NCT03829085: PADI

Study of the Diet in Patients With the Diagnostic of Acute Pancreatitis

Completed NA Last updated 5 February 2019

What this trial tests

NA trial testing EARLY ORAL REFEEDING in Pancreatitis, Acute in 120 participants. Completed in 31 December 2018.

Timeline

1 June 2017

Primary endpoint
31 December 2018

31 December 2018

Quick facts

Lead sponsor	Consorci Sanitari del Garraf
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	120
Start date	1 June 2017
Primary completion	31 December 2018
Estimated completion	31 December 2018
Sites	1 location across Spain

Drugs / interventions tested

• EARLY ORAL REFEEDING

Conditions studied

• Pancreatitis, Acute — all drugs for Pancreatitis, Acute →

Sponsor

Consorci Sanitari del Garraf

Who can join

Adults 18 to 95, any sex, with Pancreatitis, Acute. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Acute pancreatitis (AP) is a common condition in emergency services worldwide. Approximately 85% of AP are mild and the patients usually recover within 1 to 2 weeks, not requeiring any critical care and organ support. The management of mild AP conventionally involves fasting, intravenous hydration and adequate analgesia until pain improves in order to prevent stimulation and allow the pancreas gland to rest.

The current guidelines recommend the oral food intake should be tried as soon as possible, and beneficial effects or early enteral nutrition with mild AP have been reported in literature.

Then, early oral refeeding (EORF) after mild and moderate AP is beneficial, but the optimal timing and starting criteria are unclear. Even now, refeeding after mild and moderate AP is typically started until clinical symptoms have resolved and pancreatic enzymes are decreasing, in a successively increasing manner. The aim of this study is to evaluate length of hospital stay, clinical findings and complications for EORF with immediately full caloric intake in patients with mild and moderate AP.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Immediate Oral Refeeding in Patients With Mild and Moderate Acute Pancreatitis: A Multicenter, Randomized Controlled Trial (PADI trial).
   Ramírez-Maldonado E, López Gordo S, Pueyo EM, Sánchez-García A, et al · · 2021 · cited 37× · PMID 33196485 · DOI 10.1097/sla.0000000000004596
2. Response to Comment by Dr. Kuang on Our Manuscript "Immediate Oral Refeeding in Patients With Mild and Moderate Acute Pancreatitis: A Multicenter, Randomized Controlled Trial (PADI trial)".
   Ramírez-Maldonado E, López Gordo S, Memba R, Jorba R. · · 2024 · PMID 39310339 · DOI 10.1097/as9.0000000000000472