Acute PAncreatitis and Home Care vs. Hospital Admission Study

Acute Pancreatitis Clinical Trial

— PADI_2  

Official title:

Randomized Multicenter Prospective Clinical Trial to Compare the Effectiveness of Home Care vs Hospital Admission in Patients With Acute Pancreatitis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05360797
• Other study ID #: PADI_2
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: July 31, 2024

Study information

• Verified date: April 2022
• Source: Hospital Universitari Joan XXIII de Tarragona.
• Contact: Elena Ramírez-Maldonado, PhD
• Phone: 977295800
• Email: padibarcelona[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Acute pancreatitis (AP) is one of the most common reason for hospitalization among gastrointestinal diseases in U.S.. The costs caused by severe AP are higher than mild AP. Nevertheless, approximately 70% of hospital admissions for AP are mild cases, if health cost saving is to be realized, it would be by lowering the cost of managing patients with mild AP without affecting patient's safety and satisfaction.

With the PADI-1 study, where it was possible to confirm the benefits of an early diet, the rapid recovery of patients with mild AP and the reduction of hospital costs, now a new scope is to be given in the treatment of patients with this pathology.

Considering the application of predictive factors of AP severity, and being sure of diagnosing mild AP, a study of home care versus hospitalization for patients with mild AP is proposed. Based on the hypothesis that outpatient care of mild AP patients would be as sage and affective as hospitalization, the aim this study is to campare the results of 3 different strategies of treatment of patients with AP mild. Additionally, satisfaction patient and costs will be analyzed.

Description:

This is prospective, randomized, controlled, multicentre trial.

OBJECTIVES

Primary objective Compare the results of 3 different strategies for the management of patients with mild acute pancreatitis (AP) and to analyze differences in satisfaction patients and economic costs.

METHODS

Patients with mild AP will be randomly in three groups: group A: outpatient treatment, group B: medical home care and group C: hospitalization.

The primary and several secondary endpoints will be obtained:

1. Treatment failure rate (the primary endpoint).

2. Serum amylase, lipase, electrolytes, BUN (blood urea nitrogen), creatinine, liver function tests, and full blood count at hospital admission, 24 hours and 72 hours.

3. Relapse pain.

4. Diet intolerance.

5. Systemic complications including hemodynamic instability, renal failure, intensive care admission, surgery, radiological and endoscopic procedures.

6. Pain and Analgesic requirement.

7. Local complications including pancreatic necrosis, abscess, pseudocyst.

8. Health costs

9. Patient satisfaction

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 225
• Est. completion date: July 31, 2024
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Diagnosed of AP by at least two of these three criteria: compatible abdominal pain, amylase or lipase level superior in three-fold respective laboratory baseline levels, and suitable findings in imaging techniques (CT, ultrasound or MRI).

2. age > 18 years, sign consent form.

Exclusion Criteria:

1. pregnant o breastfeeding women.

2. abdominal pain lasting >96 horas before admission.

3. the possibility of poor oral intake for reasons other than AP.

4. Pancreatic neoplasm, endoscopic retrograde cholangiopancreatography or trauma etiology, biliar obstruction.

5. Chronic pancreatitis.

6. ASA =3.

7. Randomization lesser the 24 hours after randomization.

Related Conditions & MeSH terms

• Acute Pancreatitis
• Home Care
• Pancreatitis

Intervention

Other:
• Outpatient
After a 24-hour stay in the emergency department, the predictive factors of severity evaluation and the diagnosis of mild acute pancreatitis is confirmed, the patient is discharged and contacted daily for 4 consecutive days by the study investigators in each center.
• Medical home care
After a 24-hour stay in the emergency department, the predictive factors of severity evaluation and the diagnosis of mild acute pancreatitis is confirmed, the patient is discharged and contacted daily for 4 consecutive days by the medical home care department in each center.
• Hospitalization
After a 24-hour stay in the emergency department, the predictive factors of severity evaluation and the diagnosis of mild acute pancreatitis is confirmed, the patient is hospitalized with usual treatment (PADI_1) in each center.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Elena Ramírez-Maldonado	Consorci Sanitari del Maresme, Hospital Clinic of Barcelona

References & Publications (7)

Greenberg JA, Hsu J, Bawazeer M, Marshall J, Friedrich JO, Nathens A, Coburn N, May GR, Pearsall E, McLeod RS. Clinical practice guideline: management of acute pancreatitis. Can J Surg. 2016 Apr;59(2):128-40. Review. — View Citation

Ince AT, Senturk H, Singh VK, Yildiz K, Danalioglu A, Cinar A, Uysal O, Kocaman O, Baysal B, Gürakar A. A randomized controlled trial of home monitoring versus hospitalization for mild non-alcoholic acute interstitial pancreatitis: a pilot study. Pancreat — View Citation

Pando E, Alberti P, Mata R, Gomez MJ, Vidal L, Cirera A, Dopazo C, Blanco L, Gomez C, Caralt M, Balsells J, Charco R. Early Changes in Blood Urea Nitrogen (BUN) Can Predict Mortality in Acute Pancreatitis: Comparative Study between BISAP Score, APACHE-II, — View Citation

Ramírez-Maldonado E, López Gordo S, Pueyo EM, Sánchez-García A, Mayol S, González S, Elvira J, Memba R, Fondevila C, Jorba R. Immediate Oral Refeeding in Patients With Mild and Moderate Acute Pancreatitis: A Multicenter, Randomized Controlled Trial (PADI — View Citation

Tenner S, Baillie J, DeWitt J, Vege SS; American College of Gastroenterology. American College of Gastroenterology guideline: management of acute pancreatitis. Am J Gastroenterol. 2013 Sep;108(9):1400-15; 1416. doi: 10.1038/ajg.2013.218. Epub 2013 Jul 30. — View Citation

Working 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. — View Citation

Yokoe M, Takada T, Mayumi T, Yoshida M, Isaji S, Wada K, Itoi T, Sata N, Gabata T, Igarashi H, Kataoka K, Hirota M, Kadoya M, Kitamura N, Kimura Y, Kiriyama S, Shirai K, Hattori T, Takeda K, Takeyama Y, Hirota M, Sekimoto M, Shikata S, Arata S, Hirata K. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The treatment failure rate	Treatment failure is defined as persistence, increase or recurrence of abdominal pain, and or intolerance diet, hospital admission, and mortality	30 days
Secondary	Relapse of abdominal pain	Pain Scale: 0=No pain, 1=Very mild, 2=Discomforting, 3=Tolerable, 4=Distressing, 5=Distressing, 6=Intense pain, 7=Very intense pain, 8=Horrible pain, 9=Excruciating, 10=Unimaginable pain	30 days
Secondary	Diet tolerance	Patient can eat at least 50% of the meals	30 days
Secondary	Systemic Inflammatory Response Syndrome (SIRS) Score	SIRS is a simple clinical score, ranging from 0-4, that utilizes objective, routine clinical parameters (body temperature, heart rate, respiratory rate or arterial carbon dioxide tension and white blood count) that directly reflect the underlying inflammatory response. A lower change in SIRS score (negative number) indicates a better outcome (less inflammation).	4 days
Secondary	Number of Participants who Development of Organ Failure	Including respiratory, renal and cardiovascular failures defined as modified Marshal score of equal and greater than 2. The minimum and maximum values in the modified Marshal score for each organ failure range from 0 to 4 with a higher value representing worse outcomes.	4 days
Secondary	Mortality	Enrolled subjects that died. A death indicates a worse outcome.	30 days
Secondary	Hospital admission	The AP patient needs hospital admission due to treatment failure	30 days
Secondary	Satisfaction medical / hospital care	patient satisfaction is asessed comparing management with and without admittance to the hospital. Will be assessed Patient satisfaction feedback (PSF). Scale: Strongly agree, Agree, Not sure, Disagree, Strongly disagree.	30 days
Secondary	Health costs	The costs in euros caused by diagnosis, treatment, stay in the emergency room, complications and follow-up	30 days