
- Results publication: PubMed 24054878Working Group IAP/APA Acute Pancreatitis Guidelines. IAP/APA evidence-based guidelines for the management of acute pancreatitis. Pancreatology. 2013 Jul-Aug;13(4 Suppl 2):e1-15. doi: 10.1016/j.pan.2013.07.063.
- Results publication: PubMed 19245846Lankisch PG, Weber-Dany B, Hebel K, Maisonneuve P, Lowenfels AB. The harmless acute pancreatitis score: a clinical algorithm for rapid initial stratification of nonsevere disease. Clin Gastroenterol Hepatol. 2009 Jun;7(6):702-5; quiz 607. doi: 10.1016/j.cgh.2009.02.020. Epub 2009 Feb 24.
- Results publication: 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.
- Individual participant dataSharing planned: Undecided
Related trials for Acute Pancreatitis (AP)
Not yet recruiting
Cold Water Papillary Irrigation Plus Rectal NSAIDs vs Rectal NSAIDs Alone for Post-ERCP Pancreatitis (COLD)
Post ERCP Pancreatitis, Acute Pancreatitis (AP)
Not yet recruitingPhase 4
Varenicline for Smoking Cessation in Pancreatitis
Pancreatitis, Chronic Pancreatitis
RecruitingObservational study
iMmune SignAtures and Clinical outComes in AP
Acute Pancreatitis
RecruitingObservational study
ENDoscopic Assessment in Acute PANcreatitis Study (ENDOPAN Study)
Acute Pancreatitis (AP)
Not yet recruiting
A Trial of the Arctx Cool Catheter in Acute Pancreatitis
Acute Pancreatitis (AP)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Outpatient Management (Group A) and Standard Inpatient Management (Group B) in people with Acute Pancreatitis (AP) and Biliary Pancreatitis, run by Center for Traumatology and Major Burns, Ben Arous at 1 site in Tunisia.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Imen Ben Ismail, M.D (+21696121434, imen.benismail@fmt.utm.tn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Failure Rate at 30 Days (time frame: 30 days from randomisation). 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 NCT07643961, which also lists 4 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 10 Jul 2026.